近十年中医药干预糖尿病周围神经病变临床RCT研究证据图

Evidence Map of Clinical RCT Studies on the Intervention of Diabetic Peripheral Neuropathy by Traditional Chinese Medicine in Recent Ten Years

目的通过系统检索并整合分析近十年中医药治疗糖尿病周围神经病变(DPN)的临床随机对照试验(RCTs)及系统评价/Meta分析,旨在归纳中医药治疗DPN整体证据分布。方法检索的数据库涵盖CNKI、WANFANG、VIP、CBM、PubMed、Web of Science、Embase、The Cochrane Library,检索时限为2012年1月1日-2022年10月23日,纳入RCTs及系统评价/Meta分析,证据分布采用图表进行展示;利用AMSTAR-1量表对系统评价/Meta进行方法学质量评估。结果共纳入1648篇RCTs和59篇系统评价/Meta分析。整体而言,RCTs发文量呈上升趋势,但大多数研究规模比较小,68%的单个研究样本量集中在50-100;干预时长多为4-8周;多疗法是最常用的干预措施类别,其中涉及最多的干预措施为中药汤剂联合应用;单一中医药疗法以口服中药汤剂为主。临床疗效评价指标对总有效率、神经传导速度、中医病证等方面关注较多;经济学指标、生活质量、远期疗效等指标尚未引起研究者的重视。系统评价/Meta分析整体方法学质量不高,大多数显示具有良好的临床疗效,但缺乏足够的证据支撑。结论研究结果显示中医药治疗糖尿病周围神经病变具有良好的特色优势。不足之处主要体现在系统评价/Meta整体方法学质量较低。提示未来仍需要进行更多具有广度及深度的高质量临床RCTs研究,以验证中医药治疗糖尿病周围神经病变的特色优势,为循证医学证据提供数据信息支持。

Objective To systematically retrieve and integrate the clinical randomized controlled trials(RCTs)and systematic reviews/Meta-analyses of traditional Chinese medicine in the treatment of diabetic peripheral neuropathy(DPN)in recent 10 years,aiming to summarize the overall evidence distribution of traditional Chinese medicine in the treatment of DPN.Methods CNKI,WANFANG,VIP,CBM,PubMed,Web of Science,Embase and the Cochrane Library were used as retrieval database.The retrieval time was from January 1,2012 to October 23,2022.RCTs and systematic reviews/Meta-analyses were included.The distribution of evidence was displayed in the form of charts.AMSTAR-1 was used for the methodological quality evaluation of systematic reviews/Meta-analyses.Results A total of 1648 RCTs and 59 systematic reviews/Meta-analyses were included.The overall number of RCTs were on the rise,but most of the scale of the RCTs were relatively small,with 68%of the samples size of a single study concentrated between 50-100;The Duration of intervention was 4-8 weeks;Multi-therapy was the most commonly used intervention,among which the most involved intervention was the combination of TCM decoction;Traditional Chinese medicine monotherapy was mainly oral traditional Chinese medicine decoction.The evaluation indexes of clinical efficacy paid much attention to the total effective rate,nerve conduction velocity,TCM diseases and syndromes;economic index,quality of life,longterm efficacy and other indicators had attracted less attention of researchers.The overall methodological quality of systematic reviews/Meta-analyses was not high,most of which show good clinical efficacy,but lack sufficient evidence support.Conclusion The research results show that the treatment of diabetes peripheral neuropathy with TCM have good characteristics and advantages,the shortcomings are mainly reflected in the low quality of the overall methodology of systematic reviews/Meta-analyses.Suggesting that more high-quality clinical RCTs with breadth and depth are still needed in the future to verify the characteristics and advantages of traditional Chinese medicine in the treatment of diabetic peripheral neuropathy and provide data information support for evidence-based medicine.