六味五灵片联合核苷(酸)类抗病毒药对慢性乙型肝炎肝纤维化的Meta分析

Effects of Liuwei Wuling Tablet with Analogues on Liver Fibrosis Due to Chronic Hepatitis B: A Meta-analysis

目的:评价六味五灵片联合核苷(酸)类抗病毒药对慢性乙型肝炎肝纤维化的临床疗效及安全性。方法:根据检索式计算机检索相关文献,全面收集关于六味五灵片联合核苷(酸)类抗病毒药对慢性乙型肝炎肝纤维化的临床随机对照试验(RCT),对符合纳入标准的试验依据Cochrane协作网进行质量评价、资料数据提取,采用Rev Man5.2软件进行系统评价。结果:共纳入9项RCT,1319例患者。大部分纳入文献研究方法学质量较差,且存在较大的偏倚风险。结论:六味五灵片联合核苷(酸)类抗病毒药对比单用核苷(酸)类抗病毒药治疗慢性乙型肝炎肝纤维化有一定的优势。联合用药能够降低血清肝纤维化四项透明质酸(hyaluronicacid,HA),层粘连蛋白(laminin,LN),IV型胶原(type IV collagen,IV-c),III型前胶原蛋白(procollagen type III,PCIII)水平;在改善肝功能方面,联合用药能够降低血清丙氨酸转氨酶(alanine aminotransferase,ALT),天门冬氨酸转氨酶(aspartarte aminotransferase,AST),总胆红素(total bilirubin,TBil)水平;在降低门脉高压方面,联合用药能够降低门静脉内径;在临床治疗有效率方面,联合用药的有效率大于单独用药组。但在降低血清白蛋白(albumin,ALB),血清球蛋白(serum globulin,GLB),乙型肝炎DNA病毒载量(HBV DNA)含量水平差异没有统计学意义。由于纳入的试验部分质量较低,故仍需多中心,大样本的双盲随机对照试验进一步验证支持,以期做出更为严谨的系统评价。

Objective ： To assess the curative effect and safety of effects of Liuwei Wuling Tablet with analogues on liver fibrosis due to chronic hepatitis B. Methods ： According to the related literature which was retrieved by the indexing computer, a comprehensive collection of the clinical randomized controlled trial（RCT） about effects of Liuwei Wuling Tablet with analogues on liver fibrosis due to chronic hepatitis B and have quality evaluation and data extraction for those tests which were included in the standard according to the Cochrane and use Rev Man5.2 software system to evaluate. Result ： Participants included 9 RCTs and 1319 cases of patients. Most included literature had poor quality and greater risk of bi- as. Conclusion： Compared with using nucleotide analogues alone, the combination of nucleotide analogues and Liuwei Wuling Tablet can significantly improve the degree of liver fibrosis and liver function indices. Combination medication can decrease serum levels of hyaluronicacid （HA） , laminin （ LN）, type Ⅳ collagen（ Ⅳ - c） and procollagen type Ⅲ（ PCI- Ⅱ）. In the respect of improving the liver function, combination medication can decrease serum levels alanine aminotransferase （ALT）, aspartarte aminotransferase （AST）, total bilirubin （TBil）. Moreover, combination medication can decrease serum levels of partial vein diameter and improve clinical effective rate. But the differences in the decrease of serum levels of albumin （ ALB）, serum globulin （GLB） and HBV DNA. Due to the poor quality of the part of text which was included in the literature research methodology, we still need more centers, large sample double - blind randomized controlled trial in the hope of the rigorous system evaluation.