湿润烧伤膏在慢性糖尿病足溃疡愈合中的作用:随机对照试验

Role of Moist Exposed Burn Ointment(MEBO) in Healing of Chronic Diabetic Foot Ulcers:A Controlled Randomized Trial

目的评估湿润烧伤膏(MEBO)在促进慢性糖尿病足溃疡(DFUs)愈合中的疗效和安全性。方法 2005年至2010年间就诊于科威特艾哈迈迪医院的慢性糖尿病足溃疡患者被随机分为MEBO组(66例患者,82处溃疡)和生理盐水湿润敷料组(62例患者,78处溃疡)。前瞻性收集患者的人口统计学特征以及溃疡创面特点等数据。试验12周期间每隔两周计算一次患者的溃疡表面积(SA)和愈合指数(HI),24周时记录继发性截肢和新溃疡形成的情况。结果两组患者的人口学特征。临床症状及溃疡特点相似。MEBO组患者在第2周和第4周时分别有愈合指数的明显升高和溃疡表面积的明显下降(P<0.01);与生理盐水组在治疗12周时25.7%的完全愈合率相比,MEBO组一半以上的溃疡创面(53.7%)都实现了完全愈合(P=0.0006);治疗12周时,生理盐水组28.2%的患者愈合指数<0.5,而MEBO组无1例此状况(P=0.0001);治疗24周时,13位患者(10.2%)行足前段截肢术,而其中只有2例患者(3%)来自MEBO组(P=0.035);此外,每组各有2例患者在治疗24周后出现了新溃疡(P>0.05)。实验过程中MEBO组未见任何副反应。结论(1)除了具备安全性以外,MEBO可显著促进慢性糖尿病足溃疡的愈合,治疗12周时就可实现超过50%的完全愈合结果 ;2)MEBO组患者治疗24周后的截肢率也明显下降。

Objective To assess the efficacy and safety of Moist Environment Burn Ointment （MEBO） in promo- ting healing of chronic diabetic foot ulcers （DFUs）. Methods Patients with chronic DFUs seen at the Ahmadi Hospital, Kuwait （2005 -2010） were randomized to receive MEBO （n = 66 with 82 ulcers） or saline wet-to-moist dressing （n = 62 with 78 ulcers）. Data collected prospectively included demographics, patient features and ulcer characteristics. Ulcer sur- face area （SA） and healing index （HI） were calculated at two-week intervals for 12 weeks, Secondary amputations and de- velopment of new ulcers were recorded at 24 weeks. Results Patients in both groups had similar demographic, clinical and ulcer characteristics. There was a significant increase in HI and reduction in SA starting on weeks two and four respectively, in patients treated with MEBO （ P 〈 0. 01 ）. More than half of ulcers （53.7 % ） treated with MEBO had complete healing by 12 weeks versus 25.7% of those treated with saline （P =0. 0006）. None of the patients receiving MEBO had a HI of 〈0. 5 by 12 weeks as compared to 28.2% of those receiving saline （P =0. 0001）. At 24 weeks, 13 patients （10. 2% ） had un- dergone fore foot amputations; with only two （3 % ） belonging to the MEBO Group （P = 0. 035 ）. Two patients in each group developed a new ulcer by 24 weeks （P 〉 0. 05 ）. No adverse effects of MEBO were encountered. Conclusion （ 1 ） In ad- dition to its safety, MEBO significantly promotes the healing of chronic DFUs, with complete healing of 〉 50% of ulcers by 12 weeks, and （2） Significantly fewer secondary amputations were required by 24 weeks in patients treated with MEBO.