外用富林蜜凝胶治疗烧伤残余创面的多中心临床试验  

Multi-center clinical trial of FLAMIGEL （hydrogel dressing） for the treatment of residual burn wound

作　　者：杨惠忠[1] 王文奎[1] 原莉莉[2] 王顺宾[3] 罗高兴[2] 吴军[2] 牛希华[4] 孙炳伟[5] 杜广刚[6] 李海晖[3] 陈舜[3] 陈昭宏[3] 夏成德[4] 李树仁[4] 吕涛[4] 孙晖[5] 陈曦[5] 何小龙[6] 张兵[6] 郇京宁[1] 

机构地区：[1]上海交通大学医学院附属瑞金医院烧伤整形科,上海200025 [2]第三军医大学西南医院全军烧伤研究所、创伤、烧伤与复合伤国家重点实验室 [3]福建医科大学附属协和医院烧伤科 [4]郑州市第一人民医院烧伤科 [5]江苏大学附属医院烧伤整形科 [6]四川省人民医院烧伤科

出　　处：《中华烧伤杂志》2013年第2期177-180,共4页Chinese Journal of Burns

摘　　要：目的 评价富林蜜凝胶在烧伤患者残余创面中的应用价值。方法 2011年11月—2012年5月，选择6家笔者单位的60例烧伤残余创面患者进行多中心、随机、自身对照临床试验。将每例患者的2个残余创面按照随机数字表法分为治疗组与对照组，治疗组使用富林蜜凝胶处理，对照组采用碘伏纱布处理。用药后7、14 d比较2组创面的愈合率，并统计完全愈合创面数量；以视觉模拟评分法（VAS）评价患者每次换药的疼痛主诉，统计0分、大于0分且小于或等于3分、大于3分且小于或等于6分、大于6分且小于或等于10分的平均创面数量；统计2组创面的细菌检出情况并观察治疗过程中患者的不良反应。对数据进行重复测量方差分析、t检验、χ2检验或非参数秩和检验。结果 用药后7 d，治疗组与对照组创面愈合率分别为（67±24）%和（45±25）%；用药后14 d，治疗组与对照组创面愈合率分别为（92±16）%和（72±23）%，组间比较差异有统计学意义（F=32.388,P〈0.01）。用药后7 d,治疗组和对照组分别有10、4个残余创面愈合，组间比较差异无统计学意义（χ2=0,P〉0.05）；用药后14 d，治疗组和对照组累计分别有42、7个残余创面愈合，组间比较差异有统计学意义（χ2=42.254,P〈0.01）。治疗组37个创面换药时患者感到轻微疼痛，VAS评分为大于0分且小于或等于3分；对照组43个创面换药时患者感到明显疼痛，VAS评分为大于3分且小于或等于6分，组间各级疼痛评分的平均创面数量比较，差异有统计学意义（Z=-4.638，P〈0.01）。2组创面换药过程中检出的细菌包括金黄色葡萄球菌、铜绿假单胞菌、肺炎克雷伯菌、大肠杆菌、鲍氏不动杆菌、表皮葡萄球菌，组间比较差异无统计学意义（χ2=0.051，P〉0.05）。患者在用药过程中无不良反应。结论 富林蜜凝胶可以显著促进烧伤残余创面愈合，明显ObjectiveTo evaluate the effect of FLAMIGEL （hydrogel dressing） on the repair of residual burn wound.MethodsSixty burn patients with residual wounds hospitalized in 6 burn units from November 2011 to May 2012 were enrolled in the multi-center, randomized, and self-control clinical trial. Two residual wounds of each patient were divided into groups T （treated with FLAMIGEL） and C （treated with iodophor gauze） according to the random number table. On post treatment day （PTD） 7 and 14, wound healing rate was calculated, with the number of completely healed wound counted. The degree of pain patient felt during dressing change was evaluated using the visual analogue scale （VAS）. The mean numbers of wounds with score equal to zero, more than zero and less than or equal to 3, more than 3 and less than or equal to 6, more than 6 and less than or equal to 10 were recorded respectively. Wound secretion or exudate samples were collected for bacterial culture, and the side effect was observed. Data were processed with repeated measure analysis of variance, t test, chi-square test, and nonparametric rank sum test.ResultsWound healing rate of groups T, C on PTD 7 was respectively （67±24）%, （45±25）%, and it was respectively （92±16）%, （72±23）% on PTD 14. There was statistically significant difference in wound healing rate on PTD 7, 14 between group T and group C （F=32.388, P〈0.01）. Ten wounds in group T and four wounds in group C were healed completely on PTD 7, with no significant difference between them （χ2=0, P〉0.05）. Forty-two wounds in group T and seven wounds in group C healed completely on PTD 14, with statistically significant difference between them （χ2=42.254, P〈0.01）. Patients in group T felt mild pain during dressing change for 37 wounds, with VAS score higher than zero and lower than or equal to 3. Evident pain was observed in patients of group C during dressing change for 43 wounds, and it scored higher than 3 and less than or equal to 6 by VAS evaluation.

关 键 词：烧伤 敷料 水胶体 多中心研究 残余创面 疼痛评分 

分 类 号：R6[医药卫生—外科学]