聚乙二醇干扰素α-2b联用利巴韦林治疗慢性丙型肝炎的临床安全性研究

Clinical study on safety of peginterferon α-2b plus ribavirin for treating chronic hepatitis C

目的:研究聚乙二醇干扰素α-2b联用利巴韦林治疗慢性丙型肝炎的安全性。方法:40例慢性丙型肝炎患者随机分为两组:治疗组(26例)与对照组(14例)。两组患者的一般特征包括平均年龄、身高、体重、血压、心率、体温等相似,无统计学差异(P>0.05)。治疗组患者皮下注射聚乙二醇干扰素α-2b50μg,1次/周,口服利巴韦林800～1050mg,1次/d。对照组患者皮下注射重组干扰素α-2b,3MIU,3次/周,口服利巴韦林800～1050mg,1次/d。总疗程两组均为48周,停药后再观察24周。结果:两组的不良反应表现基本一致,其体征和症状为疲乏、不适、发热、恶心、血小板减少及甲状腺功能低下等。两组的不良反应发生率无明显差异。结论:聚乙二醇干扰素α-2b联用利巴韦林治疗慢性丙型肝炎的安全性与重组干扰素α-2b联用利巴韦林的安全性相当。

Objective： To study the safety of peginterforon α-2b plus fibavifin for treating chronic hepatitis C. Methods： Forty patients with chronic hepatitis C were divided randomizely into two groups： treatment group （26 cases）and control group （14 cases）. The two groups were well-matched at entry, with no statistical differences in the patients＇ characteristics including average age, hight, weight, blood pressure, heart rate, temperature, and so on （P 〉 0.05）. The patients in the treatment group were administered with peginterferon α-2b 50 μg subcutaneously, once a week, plus fibavifin 800-1050 mg by mouth, once daily. The patients in the control group were administered with recombinant interferon α-2b 3 MIU subcutaneously, three times a week, plus fibavirin 800～1050 mg by mouth, once daily. The total therapy duration for the two groups was 48 weeks, and a 24-week observation was performed after treatments. Results： The manifestations of adverse reactions in the two groups were almost same, and the common signs and symptoms were fatigue, indisposition, fever, nausea, thrombocytopenia, hypothyroidism, and so on. There was no significant difference between the two groups in the incidence of adverse reactions.Conclusion： The safety of peginterferon α-2b plus fibavifin for treating chronic hepatitis C is comparable to that of recombinant interferon α-2b plus fibavirin.