扶正化瘀胶囊与安络化纤丸治疗慢性乙型肝炎肝纤维化疗效的间接Meta分析

Meta-analysis on indirect comparison of Fuzheng Huayu Jiaonang and Anluo Huaxian Wan in treatment of chronic hepatitis B with liver fibrosis

探讨扶正化瘀胶囊和安络化纤丸治疗慢性乙型肝炎肝纤维化的有效性和安全性。采用Jadad评分法进行文献质量评价,运用Rev Man 5.3软件进行Meta分析,利用ITC软件进行间接比较,以单用恩替卡韦片（ETV）为共同对照,查找相关随机对照试验（RCT）,纳入扶正化瘀胶囊（FZ）或安络化纤丸（AL）联合ETV对比单用ETV治疗慢性乙型肝炎肝纤维化的RCTs进行间接Meta分析。最终纳入文献15篇（FZ 10篇,AL 5篇）,包括1 316个病例。Meta分析显示FZ联合ETV在治疗慢性乙型肝炎肝纤维化时透明质酸（HA）、层黏连蛋白（LN）、Ⅲ型前胶原（PCⅢ）和Ⅳ型胶原（Ⅳ-C）均显著改善;AL联合ETV在治疗慢性乙型肝炎肝纤维化时LN,PCⅢ,Ⅳ-C均显著改善,但HA没有显著改善。间接Meta分析显示FZ与AL在降低HA,LN,PCⅢ,Ⅳ-C方面没有显著性差异,不具有统计学意义。安全性方面,所纳入的研究中FZ试验组的不良反应发生率为5.33%,主要不良反应为胃部不适、头晕等;对照组的不良反应发生率为4.17%,主要不良反应为腹胀、头痛等。AL试验组和对照组均未发现明显不良反应。目前有限的证据表明FZ和AL治疗慢性乙型肝炎肝纤维化在疗效方面无显著性差异,不具有统计学意义。AL的安全性高于FZ。但所纳入的研究整体质量不高,数量有限且存在异质性,二者的评估有待高质量大样本的临床试验加以证实。

To investigate the efficacy and safety of Fuzheng Huayu Jiaonang（ FZ） and Anluo Huaxian Wan（ AL） in the treatment of chronic hepatitis B liver fibrosis. Jadad scoring method was adopted to evaluate the quality of literature,Rev Man 5. 3 software was used for Meta-analysis,and indirect comparison was carried out by ITC software. The randomized controlled trials（ RCTs） were collected for comparing FZ and AL in treatment of chronic hepatitis B with liver fibrosis. With ETV as the common control,they were compared through indirect Meta-analysis（ ITC）. Finally,15 articles（ 10 FZ,5 AL） involving 1 316 patients were included. According to the indirect comparison,FZ combined with ETV had significant improvements in hyaluronic acid,laminin,procollagen type Ⅲ,and collagen type Ⅳ. AL combined with ETV had significant improvements in laminin,procollagen type Ⅲ,collagen type Ⅳ,but with no difference in hyaluronic acid. The safety of AL was higher than that of FA. The limited evidences in this study showed that Anluo Huaxian Wan had a higher safety than Fuzheng Huayu Jiaonang,but a lower total efficiency. Due to the low quality of the included RCTs,these two medicines shall be comprehensively compared in further high-quality clinical trials.