骨化三醇软膏治疗慢性轻中度斑块型银屑病的随机单盲对照临床试验

Randomized controlled single blind clinical trial of calcitriol cream in the treatment of psoriasis vulgaris

目的研究骨化三醇外用治疗寻常型银屑病的疗效和安全性。方法用随机单盲卡泊三醇对照试验方法,共入选50例,试验组与对照组分别入选24,26例,临床疗效评价病例分别为22,23例,安全性评价24,26例。治疗时间为12周。结果试验组:痊愈率为27.3%,有效率为90.9%;对照组:痊愈率为39.1%,有效率为73.9%。2组疗效比较无显著性差异(P>0.05)。试验组和对照组药物不良反应率分别为8.3%(2/24例),7.7%(2/26例),主要是局部刺激,未见血钙异常及全身不良反应。结论骨化三醇软膏治疗寻常型斑块银屑病安全、有效。

Objective To evaluate the efficacy and safety of calcitriol in the treatment of psoriasis vulgaris. Methods A randomized, placebo, controlled, single blind clinical trial was used to evaluate the efficacy and safety of psoriasis vulgaris. The trial was conducted for the treatment of 50 outpatients. 24 patients were enrolled in trial treatment group,22 patients were assessable for efficacy and 24 patients assessable for safety while 26 patients were enrolled in controlled group ,23 patients were assessable for efficacy and 26 patients assessable for safety. Results The results showed that cure 6 ,excellent 14,improvement 1 ,failure 1, and cure rate, efficacy rate was 27.3% ,90.9% respectively for trial group. Whereas cure 9, excellent 8, improvement 5, failure 1, and cure rate, efficacy rate was 39. 1%, 73. 9% respectively for controlled group. The results showed that there was not significant statistical difference （ P 〉 0.05 ）. The incidence of adverse reaction of trial and controlled group was 8.3% % ,7.7% respectively ,and most of them were local irritant reaction, no systemic reaction and hyperealeimia. Conclusion Caleitriol ointment topical is effective and safe in the treatment of plaque psoriasis vulgaris.