摘要
该研究系统分析中医药治疗糖尿病肾脏病(diabetic kidney disease,DKD)随机对照试验(randomized controlled trial,RCT)的结局指标应用现状,为构建DKD的核心指标集提供参考.计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、Cochrane Library、Web of Science数据库2019年1月至2024年3月中医药治疗DKD的RCT,评估偏倚风险,定性分析结局指标.最终纳入323篇RCTs,报告了199种结局指标,使用频次3744次,分属7个指标域:中医病证(196次,5.24％)、症状/体征(275次,7.35％)、理化检测(2820次,75.32％)、安全性事件(422次,11.27％)、远期预后(21次,0.56％)、生活质量(9次,0.24％)、经济学评估(1次,0.02％).其中使用频次最高的3种指标为临床总有效率(268次,82.97％)、肌酐(251次,77.71％)、尿素氮(206次,63.78％).结果表明,中医药治疗DKD存在结局指标偏倚风险较高、中医证型及疗效评价欠规范、忽视终点指标、结局指标及测量时点差异较大、主次结局指标不明确、远期预后、生活质量及经济学指标应用少、安全性事件报告不充分的局限性,建议积极构建DKD核心指标集,提升临床研究的质量和参考价值.
Abstract
This study systematically analyzed the current status of outcomes in randomized controlled trial (RCT) of traditional Chinese medicine (TCM) treatment of diabetic kidney disease (DKD),aiming to provide a reference for constructing the core outcome set (COS) of TCM treatment of DKD.The clinical RCTs of TCM treatment of DKD that were published from January 2019 to March 2024 were retrieved from seven databases:CNKI,Wanfang,VIP,SinoMed,PubMed,Cochrane Library,and Web of Science.The risk of bias was assessed and outcome indicators were qualitatively analyzed.A total of 323 RCTs were included,reporting 199 outcome indicators with the frequency of 3744 in seven indicator domains:TCM syndromes (196 times,5.24％),symptoms and signs (275 times,7.35％),physical and chemical examinations (2820 times,75.32％),safety events (422 times,11.27％),long-term prognosis (21 times,0.56％),quality of life (9 times,0.24％),and economic evaluation (1 time,0.02％).The three most frequently applied outcome indicators were total clinical response rate (268 times,82.97％),serum creatinine (251 times,77.71％),and urea nitrogen (206 times,63.78％).The outcomes in the studies of TCM treatment of DKD had the limitations of high risk of bias,lack of standardization of TCM syndromes and efficacy evaluation,neglect of endpoint indicators,large differences in endpoint indicators and time points of measurement,unclear primary and secondary outcomes,few application of long-term prognosis,quality of life,and economic indicators,and insufficient reporting of safety events.In the future,efforts should be made to actively promote the construction of COS in the studies about the TCM treatment of DKD and enhance the quality of the clinical studies.
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