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1、EBM,Reporter: R2 王人緯 Supervisor: MA 董淳武 2010/01/28,情境,李先生在3年前因為尿毒症狀與急性肺水腫開始接受規則的血液透析治療。原本對於自己慢性C型肝炎帶原的狀況也多不以為意，只是順從醫囑接受每個月肝功能檢測與定期每半年接受肝臟超音波的篩檢。但是從去年的8月到現在，每個月的肝功能檢測在AST和ALT (肝臟轉胺酶)部分均有明顯異常的現象，其數值都一直維持在70至100 U/L之間。他聽從查房主治醫師的建議去肝臟科門診求診，追蹤的超音波檢查並沒有發現肝臟硬化或是肝腫瘤的情形，所以門診醫師只建議他定期追蹤就好。但李先生真的很擔心，因為在他隔壁床的李媽媽
2、於去年底才因慢性C型肝炎帶原併發肝癌去世，而李媽媽的每個月抽血也經常發現AST和ALT多有偏高的現象。李先生又聽說很多人因為C型肝炎久了產生肝硬化現象而造成腹水和食道靜脈瘤出血，為此他真的很害怕且煩惱。剛好健保局在去年10月公告要擴大B 、C肝炎藥物給付條件與延長治療的療程。所以李先生想知道，他是否可以符合健保的給付以接受C型肝炎的治療(干擾素治療加上抗病毒藥物)；以及接受這一項治療的好處和可能帶來的副作用或後遺症。,Five steps to practice EBM (Q-S-A-P-A),Question Asking an answerable question Search Trac
3、king down the best evidence Appraisal Critical appraisal Practice Integrating the appraisal with clinical experise and patients preference Audit Evaluation the effectiveness and efficiency in executing step 1-4,The Question Formation,Formulate the clinical question:,In a hemodialysis patient with HC
4、V infection, is the intervention of IFN/RBV treatment effective to viral eradication without massive adverse events compared to no treatment?,Five steps to practice EBM (Q-S-A-P-A),Question Asking an answerable question Search Tracking down the best evidence Appraisal Critical appraisal Practice Int
5、egrating the appraisal with clinical experise and patients preference Audit Evaluation the effectiveness and efficiency in executing step 1-4,Five steps to practice EBM (Q-S-A-P-A),Question Asking an answerable question Search Tracking down the best evidence Appraisal Critical appraisal Practice Int
6、egrating the appraisal with clinical experise and patients preference Audit Evaluation the effectiveness and efficiency in executing step 1-4,Critical Appraisal Skills Program (CASP),Validity (Reliability) 效度/信度 Can we believe it ? (研究方法的探討) Importance (Impact) 重要性 We believe it ! But does it matter
7、? (研究結果的分析) Practice (Applicability) 臨床適用性 If we believe it - does it apply to our patients? (如何在臨床運用),Oxford Center for Evidence-based Medicine Levels of Evidence (May 2001),American Gastroenterological Association medical position statement on the management of hepatitis C Dienstag JL, McHutchison
8、 JG. American Gastroenterological Association medical position statement on the management of hepatitis C. Gastroenterology 2006 Jan;130(1):225-30.,Guideline,End-stage renal disease. Currently, ribavirin is contraindicated in patients with renal failure; however, clinical trials are in progress to a
9、ssess the safety and efficacy of low-dose ribavirin combined with PEG-IFN. At present, the role of antiviral therapy in patients with end-stage renal disease remains undefined. For individual patients, the potential benefit of therapy should be weighed against the higher risk of toxicity, and treatm
10、ent should be undertaken in centers with experienced clinicians, ideally in clinical trials. For PEG-IFN alfa-2a, a dose reduction from 180 to 135 micrograms is recommended by the manufacturer for patients with renal failure; for PEG-IFN alfa-2b, the manufacturer makes no specific recommendation abo
11、ut dose reduction for patients with renal failure, but 50% dose reductions are recommended for other clinical indications (e.g., hematologic). Patients with end-stage renal disease and chronic hepatitis C who are candidates for kidney transplantation should be evaluated for advanced hepatic fibrosis
12、, which is associated with reduced graft and patient survival.,Diagnosis, management, and treatment of hepatitis C: an updateGhany MG, Strader DB, Thomas DL, Seeff LB, American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 200
13、9 Apr;49(4):1335-74.,Guideline,Treatment of HCV in patients on dialysis may be considered with either standard interferon (2a or 2b) in a dose of 3 mU 3 times a week (t.i.w.) or reduced dose pegylated interferon 2a, 135 micrograms/week or 2b 1 microgram/kg/week. (Class IIa, level C) Ribavirin can be
14、 used in combination with interferon in a markedly reduced daily dose with careful monitoring for anemia and other adverse effects. (Class IIb, level C),Level 1b,OBJECTIVES The goal of the study was to determine the efficacy and safety of pegylated interferon a-2b in haemodialysis patients with chro
15、nic hepatitis CMethod Randomized clinical trials Patient number: 16(HCV RNA positive by PCR and under H/D) Randomized haemodialysis patients with chronic hepatitis C to 1.0 or 0.5 mg/kg of pegylated interferon a-2b subcutaneously, weekly for up to 48 weeks. End-points were sustained viral response a
16、nd adverse events.,Inclusion criteria Age =18 y/o Serum positive for HCV RNA by PCR Liver biopsy within 36 months of inclusion confirming a pathological diagnosis of chronic hepatitis C Compensated liver disease defined as absence of ascites, variceal bleeding, or encephalopathy and, PLT90.000mm3 Hb=8.0g/dl WBC=2500/mm3 and neutrophil count =1500/mm3 Thyroid-stimulating hormone within normal limits or thyroid disease under control Never treated with interferon before Subjects were required to use two elective methods of contraception.,
