摘要
目的:系统评价以半夏泻心汤为基础方并随证加减治疗溃疡性结肠炎(ulcerative colitis,UC)的临床疗效及其安全性。方法:采用检索电子数据库的方式,分别检索国外和国内共7个数据库,包括Cochrane图书馆、Pub Med、EMBASE、中国生物医学文献数据库(Sino Med)、中国知网知识发现网络平台(CNKI)、重庆维普科技数据库(VIP)和万方数据知识数据库(Wan Fang Date)等,纳入半夏泻心汤及其加减方与其他药物治疗溃疡性结肠炎的临床随机对照试验(RCT),纳入文献语种限定为中文或者英文,所有检索时间范围为各数据库建库至2015年8月1日。两名研究人员各自独立对文献资料的各项数据进行提取,同时并完成对文献资料的方法学质量评价和结果分析,Meta分析采用软件Rev Man 5.2.3完成。结果:本次研究共纳入14篇随机对照临床试验,所纳入文献均质量偏低。Meta分析结果显示:所有14个研究均报道总有效率。结果:研究结果显示,研究组无论单独以半夏泻心汤为基础方随证加减或者联合其他药物治疗溃疡性结肠炎总有效率均优于对照组。14项研究中仅有1篇文献对不良反应进行了报道。结论:半夏泻心汤及其加减方治疗UC的临床疗效较一般中成药和西药好,但鉴于本研究纳入的原始文献均为中文文献且所有文献质量均不高,因此不能对该药物的临床疗效和安全性给予肯定的结论,而开展更多大样本、多中心、科学化和规范化的高质量随机时照试验显得尤为必要。
Objective：To make a systematic review on the clinical effect and safety of modified Banxia Xiexin Decoction in the treatment of UC（ulcerative colitis）. Methods：The retrieval of electronic database was applied;the foreign retrieval database included Cochrane,Pub Med and EMBASE;the domestic retrieval database included Sino Med,CNKI,VIP and Wang Fang Date. RCT on the modified Banxia Xiexin Decoction in the treatment of UC was conducted. The language was limited to Chinese or English. The valid retrieval time started from the launch of the database to August 1,2015.Two researchers would independently collect the data,evaluate the methodology quality and analyze the results. Rev Man 5.3 software was available to make the Meta analysis. Results：14 RCT was conducted of which the research quality was not favorable. Meta-analysis results：it was known that the total effective rate of modified Banxia Xiexin Decoction in the treatment of UC was better than that of the other conventional therapies. One RCT had made a description on the adverse reactions and 13 RCT had not recorded the adverse reactions. Conclusion：In the treatment of UC,the clinical effect of modified Banxia Xiexin Decoction is better than that of the general Chinese patent medicine and western medicine. Since the quality of the available Chinese literature is not ideal,it is unable to confirm its clinical effect and safety. It is quite necessary to condut the scientific,normalized and high quality RCT with more samples and multiple centers.
出处
《辽宁中医药大学学报》
CAS
2016年第12期104-108,共5页
Journal of Liaoning University of Traditional Chinese Medicine
基金
内蒙古自治区高等学校科学研究项目(NJZY14136)
