系统梳理中医药干预脓毒症肾损伤随机对照试验(randomized controlled trial，RCT)的临床特征及结局指标现状，为优化临床研究设计及构建中医药治疗脓毒症肾损伤核心指标集提供参考。计算机检索PubMed、Cochrane Library、EMbase、Web of Science、中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)近5年发表的中医药干预脓毒症肾损伤RCT，提取纳入研究的基本特征、干预措施、结局指标等，并进行描述性分析。最终纳入53篇RCTs，样本量多集中于60～80例，合并腹腔感染最多(15篇，83。3％)，中医证候频次最高的是瘀血内阻证(9篇，50。0％)，干预方式频次从高到低为中药汤剂(28篇，52。8％)、中成药(22篇，41。5％)、中医疗法联合(3篇，7。5％)，干预周期多集中于≤7 d(34篇，69。4％)。纳入研究偏倚风险多不明确。共涉及84种结局指标，分为9个指标域:理化检测63种(305次，72。2％)、病情程度4种(48次，11。6％)、临床有效率4种(15次，3。6％)、生存质量1种(1次，0。2％)、经济学评估2种(14次，3。3％)、中医病证1种(9次，2。1％)、远期预后2种(16次，3。8％)、安全性事件2种(6次，1。4％)、其他指标5种(8次，0。7％);累计频次422次，其中频次较高的结局指标有炎性因子(42篇，79。2％)、肾功能及肾损伤标志物(40篇，75。5％)等。纳入研究仅1篇(1。9％)提及主要与次要结局指标，6篇(11。3％)提及安全性事件，13篇(24。5％)提及经济学评估。中医药干预脓毒症肾损伤RCT质量整体偏低，脓毒症、肾损伤及中医证候诊断参考标准不统一。结局指标存在主次区分不明确、忽视终点指标、缺乏中医特色指标的应用、安全性事件与经济学评估关注不足等问题。建议未来提升临床研究方法学质量，构建核心指标集，为中医药干预脓毒症肾损伤提供高级别循证证据。
Analysis of clinical research features and outcome indexes of traditional Chinese medicine intervention in septic kidney injury
This study aims to systematically review the clinical features and outcome indicators in randomized controlled trial(RCT)of traditional Chinese medicine(TCM)intervention in septic kidney injury and provide a reference for optimizing clinical study design and building the core outcome set(COS)of TCM treatment of septic kidney injury.Computer searches were conducted on PubMed,Cochrane Library,EMbase,Web of Science,CNKI,Wanfang,VIP,and SinoMed to find published RCT of TCM interven-tion in septic kidney injury in the past five years,extract the basic characteristics,intervention measures,outcome indicators,and other data of included studies,and conduct descriptive analysis.53 RCTs were included,and the sample size was mostly concentrated in 60-80 cases,with abdominal infection being the most common(15 articles,83.3％)and the TCM syndrome of blood stasis being the most frequent(9 articles,50.0％).The frequency of intervention methods from high to low were TCM decoction(28 articles,52.8％),Chinese patent medicine(22 articles,41.5％),and combined TCM therapy(3 articles,7.5％);the intervention time of the trial was more than 7 d(34 articles,69.4％).The risk of bias in included studies was unclear.A total of 84 outcome indicators were involved,which were divided into 9 fields,including 63 physical and chemical tests(305 times,72.2％),4 kinds of disease degree(48 times,11.6％),4 kinds of clinical effective rate(15 times,3.6％),1 kind of quality of life(1 time,0.2％),2 kinds of economic evaluation(14 times,3.3％),1 kind of TCM disease(9 times,2.1％),2 kinds of long-term prognosis(16 times,3.8％),2 kinds of safety events(6 times,1.4％),and 5 other indicators(8 times,0.7％).The cumulative frequency was 422 times,among which the outcome indicators with higher frequency were inflammatory factors(42 articles,79.2％)and markers of renal function and kidney injury(40 articles,75.5％).Only 1(1.9％)of the included articles mentioned primary and secondary outcome indicators,and 6 articles(11.3％)mentioned safety events,13 articles(24.5％)mentioned economic assessment.The RCT quality of TCM intervention in septic renal injury was generally low,and the reference standards for sepsis,kidney injury,and TCM syndrome diagnosis were not uniform.There are some problems in outcome indicators,such as unclear distinction between primary and secondary indicators,neglect of endpoint indicators,lack of application of TCM characteristic indicators,and insufficient attention to safety events and economic assessment.It is suggested that the quality of clinical research methodology should be improved in the future,and the COS should be constructed to provide high-level evidence-based evidence for TCM intervention in septic kidney injury.
sepsiskidney injurytraditional Chinese medicinerandomized controlled trialoutcome indicatorcore outcome set
NETL
NSTL
万方数据
