益气解毒通络方治疗乙型病毒性肝炎肝硬化的系统评价

Systematic Review on Yiqi Tongluo Formula in the Treatment of Hepatitis B Cirrhosis

目的:系统评价益气解毒通络方治疗乙型病毒性肝炎肝硬化的有效性与安全性,为临床治疗与合理用药提供循证依据.方法:计算机检索中国期刊全文数据库、万方数据知识服务平台、维普中文期刊服务平台及中国生物医学文献服务系统等中文数据库和PubMed、the Cochrane Library及EMBase等外文数据库,检索益气解毒通络方治疗乙型病毒性肝炎肝硬化的随机对照试验(对照组患者采用常规治疗,观察组患者在对照组治疗基础上联合应用益气解毒通络方),检索时限为建库至2019年6月.采用Cochrane风险评价表评价其研究质量,提取资料并通过RevMan 5.3软件进行文献荟萃分析(Meta分析).结果:共纳入9篇文献,涉及728例患者.Meta分析结果显示,治疗后,观察组患者的总有效率明显优于对照组(OR=0.16,95%CI=0.09~0.86,P<0.00001);中医证候积分明显低于对照组(MD=2.84,95%CI=-0.18~5.87,P<0.007);丙氨酸氨基转移酶(MD=29.15,95%CI=12.62~45.68,P=0.0005)、天门冬氨酸氨基转移酶(MD=22.15,95%CI=9.09~35.22,P=0.0009)、总胆红素(MD=4.96,95%CI=6.53~7.04,P<0.00001)、透明质酸(MD=156.47,95%CI=152.22~160.73,P<0.00001)、层粘连蛋白(MD=36.65,95%CI=32.91~40.38,P<0.00001)、Ⅲ型前胶原(MD=64.99,95%CI=54.92~75.06,P<0.00001)以及Ⅳ型胶原(MD=67.09,95%CI=42.40~91.78,P<0.00001)水平均明显低于对照组;不良反应较少且发生率明显低于对照组(MD=3.95,95%CI=-1.62~9.66,P<0.003),上述差异均有统计学意义.结论:益气解毒通络方用于乙型病毒性肝炎肝硬化的治疗,能有效改善患者肝功能、肝纤维化情况,其临床疗效及安全性优于单独应用常规治疗.

OBJECTIVE:To systematically evaluate the efficacy and safety of Yiqi Tongluo formula in the treatment of hepatitis B cirrhosis,so as to provide evidence-based evidence for clinical treatment and rational use of drugs.METHODS:CNKI,Wanfang database,VIP database,SinoMed,PubMed,the Cochrane Library and EMBase were retrieved to collect the randomized controlled trials of Yiqi Tongluo formula in the treatment of hepatitis B cirrhosis(the control group was treated with conventional treatment,while the observation group received Yiqi Tongluo formula based on the control group).the retrieval time was from the establishment of the database to Jun.2019.The Cochrane risk assessment form was used to evaluate the quality of the study,data was extracted and Meta-analysis was performed by RevMan 5.3 software.RESULTS:Totally 9 literature was collected,including 728 patients.Meta-analysis results showed that the total effective rate of the observation group was significantly better than that of the control group(OR=0.16,95%CI=0.09-0.86,P<0.00001),TCM syndrome score was significantly lower than that of the control group(MD=2.84,95%CI=-0.18-5.87,P<0.007).The alanine aminotransferase(MD=29.15,95%CI=12.62-45.68,P=0.0005),aspartate aminotransferase(MD=22.15,95%CI=9.09-35.22,P=0.0009),total bilirubin(MD=4.96,95%CI=6.53-7.04,P<0.00001),hyaluronic acid(MD=156.47,95%CI=152.22-160.73,P<0.00001),laminin(MD=36.65,95%CI=32.91-40.38,P<0.00001),typeⅢprocollagen(MD=64.99,95%CI=54.92-75.06,P<0.00001)and typeⅣcollagen(MD=67.09,95%CI=42.40-91.78,P<0.00001)in the observation group were significantly lower than those in the control group.There were fewer adverse drug reactions and the incidence of adverse drug reactions in the observation group was significantly lower than that in the control group(MD=3.95,95%CI=-1.62-9.66,P<0.003).CONCLUSIONS:The efficacy of Yiqi Tongluo formula in the treatment of hepatitis B cirrhosis is better than conventional treatment alone,which can effectively improve the liver function and liver fibrosis of patients.