聚乙二醇干扰素α-2b联合利巴韦林治疗慢性丙型肝炎的随机对照临床研究  

A randomized controlled clinical study of lower-dose peginterferon alfa-2b in combination with ribavirin in the treatment of chronic hepatitis C

作　　者：罗端德[1] 易建华[1] 蔡淑清[1] 张继明[2] 张树林[3] 王耀宗[4] 韦嘉[5] 杨玉秀[6] 

机构地区：[1]华中科技大学附属协和医院,武汉430022 [2]复旦大学附属华山医院 [3]西安交通大学第一医院 [4]济南市传染病医院 [5]昆明医学院附属第一医院 [6]河南省人民医院

出　　处：《中华传染病杂志》2006年第3期175-178,共4页Chinese Journal of Infectious Diseases

摘　　要：目的评价小剂量聚乙二醇干扰素α-2b联合利巴韦林治疗慢性丙型病毒性肝炎的疗效和安全性。方法192例慢性丙型肝炎患者随机分为两组：聚乙二醇干扰素α-2b 0．5μg/kg每周一次联合利巴韦林750～1050 mg/d,或普通干扰素α-2b 3 MIU每周3次联合利巴韦林750～1050 mg/d。疗程48周,治疗结束后随访24周。结果聚乙二醇干扰素α-2b联合利巴韦林治疗的持续病毒学应答率为53．8%,而普通干扰素α-2b联合利巴韦林治疗的持续病毒学应答率为58．1%,两组持续病毒学应答率相当(P=0．966)。聚乙二醇干扰素α-2b治疗组的药物相关性不良反应发生率为100%,而普通干扰素α-2b治疗组的不良反应发生率为95．2%,两组间差异有统计学意义(P= 0．033)。但是没有与干扰素α-2b聚乙二醇化相关的特有的新的不良反应发生。结论小剂量聚乙二醇干扰素α-2b联合利巴韦林治疗慢性丙型肝炎的疗效和安全性与普通干扰素α-2b联合利巴韦林治疗的疗效和安全性相当。Objective To compare the effecacy and safety of lower-dose peginterferon alfa-2b plus ribavirin versus standard interferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in China. Methods 192 patients with chronic hepatitis C were assigned peginterferon alfa-2b 0.5 μg/kg each week plus ribavirin 750～1050 mg/d or standard interferon alfa-2b 3 MIU T1W pins ribavirin 750～1050 mg/d for 48-week treatment and 24-week fellow-up. Results The sustained virological response （SVR） rate in lower-dose peginterferon alfa-2b plus ribavirin group was 53.8 %, and the SVR rate in standard interferon alfa-2b pins ribavirin was 58. 1%. The SVR was similar between the two treatment group （P=0. 966 for both comparisons）. The adverse event rate was higher in peginterferon alfa-2b plus ribavirin group than in standard interferon alfa-2b plus ribavirin group （P=0. 033 for both comparisons）, but there was no new or unique adverse event in related to pegylation of interferon alfa-2b. Conclusion The effecacy and safety was similar between lower-dose peginterferon alfa-2b plus ribavirin and standard interferon alfa-2b pins ribavirin for treatment of chronic hepatitis C.

关 键 词：肝炎 丙型 慢性 聚乙烯二醇类 干扰素Α-2B 利巴韦林 

分 类 号：R512.63[医药卫生—内科学] R978.1[医药卫生—临床医学]