摘要
目的系统梳理中药制剂治疗溃疡性结肠炎(UC)随机对照试验(RCT)的方法学和临床特征,为深入进行荟萃分析以及为临床试验核心指标集的构建提供参考。方法计算机检索中国知网、维普数据库、万方数据知识服务平台、中国生物医学文献服务系统、PubMed、Cochrane Library从建库至2020年6月6日收录的中药治疗UC的RCT,进行资料提取,分析其方法学质量和临床特征。结果共检索到中药制剂治疗UC的文献11 527篇,最终纳入406篇,包括35 485例受试者。单中心临床试验占比最高(332/406,81.8%),35.5%(144/406)的试验报告了详细的随机方法,4.9%(20/406)的试验实施了盲法。干预措施共261种,包含中成药21种,有3种方药的RCT研究超过10项。汤剂是最常见的中药剂型,给药途径多见口服、灌肠或二者结合,82.0%(214/261)的干预措施仅有1项随机对照试验。临床综合疗效是受关注最多的结局指标。结论中药制剂治疗UC的RCT研究大多数干预方案RCT证据不足,同时需要关注对于缓解期患者的药物干预及卫生经济学、生命质量、安全性指标等结局指标的报道。
ObjectiveTo systematically analyze and assess the clinical characteristics and methodological quali-ty of randomized controlled trials(RCTs)on Chinese herbal preparations for ulcerative colitis(UC),to provide refer-ences for further meta-analysis as well as the construction of core outcome set in UC clinical trials.MethodsElec-tronic databases including CNKI,VIP,Wanfang,Sino Med,Pub Med and Cochrane Library were searched from theinception dates to June 6,2020 for RCTs on Chinese herbal preparations for UC.After the data was extracted,theclinical characteristics was analyzed,and the methodological quality was assessed.ResultsA total of 11 527 paperswere retrieved,and finally 406 papers on Chinese herbal preparations for UC were included,involving 35 485 patients.Most RCTs were single-center clinical trials(332/406,81.8%);35.5% trials(144/406)reported therandomization method,and 4.9% trials(20/406)implemented blinding.There were 261 kinds of interventions in-volved,which included 21 Chinese patent medicin;and more than 10 RCTs were found on three herbal prescriptions.Decoction was the most common form;oral administration,enema administration or a combination of both were mostlycommon seen.Only one RCT was available for 82.0%(214/261)interventions.The comprehensive clinical effective-ness was the most concerned outcome indicator.ConclusionIn RCTs for Chinese herbal preparations for treatmentof UC,most intevention showed insufficient evidence.More attention should be payed to the management of patientsin remission period,as well as the report of outcome indicators related to health economics,quality of life and safety.
作者
孙屿昕
王晓
侯文斌
郑酉友
刘建平
刘兆兰
SUN Yuxin;WANG Xiao;HOU Wenbin;ZHENG Youyou;LIU Jianping;LIU Zhaolan(Center for Evidence-based Chinese Medicine,Beijing University of Chinese Medicine,Beijing,100029)
出处
《中医杂志》
CSCD
北大核心
2021年第20期1780-1787,共8页
Journal of Traditional Chinese Medicine
基金
十三五国家重点研发计划(2018YFC1705401)
国家自然科学基金资助项目(81904052)。
关键词
溃疡性结肠炎
中药制剂
随机对照试验
结局指标
方法学质量
ulcerative colitis
Chinese herbal preparations
randomized controlled trials
outcome indicators
methodological quality
