中华皮肤科杂志 ›› 2007, Vol. 40 ›› Issue (1): 38-41.

• 论著 • 上一篇    下一篇

曲尼司特胶囊治疗特应性皮炎的多中心随机双盲对照研究

鞠梅1, 陈昆1, 常宝珠1, 顾军1, 郭在培3, 顾恒1,2   

  1. 1. 中国医学科学院、中国协和医科大学皮肤病研究所 南京 210042;
    2. 第二军医大学长海医院;
    3. 四川大学华西医院
  • 收稿日期:2006-02-16 出版日期:2007-01-15 发布日期:2007-01-15
  • 通讯作者: 顾恒,email:guhengy@yahoo.com.cn E-mail:guhengy@yahoo.com.cn

Treatment of atopic dermatitis with tranilast capsule：A multicenter, randomized, double-blind, placebo-controlled trial

JU Mei1, CHEN Kun1, CHANG Bao-zhu1, GU Jun1, GUO Zai-pei3, GU Heng1,2   

  1. Institute of Dermatology, Chinese Academy of Medical Sciences&Peking Union Medical College, Nanjing 210042, China
  • Received:2006-02-16 Online:2007-01-15 Published:2007-01-15

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摘要： 目的 评价曲尼司特胶囊治疗特应性皮炎的安全性和有效性.方法 采用多中心、随机双盲、安慰剂平行对照的研究方法,将人选患者随机分为治疗组和对照组,分别接受曲尼司特和安慰剂治疗,于治疗前(基线)及治疗后第1-3周访视1次,连续4周.主要疗效指标为SCORAD,次要疗效指标包括炎症性皮损范围指数、痰痒的视觉模拟评分及影响睡眠评分等.结果 共144例特应性皮炎患者(曲尼司特治疗组和安慰剂对照组各72例)参加本研究,其中139例(曲尼司特治疗组70例,安慰剂对照组69例)纳人疗效可评估分析集(FAS).研究结束根据SCORAD下降进行评价时,治疗组和对照组的有效率分别为61.43%和24.64%,两组间差异有统计学意义(P=0.0001).用药2,3,4周后,SCORAD评分、瘙痒的视觉模拟评分及影响睡眠评分等指标均显著下降,两组比较差异有统计学意义(P<0.05).治疗组少数患者出现胸闷、嗜睡等现象,两组不良事件的发生率为8.45%和11.43%,两组差异无统计学意义.结论 曲尼司特胶囊治疗特应性皮炎安全有效.

关键词: 沙眼衣原体；主要外膜蛋白；克隆；蛋白疫苗, 皮炎,特应性, 曲尼司特, 随机对照试验

Abstract: Objective To evaluate the safety and efficacy of tranilast capsule in the treatment of atopic dermatitis. Methods This multicenter, randomized, double-blind, parallel, placebo-controlled clinical trial was conducted at 3 research sites in China. Patients with atopic dermatitis were randomly assigned to 4 weeks of treatment with tranilast capsule or placebo three times daily. Efficacy evaluations were performed at baseline and at each weekly visit for 4 weeks. The primary efficacy parameter was the Severity Scoring of Atopic Dermatitis(SCORAD).Secondary parameters included the extent of skin inflammation index, visual analog scores of pruritus, and sleep disturbance score. Results A total of 144 patients with atopic dermatitis were enrolled in the study. Of these, 139 patients(70 on tranilast and 69 on placebo)who received at least one dose of study medication and completed at least one efficacy evaluation were included in the full analysis set(FAS).At the end of study, tranilast had significantly greater efficacy than placebo as assessed by improvement in SCORAD(61.43% vs 24.64%, P=0.0001).Furthermore, tranilast-treated patients experienced significantly greater improvement than placebo-treated patients in SCORAD, visual analog scores of pruritus, and sleep disturbance score at weeks 2, 3, and 4(P<0.05).There was no significant difference in the incidence of adverse events between the tranilast and placebo groups(8.45% vs 11.43%, P=0.5864).The adverse events in the tranilast-treated group included chest tightness, drowsiness, and eyelid edema, etc. Conclusion Tranilast capsule is safe and effective in the treatment of atopic dermatitis.

Key words: Dermatitis, atopic, Tranilast, Randomized controlled trails