Jiang Yi-Jia, Wei Mao-Ying, Zhang Wen-Hua, Yin Dan, Tang Yi-Ting, Jia Wei-Yu, Guo Jing-Yi, Li Ai-Jing, Gong Yan-Bing
Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China.
Beijing University of Chinese Medicine Beijing 100029, China.
Zhongguo Zhong Yao Za Zhi. 2024 Dec;49(24):6813-6824. doi: 10.19540/j.cnki.cjcmm.20240826.502.
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 3 744 in seven indicator domains: TCM syndromes(196 times, 5.24%), symptoms and signs(275 times, 7.35%), physical and chemical examinations(2 820 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.
本研究系统分析了中医药治疗糖尿病肾病（DKD）随机对照试验（RCT）的结局现状，旨在为构建中医药治疗DKD的核心结局集（COS）提供参考。通过检索中国知网、万方、维普、中国生物医学文献数据库、PubMed、考克兰图书馆和Web of Science这七个数据库，获取2019年1月至2024年3月发表的中医药治疗DKD的临床RCT。评估偏倚风险并对结局指标进行定性分析。共纳入323项RCT，报告了199项结局指标，在七个指标领域出现3744次，分别为中医证候（196次，5.24%）、症状体征（275次，7.35%）、理化检查（2820次，75.32%）、安全事件（422次，11.27%）、远期预后（21次，0.56%）、生活质量（9次，0.24%）和经济评价（1次，0.02%）。应用最频繁的三项结局指标为总临床有效率（268次，82.97%）、血清肌酐（251次，77.71%）和尿素氮（206次，63.78%）。中医药治疗DKD的研究结局存在偏倚风险高、中医证候及疗效评价缺乏规范、忽视终点指标、终点指标及测量时间点差异大、主次结局不明确、远期预后、生活质量及经济指标应用少、安全事件报告不足等局限性。未来应积极推动中医药治疗DKD研究中COS的构建，提高临床研究质量。
