安络化纤丸联合核苷(酸)类药物治疗慢性乙型肝炎肝纤维化的系统评价

Systematic Review of Combinative Effects of Anluo Huaxian Pills with Nucleotide Analogues on Liver Fibrosis Due to Chronic Hepatitis B

目的:通过收集安络化纤丸联合核苷(酸)类抗病毒药物治疗慢性乙型肝炎肝纤维化的临床随机对照试验和半随机对照试验进行系统评价,评估安络化纤丸联合核苷(酸)类抗病毒药物治疗慢性乙型肝炎肝纤维化疗效及安全性。方法:根据相关检索式计算机检索中国知网、万方数据系统、维普生物医药数据库,Medline,EMbase,CBM数据库,收集关于安络化纤丸联合核苷(酸)类抗病毒药物治疗慢性乙型肝炎肝纤维化的随机对照试验,按照国际Cochrane协作网的系统评价方法进行评价,由两名评价员分别独立对符合纳入标准的试验进行质量评价和资料提取,然后交叉核对。结果:共有7个临床试验纳入本研究,7项研究方法学质量均较差,且存在较大的偏倚风险。安络化纤丸联合核苷(酸)类抗病毒药物组对比单用抗病毒药物组在改善肝纤维化和肝功能方面有一定的优势。联合用药可以降低肝纤维化血清学标志物透明质酸(hyaluronic acid,HA),层粘连蛋白(laminin,LN),Ⅳ型胶原(type IV collagen,Ⅳ-c)水平,在改善肝功能方面,能降低丙氨酸转氨酶(alanine aminotransferase,ALT),天门冬氨酸转氨酶(aspartarte aminotransferase,AST)水平。但是对降低Ⅲ型前胶原肽(procollagen type III,P-Ⅲ-P)水平、减轻患者脾脏肿大程度和门脉高压、提高血清白蛋白(albumin,Alb)含量、降低总胆红素(total bilirubin,TBIL)含量的影响差异没有统计学意义。结论:但由于文献质量均较低,故仍需要多中心,大样本的高质量的随机对照临床研究,以期做出更为严谨的系统评价。

Objective： The aim of this study was to systematically evaluate the efficacy of Anluo Huaxian pills combined with nucleotide analogues in treating liver fibrosis resulting from chronic hepatitis B. Method： Medline, Embase, CNKI, CBM, VIP, and Wanfang database were searched to collect Randomized controlled trials （RCT） about cases of treating liver fibrosis resulting from chronic hepatitis B using Anluo Huaxian pills combined with nucleotide analogues. Result： Seven clinical trials were included. The Cochrane Collaboration＇s method was used for data analysis. Compared with using nucleotide analogues alone, the combination of nucleotide analogues and Anluo Huaxian Wan can significantly improve the degree of liver fibrosis and liver function indices. Combination medication might decrease serum levels of hyaluronic acid （HA） and laminin （LH）, type Ⅳ collagen （Ⅳ-c）, and in the respect of improving the liver function, combination medication might decrease serum levels of alanine aminotransferase （ALT） , aspartarte aminotransferase （AST）.Conclusion ： But the differences in the decrease of serum levels of Pc-Ⅲ, improvement of splenomegaly and portal hypertension, increase of serum levels of albumin （Alb） was not statistically significant.