国产卡泊三醇软膏治疗寻常性银屑病多中心临床研究

目的：临床多中心研究和验证卡泊三醇软膏治疗寻常型银屑病有效性与安全性。方法：采用随机、单盲、多中心平行对照的方法对64例寻常型银屑病患者应用0.005%卡泊三醇软膏（中国香港澳美制药厂生产，商品名：澳夫清?）每日2次，连续外用8周。在治疗2、4和8周后根据PASI评分和DLQI问卷调查评估疗效，并以丹麦利奥制药有限公司生产的0.005%卡泊三醇软膏（商品名：达力士?）治疗作为对照组，共63例。结果：试验组64例治疗8周后试验组痊愈9例、显效26例、进步19例、无效10例，总有效率54.68%，PASI评分由7.87±4.72下降至3.74±2.86。与对照组相比，两组有效性、总有效率和治疗前后PASI评分下降比较无统计学差异（χ2=2.6679，Z = -1.12，χ2 =1.550，P=0.1024，0.262，0.2153）；DLQI总分下降两组比较无统计学差异（P=0.8775）。治疗组和对照组发生局部刺激反应分别为7.8％和6.3％，无统计学差异（Fisher校正χ2检验P=1.0000）。结论：卡泊三醇软膏治疗寻常型银屑病有效、安全、耐受性良好。

Domestic calcipotriol ointment in the treatment of psoriasis vulgaris: a multi-center clinical study

Objective To evaluate the efficacy and safety of Calcipotriol ointment (Cipotriol) in the treatment of psoriasis vulgaris in a multi-center clinical study. Methods A total of 127 patients were randomly divided into group trial (including 64 patients) and group control (63 patients)， treated with Cipotrio and Daivonex respectively ，twice a day for 8 weeks. PASI score and DLQI questionnaire were considered to assess the efficacy after 2, 4 8 weeks’ treatment. Results There were 9 patients totally recovery, 26 patients obviously improved, 19 patients slightly progressed and 10 patients ineffective and the PASI score decreases from 7.87±4.72 to3.74±2.86 after 8 weeks’ Cipotriol treatment in the trial group. No significant differences were observed in the efficacy, effective rate,reduction of PASI（χ2=2.6679, Z = -1.12, χ2 =1.550, P=0.1024, 0.262, 0.2153）and the DLQI assessment between the two groups .Both treatments were safe and well tolerated in which local skin irritations were found 7.8％ in group Cipotriol and 6.3％ in group control. Conclusions Our results demonstrate Calcipotriol ointment (Cipotriol) is effective, safe and well tolerated in the short-term treatment of psoriasis.