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多中心随机对照试验：再生复原技术治疗各种开放性创面的疗效评价
Assessment of Regenerative Therapy (MEBT/MEBO) in Healing of Various Open Wounds: A Multicenter Controlled Randomized Trial

Mahmoud F.Sakr,王乡宁,付子俊,Hossam Hamed,Hesham EL-Torky.多中心随机对照试验：再生复原技术治疗各种开放性创面的疗效评价[J].中国烧伤创疡杂志,2013,25(3):211~229.

DOI：10.3969/j.issn.1001-0726.2013.3.014

英文关键词:Regenerative therapy – MEBT/MEBO – Pressure ulcers – diabetic foot – open wounds

基金项目:

作者	单位
Mahmoud F.Sakr	亚历山大大学医学部外科
王乡宁	四川省雅安市人民医院烧伤整形科
付子俊
Hossam Hamed	艾哈迈迪医院外科
Hesham EL-Torky

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中文摘要:

目的　评估再生疗法（MEBT／MEBO）治疗各种急慢性开放性创面的安全性和有效性。方法　将2007年1月至2012年1月期间因各种开放性创伤就诊于3家不同医院的276例患者（376处创面）随机分组，接受MEBT／MEBO治疗（1组：患者141例，创面190处）或生理盐水湿敷治疗（2组：患者135例，创面186处）。前瞻性收集人口统计学、诱发疾病、合并症和创面特征等数据；每隔2周计算和对比创面面积和愈合指数，持续12周；记录治疗后24周的二次截肢情况。结果　开放性创伤包括慢性褥疮（202处）、糖尿病足溃疡（119处）和各种其它创面（55处）。受试患者中171例（63%）为男性，105例（37%）为女性；年龄介于5～102岁，平均年龄63岁±14.5岁。两组患者在人口统计学、临床特点、生化检查和创面特征方面接近。MEBT／MEBO治疗组在治疗2周时，其愈合指数显著升高、创面面积显著缩小；在12周时，MEBT／MEBO组中66.3%（126／190）的创面实现了完全愈合（HI＝1），而生理盐水湿敷组仅22.6%（42／186）的创面完全愈合（x2＝71.4，P＝0.000）。治疗12周时，MEBT／MEBO组无1例患者的愈合指数＜0.5；而生理盐水湿敷组38.7%（72／186）的患者愈合指数＜0.5（x2＝165，P＝0.000）。两组患者均无不良反应或过敏反应发生。治疗后24周，与生理盐水湿敷组相比，MEBT／MEBO治疗组的二次截肢率明显降低（3.3%∶19.0%）（x2＝7.57，P＝0.006）。结论　MEBT／MEBO不仅操作简便、使用安全，还能显著促进开放性创面的愈合，治疗2周就可显著提高创面愈合指数，12周时几乎2／3的创面可完全愈合，24周时糖尿病足溃疡患者中发生二次截肢的患者明显减少。

英文摘要:

Objectives: To assess the efficacy and safety of regenerative therapy (MEBO/MEBT) (SanTou MEBO Pharmaceutical CO., LTD., China) in healing of various acute and chronic open wounds. Subjects and Methods: Consecutive patients (n=276) with various open wounds (n=376) treated at 3 different hospitals, between January 2007- January 2012, were randomized to receive either MEBT/MEBO (Group 1, n=141 with 190 wounds) or saline wet-to-moist dressing (Group 2 controls, n=135 with 180 wounds). Data collected prospectively included demographics, predisposing disease, co-morbidities, and wound characteristics. Surface area (SA) and healing index (HI) were calculated and compared at two-week intervals for 12 weeks, and secondary amputations were recorded at 24 weeks post-treatment.Results: Open wounds included chronic pressure ulcers (CPUs) (n=202), diabetic foot ulcers (DFUs) (n=119), and miscellaneous group (n=55). 171 patients (63%) were male and 105 (37%) were female. Their ages ranged between 5-102 years, with a mean of 63±14.5 years. Patients in both groups had similar demographic, clinical, biochemical and wound characteristics. There was a significant increase in HI and reduction in SA starting at weeks two after initiation of treatment in patients treated with MEBT/MEBO. At 12 weeks, 66.3% of wounds (126/190) treated with MEBT/MEBO had complete healing (HI=1) as opposed to only 22.6% (42/186) of those treated with saline (X2=71.4, P=0.000). None of the patients receiving MEBT/MEBO had a HI of <0.5 at 12 weeks as compared to 38.7% (72/186) of those receiving saline (X2=165, P=0.000). No adverse or hypersensitivity reactions were encountered. At 24-weeks post-treatment, the rate of secondary amputations was significantly reduced by regenerative therapy (MEBT/MEBO) as compared to saline controls (3.3% versus 19%, respectively) (X2=7.52, P=0.006).Conclusions: In addition to its simplicity and safety, MEBT/MEBO significantly promotes the healing of open wounds with significant increase in HI of any given wound, reflected by reduction of SA, as early as two weeks post-treatment, with complete healing (HI=1) of approximately two-thirds (66.3%) of wounds by 12 weeks and total effectiveness rate (HI >0.5) of 100%. At 24 weeks after initiation of treatment, patients with DFUs treated with MEBT/MEBO undergo significantly fewer secondary amputations than controls.