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目的 评估湿润烧伤膏(MEBO)治疗慢性压力性溃疡的效果和安全性.方法 将来自世界不同国家和地区的5家医院的87名慢性压力性溃疡病例(182个创面)随机分成两组,实验组为MEBO组(n=41),对照组为Fucidin组(n=46);前瞻性收集的数据包括人口统计学、营养状况、潜在性疾病和并发症.分别按照各组的创面处理规范治疗创面,每2周计算和比较溃疡面的面积(SA)和愈合指数(HI).结果 两组都具有相同的统计学、临床、生化和溃疡特征.在持续使用MEBO治疗12周的过程中,在第2周和第4周可以观察到溃疡创面的愈合指数大幅度上升,溃疡创面明显减小.通过MEBO治疗的病例,半数以上(56.5%)的溃疡创面在12周之内都完全愈合(HI=1);通过Fucidin(P<0.001)治疗的对照组病例,只有19.6%的溃疡创面完全愈合.在连续12周的治疗中,MEBO组病例的溃疡创面没有HI<50%的,而在.Fucidin(P<0.001)治疗的对照组中,26.8%的病例HI<50%.两组均未出现不良反应与过敏症状.结论 MEBO能够在治疗开始2周后快速促进不同程度慢性压力性溃疡创面的愈合,并且HI增长明显.在12周之内,MEBO能够完全促进50%以上的创面愈合.“,”Objectives A multi-centers,randomized,controlled study to assess the efficacy and safety of MEBO(Julphar Gulf Pharmaceutical Industries,UAE,and SanTou MEBO Pharmaceutical CO.,LTD.,China)in healing of chronic pressure ulcers.Subjects and Methods Eighty seven patients with 182chronic pressure ulcers treated at five hospitals from different areas in world,between January 2003 and January 2009,were randomized into 2 groups; those in group 1(n = 46)received MEBO while those in group 2(n =41)received Fucidin(Leo Pharmaceutical,Denmark).Data collected prospectively included demographics,nutritional status,underlying predisposing disease and co-morbidities.Ulcer surface area(SA)and healing index(HI)were calculated and compared at two-week intervals for 12 weeks.Results Patients in both groups had similar demographic,clinical,biochemical features,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 patients treated with MEBO.More than half of ulcers(56.5%)treated with MEBO had complete healing(HI = 1)by 12 weeks,as opposed to only 19.6% of those treated with Fucidin(P <0.001).Moreover,none of the patients receiving MEBO had a HI of <50% of their ulcers by 12 weeks as compared to 26.8% of those receiving Fucidin(P<0.001).No adverse effects or allergic reactions of topical ointment were encountered in either group.Conclusions In addition to its safety,MEBO significantly promotes the healing of chronic pressure ulcers with significant increase in HI of any given ulcer as early as two weeks following initiation of treatment,and complete healing of more than 50% of ulcers by 12 weeks.