中药溻渍法治疗糖尿病足溃疡临床疗效的Meta分析及序贯分析  

Clinical Efficacy of Traditional Chinese Medicine Soaking Treatment for Diabetic Foot Ulcer:A Meta-analysis and Sequential Analysis

作　　者：王雪皖 王宁 周彤 邓莉娟 杨光耀 张莹 李创 王刚[4] 鞠上[4] WANG Xue-wan;WANG Ning;ZHOU Tong(Beijing University of Traditional Chinese Medicine,Beijing(100029),China)

机构地区：[1]北京中医药大学,北京100029 [2]北京市石景山区中医医院外科,北京100043 [3]北京市宣武中医医院周围血管科,北京1000504 [4]北京中医药大学东直门医院周围血管科,北京100700

出　　处：《中国中西医结合外科杂志》2022年第4期478-484,共7页Chinese Journal of Surgery of Integrated Traditional and Western Medicine

基　　金：国家重点研发计划项目(2019YFC1709300、2019YFC1709302)。

摘　　要：目的:系统评价中药溻渍法治疗糖尿病足溃疡的有效性和安全性。方法:计算机检索PubMed、Cochrane Library、中国知网、万方、维普数据库,检索时限为建库至2021年9月1日,搜集关于中药溻渍法治疗糖尿病足溃疡的随机对照试验(RCT)研究。采用Cochrane偏倚风险评估表对文献方法学质量进行评价,运用RevMan 5.3软件进行Meta分析,采用TSA 0.9软件对结局指标进行试验序贯分析。结果:最终纳入16项研究,涉及1404例患者。Meta分析结果显示,溻渍法的临床有效率显著高于对照组[RR=1.22,95%CI(1.12,1.33)]。试验序贯分析显示,有效率的累计Z值在第3项试验穿过TSA界值,中药溻渍法治疗糖尿病足溃疡证据确切,结论可排除假阳性可能。结论:中药溻渍法是治疗糖尿病足溃疡有效安全方法,但存在发表偏倚,且无高质量的研究,亟需针对溻渍法开展高质量、大样本、多中心随机对照试验的临床研究。Objective To conduct a Meta-analysis to evaluate the clinical efficacy of traditional Chinese medicine soaking treatment for diabetic foot ulcer(DFU).Methods Databases including PubMed,Cochrane Library,CNKI,Wanfang and VIP data were searched to collect randomized controlled trials(RCTs)about traditional Chinese medicine soaking in the treatment of DFU from inception to September 1 st,2021.The Cochrane risk assessment of bias was used to evaluate the methodological quality of the literature,and RevMan5.3software was used for Meta analysis.Experimental sequential analysis of outcome indicators using TSA 0.9software.Results A total of 16 RCTs involving 1404 patients were included.The result of Meta-analysis showed that clinical effectiveness of traditional Chinese medicine soaking was significantly higher than that of the control group in DFU[RR=1.22,95%CI(1.12,1.33)].The trial sequential score showed that the cumulative Z value for the effective rate crossed the TSA cut-off in test 3.The evidence for the treatment of diabetic foot ulcers by Chinese herbal medicine(TCM)with sweat stain was conclusive and the conclusion could exclude the possibility of a false positive.Conclusion Traditional Chinese medicine soaking method is an effective and safe method for the treatment of diabetic foot ulcer,however,there is publication bias as well as no high-quality research,so high-quality large-sample multicenter randomized controlled trials should be carried out.

关 键 词：溻渍法 糖尿病足溃疡 META分析 序贯分析 

分 类 号：R244.9[医药卫生—针灸推拿学] R654.4[医药卫生—中医临床基础]