CAJ | 학술논문

三乙醇胺乳膏治疗皮肤溃疡的多中心研究
삼을순알유고치료피부궤양적다중심연구
Triethanolamine cream in the treatment of skin ulcer: a multicenter study

万方数据

中华皮肤科杂志中華皮膚科雜誌 중화피부과잡지
Chinese Journal of Dermatology
2012年 10期 741-744 ,共4页

布文博%赵亮%邓军%陈晓栋%张琬%王焱%吴敏智%黄莉明%王强%吴信峰%张倩%于浩%方方

포문박%조량%산군%진효동%장완%왕염%오민지%황리명%왕강%오신봉%장천%우호%방방

目的探讨三乙醇胺乳膏治疗皮肤溃疡的安全性和有效性.方法多中心、随机、单盲及阳性药平行对照研究.选取年龄为18 ～ 65岁皮肤溃疡的患者,按试验组和对照组2∶1分配,总共120例.试验组使用三乙醇胺乳膏,对照组使用重组牛碱性成纤维细胞生长因子凝胶.观察溃疡愈合率、上皮形成率、肉芽生成率等指标,观察期为4周.结果随着治疗时间的延长,两组患者的病情均得到改善.治疗4周时,试验组80例,完成76例；对照组40例,完成38例.痊愈率:试验组为71.05％,对照组为34.21％,P=0.0002;上皮形成率:试验组为66.25％,对照组为37.5％,P=0.0035;肉芽生成率:试验组为85％,对照组为50％,P=0.0001.两组患者均未发现与药物相关的不良事件.结论三乙醇胺乳膏在溃疡愈合率、上皮形成率、肉芽生成率等方面优于重组牛碱性成纤维细胞生长因子凝胶的对照组,是治疗皮肤溃疡一种较好的外用药物.
목적 탐토삼을순알유고치료피부궤양적안전성화유효성.방법 다중심、수궤、단맹급양성약평행대조연구.선취년령위18 ～ 65세피부궤양적환자,안시험조화대조조2∶1분배,총공120례.시험조사용삼을순알유고,대조조사용중조우감성성섬유세포생장인자응효.관찰궤양유합솔、상피형성솔、육아생성솔등지표,관찰기위4주.결과 수착치료시간적연장,량조환자적병정균득도개선.치료4주시,시험조80례,완성76례；대조조40례,완성38례.전유솔:시험조위71.05％,대조조위34.21％,P=0.0002;상피형성솔:시험조위66.25％,대조조위37.5％,P=0.0035;육아생성솔:시험조위85％,대조조위50％,P=0.0001.량조환자균미발현여약물상관적불량사건.결론 삼을순알유고재궤양유합솔、상피형성솔、육아생성솔등방면우우중조우감성성섬유세포생장인자응효적대조조,시치료피부궤양일충교호적외용약물.
Objective To evaluate the efficacy and safety of triethanolamine cream in the treatment of skin ulcer. Methods A multicenter,single-blind,randomized,positive-control study was conducted.One-hundred and twenty patients aging 18-65 years with skin ulcer were randomly classified into the test and control group at a ratio of 2 ∶ 1 to be treated with triethanolamine cream and recombinant bovine basic fibroblast growth factor gel respectively for 4 weeks.The healing rate of ulcer,granulation tissue production rate and epithelialization rate were calculated.Results After the beginning of treatment,the condition of all patients was improved with time.In total,76 out of 80 triethanolamine-treated patients and 38 out of 40 basic fibroblast growth factor gel-treated patients completed the 4-week trial.Significant differences were observed in the healing rate of ulcer,epithelialization rate and granulation tissue production rate between the test and control group (71.05％ vs.34.21％,P =0.0002; 85％ vs.50％,P =0.0001; 66.25％ vs.37.5％,P =0.0035).No adverse events occurred in any of the patients.Conclusions Triethanolamine cream seems superior to recombinant bovine basic fibroblast growth factor gel with regard to the healing rate of ulcer,epithelialization rate and granulation tissue production rate,and may be a promising drug for the treatment of skin ulcer.