疏肝健脾法治疗非酒精性脂肪性肝病随机对照的系统评价

The effectiveness and safety of soothing liver and activating spleen method treating nonalcoholic fatty liver disease

目的评价疏肝健脾法治疗非酒精性脂肪性肝病的疗效及安全性。方法在PubMed、EMBASE、CENTRAL、中国生物医学文献数据库(CBM)和中国期刊全文数据库(CNKI)等数据库中检索从创建以来至2012年9月关于疏肝健脾法治疗非酒精性脂肪肝的随机对照试验文献,由研究人员对文献进行筛选和数据提取,并用RevMan 5.0进行Meta分析。结果纳入17项研究,1 691例非酒精性脂肪性肝病。其中疏肝健脾法901例和西药组790例。Meta分析显示:疏肝健脾法组临床有效率(OR=4.33,95%CI:3.26~5.74,P<0.001)、肝功能〔ALT(MD=-14.80,95%CI:-21.63~7.96,P<0.000 01)、AST(MD=-9.48,95%CI:-13.95~5.01,P<0.001)〕;血脂〔TC(MD=-0.70,95%CI:-1.01~0.39,P<0.001)、TG(MD=-0.72,95%CI:-0.958~0.149),P<0.001〕B超改变(OR=2.33,95%CI:1.41~3.82,P=0.001)均优于西药组(均P<0.05)。在不良反应上,疏肝健脾方治疗非酒精性脂肪性肝病未出现明显不良反应,但GRADE证据质量所选文献显示为低级别证据,具有很强的偏倚性。结论与单纯西药相比,疏肝健脾法能够更好地治疗非酒精性脂肪性肝病,且具有良好的安全性。有必要可以开展更多高质量的多中心、大样本、前瞻性、随机、双盲临床试验加以验证。

Objective To evaluate the effectiveness and safety of soothing liver and activating spleen method treating nonalcoholic fatty liver disease. Methods The PubMed,EMBASE,Cochrane Central Register of Controlled Trials( CENTRAL),Chinese Biomedical Abstract Database( CBM) and China National Knowledge Infrastructure Database( CNKI) were searched up from establish to September 2012to find the randomized controlled trials of soothing liver and activating spleen method in the treatment of nonalcoholic fatty liver disease,screening and data extraction by researchers literature,and Meta-analysis with RevMan 5. 0. Results 17 clinical trials with 1 691 nonalcoholic fatty liver disease patients were included,901 patients were in the therapies of soothing liver and activating spleen,790 patients were in medicine therapy. Meta analysis shows as follow : the clinical effective rate( OR = 4. 33,95% CI: 3. 26 ~ 5. 74,P < 0. 000 01),liver function( ALT MD =- 14. 80,95% CI:- 21. 63 ^- 7. 96,P < 0. 000 01),lipids〔TC( MD =- 0. 70,95% CI:- 1. 01 ~ 0. 39,P < 0. 000 01),TG( MD =- 0. 72,95% CI:- 0. 958 ^- 0. 149,P < 0. 000 01) 〕,B ultrasonic( OR = 2. 33,95% CI: 1. 41 ~ 3. 82,P = 0. 0009) of Chinese medicine group were better than those of control group. GRADE ratings indicated that all the studies included were low quality,with high bias. Conclusions Soothing liver and activating spleen method could some extent enhance the effectiveness and the security in the treatment of nonalcoholic fatty liver disease,and make it necessary to carry out more high quality multicenter,large sample,prospective,randomized,double-blind clinical experiments.