六味五灵片联合恩替卡韦治疗慢性乙型肝炎的Meta分析

Meta-analysis of Liuwei Wuling Tablets Combined with Entecavir in the Treatment of Chronic Hepatitis B

目的:系统评价六味五灵片联合恩替卡韦治疗慢性乙型肝炎的有效性,为临床提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Web of Science、中国期刊全文数据库(CJFD)、万方数据库和中文科技期刊数据库(VIP),收集六味五灵片联合恩替卡韦(试验组)对比恩替卡韦单用(对照组)治疗慢性乙型肝炎的随机对照试验(RCT),提取数据并按照Cochrane系统评价员手册5.1.0评价质量后,采用Rev Man 5.3统计软件进行Meta分析。结果:最终纳入8项RCT,共计728例患者。Meta分析结果显示,试验组患者血清丙氨酸转氨酶[MD=-16.67,95%CI(-19.83,-13.51),P<0.001]、天冬氨酸转氨酶[MD=-20.52,95%CI(-25.65,-15.39),P<0.001]、总胆红素[MD=-5.85,95%CI(-11.31,-0.38),P=0.04]水平显著低于对照组,临床总有效率[RR=1.23,95%CI(1.03,1.46),P=0.02]和乙肝e抗原(HBe Ag)转阴率[RR=1.26,95%CI(1.03,1.54),P=0.02]显著高于对照组,差异均有统计学意义。两组患者血清乙肝病毒基因转阴率比较,差异无统计学意义[RR=1.22,95%CI(0.99,1.52),P=0.07]。结论:与恩替卡韦单用相比,六味五灵片联合恩替卡韦治疗慢性乙型肝炎疗效较好,可以显著改善患者肝功能生化指标。

OBJECTIVE： To evaluate the effectiveness of Liuwei wuling tablets combined with entecavir in the treatment of chronic hepatitis B （CHB） , and to provide evidence-based reference in clinic. METHODS： Retrieved from Cochrane library, PubMed, Web of Science, CJFD, Wanfang database and VIP, randomized controlled trials （RCTs） about Liuwei wuling tablets combined with entecavir （trial group） vs. entecavir alone （control group） in the treatment of CHB were collected. Meta-analysis was conducted by using Rev Man 5.3 statistical software after data extraction and quality evaluation with Cochrane systematic evalu- ator manual 5.1.0. RESULTS： A total of 8 RCTs were included, involving 728 patients. Results of Meta-analysis showed that the levels of ALT [MD=- 16.67,95% CI （ - 19.83, - 13.51）, P〈0.001], AST [MD= - 20.52,95 % CI （ - 25.65, - 15.39） ,P〈0.001] and TBIL [MD = - 5.85,95 % CI （ - 11.31, - 0.38）, P= 0.04] in trial group were significantly lower than control group; clinical to- tal response rate [RR=1.23,95%CI（1.03, 1.46） ,P=0.02] and HBeAg negative conversion rate [RR=1.26,95%CI（1.03, 1.54）, P=0.02] were significantly higher than control group, with statistical significance. There was no statistical significance in the rate of serum HBV DNA negative conversion [RR= 1.22,95% CI （0.99, 1.52）, P=0.07] between 2 groups. CONCLUSIONS： Compared with entecavir alone, Liuwei wuling tablets combined with entecavir in the treatment of CHB have better efficacy, can signifi- cantly improve the biochemical indexes of liver function in patients.