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系统评价六味五灵片联合核苷(酸)类药物治疗慢性乙型肝炎肝纤维化有效性及安全性。计算机检索Pubmed、Embase、Cochrane Library(2015年第9期)、中国生物医学数据库(CBM)、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)、万方数据在线知识服务平台,全面收集有关六味五灵片联合核苷(酸)类药物治疗慢性乙型肝炎肝纤维化的随机对照试验(RCT),检索时限均从建库至2015年10月29日。由2位评价员按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用Rev Man5.3软件进行Meta分析。最终纳入7个RCTs,共1 021例慢性乙型肝炎肝纤维化患者,其中治疗组529例,对照组492例。分析结果显示:与单用核苷(酸)类药物相比,六味五灵片联合核苷(酸)类药物不仅可降低慢性乙型肝炎肝纤维化患者血清肝纤维化指标:HA[SMD=-1.26,95%CI(-1.92,-0.59),P=0.000 2]、LN[SMD=-1.55,95%CI(-2.27,-0.83),P<0.000 1]、PC-III[SMD=-1.39,95%CI(-2.21,-0.58),P=0.000 8]、IV-C[SMD=-1.49,95%CI(-2.25,-0.72),P=0.000 1];还可以改善肝功能生化指标:ALT[SMD=-1.17,95%CI(-1.41,-0.94),P<0.000 01]、AST[SMD=-1.25,95%CI(-1.54,-0.96),P<0.000 01]、TBIL[SMD=-0.87,95%CI(-1.21,-0.53),P<0.000 01];提高临床总有效率[OR=4.59,95%CI(2.05,10.25),P=0.000 2];但并不能提高HBV DNA转阴率[OR=1.51,95%CI(0.96,2.39),P=0.08];且无明显不良反应报道。六味五灵片联合核苷(酸)类药物可明显改善患者肝功能,抑制肝纤维化,提高临床总有效率,且不良反应少、耐受性较好;虽然近年来RCTs研究的数量和质量有逐年上升的趋势,但仍需从临床设计的科学性、报告的规范性等诸多环节来提高研究水平。
To evaluate the effectiveness and safety of Liuwei Wuling tablet combined with nucleoside (acid) drugs in treatment of chronic hepatitis B liver fibrosis. Pubmed, Embase, Cochrane Library (No. 9, 2015), China Biomedical Database (CBM), Chinese Journal Full-text Database (CNKI), Chinese Scientific and Technical Periodicals Full-text Database (VIP), Wanfang Data Online Knowledge Service Platform To collect randomized controlled trials (RCTs) about Liuwei Wuling tablets combined with nucleoside (acid) drugs for the treatment of chronic hepatitis B liver fibrosis, the search time from the database to October 29, 2015. After two reviewers independently screened the literature for inclusion and exclusion criteria, extracted data, and assessed the quality of the included studies, Meta-analysis was performed using Rev Man 5.3 software. Finally, 7 RCTs were enrolled in a total of 1 021 cases of chronic hepatitis B patients with liver fibrosis, including 529 cases in the treatment group and 492 cases in the control group. The results showed that compared with single nucleoside (acid) drugs, Liuwei Wuling tablets combined with nucleoside (acid) drugs not only could reduce the serum hepatic fibrosis index in patients with chronic hepatitis B liver fibrosis: HA [SMD = -1.26, 95% CI (-1.92, -0.59), P = 0.0002], LN [SMD = -1.55,95% CI -2.27, -0.83, P <0.0001] -1.39, 95% CI (-2.21, -0.58), P = 0.0008], IV-C [SMD = -1.49,95% CI (-2.25, -0.72), P = 0.0001] Functional biochemical indicators: ALT [SMD = -1.17, 95% CI (-1.41, -0.94), P <0.000 01], AST [SMD = -1.25,95% CI (-1.54, -0.96), P <0.000 01 (OR = 4.59, 95% CI (2.05, 10.25), P = 0.0002], TBIL (SMD = -0.87,95% CI -1.21, -0.53, P < ; But did not improve the rate of HBV DNA negative conversion [OR = 1.51,95% CI (0.96,2.39), P = 0.08]; and no obvious adverse reactions were reported. Liuwei Wuling tablets combined with nucleoside (acid) drugs can significantly improve liver function, inhibit liver fibrosis and improve the overall clinical efficiency, and less adverse reactions, better tolerability; although the number and quality of RCTs research in recent years However, there is still a need to improve the research level from many aspects such as the scientific nature of clinical design and the normative nature of the report.