参苓白术散治疗非酒精性脂肪肝随机对照试验Meta分析

Effect of Shenling Baizhu San on Nonalcoholic Fatty Liver Disease:A Meta-analysis of Randomized Controlled Trials

目的:采用Meta分析的方法评价参苓白术散治疗非酒精性脂肪肝(NAFLD)的临床疗效及安全性。方法:检索数据库CBM、CNKI、万方、VIP、Pubmed,鉴定并纳入参苓白术散加减与安慰剂、西药等对比治疗NAFLD的随机对照试验(RCT),采用Jadad Scale评分对纳入试验进行质量评价和数据提取,然后用Revman 5.0软件对临床疗效指标进行Meta分析。结果:共计纳入6项RCT,其Meta分析结果显示:参苓白术散加减治疗NAFLD的总有效率高于对照组,差异有统计学意义[OR=4.41,95%CI(2.48,7.84),P<0.00001];ALT治疗后加权合并结果为-30.00,95%CI为(-36.54,-23.45),P<0.00001;AST治疗后加权合并结果为-9.40,95%CI为(-12.96,-5.85),P<0.00001;TC治疗后加权合并结果为-0.59,95%CI为(-0.83,-0.34),P<0.00001;TG治疗后加权合并结果为-0.35,95%CI为(-0.55,-0.15),P<0.00001。所纳入的研究均未报道不良反应。结论:现有临床研究证据表明参苓白术散加减在治疗NAFLD方面存在其优势,但由于所纳入的研究总体质量较低,研究的数量和样本量均较少,需进一步开展高质量的多中心、大样本、严格设计的随机对试验来验证其疗效与安全性。

Objective： Using Meta-analysis to access the efficacy and safety of Shenling Baizhu San for the treatment of nonalcoholic fatty liver disease （ NAFLD ）. Methods ： We searched CBM, CNKI, VIP, Wanfang and Pubmed database. We assess and bring into randomized controlled trials （ RCT ） comparing Shenling Baizhu San with no treatment, placebo, or medications for NAFLD. We assessed the quality of included studies using the Jadad rating scale. The RevMan 5.0 software was used for Meta-analysis. Results ： Six studies were included and made a Meta-analysis. The Meta-analysis results showed that when Shenling Baizhu San treatment group compared with control group, the clinical total efficiency rate＇s odds ratio （ OR ） was 4.41 and 95%CI was （ 2.48,7.84 ）, P〈0.00001, and the difference was statistically significant. ALT MD was-30.00 and 95% CI （ -36.54,-23.45 ） （ P〈0.00001 ）. AST MD was -9.40 and 95%CI （ -12.96,-5.85 ）, P〈0.00001. TC MD was -0.59 and 95%CI （-0.83, -0.34 ）, P〈0.00001 ; TG MD was -0.35,95%CI （ -0.55, -0.15 ）, P〈0.00001. All studies included did not report adverse reactions. Conclusion：Shenling Baizhu San in the treatment of NAFLD has significant clinical curative effect. However, the number and the study sample size are small and the methodological quality is low. To further evaluate the effect and safety of Shenling Baizhu San for NAFLD, more rationally designed and strictly executed RCTs with large samples need to be made.