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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 investigate the safety of peginterferon alfa-2b combined with ribavirin in the treatment of chronic hepatitis C Methods: Forty patients with chronic hepatitis C were randomly divided into two groups: treatment group (26 cases) and control group (14 cases). The general characteristics of two groups of patients, including the average age, height, weight, blood pressure, heart rate, body temperature and other similar, no significant difference (P> 0.05). Patients in the treatment group were subcutaneously injected with peginterferon alfa-2b (50 μg) once a week for oral ribavirin 800 to 1050 mg once daily. Patients in the control group received subcutaneous injections of recombinant interferon alpha-2b, 3MIU, 3 times / week and oral ribavirin 800-1050mg once daily. The total course of treatment was 48 weeks in both groups, and then observed for 24 weeks after withdrawal. Results: The two groups showed basically the same adverse reactions, signs and symptoms of fatigue, malaise, fever, nausea, thrombocytopenia and hypothyroidism. There was no significant difference in the incidence of adverse reactions between the two groups. Conclusions: The safety of peginterferon alfa-2b combined with ribavirin in the treatment of chronic hepatitis C is equivalent to that of recombinant interferon α-2b in combination with ribavirin.