阿德福韦酯联合双环醇片治疗慢性乙型肝炎的疗效和安全性分析

Effectiveness and safety of adefovir dipivoxil combined with bicyclol in treatment of chronic hepatitis B

目的研究阿德福韦酯联合双环醇片治疗慢性乙型肝炎的疗效和安全性。方法选择125例曾应用拉米夫定治疗的慢性乙型肝炎患者,随机分2组接受治疗。试验组63例,每日口服阿德福韦酯10mg,同时每日服用双环醇片75mg;对照组62例,仅给予每日口服阿德福韦酯10mg。2组均连续用药48周。观察治疗前后血清氨基转移酶水平及病毒学指标方面的改变。结果2组血清氨基转移酶均明显下降,试验组更为显著(P<0.05或<0.01)。试验组HBV DNA阴转率(58.7%)显著高于对照组(40.3%),P<0.05;HBeAg阴转率(31.8%)显著高于对照组(16.1%),P<0.05;HBeAg血清转换率(19.1%)虽高于对照组(11.3%),但差异无统计学意义。2组均未发生与研究药物相关的不良反应。结论阿德福韦酯与双环醇片联合应用治疗慢性乙型肝炎在肝功能及病毒学方面取得较好疗效且安全。

Objective To analyze the effectiveness and safety ofadefovir dipivoxil combined with bieyclol in treatment of chronic viral hepatitis B （ CHB ）. Methods A total of 125 patients with CHB were randomized into the experimental group and the control group. The patients in the experimental group （63 samples ） received adefovir dipivoxil orally 10 mg daily and bieyelol orally 75 mg daily for 48 weeks and those in the control group （ 62 samples ） received adefovir dipivoxil orally 10 mg daily alone for 48 weeks. The serum aminotransferaee （ ALT/AST ）, HBV DNA,and HBeAg/antiHBe were observed before and after treatment. Results Compared with pre-treatment, the serum aminotransferaee decreased obviously in two groups, especially in the experimental group （ P〈0.05,P〈0.01 ）. HBV DNA negative conversion rate was significantly higher in the experimental group than that in the control group （ 58.7% vs. 40.3%, P〈0.05 ）. HBeAg loss rate was significantly higher in experimental group than that in the control group （ 31.8% vs.16.1%,P〈0.05 ）. There were no statistical difference between the two groups in the portion of HBeAg seroeonversion rate. There were no obvious adverse events which were probably related to drugs in the study. Conclusion Adefovir dipivoxil combined with bieyelol is effective and safe in the treatment of chronic hepatitis B.