CAJ | 학술논문

目的评估积雪苷治疗鱼尾纹的临床疗效及安全性.方法采用12周随机、双盲、赋形剂自身对照试验,通过第0、4、8、12周研究者盲法评价皱纹程度、受试者盲法自评、仪器测量3个方面评价试验用药侧与对照侧鱼尾纹的改善情况.结果完成试验的35名受试者的双侧鱼尾纹程度根据研究者盲法评估,在使用第4周,治疗组与对照组的皱纹变化有统计学意义(P＜0.05).在第8、12周试验用药侧的皱纹程度的减轻优于对照侧,皱纹评分具有统计学意义(P＜0.05).采用Visioscan VC98定量测量双侧鱼尾纹SEw值结果显示,试验用药侧随时间的变化SEw的值增大,即皱纹程度减轻,与对照侧相比,差异有统计学意义.受试者评估显示,双侧药物在使用过程中刺激性及粗皱纹的改善情况无差异,外眦部位肌肤纹理改善方面治疗侧优于对照侧(P＜0.05).结论积雪苷霜软膏每日3次局部外用改善鱼尾纹有一定疗效,无不良反应.
목적 평고적설감치료어미문적림상료효급안전성.방법 채용12주수궤、쌍맹、부형제자신대조시험,통과제0、4、8、12주연구자맹법평개추문정도、수시자맹법자평、의기측량3개방면평개시험용약측여대조측어미문적개선정황.결과 완성시험적35명수시자적쌍측어미문정도근거연구자맹법평고,재사용제4주,치료조여대조조적추문변화유통계학의의(P＜0.05).재제8、12주시험용약측적추문정도적감경우우대조측,추문평분구유통계학의의(P＜0.05).채용Visioscan VC98정량측량쌍측어미문SEw치결과현시,시험용약측수시간적변화SEw적치증대,즉추문정도감경,여대조측상비,차이유통계학의의.수시자평고현시,쌍측약물재사용과정중자격성급조추문적개선정황무차이,외자부위기부문리개선방면치료측우우대조측(P＜0.05).결론 적설감상연고매일3차국부외용개선어미문유일정료효,무불량반응.
Objective To evaluate the efficacy and safety of centella triterpenes cream(R) for treating crow's feet.Methods A double-blind,randomized,vehicle-controlled 12-week study was conducted.Centella triterpenes cream(R) was applied to the lateral canthus on one side (treatment side) and vehicle-(c)ontrol cream to the lateral canthus on the other side (control side) 3 times daily.Efficacy was evaluated based on an investigator-blinded assessment,subject self-blinded assessment and a quantitative analysis by Visioscan(R)VC98 at the baseline,4,8,12 weeks after the beginning of treatment.Results Thirty-six volunteers were recruited and 35 subjects completed the 12-week trial.The investigator-blinded assessment showed a significant difference in the changes of wrinkle scores between the treatment side and control side after 4 weeks (P ＜ 0.05),and the improvement of wrinkles was more obvious on the treatment side than on the control side at 8 and 12 weeks with a statistical difference in the wrinkle scores (both P ＜ 0.05).Compared with the control side,a significant increase in SEw value,which suggested an improvement in wrinkles,was observed on the treatment side after the application of centella triterpenes cream(R).Subjects' assessments revealed no significant difference in the occurrence of irritation or the improvement of coarse wrinkles,whereas the treatment side was superior to the control side in the improvement of skin texture (P ＜ 0.05) at the lateral canthus.Conclusion Centella triterpenes cream(R) thrice daily is effective for the improvement of crow's feet with no obvious side effects.