高压氧治疗糖尿病足溃疡临床疗效及安全性的Meta分析

Hyperbaric Oxygenation Therapy in Diabetic Foot Ulcer: A Meta-analysis

目的评价高压氧(HBO)治疗糖尿病足溃疡(DFU)的临床疗效及安全性。方法通过计算机检索MEDLINE、EMBase、Ovid、Cochrane数据库和中国生物医学文献数据库、维普中文科技期刊数据库、中国知网和万方数据库,筛选2012年8月之前报道的HBO治疗DFU的随机对照试验(RCT);同时手工检索杂志刊登的相关文献,必要时与作者取得联系。文献入选标准:在常规治疗的基础上,试验组采用HBO治疗,对照组采用安慰剂或空白对照。主要结局指标为创面完全愈合;次要结局指标为高位截肢或低位截肢、死亡及HBO治疗相关的不良反应。结果最终共纳入8篇符合标准的文献,共包括470例患者。Meta分析结果显示:试验组治疗结束及6周后〔RR=3.20,95%CI(2.01,5.10),P=0.000〕、治疗1年后〔RR=2.17,95%CI(1.27,3.71)〕溃疡愈合率均高于对照组,治疗结束后高位截肢率低于对照组〔RR=0.43,95%CI(0.21,0.89),P=0.0230〕,但试验组治疗结束后低位截肢率与对照组比较,差异无统计学意义〔RR=1.55,95%CI(0.97,2.47),P=0.066〕。对照组3例患者死亡,2例患者出现中耳气压伤;试验组1例患者死亡,3例患者出现中耳气压伤。结论在常规治疗的基础上加用HBO治疗可提高DFU患者溃疡愈合率,降低高位截肢率,且不良反应少,是一种安全、有效的方法。

Objective To evaluate the clinical efficacy of hyperbaric oxygenation（HBO） on diabetic foot ulcer（DFU） and its safety.Methods Random controlled trials of HBO for DFU reported before August 2012 were retrieved through EDLINE,EMBase,Ovid Database,the Cochrane Central Register of Controlled,CBM disc,VIP,CNKI,Wanfang database,and relevant literatures were searched in magazines.Based on conventional treatment,experimental group received HBO treatment,control group received placebo or blank control.Main outcome measure was complete wound healing,secondary was high or low amputation,death and HBO-related adverse reactions.Results Eight literatures were enrolled including 470 cases.By Meta-analysis,the ulcer healing rate of experimental group was higher than that of control group after 6 weeks,1 year of treatment 〔RR = 3.20,95% CI（2.01,5.10）,P = 0.000;RR = 2.17,95% CI（1.27,3.71） 〕,respectively;High amputation rate was lower in experimental group than in control group 〔RR = 0.43,95% CI（0.21,0.89）,P = 0.0230〕,but no significant difference was noted in low amputation rate 〔RR = 1.55,95% CI（0.97,2.47）,P = 0.066〕.In control group,3 patients died,2 had barotraumas of middle ear;In experimental group,1,3,respectively.Conclusion HBO based on conventional treatment,which can improve DFU healing rate and reduce high amputation rate with few adverse reactions,is a safe and effective methods.