茵兰益肝颗粒治疗急性黄疸型病毒性肝炎的疗效及安全性研究

Efficacy and Safety of Yinlan Yigan Granula in Treating Acute Icteric Viral Hepatitis

目的初步评价茵兰益肝颗粒治疗急性黄疸型病毒性肝炎(肝胆湿热、气滞血瘀证)的疗效及安全性,为Ⅲ期临床试验提供依据。方法采用多中心、随机、双盲、阳性药平行对照方法,治疗组60例,服用茵兰益肝颗粒;对照组60例,服用利肝隆颗粒;疗程4周。服药后1周、2周、3周、4周各进行1次访视,观察血清丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)的复常率,中医证候总积分以及安全性指标。结果治疗4周,试验组ALT、AST复常率分别为81.4%、83.1%,对照组分别为85.0%、88.3%,两组比较差异无统计学意义(P>0.05);两组中医证候总积分比较差异无统计学意义(P>0.05)。两组不良事件发生率均为1.7%,差异无统计学意义(P>0.05)。结论茵兰益肝颗粒治疗急性黄疸型病毒性肝炎有效、安全,能够恢复ALT、AST,改善患者症状,疗效与利肝隆颗粒相仿,可开展Ⅲ期临床研究。

Objective To preliminarily evaluate the efficacy and safety of Yinlan Yigan granula in treating acute icteric viral hepatitis with the syndrome of damp-heat in liver and gallbladder and with the syndrome of qi stagnation and blood stasis, thus to supply evidence for phase III clinical trial. Methods A muhicenter, randomized, double-blind, and positive-medicine paralleled controlled trail was carried out in 120 qualified patients. The treatment group had 60 cases, and was administered with Yinlan Yigan granula. The control group also had 60 cases, and was administered with Liganlong granula. The course of treatment lasted 4 weeks. An interview was made on week 1, 2, 3, 4 after medication. The normalization rate of alanine aminotransferase （ALT） and aspartate aminotransferase （AST） was detected, and the changes in total scores of traditional Chinese medical syndromes as well as relevant safety indexes were examined. Results After treatment for 4 weeks, the ALT normalization rate was 81.4 % in the treatment group and was 85.0 % in the control group, and the difference between them was insignificant （P 〉 0.05）. The AST normalization rate was 83.1% in the treatment group and was 88.3 % in the control group, and the difference between them was insignificant（P〉 0.05）. The differences of the total scores of traditional Chinese medical syndromes were also insignificant between the two groups. The incidence of adverse events was 1.7% in both groups, the difference being not significant（P〉 0.05 ）. Conclusion Yinlan Yigan granula is effective and safe in treating acute icteric viral hepatitis through recovering the ALT and AST levels and by relieving the symptoms, and its effect is similar to that of Liganlong granula, indicating that phase III clinical trial can be developed.