中西药联用治疗肝胆湿热型慢性乙型肝炎的疗效与安全性Meta分析

Meta-analysis of the efficacy and safety of combined Chinese and Western medicine in the treatment of chronic hepatitis B with liver and gallbladder damp-heat

目的系统评价中西药联合干预治疗肝胆湿热型慢性乙型肝炎的疗效与安全性。方法检索CNKI、CBM、万方、PubMed、Web of Science网络数据库中有关中西药联合干预治疗肝胆湿热型慢性乙型肝炎的随机对照试验(RCT)文献,检索时限为各数据库建库以来至2021年4月,检索的文献由两名研究者进行筛选并采用评价手册进行质量评价,文献中的RCT分为对照组和治疗组,对照组采用西药治疗,治疗组采用中西药联合干预治疗,运用RevMan 5.3 Meta分析软件分析两组患者在用药后的有效率、丙氨酸转氨酶(ALT)、总胆红素(TBIL)、天门冬氨酸氨基转移酶(AST)、证候疗效、证候积分、血清乙型肝炎病毒e抗原(HBeAg转阴率)、乙肝病毒基因(HBV-DNA)转阴率各方面情况。结果共筛选纳入16篇RCT文献,共1402例肝胆湿热型慢性乙型肝炎患者。Meta分析各研究结果提示,治疗组与对照组有效率比较有显著统计学意义(RR=1.27,95%CI:1.19~1.35,P<0.00001),治疗组在降低患者肝功能指标ALT(WMD=-0.98,95%CI:-1.24~-0.72,P<0.00001)、TBIL(WMD=-1.19,95%CI:-1.83~-0.56,P=0.0002)、AST(WMD=-1.66,95%CI:-2.36~-0.96,P<0.00001)方面优于对照组,治疗组在证候疗效(RR=1.29,95%CI:1.16~1.43,P<0.00001)、HBV-DNA转阴率(RR=1.19,95%CI:1.04~1.36,P=0.01)、HBeAg转阴率(RR=1.64,95%CI:0.55~1.20,P=0.02)、证候积分(WMD=-0.89,95%CI:-1.13~-0.64,P<0.00001)方面优于对照组。16篇文献中提及不良反应或者毒副作用有7篇,文献提示不良反应或者毒副作用发生少,且治疗组少于对照组,症状轻微。结论中西药联用治疗肝胆湿热型慢性乙型肝炎的疗效优于单纯西药治疗,且不良反应发生少,但研究缺乏高质量文献,且数量有限,相关结论还有待进一步验证。

Objective To systematically access the efficacy and safety of combined intervention of Chinese and Western medicines in the treatment of chronic hepatitis B with liver and gallbladder damp-heat.Methods Databases including CNKI,CBM,Wanfang,PubMed,and Web of Science were searched for randomized controlled trials(RCTs)literatures related to combined intervention of Chinese and Western medicines in the treatment of chronic hepatitis B with liver and gallbladder damp-heat,and the search time limit was from the establishment of each database to April 2021.The retrieved literatures were screened by two researchers and the evaluation manual was used for quality evaluation.The RCTs in the literature were divided into a control group and a test group.The control group was treated with western medicines,and the test group was treated with a combined intervention of Chinese and Western medicines.RevMan 5.3 Meta analysis software was used to analyze the efficiency of the two groups after medication,as well as alanine aminotransferase(ALT),total bilirubin(TBIL),aspartate aminotransferase(AST),syndrome efficacy,syndrome scores,serum hepatitis B virus E antigen(HBeAg)seroconversion rate,and hepatitis B virus gene(HBV-DNA)negative conversion rate in two groups after medication.Results A total of 16 RCT articles were screened and included,including 1402 cases of chronic hepatitis B with liver and gallbladder damp-heat.The results of the meta-analysis showed that the effective rate between the test group and the control group was statistically significant(RR=1.27,95%CI:1.19 to 1.35,P<0.00001);the test group was better than the control group in reducing the liver function index,such as ALT(WMD=-0.98,95%CI:1.24 to 0.72,P<0.00001),TBIL(WMD=1.19,95%CI:1.83 to 0.56,P=0.0002)and AST(WMD=1.66,95%CI:2.36 to 0.96,P<0.00001);and the test group was superior to the control group in syndrome efficacy(RR=1.29,95%CI:1.16 to 1.43,P<0.00001),HBV-DNA negative conversion rate(RR=1.19,95%CI:1.04 to 1.36,P=0.01),HBeAg seroconversion rate(RR=1.64,95%CI:0.55 to 1.20,P=0.02),and syndrome score(WMD=-0.89,95%CI:-1.13 to-0.64,P<0.00001).Among the 16 articles,7 mentioned adverse reactions or toxic side effects;most of the literatures suggested that there are fewer adverse reactions or toxic side effects,the test group was less than the control group and the symptoms were mild.Conclusion Combination of Chinese and Western medicines is more effective than Western medicine alone in treating chronic hepatitis B with liver and gallbladder damp-heat type,and there are fewer adverse reactions.However,the research lacks high quality literature and the number is limited,so the relevant conclusion need to be further verified.