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黄连素治疗血脂异常有效性和安全性随机对照临床试验的系统评价与Meta分析 被引量:17

Systematic review and Meta-analysis on efficacy and safety of berberine for dyslipidemia
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摘要 评价黄连素治疗血脂异常的疗效和安全性。系统全面检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、Cochrane Library、EMbase、Medline(OVID)数据库,检索时限从建库至2019年1月,检索语种不限。收集黄连素加或不加降脂药物对照安慰剂、无药物或降脂药物的随机对照试验。按照Cochrane手册进行数据提取、文献质量评价。采用RevMan 5.3软件进行Meta分析。最终纳入25项试验,总样本量3042例,其中试验组1552例,对照组1490例,所纳入的试验临床异质性较高,总体方法学质量一般,在随机序列生成、分配隐藏、盲法和结果数据等方面可能存在多种偏倚。根据干预措施分为不同的亚组进行分析。Meta分析结果显示,与对照组相比,黄连素单药或联合其他降脂药物治疗可以降低总胆固醇(TC),甘油三酯(TG),低密度脂蛋白胆固醇(LDL-C)水平,并升高高密度脂蛋白胆固醇(HDL-C)水平,差异有统计学意义。与对照组相比,不良事件的发生率无统计学差异,所有试验未报告严重不良事件。结果显示黄连素治疗血脂异常具有良好的疗效及安全性。由于纳入试验的质量限制,上述结论还需进一步开展高质量、大样本、多中心的临床试验进行验证。 To evaluate the clinical efficacy and safety of berberine in the treatment of dyslipidemia.In this review,CNKI,WanFang,VIP,CBM,PubMed,Cochrane Library,EMbase,and Medline(OVID)were retrieved from database establishment to January,2019 in any language.Randomized controlled trials(RCTs)of berberine with or without lipid-lowering drugs vs placebo,without drugs or lipid-lowering drugs only in treatment of dyslipidemia were collected.Data extraction and paper quality assessment were conducted according to the Cochrane Handbook.Then RevMan 5.3 software was used for Meta-analysis.A total of 25 trials were included,covering 3042 cases,including 1552 cases in the experimental group and 1490 cases in the control group.The clinical heterogeneity of the included trials was relatively high,and the methodological quality of most trials was generally low,with bias in terms of random sequence generation,allocation hiding,blind method and result data.Interventions were divided into different subgroups for analysis.Meta-analysis suggested that use berberine alone or along with lipid lowing drugs could reduce TC,TG,LDL-C levels and increased HDL-C levels with statistically significant difference as compared with control group.As compared with control group,there was no statistically significant difference in the incidence of adverse events.No severe adverse effects were reported in all trials.Berberine has good efficacy and safety in the treatment of dyslipidemia.Due to the quality limitations of the included trials,the above conclusions need to be further verified by high-quality,large sample size and multi-center clinical trials.
作者 赵颖 杨园园 杜雅薇 杨惠民 吴圣贤 ZHAO Ying;YANG Yuan-yuan;DU Ya-wei;YANG Hui-min;WU Sheng-xian(Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing 100700,China)
出处 《中国中药杂志》 CAS CSCD 北大核心 2020年第3期664-673,共10页 China Journal of Chinese Materia Medica
基金 国家“重大新药创制”科技重大专项(2017ZX09304019).
关键词 黄连素 血脂异常 系统评价 META分析 有效性 安全性 berberine dyslipidemia systematic review Meta-analysis efficacy safety
作者简介 通讯作者:吴圣贤,主任医师,医学博士,博士生导师,研究方向为动脉粥样硬化和中药临床药理,Tel:(010)84015528,E-mail:wushx@sina.com;通讯作者:杨惠民,主任医师,医学硕士,博士生导师,研究方向为中医药防治老年病,Tel:(010)84013235,E-mail:yanghuimin012005@163.com;赵颖,博士研究生,E-mail:zhaoying920317@qq.com
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