阿德福韦酯联合复方鳖甲软肝片治疗慢性乙型肝炎52例临床分析

Efficacy and safety of adefovir dipivoxil combined with fufangbiejiaruangan in treatment of chronic hepatitis B

目的观察阿德福韦酯联合复方鳖甲软肝片治疗慢性乙型肝炎的疗效和安全性。方法选择105例慢性乙型肝炎患者,随机分为两组治疗。治疗组52例,口服阿德福韦酯10mg,1次/d,同时口服复方鳖甲软肝片2.0g,3次/d;对照组53例仅给予口服阿德福韦酯10mg,1次/d。两组均连续用药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。结果两组血清氨基转移酶均明显下降,治疗组更为显著(P<0.05);治疗组HBVDNA阴转率(67.3%)显著高于对照组(43.3%)(P<0.05);治疗组HBeAg阴转率(40.4%)显著高于对照组(18.9%),(P<0.05);治疗组HBeAg血清转换率(21.1%)高于对照组(13.2%),但无统计学意义。两组均未发生与治疗药物相关的不良反应。结论阿德福韦酯联合复方鳖甲软肝片治疗慢性乙型肝炎在肝功能、病毒学方面取得较好疗效且安全。

Objective To observe the efficacy and safety of adefovir dipivoxil（ADV） combined with fufangbiejiaruangan in treatment of chronic hepatitis B （CHB）. Methods A total of 105 patients with CHB were randomized into the experimental group and the control group. 7he patients in the experimental group （52 samples） received ADV orally 10 mg daily and fufangbiejiaruangan orally 2.0 tid for 48 weeks and those in the control group （53 samples） received ADV orally 10 mg daily alone for 48 weeks. The serum aminotransferace（ ALT/AST）, HBV DNA, and HBeAg/antiHBe were observed before and after treatment. Results Compared with pre - treatment, the serum aminotransferace decreased obviously in two groups, especially in the experimental group （ P 〈 0.05 ）. HBV DNA negative conversion rate was significantly higher in the experimental group than that in the control group （67. 3% vs. 43.3%, P 〈 0.05 ）. HBeAg loss rate was significantly higher in experimental group than that in the control group（40.4% vs. 18.9%, P 〈 0.05）. There were no statistical difference between the two groups in the portion of HBeAg seroconversion rate. There were no significant adverse events which were probably related to drugs in the study. Conclusion ADV combined with fufanghiejiaruangan is effective and safe in the treatment of CHB.