外用重组人表皮生长因子衍生物(依济复)Ⅳ期多中心临床研究  

Phase Ⅳ multicenter clinical study of recombinant human epidermal growth factor derivative(Yijifu) for external use

作　　者：王世岭 柴家科[2] 沈祖尧[3] 周一平[4] 廖镇江[5] 周亮[2] 马建丽[2] 高飞[2] 付小兵[2] 李利根[2] 

机构地区：[1]解放军第三○七医院,北京100039 [2]解放军第三○四医院,北京100037 [3]北京积水潭医院,北京100035 [4]第一军医大学南方医院,广东广州510515 [5]上海第二医科大学附属瑞金医院,上海200025

出　　处：《中国危重病急救医学》2002年第7期389-393,共5页Chinese Critical Care Medicine

基　　金：国家重大基础研究规划资助项目 (No.19990 5 42 0 4);国家药品监督管理局药品评价中心临床研究课题(No.2 0 0 0 114 )

摘　　要：目的 :进行 期临床试验 ,进一步考察和评价外用重组人表皮生长因子衍生物 (依济复 )在试生产期的临床适应证、疗效和安全性。方法 :入选病例 12 71例 ,采用多中心、随机自身对照和开放临床试验。在常规治疗的基础上 ,治疗组用依济复局部均匀喷湿创面 ,每日换药 1次 ,观察至创面愈合或用药 4周时终止试验。以创面愈合为指标 ,判读愈合时间。结果 :用依济复治疗烧伤浅 度、深 度、刃厚供皮区、中厚供皮区、植皮区、残余创面 ,其平均愈合时间分别为 (9.6 9± 2 .5 5 )日、(18.79± 4 .5 2 )日、(8.4 1± 3.2 7)日、(14 .2 5± 4 .19)日、(14 .0 7± 5 .0 1)日、(15 .2 4± 6 .37)日 ,治疗组愈合时间较对照组有明显缩短 ,中期愈合率明显提高。上述各类创面的综合有效率分别为 90 .2 9%、94 .93%、96 .0 8%、81.82 %、10 0 .0 0 %、97.37% ;各类慢性创面 4周愈合率达91.2 3% ,综合有效率为 98.4 6 %。结论 :依济复用于治疗各类烧伤创面和慢性创面具有较好的疗效 。Objective:To further investigate and evaluate the clinical efficacy and safety of recombinant human epidermal growth factor derivative(Yijifu) for external use.Methods:One thousand two hundred and seventyone patients were enrolled in the multicenter randomized selfcontrol and open clinical trials.On the basis of routine treatment,Yijifu was sprayed on the wounds of the trial group once a day.The healing time was observed up to 4 weeks.Results:The average healing time of superficialⅡ,deepⅡ,razorthin skin donor areas,splitthickness skin donor areas,skingrafted areas,remnant wounds were (9 69±2 55) d,(18 79±4 52) d,(8 41±3 27) d,(14 25±4 19) d,(14 07±5 01) d,(15 24±6 37) d respectively after the application of Yijifu.They were significantly shorter than those of control wounds.The total effective rates of above wounds were 90 29%,94 93%,96 08%,81 82%,100 00%,97 37% respectively.The healing rate of chronic wounds up to 4 weeks was 91 23%,and total effective rate was 98 46%.Conclusions:Yijifu can promote the healing of various burn wounds and chronic wounds.The adverse reaction of Yijifu was minimal.

关 键 词：外用重组人表皮生长因子衍生物喷剂 依济复 烧伤创面 慢性创面 愈合 多中心临床试验 

分 类 号：R644.05[医药卫生—外科学]