中药箍围法治疗糖尿病足溃疡随机对照试验的系统评价

Systematic review of randomized controlled trials on the therapy of encircling lesion with Chinese medicine in diabetic foot ulcer

目的 系统评价中药箍围法治疗糖尿病足溃疡(DFU)的临床疗效与安全性。方法 计算机检索中国知网、维普中国科技期刊数据库、万方数据库、中国生物医学文献数据库、PubMed、Cochrane Library、Web of Science数据库,检索时间为建库至2022年10月1日,并手工检索相关内部报告、会议论文及相关主题的灰色文献,纳入中药箍围法治疗DFU的随机对照试验(RCT),由2名研究成员进行数据提取及质量评价,采用RevMan5.4.1软件进行Meta分析。结果 共纳入8篇文献632例患者,方法学质量评价较差。Meta分析结果显示,中药箍围法对糖尿病足创面面积和局部症状改善的总有效率高于西医外治疗法,差异有统计学意义(RR=1.14,95%CI:1.07~1.22,P<0.01)。仅1篇文献在中药箍围法干预过程中出现了创面及创周的轻度瘙痒及斑疹等过敏症状,停药后自行缓解,其他文献均未报道与中药箍围法相关的不良反应。结论 与西医外治疗法相比,中药箍围法在治疗DFU疗效与安全性方面存在优势,但因本研究系统评价纳入的研究证据强度不高、样本量小,故仍需要大样本、高质量的临床试验给予进一步验证。

Objective To systematically review the randomized controlled trials on therapy of encircling lesion with Chinese medicine in diabetic foot ulcer(DFU). Method Databases of CNKI, VIP, Wanfang, CBM, PubMed, Cochrane Library, and Web of Science from establishment to October 1, 2022 were searched, the internal report, conference papers and literatures of related subject were searched to include randomized controlled trial(RCT) on therapy of encircling lesion with Chinese medicine in DFU. Data extraction and quality evaluation were conducted by 2 investigators and Rev Man5.4.1 was used for Meta analysis. Result A total of 8 trials involving 632 patients, the methodological quality of included RCT was generally lower. Meta-analysis showed the therapeutic efficacy of encircling lesion with Chinese medicine was higher than external application of western medicine(RR=1.14, 95%CI: 1.07-1.22, P<0.01). Only 1 included literature reported mild allergy including mild pruritus and macula in the wound and surrounding area by therapy of encircling lesions with Chinese medicine, which resolved spontaneously after discontinuation of medicine,and no related adverse reactions reported in other literatures. Conclusion Compared with Western external treatment,therapy of encircling lesion with Chinese medicine is more efficient and safer in DFU. Further large-sample and highquality clinical trials are required to provide reliable evidence due to the low quality and small samples included in the systemic review.