摘要
[目的]对目前运用中医药治疗糖尿病下肢血管病变的随机对照试验中结局指标的使用情况进行系统分析,为临床应用和研究提供更加合理科学的依据。[方法]系统检索中国知网(CNKI)、万方数据知识服务平台(Wanfang)、维普期刊资源整合服务平台(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed数据库、Cochrane Library、Web of Science核心合集,筛选出关于中医药治疗糖尿病下肢血管病变的随机对照试验文献,根据Cochrane偏倚风险评估工具对所选文献的方法学质量展开评估,并运用描述性统计方法对研究结果进行定量分析。[结果]最终纳入73篇文献,从中提取106种结局指标,主要分为8类。根据使用频次由高到低排序,结局指标类依次为:生化指标、安全性评价指标、临床疗效率、中医证候疗效、血压指标、其他指标和生活质量指标。[结论]中医药治疗糖尿病下肢血管病变的结局指标偏倚风险较高,部分文献研究存在设计不严谨、中医药特色指标缺乏诊断标准待规范、结局指标多样选择缺乏标准化与一致性、主次要指标区分不明确等问题。建议未来中医药治疗糖尿病下肢血管病变的临床研究,提升方法学质量,规范结局指标的选择,并加强远期预后及安全性的评估,以确保研究结果能够更加客观、可靠且全面地反映研究的真实情况。
[Objective]This study aims to comprehensively evaluate the utilization patterns of efficacy measures in clinical trials investigating traditional Chinese medicine(TCM)interventions for diabetic peripheral vascular complications.The findings are expected to establish an evidence-based framework to optimize therapeutic strategies and enhance methodological rigor in future clinical investigations.[Methods]A comprehensive systematic search was conducted across multiple databases,including China National Knowledge Infrastructure(CNKI),Wanfang Database,VIP Journal Integration Platform,SinoMed,PubMed,Cochrane Library,and Web of Science Core Collection.The search aimed to identify randomized controlled trials(RCTs)focusing on the treatment of diabetic lower extremity vascular disease with traditional Chinese medicine.The methodological quality of the included studies was assessed using the Cochrane Risk of Bias tool.Descriptive statistical methods were employed to quantitatively analyze the study outcomes.[Results]Finally,73 articles were included,and the outcome indicators were extracted,which were mainly divided into 8 categories.According to the frequency of use,the outcome indicators from high to low were biochemical indicators,safety evaluation indicators,clinical efficacy rate,symptoms and signs,TCM syndrome efficacy,blood pressure indicators,other indicators and quality of life indicators.[Conclusion]The results showed that the risk of bias in outcome indicators for the treatment of diabetic lower extremity vascular ratio changes in traditional Chinese medicine was high.Some literature research had problems like designs not rigorous,the characteristic indicators of traditional Chinese medicine lacked diagnostic criteria to be standardized,the diverse selection of outcome indicators lacked standardization and consistency,the distinction between primary and secondary indicators was not clear,etc.It is suggested that the clinical research of traditional Chinese medicine in the treatment of diabetic lower extremity vascular disease in the future needs to improve the methodological quality,standardize the selection of outcome indicators,and strengthen the evaluation of long-term prognosis and safety indicators to ensure the objectivity,reliability and comprehensiveness of the research results.
作者
李芹
何佳怡
杨硕
李海燕
LI Qin;HE Jiayi;YANG Shuo;LI Haiyan(Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《天津中医药》
2025年第9期1149-1156,共8页
Tianjin Journal of Traditional Chinese Medicine
基金
中医药信息学创新团队(CI2021B002)。
关键词
中医药
糖尿病下肢血管病变
随机对照试验
结局指标
traditional Chinese medicine
diabetic lower extremity vascular disease
randomized controlled trial
outcome indicator
作者简介
李芹(1997-),女,博士研究生在读,研究方向为中医药信息学。;通讯作者:李海燕,E-mail:lihaiyan01@126.com。
