含决明子的中药复方制剂治疗非酒精性脂肪性肝病的系统评价

摘要

OBJECTIVE:To systematic review the clinical efficacy and safety of cassiae semen-containing Chinese herbal compound preparations in treatment of nonalcoholic fatty liver .METHODS: PubMed, CNKI, Chongqing VIP database and Wanfang database were retrieved by computers to collect the RCTs of cassiae semen -containing Chinese herbal compound preparations in treatment of nonalcoholic fatty liver till Nov .20th, 2016.The control group were treated with routine treatment combined with western medicine or Chinese and western medicine , while the observation group were given cassiae semen-containing Chinese herbal compound preparations based on the routine treatment .The qualified researches were screened , according to Cochrane network system evaluation method , publication bias risk assessment was conducted , clinical efficacy of Meta-analysis was conducted by using Review Manager 5.2; and descriptive analysis was conducted on the adverse drug reactions during treatment process .RESULTS: Totally 9 literatures were involved, including 695 cases. According to Meta-analysis, there were statistically significant differences between two groups in the total effective rate (RR =1.31,95%CI =1.19-1.43,P <0.00001), ALT (WMD=-19.48,95%CI=-28.35--10.62,P<0.00001), AST(WMD=-20.96,95%CI=-31.13--10.79, P<0.00001), TC (WMD=-0.26,95%CI=-0.35--0.17,P<0.00001) and TG (WMD=-0.52,95%CI=-0.83--0.22, P <0.001).The main adverse drug reactions were abdominal pain , abdominal distension and diarrhea .CONCLUSIONS: The efficacy of cassiae semen-containing Chinese herbal compound preparations in treatment of nonalcoholic fatty liver is significant with high safety .However , due to the quality of the included literatures are still relatively low and the number of cases and samples are small , the rationality , effectiveness andsafety of cassiae semen-containing Chinese herbal compound remain to be conformed through more high-quality , multicenter and large-scale samples RCTs .%目的:系统评价含决明子的中药复方制剂治疗非酒精性脂肪性肝病的临床疗效和安全性.方法:检索PubMed、中国知网数据库、重庆维普中文科技期刊数据库和万方数据库从建库至2016年11月20日含决明子的中药复方制剂治疗非酒精性脂肪性肝病的随机对照试验,对照组患者采用常规治疗配合西药或中西药联合治疗,观察组患者采用含决明子的中药复方制剂治疗,并辅以与对照组一致的常规治疗.筛选合格研究,参考Cochrane协作网系统评价方法,进行发表偏倚风险评价;应用Review Manager 5.2软件对临床疗效进行文献荟萃(Meta)分析;对治疗过程中发生的不良反应进行描述性分析.结果:共纳入9篇文献、695例患者.Meta分析结果显示,2组患者总有效率(RR=1.31,95%CI=1.19~1.43,P<0.00001)、丙氨酸氨基转移酶水平(WMD=-19.48,95%CI=-28.35~-10.62,P<0.00001)、天门冬氨酸氨基转移酶水平(WMD=-20.96,95%CI=-31.13~-10.79,P<0.00001)、总胆固醇水平(WMD=-0.26,95%CI=-0.35~-0.17,P<0.00001)、三酰甘油水平(WMD=-0.52,95%CI=-0.83~-0.22,P<0.001)的差异均有统计学意义;2组患者的不良反应主要为腹痛、腹胀、腹泻等胃肠道症状.结论:含决明子的中药复方制剂治疗非酒精性脂肪性肝病,疗效明确,安全性较高.但由于本研究纳入文献的总体质量较低,纳入研究的数量较少,样本量也较小,尚需更多高质量、多中心、大样本的随机对照试验进一步验证决明子组方的合理性、有效性和安全性.