茵兰益肝颗粒治疗慢性病毒性肝炎(肝胆湿热、气滞血瘀证)Ⅱ期临床研究

The summary of the Ⅱ period clinical test about Yinlanyigan granula in treating chronic hepatitis B (Syndrome of damp-heat of liver and gallbladder&Qi stagnation and blood stasis)

目的初步评价茵兰益肝颗粒治疗慢性病毒性肝炎(肝胆湿热、气滞血瘀证)的疗效及安全性,为Ⅲ期临床试验研究提供依据。方法采用多中心、随机、双盲、茵兰益肝颗粒与阳性药利肝隆颗粒平行对照的研究方法,治疗组60例,服用茵兰益肝颗粒10 g,一天三次,对照组60例,服用利肝隆颗粒10g,一天三次,治疗期共12周,服药后2周、4周、8周、12周各进行1次访视,观察ALT复常率,AST复常率,中医证候总积分变化值,以及安全性指标。结果治疗12周,ALT复常率治疗组68.3%,对照组43.3%,两组差异有统计学意义(P<0.05);AST复常率治疗组60.0%,对照组48.3%,两组差异无统计学意义(P>0.05);中医证候总积分变化值治疗组要优于对照组(P<0.05);安全性方面两组均无不良事件发生。结论茵兰益肝颗粒有治疗慢性病毒性肝炎的功效,与对照组相比,在恢复ALT以及改善患者症状等方面具备优势。Ⅱ期临床试验验证了茵兰益肝颗粒的安全性和有效性,建议开展Ⅲ期临床研究,进一步加以验证。

Objective To preliminary evaluate the efficacy and safety of Yinlanyigan granula in treating the chronic viral hepatitis （Syndrome of damp -heat of liver and gallbladder ＆ Qi stagnation and blood stasis） ,and to supply the basis for the Ⅲ period clinical test. Methods Applied the methods of multicenter, randomized, doubleblind , and parallel comparison of Yinlanyigan granula and the positive medicine Liganlong granula. The 60 cases of treatment group were administered with Yinlanyigan granula 10 grams a time,three times a day. The 60 cases of Control group were administered with Liganlong granula 10 grams a time ,three times a day. The total treatment period was 12 weeks. There will be a visiting in the 2nd weeks ,the 4nd weeks,the 8nd weeks and the 12nd weeks for observing the ALT and AST normalization rates ,the changes in value of the total scores of TCM syndromes and assessing relevant safety index. Results After the 12w treating period , the ALT normalization rate was 68.3% in the treatment group and 43.3% in the control group ,and the difference between them was significant （P 〈0.05）. the AST normalization rate was 60.0% in the treatment group and 48.3% in the control group ,and the difference between them was not significant （P 〉0. 05）. As the changes in value of the total scores of TCM syndromes , the treatment group is better than the control group. No ad- verse event was found in both the two groups. Conclusion Yinlanyigan granula has the efficacy of treating chronic viral hepatitis. Compared with the control group , the treatment group is superior in recovering the ALT and improving the patients＇syndromes. The Ⅱ period clinical test has verified the efficacy and safety of Yinlanyigan granula. For having this, the m period clinical test should be carried out to make the further study.