中华皮肤科杂志 ›› 2009, Vol. 42 ›› Issue (10): 691-694.

• 论著 • 上一篇    下一篇

钙泊三醇倍他米松软膏外用治疗寻常性银屑病的随机、双盲、对照研究

黄岚1,马莉1,黄琼1,杨勤萍1,郑志忠1,朱学骏2,王宝玺3,顾军4   

  1. 1. 复旦大学附属华山医院皮肤科
    2. 北京大学第一医院皮肤科
    3. 南京 中国医学科学院北京协和医学院皮肤病研究所
    4. 上海第二军医大学附属长海医院皮肤科
  • 收稿日期:2009-04-09 修回日期:2009-05-01 发布日期:2009-10-09
  • 通讯作者: 黄岚 E-mail:doctorhl@medmail.com.cn
  • 作者简介:黄岚，复旦大学附属华山医院皮肤科副主任医师

Calcipotriol betamethasone ointment in the treatment of psoriasis vulgaris: a randomized, double-blind, active-controlled, parallel group study

HUANG Lan1,MA Li1,HUANG Qiong1,YANG Qinping1,ZHENG Zhizhong1,ZHU Xuejun2,WHANG Baoxi2,GU Jun2   

  1. 1. Department of Dermatology, Huashan Hospital, affiliated to Fudan University, Shanghai 200040, China.
    2.
  • Received:2009-04-09 Revised:2009-05-01 Published:2009-10-09
  • Contact: HUANG Lan E-mail:doctorhl@medmail.com.cn
  • About author:
    HUANG Lan Department of Dermatology, Huashan Hospital, affiliated to Fudan University, Shanghai 200040, China.     

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摘要：

目的 探讨钙泊三醇倍他米松软膏外用治疗稳定期寻常性银屑病患者的临床疗效和安全性。方法 随机、双盲、阳性药物平行对照、多中心临床试验，入组320例寻常性银屑病患者，随机纳入试验组或对照组，疗程4周。试验组早晨外用模拟剂软膏基质，晚间外用钙泊三醇倍他米松软膏；对照组早晚单用卡泊三醇软膏。于首次用药后第1、2、4周观察临床疗效及安全性。结果 治疗4周后试验组PASI评分较基线下降百分比（79.23%）大于对照组（70.43%），两组比较，P < 0.01；且在治疗1周后的疗效优于对照组。治疗4周后，PASI评分较基线下降≥75%的患者频数百分比比较，试验组有效率为73.03%，对照组为48.32%，P < 0.01，两组差异有统计学意义。治疗1、2、4周后试验组靶皮损红斑、浸润、鳞屑单独积分以及皮损总面积百分比等指标改善方面均优于对照组。320例受试者中不良事件发生率为18.1%，不良反应发生率为13.1%，两组间差异无统计学意义。药物不良反应主要为与皮肤有关的轻中度反应如瘙痒、毛囊炎、红斑等。结论 钙泊三醇倍他米松软膏治疗稳定期寻常性银屑病患者具有起效快、疗效好和用药方便、相对安全的特点。

关键词: 银屑病, 钙泊三醇, 二丙酸倍他米松, 随机对照试验

Abstract:

Objective To assess the clinical efficacy and safety of calcipotriol betamethasone ointment （Daivobet） in Chinese patients with stable psoriasis vulgaris. Methods In this double-blind, active-controlled, parallel group study, 320 patients were recruited from 4 clinical centers, and randomly divided into two groups to receive either calcipotriol betamethasone ointment once daily in the evening and placebo once daily in the morning or calcipotriol ointment twice daily. The safety and efficacy of the two regimens were evaluated on week 1, 2 and 4 after the first dosage. Results After 1 and 4 weeks of treatment, calcipotriol betamethasone-treated patients experienced a greater decrease in psoriasis area and severity index （PASI） compared with calcipotriol-treated patients （41.47% ± 18.21% vs 33.74% ± 16.94%, 79.23% ± 17.82% vs 70.43% ± 20.76%, respectively, both P < 0.001）. After 4 weeks of treatment, a 75 percent decrease in PASI was observed in 111 （73.03%） patients receiving combination therapy and 72 （48.32%） patients receiving monotherapy with significant difference between the two groups （P < 0.01）. A greater improvement was also seen in the individual score of redness, thickness, scaliness as well as area percentage of lesions at the end of week 1, 2 and 4 in patients receiving combination therapy than in patients receiving monotherapy （P < 0.05 or 0.01）. Of the 320 subjects, 58 （18.1%） reported adverse events and 42 （13.1%） reported drug-related adverse events. No statistical difference was observed in the incidence of adverse events （15.6% vs 20.6%, P > 0.05） or drug-related events （10.6% vs 15.6%, P > 0.05） between the two groups. Drug-related adverse events mainly included mild to moderate skin reactions, such as pruritus, folliculitis, erythema, etc. Conclusions Once daily calcipotriol betamethasone ointment is an effective, safe, convenient treatment with a rapid onset of action for stable psoriasis vulgaris in Chinese patients.

Key words: psoriasis, Calcipotriol, Betamethasone dipropionate, Randomized controlled trials