甘草类制剂治疗慢性乙型肝炎随机对照试验的系统评价

Glycyrrhizin and derivatives for treatment of chronic hepatitis B:A systematic review of randomized controlled trials

目的:评价甘草类制剂治疗慢性乙型肝炎的疗效和安全性。方法:参照Cochrane系统评价的要求,对选择纳入的临床试验进行方法学质量评价、数据提取和分析。结果:38篇包括3523例患者的随机或半随机对照试验纳入并进行系统评价。所纳入的试验质量普遍较低,方法学记分均低于2分。合并的结果表明,与空白组、非特异性治疗、其他中药治疗比较,甘草类制剂的临床总有效率高于对照,两组比较差异有显著性意义;复方甘草酸苷与干扰素α-2β联用对血清HBsAg、HBeAg和HBVDNA阴转的效果优于单用干扰素;强力宁与阿糖腺苷联用对清除血清HBVDNA的作用优于单独使用抗病毒药物;没有报告严重的不良反应。结论:甘草类制剂治疗慢性乙型肝炎具有改善症状和体征、促进肝功能恢复和清除HBV标志物的作用;甘草类制剂与抗病毒药物的联用对慢性乙型肝炎可能是较有希望和前景的治疗途径之一。但是,由于所纳入试验的方法学质量普遍较低,上述发现需要设计严谨的、方法学质量较高的随机对照试验的证据支持。

Objective： To evaluate the effectiveness and safety of glycyrrhizin and its derivatives for chronic hepatitis B. Methods： According to the protocol of systematic review, selection of trials for inclusion, assessment of methodological quality, data extraction and data syntheses were conducted by the reviewers. Results： 38 randomized controlled trials and quasi-randomized controlled trails （involving 3523 patients） with low methodological quality （Jadad scores≤2） were included. The pooled results showed that the total clinical effective rate of glycyrrhizin was higher than the controls including blank, non-specific treatment, and other Chinese medicines, with a statistical significance between the groups. For the combination treatment of compound glycyrrhizin with interferon α-2β, serum HBsAg, HBeAg and HBV DNA con- version rqte were significantly superior to interferon alone. Potenline combined with adenine arabinoside showed better effect of HBV DNA conversion than adenine arabinoside alone. No serious adverse events were reported. Conclusion： Glycyrrhizin and its derivatives have effect on improving symptoms, liver function, and anti-HBV markers; it might be a prospect approach for the treatment of chronic hepatitis B by glycyrrhizin combined with antiviral drugs. However, the evidence is not strong enough to recommend routine use due to the low quality of the trials. We need further randomized clinical trials with rigorous design.