目的:比较黄芪桂枝五物汤与西药治疗糖尿病周围神经病变(DPN)的有效性和安全性。方法:计算机检索CBM(1979—2010)、CNKI(1979—2010)、VIP(1989—2010)和WF(1998—2010)。辅以手工检索天津中医药大学图书馆过刊资料库。收集黄芪桂枝五物汤和西药比较治疗DPN的临床随机对照试验,由两名评价者独立提取资料并按照Co-chrane Review Handbook 5.0进行质量评估。统计学分析采用RevMan5.1.1软件。结果:共纳入21篇临床随机对照试验,共有1496例。Meta分析结果显示:①正中神经传导速度(运动神经):黄芪桂枝五物汤VS弥可保[WMD=2.33,95%CI(-0.41,5.07)]无差别;②正中神经传导速度(感觉神经):黄芪桂枝五物汤VS弥可保[WMD=2.77,95%CI(2.19,3.35)]有差别;③腓总神经传导速度(运动神经):黄芪桂枝五物汤VS弥可保[WMD=4.12,95%CI(3.14,5.10)]有差别;黄芪桂枝五物汤+弥可保VS弥可保[WMD=2.80,95%CI(2.01,3.60)]有差别;④腓总神经传导速度(感觉神经):黄芪桂枝五物汤VS弥可保:[WMD=2.39,95%CI(1.84,2.94)]有差别;⑤临床总有效率:黄芪桂枝五物汤VS维生素B1B12:[RR=1.45,95%CI(1.03,2.03)]有差别;黄芪桂枝五物汤VS弥可保:[RR=1.41,95%CI(1.23,1.62)]有差别;黄芪桂枝五物汤+弥可保VS弥可保:[RR=1.30,95%CI(0.96,1.77)]无差别。结论:黄芪桂枝五物汤对照弥可保在改善DPN正中神经传导速度(运动)上尚无优势,黄芪桂枝五物汤单用或与其他西药合用对照单用西药在改善正中神经和腓总神经传导速度(感觉、运动)上有一定优势。现有证据提示其在改善感觉神经功能的效果在一定程度上优于改善运动神经。尚需要更多高质量的随机双盲对照试验来进一步证实黄芪桂枝五物汤治疗DPN的疗效。
Objective:To assess the efficacy and safety of Huangqi Guizhi Wuwu Decoction and western medicine in the treatment of diabetic peripheral neuropathy. Methods:Randomized controlled trials(RCTs) involving Huangqi Guizhi Wuwu Decoction and western medicine in the treatment of diabetic peripheral neuropathy (DPN)were identified from CBM (1978 to 2010 ), VIP ( 1989 to 2010), WANFANG Database ( 1998 to 2010), CNKI ( 1979 to 2010). We also manually searched relevant journals from the reading room for back up issues in Tianjin University of TCM. Data was extracted and evaluated by two reviewers independent- ly. Cochrane Review Handbook 5.0 was use for quality assessment. RevManS. 1.1 - one of the Cochrane Collaboration~ software, was used for data analyses. Results:A total of 21 trials involving 1496 patients were included. The followings are what Meta-analy- ses showed. ()The motive nerve conduction velocity of median nerve in the experimental group ( the group used Huangqi Guizhi Wuwu Decoction)had no significant different when compared with the methylcobalamin group[ WMD = 2.33,95% CI( -0.41,5. 07) ]. (While there was significant difference between the experimental group used Huangqi Guizhi Wuwu Decoction and the control group used methylcobalamin in the improvement of the sensory nerve conduction velocity of median nerve[ WMD =2.77, 95 % CI (2.19,3.35) ]. (~)When it came to the motive nerve conduction velocity of peroneal nerve, Huangqi Guizhi Wuwu Decoc- tion, combined [ WMD = 2.80,95 % CI ( 2.01,3.60 ) or not combined with methylcobalamin [ WMD = 4.12,95 % CI ( 3.14,5. 10) 1, had statistical difference from methylcobalamin. As for the sensory nerve conduction velocity of peroneal nerve, significant difference was found between Huangqi Guizhi Wuwu Decoction and methylcobalamin [ WMD = 2.39,95% CI(1.84,2.94) ]. (5)In terms of the total effective rate, significant differences were noted between the experimental group( the group used Huaugqi Guizhi W