双环醇联合核苷(酸)类抗病毒药物治疗慢性乙型病毒性肝炎随机对照临床试验的Meta分析

Efficacy and safety of bicyclol tablets combined with nucleot(s)ide analogues treating patients with chronic hepatitis B:a Meta-analysis

目的以既往临床研究结果为基础,系统性评价双环醇联合核苷(酸)类抗病毒药物治疗慢性乙型病毒性肝炎(chronic hepatitisB,CHB)的疗效和安全性。方法通过检索数据库,获得双环醇联合核苷(酸)类抗病毒药物治疗CHB的随机对照临床试验(randomized controlled trials,RCTs)文献,对纳入资料完成质量标准评估后,以Cochrane协作网提供的RevMan4.2软件进行Meta分析。结果共6项RCTs(514例患者)符合入选标准。Meta分析结果显示,双环醇联用核苷(酸)类药物组患者血清ALT、AST水平的改善情况明显优于单用核苷(酸)类药物组(P<0.01)。此外,联用组HBeAg阴转率(27.6%)亦高于单用组(17.6%,P=0.030),无严重不良反应报道。结论双环醇与核苷(酸)类抗病毒药物联合用于CHB的治疗,可进一步改善患者肝功能,并取得了更好的综合疗效。

Objective To systematically evaluate the efficacy and safety of bicyclol tablets combined with nucleot（s）ide analogues in treatment of the patients with chronic hepatitis B （CHB）, based on previous clinical studies. Methods Literatures about randomized controlled trials （RCTs） of bicyclol tablets and nueleot（s）ide analogues combination therapy were retrieved from databases. Rev- Man 4.2 software was used for Meta-analysis. Results Six RCTs with 514 patients were included in the study. Meta-analysis showed that the improvement in serum ALT and AST levels in the patients treated with bieycloi and nueleot（s）ide analogues was better than that in the patients treated with nucleot（s）ide analogues only （P〈0.01）. HBeAg seroeonversion rate in combinative therapeutic patients was significantly higher than that in monotherapeutic patients （27.6% vs 17.6%, P=0.030）. No serious adverse events were reported. Conclusions Combination therapy with bicyclol and nucleot（s）ide analogues in CHB patients is proved to improve liver function, and achieve a better comprehensive efficacy.