Sebuah Pilihan dan Harapan

Pilihan itu ada,,
percaya atau tidak,, qt telah memilih
semua yg telah dipiliha akan menjadi harapan..
harapan baru,,
keinginan baru,,,
kehidupan baru,,,

sepertinya sulit taun ini, tapi taun ini cukup banyak memberi pelajaran bagi q,, skarang bagaimana aku, berjalan kedepan dengan harapan q ini, dengan suatu kepastian yang masih belum terbayang..

tinggal beberapa hari, tunjukkan pada dunia kau bisa, menjadi harapan itu,,, menjadi seseorang yg terbaik.. :-)

from : ana_diah

Pemeriksaan Kualitas Krim

Krim dianggap rusak apabila terganggu sistem campurannya terutama disebabkan oleh perubahan suhu serta perubahan komposisi. Perubahan yang terjadi dikarenakan penambahan salahsatu fase secara berlebihan atau pencampuran dua tipe krim jika zat pengemulsinya tidak tercampurkan satu sama lain ( Anonim, 1979 ).

Pemerikasaan kualitas dari sediaan krim antara lain :

a.Homogenitas
Merupakan perataan fase terdispersi dalam bahan pendispersi, tidak adanya agregasi partikel sekunder, distribusi yang merata dan teratur dari fase terdispersi serta penghalusan parikel primer yang besar. Ukuran partikel menentukan tingkat homogenitas zat aktif, tingkat kerja optimal dan bebas pengganggu ( Voigt, 1984 ).

b.Viskositas
Diartikan sebagai koefisien gesekan aliran dalam (kekentalan)suatu larutan. Didapat dengan menggunakan alat yang disebut viskometer, yaitu viscometer rotasi.Pada viskometer rotasi, sampel yang diukur berada dalam celah cicin diantara dua silinder yang disusun konsentris, dimana salah satu silindernya dapat berputar. Disebabkan oleh kekentalan dibagian dalamnya maka pada silinder sebelah dalam akan dihasilkan momen putar, yang harganya diukur dangan menggunakan sudut putaran sebuah per melingkar. Penyimpangan yang terbaca dan ditunjukkan oleh jarum penunjuk pada sebuah skala, adalah proporsional denga momen putar dan juga dengan tegangan gesera atau tumbukan τ. Operasional viskometer berjalan melaui motor sinkronisasi. Jumlah putaran, yang proporsional dengan perbedaan geseran D, diatur dengan sebuah roda. Pada alat yang dikonstruksikan menurut prinsip SEARL, roda tersebut akan memutar silinder sebelah dalam. Alat dari jenis ini yang dikenal adalah Rotovisko, Rheomat 15, Rheotest dan viskometer–Synchroelectric–BROOCKFIELD. Menurut prinsip–CUETE, dimana yang berputar adalah silinder sebelah luar, bekerja viskometer–FERRANTI–HELMES dan viskometer–rotasi–AGFA ( Voigt, 1984 ).

c.pH
Digunakan untuk melihat kondisi krim agar tidak mengiritasi kulit yang mempunyai pH normal 4,5 – 6,5 ( Wasitaatmadja, 1997 ) maka dari itu harus dijaga rentang pH krim yang dibuat .

d.Daya Sebar
Adalah kemampuan penyebaran krim pada kulit. Penentuannya dilakukan dengan extensometer. Sebuah sampel krim dengan volume tertentu diletakkan dipusat antara lempeng gelas, dimana lempeng sebelah atas dalam interval waktu tertentu dibebani anak timbangan di atasnya. Permukaan penyebaran yang dihasilkan dengan meningkatkan beban, merupakan karakteristik daya sebar ( Voigt, 1984 ). Daya sebar yang baik akan menjamin pelepasan bahan obat yang memuaskan (Voigt,1984).

e.Daya Lekat
Daya lekat merupakan kemampuan krim untuk melapisi permukaan kulit secara kedap dan tidak menyumbat pori – pori serta tidak menyumbat fungsi fisiologis kulit ( Voigt, 1984).

f.Daya Pisah
Stabilitas sebuah emulsi adalah sifat emulsi untuk mempertahankan distribusi halus dan teratur dari fase terdispersi yang terjadi dalam jnagka waktu yang panjang. Kehancuran sebuah emulsi ditunjukkan oleh penurunan stabilitasnya dan merupakan proses bertahap banyak. Sedimentasi merupakan tahap awal kerusakan dimana peristiwa ini terjadi bila berat jenis dari fase terdispersi lebih besar dari bahan pendispersi, sehingga akan menyebabkan kedua fase krim emulsi akan terpisah dan membentuk dua lapisan emulsi ( Voigt, 1984 ).

Sumber :
Anonim, 1979, Farmakope Indonesia, Edisi III, Departemen Kesehatan RI,Jakarta , 8.

Voigt, R., 1984, Buku Pelajaran Teknologi Farmasi, diterjemahkan oleh Noerono, S.,
Edisi V, UGM Press, Yogyakarta, 90 – 96. 163. 382. 434.

Wasitaatmadja, S.M., 1997, Penuntun Ilmu Kosmetik Medik, Universitas Indonesia
Press, Jakarta, 17.

Metode Simplex Lattice Design

Ada beberapa metode yang dapat dilakukan untuk mendapatkan optimasi formula. Salah satunya adalah metode simplex lattice design, metode ini cocok untuk prosedur optimasi formula dimana jumlah total dari bahan yang berbeda adalah konstan. Pelaksaan metode simplex lattice design yaitu dengan mempersiapkan formulasi yang bervariasi terdiri dari kombinasi bahan tambahan ( Bolton, 1997 ).
Untuk dua komponen atau faktor persamaan yang digunakan adalah :
Y = a ( A ) + b ( B ) + ab ( A ) ( B ) ............................. ( 1 )
Dengan, Y = Respon ( hasil percobaan )
A, B = kadar komponen dimana ( A ) + ( B ) = 1
a, b, ab = koefisien yang dapat dihitung dari hasil percobaan
Untuk penerapan 2 komponen atau faktor perlu dilakukan 3 percobaan yaitu percobaan yang menggunakan 100%A, 100%B dan campuran 50%A dan 50%B.

Contoh penerapan persamaan :
Misal percobaan yang menggunkan pelarut A 100% dapat melarutkan zat 25 mg/ml. Percobaan yang menggunakan pelarut B 100% dapat melarutkan zat 35 mg/ml. Sedangkan yang menggunakan pelarut campuran 50%A dan 50%B dapat melarutkan zat 45 mg/ml.
Cara menghitung koefisien :
Koefisien a : dihitung dari percobaan yang menggunakan pelarut A100%, berarti (A) = 1 dan ( B ) = 0
Y = 25 mg/ml
25 = a ( A ) + b ( B ) + ab ( A ) ( B )
25 = a ( 1 ) + b ( 0 ) + a b ( 1 ) ( 0 )
25 = a
Jadi, a = 25
Koefisien b : dihitung dari percobaan yang menggunakan pelarut B100%, berarti (A) = 0 dan ( B ) = 1
Y = 35 mg/ml
35 = a ( A ) + b ( B ) + ab ( A ) ( B )
35 = a ( 0 ) + b ( 1 ) + a b ( 0 ) ( 1 )
35 = b
Jadi, b = 35
Koefisien ab : dihitung dari percobaan yang menggunakan campuran pelarut A50% dan B50%, berarti (A) = 0,5 dan ( B ) = 0,5
Y = 45 mg/ml
45 = a ( A ) + b ( B ) + ab ( A ) ( B )
45 = a ( 0,5 ) + b ( 0,5 ) + ab ( 0,5 ) ( 0,5 )
45 = 25 ( 0,5 ) + 35 ( 0,5 ) + ab ( 0,5 ) ( 0,5 )
45 = 12,5 + 17,5 + ab ( 0,25 )
45 = 30 + ab ( 0,25 )
15 = ab ( 0,25 )
60 = ab
Jadi, ab = 60
Jadi persamaannya : Y = 25 ( A ) + 35 ( B ) + 60 ( A ) ( B )
Dari persamaan tersebut kita dapat menentukan profil hubungan kelarutan zat dengan campran pelarut. Misalnya dalam campuran pelarut A 65% dan 35% maka kelarutan zat adalah :
Y = 25 ( A ) + 35 ( B ) + 60 ( A ) ( B )
Y = 25 ( 0,65 ) + 35 ( 0,35 ) + 60 ( 0,65 ) ( 0,35 )
Y = 16,25 + 12,25 + 13,65 = 42,15 mg/ml
Berdasarkan profil sifat – sifat dapat ditentukan campuran span 60 – tween 60 dengan kadar optimum untuk digunakan sebagai surfaktan krim yang memenuhi persyaratan. Selain itu campuran optimum span 60 – tween 60 dipilih berdasarkan total respon tertinggi. Total respon dapat dihitung dengan rumus :
Rtotal = R1 + R2 + R3 ... + Rn ............................................... ( 2 )
Dimana R1,2,3, … n adalah respon dengan masing – masing sifat krim, masing – masing respon diberi bobot dan jumlah total bobot adalah 1. Karena satuan masing – masing respon tidak sama, maka perlu distandarisasi penilaian respon dengan menggunakan rumus berikut :
N = (X – Xmin) / (Xmax – Xmin).............................................. ( 3 )
Dimana, x = respon yang didapat dari percobaan
xmin = respon minimal yang diinginkan
xmax = respon maksimal yang diinginkan
Jadi R dapat dihitung dengan mengkalikan N dengan bobot yang telah ditentukan, perhitungan respon totalnya menjadi :
Rtotal = (bobot x Nviskositas) + (bobot x Ndaya sebar) + (bobot x Ndaya lekat)..(4)
Formula optimum terpilih dengan melihat harga respon tertinggi (Bolton, 1997).

Sumber :
Bolton, S., 1997, Pharmaceutical statistics : Practical and Clinical Applications, 3rdEd, Marcel Dekker Inc. , New York, 610 – 619.

Krim Tabir Surya

Krim tabir surya disebut pula preparat untuk proteksi sinar matahari atau kosmetika pelindung (protecting). Kosmetika pelindung disini berfungsi melindungi kulit dari kerusakan akibat adanya komponen sinar ultraviolet dari sinar matahari yang mencapai bumi (Wasitaatmadja, 1997).Kulit merupakan lapisan pelindung tubuh yang sempurna terhadap pengaruh luar, baik pengaruh fisik maupun pengaruh kimia. Kulit merupakan sawar fisiologik yang penting karena ia mampu menahan penembusan gas, cair maupun padat baik yang berasal dari lingkungan luar tubuh maupun komponen organisme (Syukri, 2002). Ada 2 macam komponen sinar ultraviolet yang mencapai bumi, yaitu UVA ( 320 – 400 nm ) dan UVB ( 290 – 320 nm ). UVB merupakan komponen yang mempunyai daya rusak tinggi pada kulit, sedangkan UVA lebih condong dapat merusak kulit dengan bantuan dari berbagai macam foto sensitizer kimia baik alami maupun sintetis yang terdapat pada kulit. Kosmetika pelindung kulit terdiri dari dua macam, yaitu proteksi terhadap polusi ( pollutant protecting ) dan proteksi terhadap ultraviolet ( ultraviolet protecting ) ( Wasitaatmadja, 1997).
Krim tabir surya merupakan kosmetika pelindung dari sinar ultraviolet. Yang dapat menyaring atau bahkan dapat menahan seluruh sinar matahari untuk mengurangi efek buruk dari sinar matahari. Ada 2 macam tabir surya :
a.Tabir surya kimia
Misalnya PABA, PABA ester, benzofenon, salisilat dan antranilat, yang dapat
mengabsorpsi energy radiasi. Tabir surya kimia mengabsorpsi hampir 95% radiasi
sinar UVB yang dapat menyebabkan sunburn (eritema dan kerut).
b.Tabir surya fisik
Misalnya titanium dioksida, Mg silikat, seng oksida, red petrolatum dan kaolin,
yang dapat memantulkan sinar. Tabir surya fisik dapat menahan UVA maupun UVB
(Wasitaatmadja, 1997).
Kemampuan menahan sinar ultraviolet dari tabir surya dinilai dalam faktor proteksi sinar ( sun protecting factor / SPF ) yaitu perbandingan antara dosis minimal yang diperlukan untuk menimbulkan eritema pada kulit yang diolesi oleh tabir surya dengan yang tidak. Nilai SPF ini berkisar antara 0 sampai 100, dan kemampuan tabir surya yang dianggap baik berada di atas 15. Pathak membagi tingkat kemampuan tabir surya sebagai berikut :
a.Minimal, bila SPF antara 2 – 4, contoh salisilat, antranilat.
b.Sedang, bila SPF antara 4 – 6, contoh sinamat, benzofenon.
c.Ekstra, bila SPF antara 6 – 8, contoh derivate PABA.
d.Maksimal, bila SPF antara 8 – 15 contoh PABA.
e.Ultra, bila SPF lebih dari 15, contoh kombinasi PABA, non-PABA, dan fisik (Wasitaatmadja, 1997).

Sumber :
Wasitaatmadja, S.M., 1997, Penuntun Ilmu Kosmetik Medik, Universitas Indonesia
Press, Jakarta, 17. 26 – 30. 117 – 120.
Syukri, Y., 2002, Biofarmasetika, Universitas Islam Indonesia Press , Yogyakarta,
85.

In the Pipeline: Nimotuzumab Active in Head and Neck Cancer

Elsevier Global Medical News. 2009 Nov 6, P Wendling

CHICAGO (EGMN) - Nimotuzumab in combination with radiation and chemoradiation appears to offer an extended survival benefit in advanced head and neck cancer without severe, class-associated toxicities, according to long-term data from the BEST trial.

A monoclonal antibody targeting the epidermal growth factor receptor (EGFR), the novel agent is in late-stage development in the United States and Canada for a variety of cancers.

The four-arm, phase IIb open-label study randomized 92 patients with inoperable, stage III/IVa head and neck cancer to radiation alone (RT), chemoradiation (CRT) alone, RT plus nimotuzumab, or CRT plus nimotuzumab.

At 48 months, overall survival was 52% in the nimotuzumab-plus-CRT arm vs. 21% in the CRT-alone arm, and 34.7% in the nimotuzumab-plus-RT arm vs. 13% in the RT-alone arm, Dr. Lokesh Viswanath reported at the annual meeting of the American Society for Radiation Oncology.

These data were a follow-up to the 30-month survival data (presented earlier this year in a poster at the annual meeting of the American Society of Clinical Oncology) that showed overall survival rates of 69.5% when nimotuzumab was added to CRT vs. 39% with CRT alone, and 21.74% whether or not nimotuzumab was added to RT alone.

What ultimately may set nimotuzumab apart from other EGFR inhibitors is its safety profile, particularly a lower rate of severe skin toxicities. Grade 3 radiation-induced skin reactions were not observed in patients taking nimotuzumab with RT or CRT. They were present in 6.6% of RT-only patients and 5% of CRT-only patients, said Dr. Viswanath of the Kidwai Memorial Institute of Oncology, Bangalore, India. Grade 1/2 skin reactions were reported in at least two-thirds of all patients, occurring in a high of 87% of patients who were treated with CRT alone or with nimotuzumab.

Grade 3 mucositis occurred in 59.2% of the RT-alone arm, 55.5% of the RT-plus-nimotuzumab arm, 29.4% of the CRT-alone arm, and 55% of the CRT-plus-nimotuzumab arm, said Dr. Viswanath, who disclosed no conflicts of interest.

All patients received 6,600 cGy of radiation over 6-6.5 weeks. Chemoradiation consisted of weekly cisplatin given 6 hours before RT as a radio sensitizer. Nimotuzumab (200 mg) was given weekly for 6 weeks as a 60-minute infusion 3 days before RT. This schedule was chosen to differentiate its adverse events from those of cisplatin, he said.

Study discussant Dr. Kie K. Ang of the University of Texas M.D. Anderson Cancer Center in Houston questioned whether the data represent a positive signal. He noted that the small sample size of 76 evaluable patients could influence outcomes, and that patients treated with nimotuzumab were more likely to have primary tumors of the oropharynx. Such tumors, if positive for the human papillomavirus, are more responsive to chemotherapy and radiotherapy.

The study was sponsored by Biocon BioPharmaceuticals Ltd., the licensee for nimotuzumab in India.

Adjuvant Capecitabine in Combination With Docetaxel and Cyclophosphamide Plus Epirubicin for Breast Cancer: An Open-Label, Randomised Controlled Trial

Lancet Oncol. 2009 Nov 10;[Epub Ahead of Print], H Joensuu, P-L Kellokumpu-Lehtinen, R Huovinen, A Jukkola-Vuorinen, M Tanner, R Asola, R Kokko, J Ahlgren, P Auvinen, A Hemminki, O Paija, L Helle, L Nuortio, K Villman, G Nilsson, S-L Lahtela, K Lehtiö, M Pajunen, P Poikonen, P Nyandoto, V Kataja, P Bono, M Leinonen, H Lindman, on behalf of the FinXX Study Investigators

ABSTRACT

Background: Standard adjuvant chemotherapy regimens for patients with moderate-to-high-risk early breast cancer typically contain a taxane, an anthracycline, and cyclophosphamide. We aimed to investigate whether integration of capecitabine into such a regimen enhances outcome.

Methods: In this open-label trial, we randomly assigned (centrally by computer; stratified by node status, HER2 status, and centre) 1500 women with axillary node-positive or high-risk node-negative breast cancer to either three cycles of capecitabine and docetaxel followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (capecitabine group, n=753), or to three cycles of docetaxel followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (control group, n=747). The primary endpoint was recurrence-free survival. A planned interim analysis was done after 3 years’ median follow-up. Efficacy analyses were by modified intention to treat. The study is registered with ClinicalTrials.gov, number NCT00114816.

Findings: Two patients in each group were excluded from efficacy analyses because of withdrawal of consent or distant metastases. After a median follow-up of 35 months (IQR 25∙5–43∙6), recurrence-free survival at 3 years was better with the capecitabine regimen than with control (93% vs 89%; hazard ratio 0∙66, 95% CI 0∙47–0∙94; p=0∙020). The capecitabine regimen was associated with more cases of grade 3 or 4 diarrhoea (46/740 [6%] vs 25/741 [3%]) and hand-foot syndrome (83/741 [11%] vs 2/741 [<1%]) and the control regimen with more occurrences of grade 3 or 4 neutropenia (368/375 [98%] vs 325/378 [86%]) and febrile neutropenia (65/741 [9%] vs 33/742 [4%]). More patients discontinued planned treatment in the capecitabine group than in the control group (178/744 [24%] vs 23/741 [3%]). Four patients in the capecitabine group and two in the control group died from potentially treatment-related causes.

Interpretation: The capecitabine-containing chemotherapy regimen reduced breast cancer recurrence compared with a control schedule of standard agents. Capecitabine administration was frequently discontinued because of adverse effects.

Vitamin D for Cancer Prevention: Global Perspective

Ann Epidemiol. 2009 Jul 1;19(7):468-483, CF Garland, ED Gorham, AR Mohr, FC Garland

ABSTRACT

PURPOSE: Higher serum levels of the main circulating form of vitamin D, 25-hydroxyvitamin D (25(OH)D), are associated with substantially lower incidence rates of colon, breast, ovarian, renal, pancreatic, aggressive prostate and other cancers.



METHODS: Epidemiological findings combined with newly discovered mechanisms suggest a new model of cancer etiology that accounts for these actions of 25(OH)D and calcium. Its seven phases are disjunction, initiation, natural selection, overgrowth, metastasis, involution, and transition (abbreviated DINOMIT). Vitamin D metabolites prevent disjunction of cells and are beneficial in other phases.


RESULTS/CONCLUSIONS: It is projected that raising the minimum year- round serum 25(OH)D level to 40 to 60 ng/mL (100–150 nmol/L) would prevent approximately 58,000 new cases of breast cancer and 49,000 new cases of colorectal cancer each year, and three fourths of deaths from these diseases in the United States and Canada, based on observational studies combined with a randomized trial. Such intakes also are expected to reduce case-fatality rates of patients who have breast, colorectal, or prostate cancer by half. There are no unreasonable risks from intake of 2000 IU per day of vitamin D3, or from a population serum 25(OH)D level of 40 to 60 ng/mL. The time has arrived for nationally coordinated action to substantially increase intake of vitamin D and calcium.

Medical Progress - Statins for people with cardiovascular risk factors: A meta-analysis

The benefits of statin treatment for people without established cardiovascular disease but with risk factors have been confirmed in a meta-analysis.

The meta-analysis included 10 studies and 70,388 subjects. With a mean follow-up of 4.1 years, statin therapy reduced all-cause mortality significantly by 12%. There were also significant reductions in major coronary events (by 30%) and major cerebrovascular events (by 19%).

Statins benefit people without established cardiovascular disease but with risk factors.

Brugts JJ, et al. The benefits of statins in people without established cardiovascular disease but with cardiovascular risk factors: meta-analysis of randomised controlled trial. BMJ 2009;339:36

Modified VISTA Regimen Easier on Elderly With Multiple Myeloma

Elsevier Global Medical News. 2009 Dec 7, JS MacNeil

NEW ORLEANS (EGMN) - Melphalan showed itself to be a better partner than thalidomide for induction bortezomib in a randomized phase III trial with important implications for the treatment of elderly patients with multiple myeloma.

Investigators from the Spanish Myeloma Group modified the intensity of what has come to be known as the VISTA regimen in the trial. Instead of receiving bortezomib (Velcade) twice a week as part of a combination regimen, 260 patients (median age, 75 years) were given the bortezomib component once a week during the induction phase. To consolidate response, the design added a maintenance regimen that combined bortezomib with either thalidomide or prednisone for up to 3 years.

The result was reduced toxicity with no loss in efficacy, Dr. Maria-Victoria Mateos of the Hospital Universitario de Salamanca (Spain) reported Dec. 6 in a plenary presentation at the annual meeting of the American Society of Hematology.

The rate of serious peripheral neuropathy, in particular, had been 17% in the earlier VISTA (Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment With Melphalan and Prednisone) trial, which established bortezomib, melphalan, and prednisone (VMP) as an induction regimen. Dr. Mateos reported that it fell to 5% with the modified VMP regimen and to 9% with an induction regimen of bortezomib, thalidomide, and prednisone (VTP). In the maintenance phase that was added to both the VMP and VTP arms, peripheral neuropathy was 2% and 5%, respectively.

Toxicity drove the conclusion favoring the alkylating agent melphalan over immunomodulatory thalidomide, Dr. Mateos said. The investigators saw almost no difference in efficacy between VMP and VTP. Overall response rates were 80% and 81%, respectively. There were slightly more complete responses in the VTP arm (20% with VMP vs. 27% with VTP).

The toxicity profiles were "clearly different," however. The VMP regimen produced more grade 3 or higher neutropenia (39% vs. 22% with VTP; P = .008) and thrombocytopenia (27% vs. 12%; P = .0001), which resulted in more grade 3 or higher infections (7% vs. fewer than 1%; P = .01).

Although no grade 3 or higher cardiotoxicity was observed with VMP, cardiac events occurred in 8% of patients on VTP (P = .001). These included five cases of cardiac failure, two of atrial fibrillation, two of hypotension, one heart attack, and one atrial valve blockage. Each arm of the trial had seven deaths, but five in the VMP arm resulted from infections and five in the VTP arm were from cardiac complications.

Because neutropenia and infections are more easily addressed than cardiac complications, the investigators concluded that melphalan was superior to thalidomide as a partner for induction bortezomib.

The investigators did find an advantage for thalidomide vs. melphalan in the maintenance arms. This was true regardless of whether patients received induction with VMP or VTP, Dr. Mateos said. At a median follow-up of 15 months, median progression-free survival had not been reached with bortezomib plus thalidomide, but was 23 months with bortezomib plus melphalan (hazard ratio, 1.7; P = .05).

In both induction arms, patients benefited from maintenance, which increased the complete response rate from 23% after induction therapy to up to 42% after maintenance.

Moreover, a subgroup analysis found that the complete response rate was "almost identical" when 27 patients with high-risk cytogenetic abnormalities were compared with standard-risk patients. At 2 years after the first randomization, 55% of standard risk patients and 58% of high-risk patients had not progressed. Dr. Mateo reported. Overall survival at 2 years was 77% and 74%, respectively.

"They set out to answer specific questions, and they answered them really well," Dr. Richard A. Van Etten, director of the Tufts Medical Cancer Center in Boston, commented in an interview after a press briefing that he moderated. "For elderly patients, this really sets the standard."

Melphalan is not used in younger patients because it is stem-cell toxic, he explained. Older patients often are not candidates for stem cell transplantation.

In her introduction of Dr. Mateos at the plenary session, Dr. Donna Weber of the University of Texas M.D. Anderson Cancer Center in Houston observed this is the first trial to compare one novel agent to another novel agent in untreated patients with multiple myeloma. "It is time to answer some of the burning questions, particularly in patients who are elderly, and Dr. Mateos and colleagues herald a new era" in which some of these questions might be answered, she said.

In the current study, which randomized 260 patients between April 2005 and October 2008, the modified protocol called for six cycles of induction therapy followed by up to 3 years of maintenance therapy. One arm received bortezomib 1.3 mg/m² twice weekly for one 6-week cycle, followed by once weekly dosing for five 5-week cycles in combination with oral melphalan 9 mg/m² and prednisone 60 mg/m² once daily on days 1-4 of each cycle. The same combination of bortezomib and prednisone was used in the VTP arm, but thalidomide 100 mg daily was substituted for melphalan.

During the maintenance phase, patients in both arms received bortezomib 1.3 mg/m² twice weekly (days 1, 4, 8, and 11) every 3 months in combination with either continuous thalidomide 50 mg daily (VT) or prednisone 50 mg on alternate days (VP).

A total of 253 patients could be evaluated for response to the induction regimen. Along with similar response rates, no significant differences between the VMP and VTP groups were observed in progression-free survival or overall survival; the latter was 81% with VMP and 84% with VTP.

Of 178 patients who were randomized to maintenance therapy, 143 were evaluable for efficacy.

For the entire cohort at a median follow-up of 24 months, Dr. Mateos reported median progression-free survival to be 33 months and a 3-year overall survival rate of 75%.

The approach of using VMP but adding maintenance is very attractive and "probably will give you the opportunity of going back and treating with bortezomib or also using another IMiD [thalidomide analogue] at the time of relapse instead of using everything up front," Dr. Jésus F. San Miguel, the principal investigator of the VISTA trial and the new study, said in an interview. "I would like very much using the best combination up front, but the best combination should be the most effective and not the most expensive."

The conclusions are "really clear and important," added Dr. San Miguel of Hospital Universitario de Salamanca. "The modification of the regimen is associated with a significant reduction in toxicity, and the second message is the addition of thalidomide is not superior to the melphalan; and the melphalan is cheaper, and the toxicity is lower," he said.

The next question to be addressed, Dr. Mateos said, will be how a maintenance regimen containing lenalidomide (Revlimid) would compare with thalidomide.

Dr. Mateos disclosed that she received honoraria and served on the speakers bureau of Janssen-Cilag and Celgene Corp.

Aliskiren: The First Direct Renin Inhibitor for the Treatment of Hypertension

Brian Tomlinson, MD, FRCP; Miao Hu, BSc

Aliskiren is a new treatment for hypertension with the novel mechanism of inhibiting the activity of renin. It shows efficacy and tolerability similar to angiotensin receptor blockers when used as monotherapy for hypertension. When combined with a thiazide diuretic or amlodipine, the antihypertensive action of aliskiren was shown to be enhanced. When aliskiren is used in combination with other inhibitors of the renin–
angiotensin–aldosterone system, there appear to be some promising additional cardiac and renal benefits, which will be clarified in ongoing studies.

Medical Progress - Glucose metabolism before type 2 diabetes

The changes that occur in glucose metabolism before the diagnosis of type 2 diabetes are not known. Data from a prospective cohort study (Whitehall II study) in London, England, have been presented.

The study began in 1985–1988 and included 10,308 people aged 35–55. Oral glucose tolerance tests were performed in 1991–1994, 1997–1999 and 2002–2004. Data were analysed from 6,538 subjects without diabetes at baseline. Diabetes was diagnosed in 505 individuals over an average follow-up of 9.7 years. Among people who developed type 2 diabetes, there was a rapid increase (from 5.79 to 7.4 mmol/L) in fasting blood glucose beginning 3 years before the diagnosis. There was a similar increase (from 7.6 to 11.9 mmol/L) in 2-hour post-load glucose levels at the same time. Homeostasis model assessment (HOMA) insulin sensitivity fell steeply to 86.7% during the 5 years before diagnosis of diabetes. HOMA beta-cell function increased 3 or 4 years before diagnosis and then decreased until diagnosis.

Knowledge of the changes could aid the assessment of diabetes risk.

Tabák AG, et al. Trajectories of glycaemia, insulin sensitivity, and insulin secretion before diagnosis of type 2 diabetes: an analysis from the Whitehall II study. Lancet 2009;373:2215–2221: Matthews DR, Levy JC. Impending type 2 diabetes.

Medical Progress - Liraglutide vs exenatide for type 2 diabetes

Although 10 different classes of drug that reduce blood glucose levels are available, treatment of type 2 diabetes may still be unsatisfactory, and the development of new drugs might help. Glucagon-like peptide-1 (GLP-1), secreted by intestinal cells, stimulates insulin secretion and inhibits glucagon secretion in response to blood glucose levels. It also diminishes appetite and promotes proliferation of pancreatic beta cells. GLP-1 itself is rapidly degraded by dipeptidyl peptidase-4, but two types of drug have been developed; GLP-1 receptor agonists and human GLP-1 analogues resistant to the enzyme. Now liraglutide (an enzyme-resistant analogue of GLP-1) and exenatide (a GLP-1 receptor agonist) have been compared in a multinational trial.

A total of 264 adults with poorly controlled type 2 diabetes on maximum tolerated doses of metformin, a sulpho­nylurea or both were randomized to subcutaneous liraglutide 1.8 mg once daily or subcutaneous exenatide 10 µg twice daily for 26 weeks. Liraglutide caused signif­icantly greater reductions in HbA1c than did exenatide (from an overall mean baseline level of 8.2%, a mean reduction of 1.12% with liraglutide and 0.79% with exenatide). An HbA1c level of <7% was achieved by 54% versus 43%. The reduction in mean fasting plasma glucose was 1.61 versus 0.6 mmol/L. Weight loss was 3.24 kg versus 2.87 kg. Nausea and minor hypoglycaemia were both less frequent with liraglutide. Major hypoglycaemia occurred in two patients on a combination of exenatide and a sulphonylurea.

The results were better with liraglutide. Liraglutide might be suitable treatment when weight gain and hypoglycaemia are problems.

Buse JB, et al. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). Lancet 2009;374:39–47; De Block CEM, Van Gaal LF. GLP-1 receptor agonists for type 2 diabetes.

Medical Progress - Famotidine to prevent gastrointestinal side effects of low-dose aspirin

Low-dose aspirin is widely used for car­diovascular prophylaxis, but it may cause peptic ulceration and its complications, and oesophagitis. Proton-pump inhibitors may prevent such complications, but there are concerns about their cost, safety and possible interaction with clopidogrel. Famotidine is a histamine H2-receptor antagonist that may also be effective prophylaxis. Now a single-centre UK study has confirmed the effectiveness of famotidine.

A total of 404 adults attending car­diovascular, cerebrovascular or diabetes clinics at a Scottish hospital, taking aspirin 75–325 mg daily, and without ulcers or erosive oesophagitis on endoscopy, were randomized to famotidine 20 mg twice daily or placebo. At 12 weeks, gastric ulcers had developed in 3.4% (famotidine) versus 15% (placebo), duodenal ulcers in 0.5% versus 8.5% and erosive oesophagitis in 4.4% versus 19%. Four patients, all in the placebo group, were admitted to hospital with upper gastrointestinal haemorrhage. Adverse events were less common in the famotidine group.

Famotidine is effective in the prevention of gastric or duodenal ulcers or erosive oesophagitis in people taking low-dose aspirin.

Taha AS, et al. Famotidine for the prevention of peptic ulcers and oesophagitis in patients taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind, placebo-controlled trial. Lancet 2009;374:119– 125; Hawkey CJ. NSAIDs and aspirin: notorious or FAMOUS.

Ekstrak Kunyit ( Curcuma Plus®, Hepagard® ) tx alternatif untuk hepatitis

# Curcuma Plus®
GENERIK : per 5 ml : vitamin B1 3mg, vitamin B2 2mg, vitamin B6 5mg, vitamin B12 5µg, β-karoten 1 %, dekspantenol 3mg, curcuminoid 2mg

INDIKASI : makanan tambahan untuk meningkatkan nafsu makan dan sebagai terapi laternatif untuk mengobati hepatitis

KEMASAN : sirup 60 ml

DOSIS : Dewasa : 3 kali sehari 1 sendok teh. Anak –anak : 1 – 2 kali sehari 1 sendok teh

PABRIK : Soho


# Hepagard®
GENERIK : ekstrak kering Silybui mariae fructus 100mg ( setara dengan 70 mg Silymarin ), ekstrak Cynarae Folium 50 mg ( setara dengan 1,2 mg Cynarin ), ekstrak kering Curcumae longae Rhizoma 20 mg ( setara dengan 5 mg Curcumin )

INDIKASI : ganguan hati, untuk mencegah dan mengobati gangguan hati seperti sirosis dan hepatitis, dispepsia

KONTRAINDIKASI : hipersensitif, ganguan saluran empedu, hamil dan meyusui

KEMASAN : kotak berisi 3 x 10 kapsul

DOSIS : dewasa : 3 kali shari 2 kapsul

PABRIK : Phapros

lok da saran atow komentar,, tulis disini,, biar informasi terus berkembang,, OK.. makasiii

Protein Virus Hepatitis A ( Havrix® dan Twinrix® )

# Havrix®
GENERIK : Protein virus Hepatitis A ( strain HM 175 )

INDIKASI : imunisasi aktif yang melawan infeksi yang disebabkan oleh virus HepatitisA

KONTRAINDIKASI : infeksi demam akut yang berat

PERHATIAN : pasien yang emnjalani hemodialisis atau dengan gangguan sistem kekebalan, hamil, menyusui, pasien dengan trombositopenia atau kelainan pendarahan

EFEK SAMPING : nyeri ringan yang bersifat sementara pada tempat penyuntikan, eritema, indurasi, bengkak dan kemerahan. Tidak terlalu sering : demam, rasa tidak enak badan yang tidak jelas, keletihan, sakit kepala, mual, kehilangan nafsu makan

KEMASAN : vial dosis tunggal untuk dewasa 720 ELISA u/ml x 0,5 ml

DOSIS :
Dewasa : tidak kurang dari 720 unit ELISA ( EU )/dosis
Anak – anak berusia 1 – 15 tahun : tidak kurang dari 360 EU/dosis
Standar rangkaian primer vaksinasi : 2 dosis, pemberian pertama pada tenggal yang dipilih dan dosis kedua 1 bulan kemudian.
Jika perlu, dosis kedua bisa diberikan minimum 2 minggu setelah dosis pertama. Suatu dosis booster dianjurkan pada waktu antara 6 dan 12 bulan setelah permulaan rangkaian primer.

PABRIK : Galaxo SmithKline


# Twinrix®
GENERIK : virus Hepatitis A ( HA ) yang diinaktivasi, HbsAg, Al(OH)3, Al fosfat

INDIKASI : dewasa dan anak – anak berumur 2 – 15 tahun yang berisiko infaksi hepatitis A dan B

KONTRAINDIKASI : Hipersensitif terhadap virus hepatitis A dan B monovalen

PERHATIAN : sakit fabrile parah akut, profilaksis setelah pemaparan. Kasus anafilaksis jarang.

EFEK SAMPING : sakit, kemerahan dan bengkak pada tempat penyutikan. Kaku, sakit kepala, rasa tidak enak badan, mual.

KEMASAN : prefilled syringe 1ml x 1 biji

DOSIS : Dewasa dan remaja ≥ 16 tahun dosis pertama : penentuan tanggal, dosis kedua : satu bulan setelahnya, dosis ketiga : 6 bulan setelah dosis pertama. Anak – anak 2 – 15 tahun dosis pertama: penentuan tanggal, dosis kedua : antara 6 – 12 bulan setelah dosis pertama

PABRIK : Galaxo Smith Kline

Vaksin Hepatitis A terinaktivasi ( Avaxim 160 ® dan Avaxim 80® )

GENERIK : Vaksin hepatitis A terinaktivasi

INDIKASI : pencegahan infeksi yang disebabkan oleh virus hepatitis A pada anak – anak usia 2 sampai 15 tahun

KONTRAINDIKASI : demam, penyakit akut, penyakit kronis progresif.

PERHATIAN : hipersensitifitas terhadap Neomisin ( dengan penyakit hati ), hamil, menyusui, mengandung formaldehid sebagi zat tambahan

EFEK SAMPING : nyeri setempat yang kadang – kadang disertai dengan kemerahan, demam sedang, sakit kepala, nyeri otot atau sendi, dan gangguan saluran pencernaan

KEMASAN : Pre-filled syringe 80 iu/0,5 ml

DOSIS : Dosis yang dianjurkan adalah 0,5 ml untuk setiap injeksi ( IM ) dan Vaksinasi primer nya 1 dosis vaksin diikuti dengan Booster 6 bulan kemudian

PABRIK : Sanofi Aventis

CARA PEMAKAIAN : injeksi intramuskular

INFEKSI SALURAN KEMIH

Definisi
•Anatomi
Bawah : uritritis, sistitis (infeksi superfisialis vesika urinaria), prostatitis
Atas : pielonefritis (proses inflamasi parenkim ginjal), anses ginjal.

•Klinis
Tanpa komplikasi : sistitis pada perempuan hamil kelainan neurologis atau struktural yang mendasarinya.
Komplokasi : infeksi saluran kemih atas atau setiap kasus ISK pada laki-laki, atau perempuan hamil, aau ISK dengan kelainan neurologis atau struktural yang mendasarinya.

Mikrobilogis
•ISK tanpa kompliksi : E. Coli (80%), proteus, klebsiella, enterokokus
•ISK dengan komplikasi : E. Coli (30%) enterokokus (20%), pseudononas (20%),
S.Epidermidis (15%), batang gram negatif lainya.
•ISK yang berhubungan dengan kateter : jamur (30%), E . coli (25%), batang gram
negatif lainya, enerokokus, S.epidermis
•Uritritis : chlamydia trachomatis, Neisseria gonorrhoeae

Manifestasi klinis
•Sistitis : piuria urgensi, frekuesi _, perubahan warna/ bau urine, nyeri
suprapublik; demam biasanya tidak ada.
•Uretritis : mungkin mirip dengan sistitis kecuali adanya discharge uretra
•prostatitis: serupa dengan sistitis kecuali gejala obstruksi orifisium uretra
(cont: hestansi, aliran lemah).
•Pielonefrritis : demam, menggigil, nyeri punggung atau bokong, mual, muntah, diare
•Abses ginjal (intrarenal atau perinefrik); serupa dengan pielonefritis kecuali
demammenetap mestipun di obati dengan antibiotik.

Pemeriksaan Diagnostik
•Urinalisis : piuria + bakteriuria ± hematuria
Hidung bakteri bermakna:_105 unit koloni/ml pada perempuan yang asimtomatik._103
unit koloni/ml pada laki-laki _102 unit koloni/ml pada pasien simtomatik atau
dengan karakter piuria steril _uretritis , tuberkulosis ginjal, benda asing.
•Kultur dan pewarnaan gram urine ( dari urine porsi tengah atau spesimen lansung
dari katater)
•Pada perempuan hamil dan pasien yang menjalanin pembedahan urologi lakukan
skrining terhadap bakteriuria asimtomatik
•Kultur darah : pertibangkan pada ISK dengan komplikasi
•Deteksi DNA atau kultur terhadap C. Trachomatis, N.gonorrhoeae pada pasien yang
kegiatan seksualnya aktif atua pada piuria steril
•Spesimen urine porsi pertama dan porsi tengah, pemijatan prostat, dan spesimen
urine pascapijatan prostat pada kasus-kasus kecurigaan prostatitis
•CT scan abdomen untuk menyingkirkan abses pada pasien pielonefritis yang demamnya
tidak turun aetelah 72 jam
•Tindakan diagnostik urolohi (USG ginjal, CT abdomen, sistografi berkemih) jiks ISK
berulang pada laki-laki

Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock

Objective: In 2003, critical care and infectious disease experts representing 11 international organizations developed management guidelines for severe sepsis and septic shock that would be of practical use for the bedside clinician, under the auspices of the Surviving Sepsis Campaign, an international effort to increase awareness and improve outcome in severe sepsis.

Design: The process included a modified Delphi method, a consensus conference, several subsequent smaller meetings of subgroups and key individuals, teleconferences, and electronic-based discussion among subgroups and among the entire committee.

Methods: We used a modified Delphi methodology for grading recommendations, built on a 2001 publication sponsored by the International Sepsis Forum. We undertook a systematic review of the literature graded along five levels to create recommendation grades from A to E, with A being the highest grade. Pediatric considerations were provided to contrast adult and pediatric management.

Results: Key recommendations, listed by category and not by hierarchy, include early goal-directed resuscitation of the septic patient during the first 6 hrs after recognition; appropriate diagnostic studies to ascertain causative organisms before starting antibiotics; early administration of broad-spectrum antibiotic therapy; reassessment of antibiotic therapy with microbiology and clinical data to narrow coverage, when appropriate; a usual 7–10 days of antibiotic therapy guided by clinical response; source control with attention to the method that balances risks and benefits; equivalence of crystalloid and colloid resuscitation; aggressive fluid challenge to restore mean circulating filling pressure; vasopressor preference for norepinephrine and dopamine; cautious use of vasopressin pending further studies; avoiding low-dose dopamine administration for renal protection; consideration of dobutamine inotropic therapy in some clinical situations; avoidance of supranormal oxygen delivery as a goal of therapy; stress-dose steroid therapy for septic shock; use of recombinant activated protein C in patients with severe sepsis and high risk for death; with resolution of tissue hypoperfusion and in the absence of coronary artery disease or acute hemorrhage, targeting a hemoglobin of 7–9 g/dL; appropriate use of fresh frozen plasma and platelets; a low tidal volume and limitation of inspiratory plateau pressure strategy for acute lung injury and acute respiratory distress syndrome; application of a minimal amount of positive end-expiratory pressure in acute lung injury/acute respiratory distress syndrome; a semirecumbent bed position unless contraindicated; protocols for weaning and sedation/analgesia, using either intermittent bolus sedation or continuous infusion sedation with daily interruptions/lightening; avoidance of neuromuscular blockers, if at all possible; maintenance of blood glucose <150 mg/dL after initial stabilization; equivalence of continuous veno-veno hemofiltration and intermittent hemodialysis; lack of utility of bicarbonate use for pH >7.15; use of deep vein thrombosis/stress ulcer prophylaxis; and consideration of limitation of support where appropriate. Pediatric considerations included a more likely need for intubation due to low functional residual capacity; more difficult intravenous access; fluid resuscitation based on weight with 40–60 mL/kg or higher needed; decreased cardiac output and increased systemic vascular resistance as the most common hemodynamic profile; greater use of physical examination therapeutic end points; unsettled issue of high-dose steroids for therapy of septic shock; and greater risk of hypoglycemia with aggressive glucose control.

Conclusion: Evidence-based recommendations can be made regarding many aspects of the acute management of sepsis and septic shock that are hoped to translate into improved outcomes for the critically ill patient. The impact of these guidelines will be formally tested and guidelines updated annually and even more rapidly as
some important new knowledge becomes available. (Crit Care Med 2004; 32:858 –873)

KEY WORDS: sepsis; severe sepsis; septic shock; sepsis syndrome; infection; guidelines; evidence-based medicine; Surviving Sepsis Campaign

Tetes Mata

Guttae ( obat tetes ) adalah sediaan cair berupa larutan, emulsi atau suspense, dimaksudkan untuk obat dlam atau obat luar, digunakan dengan cara meneteskan menggunakan penetes yang menghasilkan tetesan setara dengan tetesan yang dihasilkan penetes baku dalam Farmakope Indonesia ( Anief, 2000 ).

Sediaan obat tetes dapat berupa :
1. Guttae = obat tetes
Jika disebutkan guttae tanpa pejelasan lebih lanjut, dimaksudkan obat tetes untuk obat dalam. Obat tetes untuk obat dalam digunakan dengan cara diteteskan ke dalam minuman atau makanan ( Anief, 2000 ).

2. Guttae Oris = tetets mulut
Tetes mulut adalah obat tetes yang diperuntukkan untuk kumur – kumur, sebelum digunakan diencerkan lebih dulu dengan air dan tidak untuk ditelan ( Anief, 2000 ).

3. Guttae Auriculares = tetes telinga
Tetes telinga adalah obat tetes yang digunakan dengan cara meneteskan obat ke dalam telinga ( Anief, 2000 ).
Bila tidak dinyatakan lain cairan pembawa yang digunkan adalah bukan air. Cairan pembawa yang digunakan harus mempunyai kekentalan yang sesuai agar oat mudah menempel pada dinding telinga, biasanya digunakan gliserin dan propilenglikol. Selain tersebut dapat pula digunakan etanol, heksilenglikol dan minyak lemak nabati ( Anief, 2000 ).
Bila sediaan berupa suspense sebagai zat pensuspensi digunakan sorbitan, polisorbat atau surfaktan lain yang cocok. Kecuali dinyatakan lain pH tetes telinga adalah 5,0 – 6,0 da disimpan dalam wadah tertutup rapat ( Anief, 2000 ).

4. Guttae Nasales = tetes hidung
Tetes hidung adalah obat bebas yang digunakan dengan cara meneteskan obat ke dalam rongga hidung yang mengandung zat pensuspensi, pendapar dan pengawet. Sebagai cairan pembawa umumnya digunakan air. pH cairan pembawa sedapat mungkin antara 5,5 – 7,5, dengan kapasitas dapar sedang, isotonis atau hampir isotonis. Tidak boleh menggunakan cairan pembawa lemak mineral atau minyak lemak ( Anief, 2000 ).
Sebagai zat pensuspensi biasanya digunakan sorbitan, polisorbat atau surfaktan lain yang cocok dengan kadar tidak lebih dari dari 0,01% b/v. zat pendapar digunankan zat yang cocok dengan pH 6,5 dan dibuat isotonis dengan Natrii Chloridum ( Anief, 2000 ).
Zat pengawet yang digunakan umumnya Benzalkonium Chlorida 0,01% b/v – 0,1% b/v. Disimpan dalam wadah tertutup rapat ( Anief, 2000 ).

5. Guttae Ophthalmicae = tetes mata
Tetes mata adalah sediaan steril berupa larutan atau suspense yang digunakan dengan cara meneteskan obat pada selaput lendir mata di sekitar kelopak mata dan bola mata ( Anief, 2000, halaman 155 ).

Tetes mata harus memenuhi syarat – syarat yang telah ditentukan yaitu :
- Steril
- Sedapat mungkin isohidris
- Sedapat mungkin isotonis ( Anief, 2000 )
- Larutan jernih
- Bebas partikel asing, benang dan serat ( Anief, 2000 )
Bila obatnya tidak tahan pemanasan, maka sterilisasi dicapai dengan menggunakan pelarut steril, dilarutkan obatnya secara aseptis, dan menggunakan penambahan zat pengawet dan botol atau wadah yang steril. Isotonis dan pH yang dikehandaki diperoleh dengan menggunakan pelarut yang cocok.
Pelarut yang sering digunakan adalah :
- Larutan 2% Asam Borat ( pH = 5 )
- Larutan Boraks – Asam Borat ( pH = 6,5 )
- Larutan basa lemah Boraks – Asam Borat ( pH = 8 )
- Aquadestillata
- Larutan NaCl 0,9% ( Anief, 2000 ).
Cairan pembawa berair biasanya mengandung zat pengawet Fenilraksa nitrat, Fenilraksa asetat 0,022% b/v, Bezalkonium khlorida 0,01% b/v didasarkan pemilihannya atas ketercampuran zat pengawet dengan obat yang dikandung, selama waktu tetes mata digunakan. Bezalkonium khlorida tidak dapat campur dengan anestetikum lokal ( Anief, 2000 ).

Cara pembuatan bila tidak dinyatakan lain dilakukan dengan salahsatu cara seperti berikut :
•Cara 1
Obat dilarutkan ke dalam cairan pembawa yang mengandung salahsatu zat pengawet yang cocok dan larutan dijernihkan dengan penyaringan. Kemudian dimasukkan ke dalam wadah dan ditutup kemudian disterilkan dengan uap air pada suhu 115OC sampai 116 OC selama 30 menit dalam autoklaf.
•Cara 2
Obat dilarutkan ke dalam cairan pembawa berair yang mengandung zat pengawet yang cocok dan disterilkan dengan cara C, yaitu disterilkan dengan penyaringan melalui penyaring bakteri steril, lalu dimasukkan ke dalam wadah akhir yang streil dan ditimbang secara aseptik.
• Cara 3
Obat dilarutkan ke dalam cairan pembawa berair yang mengandung zat pengawet yang cocok, lalu disaring dan dimasukkan ke dalam wadah tertutup rapat dan disterilkan dengan cara B, yaitu disterilkan dengan pemanasan dengan bakterisida. Untuk wadah yang lebih dari 30 ml, sterilisasi diperpanjang, hingga seluruh isi tiap wadah mencapai suhu 98OC sampai 100OC.
Penyimpanan obat tetes mata dilakukan dalam wadah kaca atau plastik tertutup kedap, volume 10 ml dan dilengkapi dengan penetes. Sediaan tetes mata harus diberi etiket yang tertera “ Tidak boleh digunakan lebih dari 1 bulan setelah tutup dibuka “ ( Anief, 2000 ).

sumber : Anief, Moh, 2002, Ilmu Meracik Obat, Gadjah Mada University Press, Yogyakarta. 153 – 157.

Injeksi

Injeksi adalah sediaan steril berupa larutan, emulsi atau suspensi atau serbuk yang harus dilarutkan atau disuspensikan lebih dahulu sebelum digunakan, yang disuntikkan dengan cara merobek jaringan ke dalam kulit atau melalui kulit atau selaput lendir (Anonim, 1978 , halaman 317).
Menurut Ansel , 2005 (halaman 399) obat suntik didefinisikan secara luas sebagai sediaan steril bebas pirosgen yang dimaksudkan untuk diberikan secara parenteral. Istilah parenteral seperti yang umum digunakan, menunjukkan pemberian lewat suntikan seperti berbagai sediaan yang diberikan dengan suntikkan. Kata ini berasal dari kata Yunani, para dan enteron berarti di luar usus halus dan merupakan rute pemberian lain dari rute oral. Pirogen adalah senyawa organik yang menimbulkan demam, berasal dari pengotoran mikroba dan merupakan penyebab banyak reaksi – reaksi febril yang timbul pada penderita yang menerima suntukan intravena.
Sedangkan menurut Farmakope Indonesia, 1995 (halaman 9), sediaan steril untuk kegunaan pareteral digolongkan menjadi 5 jenis yang berbeda yaitu : (1) obat atau larutan atau emulsi yang digunakan untuk injeksi, ditandai dengan nama, Injeksi …; (2) sediaan padat kering atau cairan pekat tidak mengandung dapar, pengencer ataubahan tambahan lain dan larutan yng diperoleh setelah persyaratan Injeksi, dan dapat dibedakan dari nama bentuknya, … Steril ; (3) sediaan seperti tertera pada (2) tetapi mengandung satu atau lebih zat padat, pengencer atau bahan tambahan lain, dan dapat dibedakan dari nama bentuknya, ... untuk injeksi ; (4) sediaan berupa suspensi serbuk dalam medium cair yang sesuai dan tidak disuntikkan secara intravena atau ke dalam saluran spinal, dan dapat dibedakan dari nama bentuknya, Suspensi … Steril dan (5) sediaan padat kering dengan bahan pembawa yang sesuai membentuk larutan yang memenuhi semua persyaratan untuk suspense steril setelah penambahan bahan pembawa yang sesuai, dan dapat dibedakan dari nama bentuknya, … Steril untuk Suspensi.

Injeksi merupakan salahsatu bentuk sediaan parenteral dimana memiliki :
1.Keuntungan
- Obat memiliki onset ( mulai kerja ) yang cepat
- Efek obat dapat diramalkan dengan pasti
- Bioavailabilitas sempurna atau hampir sempurna
- Kerusakan obat dalam tractus gastrointestinalis dapat dihindarkan
- Obat dapat diberikan kepada penderita yang sakit keras atau yang sedang
dalam keadaan koma
2.Kerugian
- Rasa nyeri saat disuntik, apalagi kalau harus diberikan berulang kali
- Memberikan efek psikologis pada penderita yang takut disuntik
- Kekeliruan pemberian obat atau dosis hampir tidak mungkin diperbaiki,
terutama sesudah pemberian intravena
- Obat hanya dapat diberikan kepada penderita di rumah sakit atau tempat
pratik dokter oleh dokter dan perawat yang kompetan ( Lukas, 2006, halaman
9 – 10 ).
Persyaratan sediaan parenteral antara lain :
1.Sesuai antara kandungan bahan obat yang ada di dalam sediaan dengan pernyataan
tertulis pada etiket dan tidak terjadi pengurangan kualitas selama penyimpanan
akibat perusakan obat secara kimiawi dan lain sebagainya.
2.Penggunaan wadah yang cocok, sehingga tidak hanya memungkinkan sediaan tetap
steril, tetapi juga mencegah terjadinya interaksi antara bahan obat da material
dinding wadah.
3.Tersatukan tanpe terjadi reaksi
4.Bebas kuma
5.Bebas pirogen
6.Isotonis
7.Isohidris
8.Bebas partikel melayang ( Lukas, 2006, halaman 10 ).

Tonisitas laruan obat suntik :
1.Isotonis
Jika suatu larutan konsentrasinya sama besar dengan konsentrasi dalam sel darah merah, sehingga tidak terjadi pertukaran cairan di antara keduanya, maka larutan dikatakan isotonis ( ekuivalen dengan larutan 0,9% NaCl ).
2.Isoosmotik
Jika suatu larutan memiliki tekanan osmose sama dengan tekanan osmose serum dara, maka larutan dikatakan isoosmotik ( 0,9% NaCl, 154 mmol Na+ dan 154 mmol Cl- per liter = 308 mmol per liter, tekanan osmose 6,86 ). Pengukuran menggunakan alat osmometer dengan kadar mol zat per liter larutan.

3.Hipotonis
Turunnya titik beku kecil, yaitu tekanan osmosenya lebih rendah dari serum darah, sehingga menyebabkna air akan melintasi membrane sel darah merah yang semipermeabel memperbesar volume sel darah merah dan menyebabkan peningkatan tekanan dalam sel. Tekanan yang lebih besar menyebabkan pecahnya sel – sel darah merah. Peristiwa demikian disebut Hemolisa.

4.Hipertonis
Turunnya titik beku besar, yaitu tekanan osmosenya lebih tinggi dari serum darah, sehingga menyebabkan air keluar dari sel darah merah melintasi membran semipermeabel dan mengakibatkan terjadinya penciutan sel – sel darah merah. Peristiwa demikian disebut Plasmolisa.
Bahan pembantu mengatur tonisitas adalah : NaCl, Glukosa, Sukrosa, KNO3 dan NaNO3
( Lukas, 2006, halaman 50 – 51 ).


Anonim, 1978, Formularium Nasional, edisi kedua, Departemen Kesehatan RI, Jakarta.
134. 323. 324.
Anonim, 1979, Farmakope Indonesia, edisi III, Departemen Kesehatan RI, Jakarta. 47.
97. 133 – 134. 404. 412.
Anonim, 1995, Farmakope Indonesia, edisi IV, Departemen Kesehatan RI, Jakarta. 39 –
40. 112 – 113. 584 – 585. 589 – 590.
Ansel, 2005, Pengantar Bentuk Sediaan Farmasi, edisi IV, UI-PRESS, Jakarta. 399-437.
Lukas, Stafanus, 2006, Formulasi Steril, ANDI Yogyakarta, Yogyakarta. 9-59. 105-125.

Metode dan Cara Sterilisasi

Metode sterilisasi
1. Kimia : antibiotic, fenol, ammonium quarterner, alcohol, gas etilen oksid, formaldehid.
2. Radiasi : UV ( 253,7 nm ), rediasi plasma ( laser ), sinar gamma, ionizing radiation.
3. Fisika : panas
a. Panas kering ( 170oC, lebih dari 2 jam ). Alatnya oven.
Sediaan yang akan disterilkan dimasukkan ke dalam wadah kemudian ditutup kedap atau penutupan ini dapat bersifat sementara untuk mencegah cemaran. Jika volume tiap wadah tidak lebih dari 30 ml, panaskan suhu pada 150oC selama 1 jam. Jika volume dalam tiap wadah lebih dari 30 ml, waktu 1 jam dihitung setelah seluruh isi tiap wadah mencapai suhu 150oC. wadah yang tertutup sementara, kemudian ditutup kedap menurut teknik aseptic ( Anonim, 1978: 324 )
b. Panas basah ( uap ) : 121oC selama 15 menit. Alatnya autoclave.
Sediaan yang disterilkan diisikan ke dalam wadah yang cocok, kemudian ditutup kedap. Jika dalam volume tiap wadah tidak lebih dari 100ml, sterilisasi dilakukan dengan uap air jenuh pada suhu 115oC sampai 116oC selama 30 menit. Jika volume tiap wadah lebih dari 100 ml, waktu sterilisasinya diperpanjang, hingga seluruh isi tiap wadah berada pada suhu 115oC - 116oC selama 30 menit ( Anonim, 1978 : 323 ).
4. Mekanik : filter
- Maksimal partikel berdiameter 300nm
- Membrane dengan pori o,2µm
- Larutan disaring melalui penyaring bakteri steril, diisikan ke dalam wadah akhir yang steril kemudian ditutup kedap menurut teknik aseptic ( Anonim, 1978: 324 ).
Cara uji sterilisasi antara lain :
1. Direct Inoculation of Culture Medium
- Media tioglikat cair yang mengandung glukosa dan Na.tioglikat. cocok untuk pengembangbiakan bakteri aerob. Suhu inkubasi 30oC – 35oC.
- Soya been casein digest medium merupakan medium yang membantu pertumbuhan bakteri anaerob dan fungi. Suhu inkubasi 30oC – 35oC, sedang fungi 20oC – 25oC.
2. Membran Filtrasi
Teknik yang banyak direkomendasikan farmakope, meliputi filtrasi cairan melalui membran steril. Filter lalu ditanam dalam media. Masa inkubasi 7 – 14 hari karena mungkin organism perlu adaptasi dahulu.
3. Introduction of Concentrate Culture Medium
Medium yang pekat langsung dimasukkan dalam wadah sampel yang akan ditumbuhkan. Tidak banyak digunakan, hanya dipakai bial ada kecurigaan akan adanya bakteri.

PEMBUATAN SEDIAAN SALEP MATA

Formula standar
Komposisi. Tiap g mengandung :
Sulfacetamidum Natricum 25 mg
Oculentum simplex hingga 1 g
Penyimpanan. Dalam wadah tertutup rapat atau dalam tube.
Dosis. 5 kali sehari, dioleskan.
Catatan. 1. Oculentum simplex terdiri dari 2,5 g setil alcohol, 6 g lemak bulu
domba, 40 g paraffin cair dan vasellin putih hingga 100 g.
Disterilkan dengan cara panas kering.
2. Dibuat dengan teknik aseptik
3. Sediaan berkekuatan lain : 100 mg; 200 mg ( Anonim, 1978 ).

Formula modifikasi
R/ Sulfacetamidum Natricum 0,25 g
Setil alcohol 0,24375 g
Lemak bulu domba 0,585 g
Parafin cair 3,9 g
Vaselin flavum ad 10 g

Salep merupakan sediaan semipadat yang umumnya bersifat anhydrous, berlemak, dan mengandung obat yang tidak larut atau terdispersi ( Saifullah, 2008 : 59 ). Salep dapat digunakan sebagai sediaan untuk tujuan pengobatan atau terapi ( harus mengandung bahan obat ), sebagai pelindung, pelunak kulit, atau sebagai pembawa ( vehikulum ) ( Saifullah, 2008 : 63 ). Salep tidak boleh berbau tengik, kecuali dinyatakan lain kadar obat di dalam salep yang mengandung keras atau obat narkotik tidak boleh lebih dari 10% ( Anief, 2000 : 53 ).
Salep yang baik memiliki sifat – sifat sebagai berikut :
a. Stabil : baik selama distribusi, penyimpanan, maupun pemakaian. Stabilitas terkait dengan kadaluarsa, baik secara fisik (bentuk, warna, bau, dll) maupun secara kimia ( kadar/kandungan zat aktif yang tersisa ). Stabilitas dipengaruhi oleh banyak factor, seperti suhu, kelembaban, cahaya, udara, dan lain sebagainya.
b. Lunak : walaupun salep pada umumnya digunakan pada daerah/wilayah kulit yang terbatas, namun salep harus cukup lunak sehingga mudah untuk dioleskan.
c. Mudah digunakan: supaya mudah dipakai, salep harus memiliki konsistensi yang tidak terlalu kental atau terlalu encer. Bila terlalu kental, salep akan sulit dioleskan, bila terlalu encer maka salep akan mudah mengalir/meleleh ke bagian lain dari kulit.
d. Protektif : salap – salep tertentu yang diperuntukkan untuk protektif, maka harus memiliki kemampuan melindungi kulit dari pengaruh luar misal dari pengaruh debu, basa, asam, dan sinar matahari.
e. Memiliki basis yang sesuai : basis yang digunakan harus tidak menghambat pelepasan obat dari basis, basis harus tidak mengiritasi, atau menyebabkan efek samping lain yang tidak dikehendaki.
f. Homogen : kadar zat aktif dalam sediaan salep cukup kecil, sehingga diperlukan upaya/usaha agar zat aktif tersebut dapat terdispersi/tercampur merata dalam basis. Hal ini akan terkait dengan efek terapi yang akan terjadi setelah salep diaplikasikan ( Saifullah, 2008 : 63, 64 ).
Salahsatu macam salep adalah salep mata yang digunakan pada mata. Dasar salep yang dipilih tidak boleh mengiritasi mata, memungkinkan difusi obat dalam cairan mata dan tetap mempertahankan aktivitas obat dalam jangka waktu tertentu pada kondisi penyimpanan yang tepat. Vaselin merupakan dasar salep mata yang sering banyak digunakan. Beberapa dasar salep yang dapat menyerap, bahan dasar yang mudah dicuci dengan air dan bahan dasar larut dalam air dapat digunakan untuk obat yang larut dalam air. Bahan dasar seperti ini memungkinkan dispersi obat larut air yang lebih baik, tetapi tidak boleh menyebabkan iritasi pada mata ( Anonim,1995 : 12, 13 ).
Salep mata harus mengandung bahan atau campuran bahan yang sesuai untuk mencegah pertumbuhan atau memusnahkan mikroba yang mungkin masuk secara tidak sengaja bila wadah dibuka pada waktu penggunaan; kecuali dinyatakan lain dalam monografi atau formulanya sendiri sudah bersifat baktriostatik. Bahan obat yang ditambahkan ke dalam dasar salep berbentuk larutan atau serbuk halus. Wadah untuk salep mata harus dalam keadaan steril pada waktu pengisian dan penutupan. Wadah salep harus tertutup rapat dan disegel untuk menjamin sterilitas pada pemakaian pertama ( Anonim, 1995 : 12 ).
Sulfasetamid adalah senyawa antibakteri golongan sulfonamide yang mempunyai spectrum luas dan banyak digunakan terhadap bermacam – macam penyakit infeksi oleh kuman gram positif maupun negative, salahsatunya pada infeksi mata yang disababkan oleh kuman – kuman yang peka terhadap sulfonamide. Sulfasetamid merupakan sulfonamide aksi pendek yang mempunyai aktivitas bakterisid ( Tjay, 2002 : 22 ).

Anonim, 1978, Formularium Nasional, edisi kedua, Departemen Kesehatan RI, Jakarta.
276. 323. 324.
Anonim, 1995, Farmakope Indonesia, edisi IV, Departemen Kesehatan RI, Jakarta. 12.
13. 856. 1038.
Anief, Moh, 2002, Ilmu Meracik Obat, Gadjah Mada University Press, Yogyakarta. 53.
Saifullah, T.N, dan Rina Kuswahyuning, 2008, Teknologi dan Formulasi Sediaan
Semipadat, Pustaka Laboratotium Teknologi Farmasi UGM, Yogyakarta. 59. 63. 64
Tjay, Tan Hoan , et all, 2000, Obat – Obat Penting, Elex Media Computindo, Jakarta.
132.

Hashimoto's disease is a member of the family of "auto-immune" diseases such as Rheumatoid arthritis.

Hashimoto’s disease is a member of the family of “auto-immune” diseases such as Rheumatoid arthritis. These diseases are characterized by an immune system that, for some reason, identifies the patient’s own tissue as being “foreign” or not a normal, natural part of that person’s body. A good example of this is demonstrated when a patient receives a kidney transplant and the immune system recognizes that this new tissue is, indeed, foreign. The immune system then makes antibodies to go and attack this “foreign” tissue. This results in a battle between the antibodies and the tissue perceived as foreign, and this results in inflammation. In the case of the kidney, it causes a “nephritis”. In the case of the rheumatoid arthritis patient, the joint capsule is attacked, and this causes an “arthritis”. In the thyroid it causes a “thyroiditis”.

There are other ways the thyroid gland can become inflamed and a thyroiditis results, but if the inflammation is due to the patient producing antibodies against his or her own thyroid gland, then it is called Hashimoto’s auto-immune chronic lymphocytic thyroiditis…..a big name we simply refer to as Hashimoto’s Disease, and for this discussion we will simply say “chronic thyroiditis”.

Chronic thyroiditis takes on importance in several ways. First, years of inflammation can lead to destruction of normal thyroid tissue, which in time can result in low thyroid hormone levels in the blood, or a disorder known as “hypothyroidism”. This will require treatment with lifelong thyroid medication to insure that the patient always has normal levels of thyroid hormone in the blood stream.

Second, extended periods of inflammation can lead to scarring and fibrosis and sometimes the formation of a round, hard nodule that is very difficult to distinguish from a thyroid tumor or even a thyroid cancer. These patients will sometimes have to undergo a thyroidectomy for this reason.

Third, all scar tissue wants to get smaller. This is called the process of “contracture”. For example, if you get a 6-inch cut on your leg today, a scar will form. If you measure that scar next year, lets say, it may only be 5 ½ inches long. Well, scar tissue in the thyroid gland also wants to get smaller, but the thyroid gland sort of wraps around the windpipe and the esophagus to some degree. When this scar tissue undergoes contracture it can put pressure on those structures and produce what are called “compression symptoms”, that is, difficulty in breathing or swallowing. Some patients have actually choked on their food and have required the Heimlich maneuver because of the tightness that has been created. Others say that they have difficulty in breathing, especially when they lie down. These patients may require thyroidectomy for relief of these symptoms.

Fourth, about 30% of our patients with thyroid cancer are also found to have chronic thyroiditis. This does not mean that if you have chronic thyroiditis that you will be certain to get thyroid cancer, but note is made of this casual relationship. There are a few voices out there that would recommend that all patients with Hashimoto’s Disease undergo thyroidectomy. This seems a bit radical and a very large number of patients would undergo unnecessary thyroid surgery. Close and thoughtful observation by a thyroid specialist seems to be a prudent course of action for patients with chronic thyroiditis. Surgery can always be recommended if a patient develops a mass or symptoms which require further treatment, with little negative impact on prognosis. Please remember, I am discussing this topic in general terms for informational use only. There is no substitute for you and your physician making medical decisions based on your individual and specific case.

Fifth, some patients with chronic thyroiditis may suffer intermittent bouts of hyperthyroidism, as the disease is known to have flare-ups with release of excess quantities of thyroid hormone now and again. These flare-ups require medical treatment. Only rarely is surgery required because of failure of this medical treatment.

Sixth, there are rare instances of lymphoma developing within the thyroid gland. Lymphoma is a cancer of the lymphatic system and can manifest itself in many ways, one way being enlargement of lymphatic tissue or lymph nodes. In the thyroid gland, this is usually a rapidly growing mass and it is important to distinguish this from a possible anaplastic cancer of the thyroid, which is extremely lethal. Often these lymphoma patients have long-standing chronic lymphocytic thyroiditis, and the lymphoma is believed by some, to arise in this background of chronic inflammation and irregular cells.

The diagnosis of Hashimoto’s Disease is really quite straightforward. First, an experienced examiner can almost always suspect Hashimoto’s Disease based on physical examination alone. The gland is usually slightly enlarged, often tender to the touch, and the upper and lower parts of the thyroid lobes are usually somewhat blunted or thickened. Next, there is a blood test called the thyroid antiperoxidase antibody test that is used to detect the presence of the autoimmune antibodies. This is almost 100% accurate, but I have had a few patients I have treated for Hashimoto’s thyroiditis in spite of the fact that they had a negative antibody test. These people had classic symptoms and physical findings of the disease.

And this brings us to treatment. Surgery is not the treatment for Hashimoto’s thyroiditis alone, but it is used to treat some of the effects of the disease as described above. Probably the most appropriate treatment for chronic thyroiditis is the use of thyroid hormone medication. By taking the correct amount of thyroid hormone by mouth, the thyroid gland will soon stop functioning, as it will have no need to continue its work. The only reason the thyroid gland functions at all is because the pituitary gland in the brain sends down a hormone that stimulates the thyroid gland to work. By taking thyroid medication by mouth, we are actually “tricking” the pituitary gland into believing that the thyroid is functioning normally, and it therefore stops sending this messenger down to stimulate the thyroid gland to work. Once the thyroid stops working, it will sort of fall off the radar screen of the immune system and it will no longer send antibodies to attack the thyroid gland. If the gland is not attacked, there is no inflammation…no inflammation, no destruction of the normal thyroid tissue…therefore there will not be formation of scar tissue, and so on. This treatment then assures that the body will maintain normal thyroid hormone levels in the blood stream from the medication, and hopefully all of the bad effects of chronic thyroiditis can be avoided, such as hypothyroidism, tenderness, formation of thyroid masses, compression symptoms, and so on. It is important to note, however, that the earlier treatment begins, the more successful it is. Often I see patients after years of chronic inflammation and scarring and none of that can be undone or reversed by medical treatment.

Graves' Disease can affect virtually any person, but females are far more commonly affected, and usually in the younger age groups.

There are a number of ways that a patient may become hyperthyroid, that is, have an excess amount of thyroid hormone circulating in the body. Some thyroid tumors may produce excessive amounts of hormone. Sometimes inflammation of the entire gland may release increased amounts of thyroid hormone into the blood stream. A state of hyperthyroidism could be caused simply by a patient taking too much thyroid hormone medication. One of the more common forms of hyperthyroidism is called Graves’ Disease, where the gland is usually symmetrically enlarged, soft, and very vascular, that is, it may have an increase in the size and number of nourishing blood vessels. There may be an auto immune aspect of Graves’ Disease that is shared with one of the forms of thyroiditis. Indeed, Hashimoto’s thyroiditis is frequently found simultaneously with active Graves’ Disease. When the thyroiditis is the more prominent feature of the changes in the thyroid gland, then the gland may not be large and soft, but rather actually firm and even "rubbery" while still enlarged.

Graves’ Disease can affect virtually any person, but females are far more commonly affected, and usually in the younger age groups. We’ve seen teenage boys and elderly men with this disease however, so again, it is not just limited to younger women.

I like to explain hyperthyroidism using the engine of your car as an example. If your car is supposed to idle at 1000 rpm’s and does so, it is the equivalent of having normal thyroid hormone levels in the blood stream. If your car idles at 5000 rpm’s, then it is a sick car, hyperthyroid if you will, and this, in time, will put a tremendous strain on your cars’ engine and your car as a whole. Similarly, when you are hyperthyroid, you are idling too fast and your body over the long run will pay the price. There is not enough room here to explain every conceivable side effect of Graves’ Disease, as this is not meant to be a medical text book for aspiring physicians, but allow me to list a few of the adverse affects of Graves’ Disease: a generalized anxiety and emotional lability, the patient my cry very easily and have emotional problems with his or her personal relationships; the ability to concentrate for long periods of time is lost, making work or reading a book quite difficult; the attention span is usually shortened; there may be weight loss in spite of increased appetite; random motion or the inability to sit quietly; fingernails may become brittle and break; the hair may become thinner; there may be chronic fatigue; menstrual periods may be irregular and scant; the patient may feel his or her heart beating in the chest—a symptom called "palpitation"; the pulse may be rapid; the blood pressure may be slightly elevated; the palms of the hands may be moist; sometimes there is a dryness of the eyes or even a "bulging" of the eyes that can be observed. This is called "exophthalmos".



Diagnosis

Diagnosing Graves’ disease should be quite simple, but the fact that its symptoms mimic so many other diseases, the diagnosis can sometimes be delayed. Although there are some exceptions, the typical Graves’ Disease patient will have elevated levels of thyroid hormone in the blood. At the same time, the TSH (or thyroid stimulating hormone, a hormone made in the brain and released into the blood to stimulate the release of thyroid hormone from the thyroid gland) will be markedly suppressed, often almost down to zero. Any patient with physical findings described above, the symptoms described above, and the blood tests mentioned above should certainly be suspected of having Graves’ Disease.



Treatment

There are basically three ways to treat Graves’ Disease: medication, radiation, and surgery. Each of these modalities of treatment has it’s advantages and disadvantages. First, anti-thyroid medication can be given over an extended length of time. The most commonly used drugs are called Tapazole and Propylthiouracil, or PTU. The plan with these drugs is generally to take them for perhaps a year or more and then stop the medication to see if there has been a spontaneous remission from the hyperthyroid state. This may be a useful way to treat patients who reject the idea of radiation exposure or patients who, for medical reasons, are not candidates for surgery. There are, however, a number of drawbacks with the medication approach to Graves’ Disease. First, the recurrence rate of the disease after treatment can be very high, perhaps 30-50% in some series. Also, there are side effects of the medicine which, while rare, can be very serious, such as suppression of the immune system requiring hospitalization and extensive care. This happens in less than 1% of patients—which isn’t much unless you are in the 1%. Also, the medical treatment of Graves’ Disease requires almost constant supervision by the doctor, necessitating frequent and continuous tests, medical appointments, etc. In today’s fast paced world and $30 co-pay for a doctor visit, this is, to some, an unattractive alternative. Radioactive iodine is the second treatment option. It has the advantages of avoiding toxic medication and foregoing an operation, but it, too, has some down side to it. First, it exposes the patient to a significant dose of radiation. In young women of childbearing age, especially those who intend to have children, this raises serious questions. There is concern about the possible relationship between radiation exposure and the formation of cancers in the body. While most studies have failed to show a direct link between birth defects of future children or cancer later in life, there are still enough questions about this that in many centers there is a policy not to treat the young or women of child bearing age with radiation therapy. Too, the first dose of radiation may be insufficient requiring still another dose, and perhaps still another. We have, on occasion, been called upon to operate on some such patients who have failed multiple treatments of radiation. The extensive radiation exposure that their thyroid gland and neck was subjected to made the operation far more difficult and risky than if the thyroid gland had simply been removed in the first place. One of the alleged advantages of radioactive iodine treatment is that by doing so, one may avoid the need to take a thyroid supplement pill on a daily basis. In our experience this has not always been the case.



Surgery

The third treatment option is surgical removal of the gland. While this does require an operation, it avoids the risks and recurrence rate of the other two forms of therapy. Indeed, with a total thyroidectomy, properly performed by experienced hands, the recurrence rate of Graves’ Disease is ZERO, and the complication rate is extremely close to that number. The operation takes about forty minutes complete. This stands in stark contrast to the years of doctors appointments and volumes of tests the patient must endure when treated by other options. Surgery is never without risk, however, and should not be taken lightly. The recurrence rate and complication rate mentioned above is a reflection of OUR work and cannot be universally assumed to apply to anyone else performing these procedures. Perhaps the most important advantage of surgery over the other methods of treatment for Graves’ Disease is found in patients who suffer from the eye problem or "exophthalmos" that can sometimes accompany this disease. Total thyroidectomy may increase the chances that the exophthalmos will improve or possibly even disappear following total thyroidectomy.