金刚烷胺三联疗法治疗无应答型丙型肝炎患者

作     者：Maynard M. Pradat P. Bailly F. C. Trépo 孟欣颖(译) 王顺涛(校) 

作者机构：不详 Department of Hepato-gastroenterology HotelDieu 1 place de I'Hopital 69288 Lyon Cedex 02 France 

出 版 物：《世界核心医学期刊文摘（胃肠病学分册）》 (Core Journals in Gastroenterology)

年 卷 期：2006年第2卷第8期

页      面：53-54页

学科分类：1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1011[医学-护理学（可授医学、理学学位）] 100401[医学-流行病与卫生统计学] 10[医学] 

主　　题：丙型肝炎患者 安慰剂治疗 三联疗法 金刚烷胺 无应答 聚乙二醇干扰素 持续病毒学应答 利巴韦林 动力学特征 随机试验 

摘      要：Background/Aims: To determine whether addition of amantadine to pegylated interferon/ribavirin improved response rates among chronic hepatitis C patients, non-responders to interferon/ ribavirin and study the dynamic of response. Methods: In a double blind, multicenter, randomized trial, 200 non-responder patients received pegylated interferon 1.5 μ g/kg per week and ribavirin 800- 1200 mg/day, plus either amantadine 200 mg/day or placebo for 48 weeks. Endpoints were virological responses, ALT normalization, and histological benefit overtime. Results: Twenty percent of all patients achieved a sustained virological response (SVR). This rate was 8% higher in the triple therapy group (24% ) compared with the double therapy group (16% ) (P=0.22). A better virological response rate at week 24 was observed in the triple regimen group (43 vs 29% ; P=0.06), which was lost at week 48 suggesting viral escape. The biochemical response rate was also significantly higher with triple therapy at week 12 (63 vs 49% ; P=0.05) and week 24 (64 vs 49% ; P=0.03). Fibrosis stabilized or improved in 77% of all patients. Conclusions: Re-treatment of interferon/ ribavirin non-responder patients should be encouraged since a substantial proportion benefits from retreat-ment with pegylated interferon/ribavirin ± amantadine. In triple therapy involving amantadine, a time wise response and an increased SVR rate in subgroups less prone to viral breakthrough suggest clues for existing controversies.