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

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

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，将入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、瘙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）纳入疗效可评估分析集（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。

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.