中医药治疗糖尿病痛性神经病变的临床RCT证据图分析  

Evidence of Clinical Randomized Controlled Trial Research in Treatment of Diabetic Painful Neuropathy with TCM

作　　者：陈凤 张广德[2] CHEN Feng;ZHANG Gang-de(Graduate School of Beijing University of Chinese Medicine,Beijing 100029;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100089)

机构地区：[1]北京中医药大学研究生院,北京100029 [2]中国中医科学院西苑医院,北京100089

出　　处：《世界中西医结合杂志》2024年第3期449-456,共8页World Journal of Integrated Traditional and Western Medicine

基　　金：中国中医科学院科技创新工程重大攻关项目(CI2021A01608)。

摘　　要：目的通过证据图方法对中医药治疗糖尿病痛性神经病变临床RCT现状进行梳理与展示,以期充分挖掘并发挥中医药治疗糖尿病痛性神经病变的优势,促进中医药治疗糖尿病痛性神经病变临床和循证医学的共同发展。方法计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、SinoMed、PubMed、Cochrane Library、Web of Science等数据库,筛选出符合条件的文献,并对文献中相关信息进行整理,然后以文字和图表相结合的方式对证据进行分析和展示。结果纳入中医药治疗糖尿病痛性神经病变相关文献125篇,总的来说文献量较少,但整体发文趋势呈逐年增长,但是临床试验规模大多较小。中医药治疗糖尿病痛性神经病变主要干预措施以中药口服、针灸为主,中药汤药多以益气活血温阳通络为主,关注较多的结局指标包括症状体征、神经传导速度指标、总有效率、血糖、中医证候积分,在感觉检查、远期预后、情志心理方面关注较少。对文献进行质量评价显示相关随机对照研究大多质量不高,同时相关系统评价/Meta分析的文献量非常少。结论中医药方法对治疗糖尿病痛性神经病变具有一定优势,但目前相关临床随机对照研究的设计大多不够严谨,也没能将中医特色更好地展现出来,从循证医学角度来说高质量证据较少,未来需要进一步改善。Objective To review and present the current status of clinical randomized controlled trials(RCTs)on the treatment of diabetic painful neuropathy(DPN)with traditional Chinese medicine(TCM)using an evidence diagram approach,aiming to fully explore and leverage the advantages of TCM in treating DPN,and to promote the mutual development of clinical TCM treatment for DPN and evidence-based medicine.Methods Databases,including China National Knowledge Infrastructure(CNKI),Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,and Web of Science were searched.Relevant literature was screened,and information was extracted and organized.The evidence was then analyzed and presented through a combination of textual description and graphical representation.Results A total of 125 relevant articles on TCM treatment for DPN were included.Overall,the volume of literature was relatively low,but there was an increasing trend in publications over the years.However,most clinical trials had relatively small sample sizes.TCM interventions for DPN mainly focused on oral Chinese medicine and acupuncture and moxibustion.Chinese herbal medicine decoctions primarily aimed at nourishing qi,activating blood,warming yang,and dredging collaterals.Common outcome measures included symptoms and signs,nerve conduction velocity,total effective rate,blood glucose levels,and TCM syndrome scores,while there was less emphasis on sensory examination,long-term prognosis,and psychosocial aspects.Quality assessment of the literature revealed that most relevant RCTs were of low quality,and there was a scarcity of systematic reviews/Meta-analyses.Conclusion TCM approaches showed certain advantages in treating DPN.However,the designs of most related clinical RCTs were generally not rigorous enough to fully demonstrate the characteristics of TCM.From the perspective of evidence-based medicine,there is a lack of high-quality evidence,indicating a need for further improvement in future research.

关 键 词：中医药 糖尿病痛性神经病变 临床研究 证据图 

分 类 号：R587.2[医药卫生—内分泌]