骨化三醇软膏与卡泊三醇软膏治疗银屑病多中心随机研究

Calcitriol ointment versus calcipotriol ointment in the treatment of psoriasis： a single-blind, randomized, multieenter trial

目的 评价骨化三醇软膏外用治疗斑块状银屑病的疗效及安全性。方法 采用随机、单盲、阳性药物平行对照方法。5个中心共231例斑块状银屑病患者完成治疗，其中骨化三醇软膏组117例，卡泊三醇软膏组114例。入组时两组患者的性别、年龄、病情严重程度（靶皮损总积分）等方面差异无统计学意义（P〉0．05）。每日外用药物2次，连续12周，于治疗后2，4，8和12周分别进行疗效和安全性评价。结果治疗8周时，试验组基愈率为4．2％，有效率为67，5％；对照组基愈率为14．4％，有效率为74．6％，两组有效率比较，差异无统计学意义（P〉0．05）。12周结束时，研究者对总体疗效进行评价。试验组基愈37例，显效76例，有效率91．1％；对照组基愈43例，显效56例，有效率81％，两组疗效比较，差异无统计学意义（P=0．78）。两组未见药物系统不良反应，局部刺激反应的发生率试验组和对照组分别为4％和11．2％，试验组发生率低于对照组（P〈0．01）。结论 骨化三醇软膏治疗斑块状银屑病安全、有效。

Objective To evaluate the efficacy and safety of calcitriol ointment in the treatment of psoriasis vulgaris. Methods A 12-week, single-blind, randomized, multicenter trial was performed. Totally, 231 patients were enrolled in this study, The patients were divided into calcitriol group （n = 117） receiving single calcitriol treatment, and calcipotriol group （n = 114） receiving single calcipotriol treatment. Ointments were used twice daily for 12 weeks. Evaluation was performed at the baseline, and after 2, 4, 8, 12 weeks of therapy, clinical effects and adverse reactions were recorded. Results On week 8, the response and effective rates were 4.2% and 67.5%, respectively, in the calcitriol group; 14.4% and 74.6%, respectively, in the calcipotriol group; no statistically significant difference was found between the two groups （both P 〉 0.05 ）. At the end of treatment, improvement of lesions was achieved in 91.1% of the calcitriol-applying patients and in 81% of calcipotriol-applying patients without significant difference between the two groups （P = 0.78）. Local irritating reactions occurred in 4% of calcpotriol-applying patients and I 1.2% of calcpotriol- applying patients, with significant difference in the occurrence rates （P 〈 0.01 ）. No systemic reactions were found in either group. Conclusion The study shows that topical calcitriol ointment is safe and effective for the treatment of psoriasis vulgaris.