蒲参胶囊治疗高脂血症有效性和安全性的系统评价与Meta分析  

Systematic Evaluation of Pushen Capsule in the Treatment of Hyperlipidemia:A Meta-analysis

作　　者：李慧敏 胡瑞学 戴泽琦 徐思敏 胡晶 廖星[1] LI Hui-min;HU Rui-xue;DAI Ze-qi;XU Si-min;HU Jing;LIAO Xing(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Beijing Hospital of Traditional Chinese Medicine(TCM)Affiliated to Capital Medical University,Evidence-based Medicine Center,Beijing Institute of TCM,Beijing 100010,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]首都医科大学附属北京中医医院,北京市中医研究所循证医学中心,北京100010

出　　处：《中国实验方剂学杂志》2021年第21期198-206,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院基本科研业务费优秀青年科技人才(创新类)培养专项(ZZ13-YQ-075);“中国中医药循证中心业务研究室主任专项课题”(2020YJSZX-2)。

摘　　要：系统评价蒲参胶囊(PS)治疗高脂血症(HPL)的疗效及安全性,为未来临床应用提供证据基础。基于四大中文数据库和三大外文数据库,全面检索蒲参胶囊治疗高脂血症的随机对照试验(RCT),采用Cochrane手册中的偏倚风险评估工具对纳入的研究进行评估,并用Revman 5.3软件进行Meta分析。共纳入24项RCT,共计2634例患者。试验组为PS或PS联合常规治疗(UC)或PS联合中成药治疗,对照组为常规治疗或中成药治疗。Meta分析结果显示,PS单独或联合其他治疗在改善总胆固醇(TC),甘油三脂(TG),高密度脂蛋白胆固醇(HDL-C),低密度脂蛋白胆固醇(LDL-C),总有效率方面均优于对照组。14项研究报告了不良反应情况,其中7项研究报告了具体结果,不良反应以胃脘部不适为多,但差异无统计学意义。然而受纳入研究的质量影响,该研究结论的证据强度不足,尚需更多高质量、报告详细的RCT进一步证实。The present study systematically evaluated the efficacy and safety of Pushen capsule(PC)in the treatment of hyperlipidemia(HPL)to provide the basis for its clinical application in the future.The randomized controlled trials(RCTs)of PC in treating HPL were comprehensively retrieved from four Chinese databases and three English databases.The included RCTs were evaluated using the Cochrane risk-of-bias tool,followed by the Meta-analysis by RevMan 5.3.Twenty-four RCTs were included,with 2634 patients involved.The patients in the experimental group were treated with PC,PC combined with conventional therapy,or PC combined with other Chinese patent medicine.The cases in the control group were treated conventionally or by other Chinese patent medicine.Meta-analysis results showed that PC alone or in combination was superior to the treatment in the control group in improving total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),and total response rate.Fourteen trials reported adverse reactions,including seven reporting specific results.The adverse reactions were dominated by epigastric discomfort,but the difference was not statistically significant.However,affected by the quality of the included trials,the evidence strength of the conclusion of this study is graded low.More high-quality RCTs reported in detail are needed for further confirmation.

关 键 词：蒲参胶囊 高脂血症 随机对照试验 系统评价 META分析 

分 类 号：R285[医药卫生—中药学] R289[医药卫生—中医学]