六味五灵片治疗慢性乙型肝炎多中心随机对照研究  

The clinical study of Liuweiwuling tablet on patients with chronic hepatitis B

作　　者：辛绍杰[1] 韩晋[1] 丁晋彪[1] 陈建杰[2] 王融冰[3] 李秀惠[4] 王业东[1] 陈菊梅[1] 

机构地区：[1]中国人民解放军第三○二医院,北京100039 [2]上海中医药大学附属曙光医院 [3]北京地坛医院中西医结合科 [4]北京佑安医院中西医结合科

出　　处：《中西医结合肝病杂志》2009年第1期7-9,共3页Chinese Journal of Integrated Traditional and Western Medicine on Liver Diseases

摘　　要：目的:观察六味五灵片治疗慢性乙型肝炎(CHB)的临床疗效和安全性。方法:采用多中心、随机、对照方法。治疗组324例,口服六味五灵片;对照组108例,口服联苯双酯滴丸。研究分临床治疗阶段和随访阶段。临床治疗阶段6个月,分为常规量治疗期3个月和减量治疗期3个月两个分阶段。在完成6个月的治疗后,ALT恢复正常或下降75%的病例进入随访阶段。随访阶段为3个月。结果:两组患者治疗3个月及6个月后肝功能及中医证候均有明显改善;在降低AST水平方面,六味五灵片治疗组明显高于联苯双酯滴丸对照组(P<0.01、P<0.05),且AST复常的总有效率亦明显高于对照组(P<0.05)。两组病例治疗结束后随访3个月,治疗组ALT反跳率(11.11%)低于对照组(32.41%)(P<0.05);治疗组AST反跳率(14.20%)亦低于对照组(20.37%)(P<0.05)。结论:六味五灵片治疗CHB,ALT、AST反跳率低、稳定性好,有很好的安全性。Objective： To observe the clinical efficacy and safety of Liuweiwuling tablet in the treatment of chronic hepatitis B. Methods： This trail was a multi-center, randomized and control design. The treatment group had 324 patients with oral administration of Liuweiwuling tablet. The control group had 108 patients with oral administration of Biphenyldicarboxylate. The study was divided into 2 periods, that is, clinical therapeutic period and follow-up period. The period of clinical treatment was for 6 months, including the treatment of routine dosage for 3 months and decreased dosage for 3 months. After the 6 months of therapeutic period, the patients with ALT value coming back to normal or decreasing more than 75% came into the stage of followup. The period of follow-up was for 3 months. Results： After the treatment for 3 months and 6 months, the liver function and TCM syndrome of patients in the two groups were both improved obviously. The effect of Liuweiwuling tablet in making the level of AST normal was better than that of Biphenyldicarboxylate （ P 〈 0. 01, P 〈 0. 05 ） . And in the effect of AST resuming normal level, the total efficacy of Liuweiwuling tablet was much higher than that of Biphenyldicarboxylate （P 〈 0. 05） . TCM syndrome was improved obviously. After the treatment, the two groups was followed up for 3 months. The rebounding rate of ALT in the treatment group was 11.11%, while in the control group was 32. 41% （P 〈0. 05） . The rebounding rate of AST in the treatment group was 14. 20%, while in the control group was 20. 37% （P〈0. 05） . Conclusion： Liuweiwuling tablet had lower rebounding rate of ALT and AST, better stability and safety in the treatment of chronic hepatitis B.

关 键 词：肝炎 乙型 慢性 六味五灵片/治疗应用 病例对照研究 

分 类 号：R259[医药卫生—中西医结合]