系统收集、分析和评价中成药治疗糖尿病足的临床随机对照试验(randomized controlled trial，RCT)，总结临床证据，以期为后续研究的开展及证据转化应用提供参考。基于中医药循证研究证据库系统(evidence database system，EVDS)旗下智能化中成药临床证据数据库(AICED-CPM)收录的文献，并补充检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、EMbase、Cochrane Library、Web of Science数据库，获取中成药治疗糖尿病足的RCT，并进行统计分析。检索得到符合要求的RCTs 275篇，其中纳入患者样本量200例及以上的RCTs仅7篇;涉及中成药66种(口服中成药25种，中药注射剂24种，外用药17种);干预/对照设计33种，其中"中成药+常规治疗vs常规治疗"为最常用设计(86篇，31。27％);纳入的275篇文献中50篇未报告具体疗程(18。18％);共应用计数指标10种(426次)，计量指标36种(962次)。方法学质量方面，均存在盲法及其他偏倚缺失，此外研究注册均未报告。结果表明，中成药治疗糖尿病足的RCT总体方法学质量不高，在分配隐藏、实施偏倚(盲法应用)、其他偏倚3个方面的报告存在明显不足，今后相关研究的开展应重视试验注册和方案设计，实施过程严格质控，以期为临床实践提供证据支持，为后续研究的开展提供参考。
Summary and evaluation of randomized controlled trial on Chinese patent medicine in treatment of diabetic foot ulcer
This study systematically collected,analyzed,and evaluated randomized controlled trial(RCT)in the treatment of diabetic foot ulcer(DFU).The aim as provide references for future studies and to enhance the application of clinical evidence.The RCT of DFU treated with Chinese Patent Medicine was obtained and analyzed using the AI-Clinical Evidence Database of Chinese Patent Medicine(AICED-CPM).The analysis was supplemented with data from CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase,Cochrane Library,and Web of Science.A total of 275 RCTs meeting the requirements were retrieved,with only 7 of them having a sample size of 200 or more.These trials involved 66 different Chinese patent medicine including 25 oral medications,24 Chinese herbal injections,and 17 external drugs.Among the 33 different intervention/control designs identified,the most common design was Chinese patent medicine+conventional treatment vs conventional treatment(86 cases,31.27％).Out of the 275 articles included in the literature,50 did not provide information on the specific course of treatment(18.18％).A total of 10 counting indicators(with a frequency of 426)and 36 measuring indicators(with a frequency of 962)were utilized.The methodological quality of the RCT for the treatment of DFU with Chinese patent medicine was found to be low,with deficiencies in blind methods,other bias factors,study registration,and sample size estimation.There were noticeable shortcomings in the reporting of allocation hiding and implementation bias(blind method application).More studies should prioritize trial registration,program design,and strict quality control during implementation to provide valuable data for clinical practice and serve as a reference for future investigations.
Chinese patent medicinediabetic foot ulcerrandomized controlled trialevidence-based medicinetraditional Chi-nese medicinegangrenosis
NETL
NSTL
万方数据
