外用川百止痒洗剂联合0.1%糠酸莫米松乳膏治疗湿疹临床研究

目的观察川百止痒洗剂联合0.1%糠酸莫米松乳膏治疗湿疹的有效性与安全性。方法采用随机、单盲、平行对照的方法对63例湿疹患者应用川百止痒洗剂联合0.1%糠酸莫米松乳膏外用治疗,同时设立对照组64例单独外用0.1%糠酸莫米松乳膏,治疗12天后评价疗效,并进行皮肤病生活质量指数(dermatology life quality index,DLQI)问卷调查。结果试验组总有效率为87.30%,与对照组70.31%相比有统计学差异(P<0.01);DLQI总分两组均下降,但无统计学差异(P=0.8775);试验组和对照组发生局部刺激反应分别为6.3%和7.8%,无统计学差异(Fisher校正χ2检验P=1.0000)。结论川百止痒洗剂联合0.1%糠酸莫米松乳膏治疗湿疹较为有效、安全。

The efficacy and safety of Chuanbaizhiyangxiji combining with 0.1%mometasone furoate cream in treatment of eczema

Objective A clinical trial was performed to estimate the efficacy and safety of patients of eczema treated with Chuanbaizhiyangxiji and 0.1%mometasone furoate cream.Methods In this single-double,parallel group study,127 patients were recruited from 2 clinical centers,and randomly divided into two groups.63 patients in trail group received both Chuanbaizhiyangxiji and 0.1%mometasone furoate ointment(Eloson).64 patients in control group received only 0.1%mometasone furoate ointment(Eloson).DLQI (Dermatology Life Quality Index)was considered the outcome measures for 12 days for the treatment of eczema.Results After 12 days of treatment,Chuanbaizhiyangxiji mometasone furoate ointment-treated patients experienced a greater decrease in eczema area and inch compared with mometasone furoate ointment-treated patients(87.30%vs 70.31%,with a significant difference between the two groups, P<0.01).There was excellent improvement with a marked reduction in the total mean DLQI,but no statistical difference was observed in two groups(P=0.8775).Drug-related adverse events mainly included mild to moderate skin reactions,such as pruitus,erythema,etc. There were found 6.3%drug-related events in trail group and 7.8%in control group,and even no statistical difference was observed in two groups(Fisher’s Exact Test Chi-Square test,P=1.0000).Conclusion Our results demonstrate a high efficacy and safety of Chuanbaizhiyangxiji combined with 0.1%mometasone furoate cream in short-term treatment of eczema.