中药治疗糖尿病足溃疡随机对照试验的系统评价

摘要

目的 评价中药治疗糖尿病足溃疡的疗效和安全性.方法 采用循证医学系统评价的方法.检索策略:电子检索数据库MEDLINE、CNKI、VIP、CBM、Cochrane图书馆(2010年第3期).检索日期截止2011年1月31日.纳入标准:中药与安慰剂对照、不治疗、局部或全身使用抗感染药物比较治疗糖尿病足溃疡的随机对照试验(RCT).试验组和对照组均允许采用西医常规治疗.资料提取与分析:两人独立提取资料,采用Cochrane协作网提供的软件RevMan 5.0.17进行资料分析.结局的效应指标为相对危险度( relative risk,RR)或均数差(mean difference,MD),均以95％可信区间表示.结果 纳入的14篇研究涉及893名糖尿病足溃疡患者用于评估.纳入的2篇英文文献质量较高,中文文献质量普遍偏低.在溃疡愈合率＞50％上:中药结合常规治疗组优于常规治疗组( RR:1.33；95％ CI[ 1.04,1.70]),中药结合常规治疗优于西药结合常规治疗组(RR:1.38；95％CI:[ 1.14,1.67])；在溃疡完全愈合上:中药结合常规治疗组优于西药结合常规治疗组(RR:1.89；95％ CI:[ 1.42,2.51])；在溃疡愈合时间(周)上:中药治疗结合常规治疗优于安慰剂结合常规治疗(MD:-3.30；95％ CI:[-4.03,-2.57]).中药治疗未发现严重不良事件.结论 目前证据表明中药对糖尿病足溃疡愈合可能具有潜在的疗效,需要设计更为严谨的大样本临床试验进行验证.%Objective To review the curative effect and safety of Chinese medicinals in treatment of diabetic foot ulcer. Methods The systematic evaluation of evidence-based medicine was used. The retrieval strategy was as follows; MEDLINE, CNKI, VIP, CBM and Cochrane Library (issue 3, 2010) were retrieved. The deadline was Jan. 31, 2011. The inclusion criteria was as follows; randomized controlled trials ( RCT) of treating diabetic foot ulcer including control of Chinese medicinals and placebo, comparison among non-specific treatment, local treatment and systemic treatment with anti-infective drugs. Experimental group and control group were all allowed to use the conventional therapy of Western medicine. The extraction and analysis of data were as follows; data were extracted by two persons independently and analyzed by using RevMan 5.0. 17 software provided by Cochrane Collaboration. The resultant effective indexes included relative risk (RR) and mean difference (MD) manifested as 95% confidence interval (95% CI). Results There were 14 studies reviewed involving 893 patients with diabetic foot ulcer, among which 2 literature in English were higher in the quality and the quality of other literature in Chinese was poor. In ulcer healing rate being over 50% , the group with Chinese medicinals combining conventional therapy had better results compared with the group with conventional therapy [RR: 1. 33; 95% C/: (1. 04, 1. 70)] , and also had better results compared with the group with Western medicinals combining conventional therapy [RR: 1.38; 95% CI: (1. 14, 1.67)]. In ulcer completely healing, the group with Chinese medicinals combining conventional therapy had better results compared with the group with Western medicinals combining conventional therapy [RR: 1.89; 95% CI: (1.42, 2. 51)]. In ulcer healing time (week), the group with Chinese medicinals combining conventional therapy had better results compared with the group with placebo combining conventional therapy [MD: -3.30; 95% CI; ( -4.03, -2.57)]. There were no severe adverse events observed in the treatment with Chinese medicinals. Conclusion The current evidence shows that Chinese medicinals have the latent curative effect in the healing of diabetic foot ulcer, which needs to be confirmed through designing more rigorous clinical expreriment with larger sample.