CAJ | 학술논문

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(χ2=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(χ2=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%)(χ2=7.52, 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.
목적 평고재생요법( MEBT/MEBO)치료각충급만성개방성창면적안전성화유효성.방법 장2007년1월지2012년1월기간인각충개방성창상취진우3가불동의원적276례환자(376처창면)수궤분조,접수 MEBT/MEBO치료(1조:환자141례,창면190처)혹생리염수습부치료(2조:환자135례,창면186처).전첨성수집인구통계학、유발질병、합병증화창면특정등수거;매격2주계산화대비창면면적화유합지수,지속12주;기록치료후24주적이차절지정황.결과 개방성창상포괄만성욕창(202처)、당뇨병족궤양(119처)화각충기타창면(55처).수시환자중171례(63%)위남성,105례(37%)위녀성;년령개우5~102세,평균년령63세±14.5세.량조환자재인구통계학、림상특점、생화검사화창면특정방면접근. MEBT/MEBO치료조재치료2주시,기유합지수현저승고、창면면적현저축소;재12주시, MEBT/MEBO조중66.3%(126/190)적창면실현료완전유합( HI=1),이생리염수습부조부22.6%(42/186)적창면완전유합(χ2=71.4, P=0.000).치료12주시, MEBT/MEBO조무1례환자적유합지수<0.5;이생리염수습부조38.7%(72/186)적환자유합지수<0.5(χ2=165, P=0.000).량조환자균무불량반응혹과민반응발생.치료후24주,여생리염수습부조상비, MEBT/MEBO치료조적이차절지솔명현강저(3.3%∶19.0%)(χ2=7.52, P=0.006).결론 MEBT/MEBO불부조작간편、사용안전,환능현저촉진개방성창면적유합,치료2주취가현저제고창면유합지수,12주시궤호2/3적창면가완전유합,24주시당뇨병족궤양환자중발생이차절지적환자명현감소.
@@@@Objective 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 Con-secutive 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 com-pared 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 miscella-neous 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 com-plete healing ( HI=1) as opposed to only 22.6% ( 42/186) of those treated with saline ( χ2 =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 receiv-ing saline ( χ2 =165, P=0.000) . No adverse or hypersensitivity reactions were encountered. At 24-weeks post-treat-ment, the rate of secondary amputations was significantly reduced by regenerative therapy ( MEBT/MEBO) as compared to saline controls ( 3.3% versus 19%, respectively) ( χ2 =7.52, P=0.006) . Conclusions In addition to its simplic-ity 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 approxi-mately 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.