六味五灵片治疗慢性乙型肝炎的降酶疗效和安全性研究  

Efficacy and safety of Liuweiwuling tablet in the treatment of chronic hepatitis B

作　　者：丁晋彪[1] 韩晋[2] 陈建杰[3] 杨帆[4] 施建飞[5] 

机构地区：[1]解放军第三〇二医院医务部,北京100039 [2]解放军第三〇二医院药学部,北京100039 [3]上海中医药大学附属曙光医院肝病科,200021 [4]湖北省中医院肝病科,武汉430061 [5]解放军第三〇二医院,北京100039

出　　处：《传染病信息》2012年第1期19-21,共3页Infectious Disease Information

基　　金：国家"十一五"重大新药创制GCP平台课题(2008ZX0-9312-011)

摘　　要：目的评价六味五灵片治疗慢性乙型肝炎(chronic hepatitis B,CHB)的降酶疗效及安全性。方法采用多中心、随机、双盲双模拟、六味五灵片与阳性药联苯双酯滴丸平行对照研究方法。临床治疗24周,分为常规量治疗期12周和减量治疗期12周两个阶段。第一阶段229例CHB患者按1:1随机双盲分成2组(试验组114例,对照组115例)。试验组口服六味五灵片(3片/次,3次/d)及联苯双酯滴丸模拟剂(5丸/次,3次/d),对照组口服六味五灵片模拟剂(3片/次,3次/d)及联苯双酯滴丸(5丸/次,3次/d)。第二阶段所有患者的用药每4周逐步递减。在完成24周的治疗后有效病例停药随访12周。结果治疗24周后,ALT下降的显效率试验组为68.42%,对照组为61.74%,2组比较差异无统计学意义。ALT下降的临床总有效率试验组为72.81%,对照组为66.96%,2组比较差异无统计学意义。表明试验药六味五灵片在降低ALT方面不亚于对照药联苯双酯滴丸。随访12周后ALT保持正常的比例,试验组为84.85%,对照组为62.30%,2组比较差异有统计学意义。表明试验组在保持ALT正常方面明显优于对照组。临床试验期间试验组和对照组均未发生严重不良反应。结论六味五灵片在降酶方面与联苯双酯滴丸疗效相当,而且停药后六味五灵片在保持ALT正常方面明显优于联苯双酯滴丸。提示六味五灵片是一种治疗CHBALT升高的安全有效的药物,其降低ALT的疗效持久稳定。Objective To evaluate the efficacy and safety of Liuweiwuling tablet in the treatment of chronic hepatitis B （CHB）. Methods A multicenter, randomized, double-blind, placebo-controlled trial of Liuweiwuling tablet for CHB was conducted. The trial included two treatment periods, 12 weeks of treatment with regular doses and another 12 weeks of treatment with reduced doses. During the first 12 weeks, 229 CHB patients were randomly divided into the test group （n=l14） and the control group （n=l15）. The patients in the test group were administered with Liuweiwuling tablet （3 tablets per time, 3 times per day） and placebo of imitating bifendate （5 pills per time, 3 times per day）, and the patients in the control group with placebo of imitating Liuweiwuling tablet （3 tablets per time, 3 times per day） and bifendate （5 pills per time, 3 times per day）. In the second 12 weeks, all patients received gradually reduced doses of treatment every 4 weeks. After 24 weeks of treatment, the effective patients were given 12 weeks of follow- up. Results At week 24 of treatment, ALT normalization rate was 68.42% in the test group and 61.74% in the control group, and the difference between them was not significant. The effectiveness rate of the decrease in ALT levels was 72.81% in the test group and 66.96% in the control group, and the difference between them was not significant. It was indicated that Liuweiwuling tablet was as good as bifendate in reducing ALT levels. After 12 weeks of follow-up, ALT levels remained normal in 84.85% of the patients in the test group and in 62.30% of the patients in the control group, and the difference between them was significant. It was shown that the test group was superior to the control group in keeping ALT at a normal level. No adverse reactions were found in the test group and the control group during clinical study. Conclusions Liuweiwuling tablet is as effective as bifendate in reducing ALT levels and superior to bifendate in keeping ALT at a normal level after with

关 键 词：六味五灵片 乙型肝炎 慢性 临床试验 对照组 治疗学 治疗结果 

分 类 号：R512.62[医药卫生—内科学]