鳖甲煎丸联合恩替卡韦对慢性乙型肝炎肝纤维化患者的肝纤维化指标影响的系统评价

Effect of Biejia Jian Pills Combined with Entecavir on Liver Fibrosis Indices in Patients with Chronic Hepatitis B Liver Fibrosis:A Systematic Evaluation

【目的】系统评价鳖甲煎丸联合恩替卡韦对慢性乙型肝炎(简称“慢乙肝”)肝纤维化患者的肝纤维化指标的影响。【方法】检索中国期刊全文数据库(CNKI)、中国生物医学文献数据库(SinoMed)、维普中文科技期刊数据库(VIP)、万方数据库(Wanfang Data)、Cochrane Library、PubMed、Embase 7个数据库中2010年1月至2022年12月发表的有关鳖甲煎丸联合恩替卡韦治疗慢乙肝肝纤维化的临床随机对照试验,使用Cochrane系统评价手册推荐的偏倚风险评估工具对纳入研究进行方法学质量的评价,采用RevMan 5.3软件进行Meta分析。【结果】共纳入10个研究进行Meta分析。结果显示,试验组(鳖甲煎丸联合恩替卡韦组)在降低慢乙肝肝纤维化患者透明质酸酶(HAase)[MD=-89.32,95%CI(-105.04,-73.60),P<0.00001]、层黏蛋白(LN)[MD=-43.47,95%CI(-54.06,-32.88),P<0.00001]、Ⅲ型前胶原(PC-Ⅲ)[MD=-51.60,95%CI(-61.56,-41.64),P<0.00001]及Ⅳ型胶原(Ⅳ-Col)[MD=-37.37,95%CI(-59.46,-15.27),P=0.0009]水平方面优于对照组(恩替卡韦组);试验组在改善肝硬度(LSM)值方面优于对照组[MD=-2.74,95%CI(-3.28,-2.20),P<0.00001];在降低不良反应发生率方面,试验组与对照组比较差异无统计学意义(P=0.67)。【结论】鳖甲煎丸联合恩替卡韦在改善慢乙肝肝纤维化患者的肝纤维化指标HA、LN、PC-Ⅲ、Ⅳ-Col、LSM值方面优于单用恩替卡韦,且未增加不良反应。但由于纳入文献的质量偏低,结论有待大样本、多中心、高质量的临床试验进一步验证。

Objective To systematically evaluate the effects of Biejia Jian Pills combined with entecavir on liver fibrosis indexes in patients with chronic hepatitis B(CHB)liver fibrosis.Methods Clinical randomized controlled trials of Biejia Jian Pills combined with Entecavir for the treatment of CHB liver fibrosis issued between January 2010 and December 2022 were retrieved from the seven databases of CNKI,SinoMed,VIP,Wanfang Data,Cochrane Library,PubMed,and Embase.The methodological quality of the included studies was assessed using the tools for analysis of bias recommended by Cochrane Reviewer’s Handbook,and meta-analysis was performed using RevMan 5.3 software.Results A total of 10 studies were included for meta-analysis.The results showed that the trial group(Biejia Jian Pills combined with entecavir group)was more effective on reducing hyaluronidase(HAase)[MD=-89.32,95%CI(-105.04,-73.60),P<0.00001],laminin(LN)[MD=-43.47,95%CI(-54.06,-32.88),P<0.00001],procollagen typeⅢ(PC-Ⅲ)[MD=-51.60,95%CI(-61.56,-41.64),P<0.00001]and collagen typeⅣ(Ⅳ-Col)[MD=-37.37,95%CI(-59.46,-15.27),P=0.0009]than the control group(entecavir group).Moreover,the trial group was superior to the control group in improving liver stiffness measurement(LSM)values[MD=-2.74,95%CI(-3.28,-2.20),P<0.00001].However,there was no statistically significant difference between the trial group and the control group in decreasing the incidence of adverse reactions(P=0.67).Conclusion The combination of Biejia Jian Pills and entecavir is superior to entecavir alone in improving the liver fibrosis indicators of HA,LN,PC-Ⅲ,Ⅳ-Col,and LSM of the patients with CHB liver fibrosis,without causing the increase of the adverse effects.However,due to the low quality of the included studies,the conclusions need to be further validated by large-sample,multicenter,high-quality clinical trials.