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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
【摘要】 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。
【Abstract】 Objective:To study the safety of peginterferon α-2b plus ribavirin 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 peginterferonα-2b 50 μg subcutaneously,once a week,plus ribavirin 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 ribavirin 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 peginterferonα-2b plus ribavirin for treating chronic hepatitis C is comparable to that of recombinant interferonα-2b plus ribavirin.
- 【文献出处】 药物不良反应杂志 ,Adverse Drug Reactions Journal , 编辑部邮箱 ,2006年06期
- 【分类号】R512.6
- 【被引频次】1
- 【下载频次】98