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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 evaluate the clinical efficacy and safety of Liuwei Wuling tablets combined with nucleoside (acid) antivirals in the treatment of chronic hepatitis B liver fibrosis. Methods: Based on the retrieval computer, the related literatures were searched to comprehensively collect clinical randomized controlled trials (RCTs) of Liuwei Wuling tablets combined with nucleoside (acid) antivirals on chronic hepatitis B liver fibrosis. According to the Cochrane Collaboration, quality evaluation, data extraction, and systematic review using RevMan5.2 software. Results: Nine RCTs and 1319 patients were enrolled. Most of the incorporated literature research methodology is of poor quality, and there is a greater risk of bias. CONCLUSION: Liuwei Wuling tablet combined with nucleoside (acid) antiviral agent has some advantages over single nucleoside (acid) antiviral agent in treating chronic hepatitis B liver fibrosis. Combination therapy can reduce the serum levels of hyaluronic acid (HA), laminin (LN), type IV collagen (IV-c), procollagen type III , PCIII). In the aspect of improving liver function, combination therapy can reduce serum ALT, AST, TBil levels ; In reducing portal hypertension, combination therapy can reduce the portal vein diameter; in the clinical treatment efficiency, the combination of the effective rate is greater than the single drug group. However, there was no significant difference in the levels of albumin (ALB), serum globulin (GLB) and hepatitis B virus DNA (HBV DNA). Due to the lower quality of the included trials, a multicentre, multicentre, double-blind, randomized controlled trial is still needed to further validate support in order to make a more rigorous systematic review.