0.05%地奈德乳膏治疗湿疹的多中心随机双盲、对照研究

0.05% desonide cream for the treatment of patients with eczema: a ramdomized, double-blind, multicenter study

目的了解0.05%地奈德乳膏治疗湿疹的临床疗效及安全性。方法采用多中心、随机双盲、安慰剂对照法,试验组及对照组患者分别外用0.05%地奈德乳膏及地奈德基质,每日2次,共治疗3周。对红斑、糜烂、浸润、丘疹、渗出/结痂、瘙痒及皮损面积的总积分进行评价。结果治疗结束时,试验组的临床总有效率为80.8%,对照组为41.1%。两组间的疗效差异有统计学意义(P<0.0001);试验组未见与用药相关的不良反应。结论0.05%的地奈德乳膏治疗湿疹临床疗效可靠,安全性高。

Objective To evaluate the efficacy and safety of 0.05% desonide cream in the treatment of patients with eczema. Methods A randomized, double-blind, multicenter, vehicle-controlled study was conducted. The patients of the study and control groups applied 0.05% desonide cream and vehicle respectively, twice daily for 3 consecutive weeks. The efficacy was determined by measuring the total scores of erythema, erosion, infiltration, papule, exudation/crust, pruritus and the extent of lesions. Results At the end of the 3 weeks study, the total clinical effective rate was 80.8% in the study group,compared to 41.1% in the control group, with a significant difference between the two groups （P 〈 0.0001 ）. No adverse effect was found related to the drug in the study group. Conclusion 0.05% desonide cream is effective and safe for patients with eczema.