中医药治疗糖尿病足的临床研究证据图分析

Evidence mapping of clinical research on traditional Chinese medicine in treatment of diabetic foot

该研究通过证据图对中医药治疗糖尿病足的临床随机对照试验(RCTs)及系统评价/Meta分析进行全面梳理,了解该领域的证据分布。通过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、EMbase、Web of Science数据库,纳入近十年中医药治疗糖尿病足的临床RCTs和系统评价,以文字与图表相结合的形式对证据进行分析与展示,采用AMSTAR测量工具进行系统评价的质量评价。共纳入1 037篇RCTs, 20篇系统评价/Meta分析。整体发文趋势较为平稳,RCTs研究规模较小。中医药治疗糖尿病足干预措施以外敷、足浴为主,关注较多的结局指标包括总有效率、踝肱指数(ABI)、中医病证,在神经病变评分、情志心理及远期预后方面关注较少。系统评价/Meta分析整体质量较低,且大多数研究显示中医药治疗糖尿病足具有潜在疗效,尚缺乏疗效明确的临床证据。结果表明中医药治疗糖尿病足既有优势,但也存在问题,目前仍缺乏更多高质量的研究,提示未来要开展更多大样本、多中心的RCTs,同时提高相关系统评价/Meta分析的质量,充分挖掘并发挥中医药治疗糖尿病足的优势,促进中医药治疗糖尿病足临床和循证医学的共同发展。

The present study comprehensively summarized the clinical randomized controlled trials(RCTs) and systematic reviews/Meta-analyses of traditional Chinese medicine(TCM) in the treatment of diabetic foot by evidence mapping and clarified the distribution of evidence in this field.CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Web of Science were searched for clinical RCTs and systematic reviews on TCM in the treatment of diabetic foot published in the past ten years.The evidence was analyzed and displayed in the form of text combined with figures and tables.AMSTAR was used for the quality evaluation of systematic reviews.A total of 1 037 clinical RCTs and 20 systematic reviews/Meta-analyses were included.The overall publishing trend was stable, and the scale of RCTs was small.TCM interventions for diabetic foot mainly included external application and foot bath.Much attention was paid to the outcome indicators including total effective rate, ankle brachial index(ABI), and TCM syndromes, while less attention to neuropathy scores, emotional psychology, and long-term prognosis.The overall quality of systematic reviews was low, and the majority of studies indicated that TCM had potential efficacy in treating diabetic foot, and there was still a lack of clear clinical evidence of efficacy.TCM has both advantages and problems in the treatment of diabetic foot.At present, there is still a lack of high-quality research, suggesting that more large-sample, multi-center RCTs should be launched in the future, and the quality of related systematic reviews/Meta-analyses should be improved to fully explore and give full play to the advantages of TCM in the treatment of diabetic foot, and promote the development of the clinical and evidence-based medicine of TCM in the treatment of diabetic foot.