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湿润烧伤膏治疗慢性糖尿病足溃疡的多中心对照研究
引用本文:Mahmoud F.Sakr,Hossam M.Hame,陈永翀,李桂如,张 勇.湿润烧伤膏治疗慢性糖尿病足溃疡的多中心对照研究[J].中国烧伤创疡杂志,2012,24(2):102-118.
作者姓名:Mahmoud F.Sakr  Hossam M.Hame  陈永翀  李桂如  张 勇
作者单位:1. 埃及亚历山大大学医学部外科教研室
2. 科威特,艾哈迈迪,科威特石油公司艾哈迈迪医院外科
3. 北京美宝烧伤创疡研究所,北京,100020
4. 卢沟桥社区卫生服务中心,北京,100165
5. 宣武中医医院烧伤科,北京,100050
摘    要:目的 通过多中心的对照研究,观察、评估湿润烧伤膏(MEBO) 治疗慢性糖尿病足溃疡的疗效及安全性.方法 对2005年1月至2010年1月间,中国和科威特的5个中心治疗的并符合入选标准的128例慢性糖尿病患者(160处溃疡),随机分为MEBO组(实验组,66例,共82处溃疡) 和生理盐水湿润敷料组(对照组,62例患者,共78处溃疡).前瞻性收集患者的人口统计学数据、患者特征以及溃疡创面特点等数据.研究的前12周,每隔2周计算、对比一次患者的溃疡表面积和愈合指数,24周时记录截肢和溃疡发展的情况.结果 两组患者的人口学特征,临床及溃疡特点相似.MEBO组患者在第2周和第3周时分别呈现出愈合指数的明显升高和溃疡表面积的明显下降,这种趋势连续保持了12周(P<0 01).在治疗12周时MEBO组一半以上的溃疡(53 7%)实现了完全愈合(愈合指数=1),与对照组在治疗12周时的25 66%的愈合率相比有非常显著性差异(P=0 0006);治疗12周时,对照组28 2%的患者愈合指数<0 5,而MEBO组无1例患者发生此状况(P=0 0001).治疗24周后,13例患者(10 2%) 因组织坏死行足前段截肢术,其中只有2例患者来自MEBO组(χ2=4 44,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).实验过程中未见局部用药引发的任何副作用或过敏反应.结论 1)除了具备安全性以外,MEBO在开始治疗2周后就显著提高了各种溃疡的愈合指数,治疗4周后溃疡表面积开始明显缩小,12周时超过50%的溃疡完全愈合,大大缩短了慢性糖尿病足溃疡的愈合过程;2)MEBO组患者治疗24周后的截肢率明显下降.

关 键 词:湿润烧伤膏  湿润环境  糖尿病足  溃疡  愈合指数  截肢

The Multi-Centers Comparative Study of Moist Exposed Burn Ointment(MEBO) in Healing of Chronic Diabetic Foot Ulcers
Mahmoud F.Sakr,Hossam M.Hame,CHEN Yong-chong,LI Gui-ru and ZHANG Yong.The Multi-Centers Comparative Study of Moist Exposed Burn Ointment(MEBO) in Healing of Chronic Diabetic Foot Ulcers[J].The Chinese Journal of Burns Wounds & Surface Ulcers,2012,24(2):102-118.
Authors:Mahmoud FSakr  Hossam MHame  CHEN Yong-chong  LI Gui-ru and ZHANG Yong
Abstract:Objective To assess the efficacy and safely of Moist Exposed Burn Ointment in healing of chronic diabetic foot uleers (DFUs). Subjects and Methods 128 patients with 160 chronic DFUs seen in 5 centers in Kuwait and China between January 2005 and January 2010 were randomized to receive MEBO (Group 1 tests, n = 66 with 82 ulcers) or saline wet-to-moist dressing (Group 2 eontrols, n = 62 with 78 ulcers). Data collected prospectively included demographics, patient features and ulcer characteristics. Ulcer surface area (SA) and healing index (HI) were calculated and compared at two - week intervals for 12 weeks. Secondary amputations and development 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 ulcer SA on weeks two and four respectively, that was maintained through 12 weeks in pa- tients treated with MEBO ( P 〈 0.01 ). More than half of ulcers ( 53.7% ) treated with MEBO had complete healing ( HI = 1 ) by 12 weeks, as opposed to only 25.66% of those treated with saline (P =0. 0006). None of the patients receiving ME- BO 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 undergone fore foot amputations because of development of necrosis; with only two patients (3%) belonging to the MEBO Group (X: = 4.44, P = 0. 035). Two patients in each group developed a new ulcer by 24 weeks ( P 〉 0. 05 ). No adverse effects or allergic reactions of topical ointment were encountered. Conclusions ( 1 ) In addition to its safety, MEBO significantly promotes the healing of chronic DFUs with significant increase in HI of any given ulcer as early as two weeks following initiation of treatment, and significant reduction of ulcer SA starting at 4 weeks, with complete healing of more than 50% of ulcers by 12 weeks, and (2) Significantly fewer secondary amputations were required by 24 weeks in patients treated with MEBO.
Keywords:MEBO  Moist environment  Diabetic foot  Ulcers  Healing index  Amputation
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