中华皮肤科杂志 ›› 2007, Vol. 40 ›› Issue (1): 34-37.

• 论著 • 上一篇    下一篇

吡美莫司乳膏治疗特应性皮炎多中心、随机双盲、平行对照研究

刘玲玲1, 闻卫兢1, 窦侠1, 王宝玺2, 马东来2, 李恒进3, 漆军3, 郑志忠4, 傅雯雯4, 顾军5, 李泉5, 林麟6, 弓娟琴6, 李春阳7, 孙青7, 朱学骏1   

  1. 1. 北京大学第一医院皮肤性病科100034;
    2. 中国医学科学院、中国协和医科大学北京协和医院;
    3. 解放军总医院;
    4. 复旦大学附属华山医院;
    5. 第二军医大学附属长海医院;
    6. 中国医学科学院、中国协和医科大学皮肤病研究所;
    7. 山东大学齐鲁医院
  • 收稿日期:2006-01-23 出版日期:2007-01-15 发布日期:2007-01-15

Pimecrolimus cream 1% for the treatment of atopic dermatitis in Chinese children and adults：a multicenter, randomized, double-bling, parallel-group, vehicle-contrnlled trial

LIU Ling-ling, WEN Wei-jing, DOU Xia, WANG Bao-xi, MA Dong-lai, LI Heng-jin, QI Jun, ZHENG Z6i-thong, FU Wen-wen, GU Jun, LI Quan, LIN Lin, GONG Juan-qin, LI Chun-yang, SUN Qing, ZHU Xue-jun   

  1. Department of Dermatology, Peking University First Hospital, Beijing 100034, China
  • Received:2006-01-23 Online:2007-01-15 Published:2007-01-15

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摘要：

目的 评价1%吡美莫司乳膏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、赋形剂平行对照的临床研究.特应性皮炎患者被随机分配至治疗组和安慰剂组,分别外用1%吡美莫司乳膏或赋形剂,每日2次,疗程4周,于治疗前(基线)及治疗后第1,2,4周各访视1次.主要疗效指标为研究者总体评估(IGA)评分,次要疗效指标包括湿疹面积与严重度指数(EASI),瘙痒程度评分及受试者/护理者主观评分等.结果 7个中心共有336例儿童和成人轻、中度特应性皮炎患者纳人意向治疗分析(ITT).治疗结束时,1%吡美莫司乳膏组总体评估的治疗成功率为31.55%,明显高于赋形剂组的18.45%(P=0.0046).其他疗效指标在治疗后第1,2,4周1%a吡美莫司乳膏组均明显优于赋形剂组(P<0.05)0.1%吡美莫司乳膏组药物相关不良反应发生率为19.64%,赋形剂组为24.40%,主要表现为红斑/红斑加重、疼痛、瘙痒/瘙痒加重、烧灼感和毛囊炎等.结论 1%吡美莫司乳膏对治疗儿童和成人轻、中度特应性皮炎疗效确切,安全性较好.

关键词: 抗环胍氨酸肽抗体, 系统性红斑狼疮, 关节炎, 皮炎,特应性, 吡美莫司, 随机对照试验

Abstract:

Objective To evaluate the safety and efficacy of 1% pimecrolimus cream in the treatment of Chinese pediatric and adult patients with mild to moderate atopic dermatitis(AD). Methods This multicenter, randomized, double-blind, parallel group, vehicle-controlled trial was conducted at 7 research sites in China. Children and adults with mild to moderate atopic dermatitis were randomly assigned to treatment with 1% pimecrolimus cream or vehicle twice daily for 4 weeks. Efficacy evaluations were performed at baseline and at weeks 1, 2, and 4. The primary efficacy parameter was the Investigator's Global Assessment(IGA)score. Secondary parameters included Eczema Area and Severity Index(EASI)and severity of pruritus scores. Subjects were also asked to assess their disease control as uncontrolled, limited, good or complete. Results A total of 336 patients were included in the intent-to-treat analysis. At the end of study, 31.55%(53 of 168)of the patients were treated successfully with pimecrolimus cream based on IGA scores, a significant improvement compared with patients treated with vehicle [18.45%(31 of 168)] (P=0.0046).Furthermore, pimecrolimus-treated patients experienced significantly greater improvement than vehicle-treated patients in all efficacy parameters at each postbaseline visit(P<0.05).There was no significant difference in the incidence of adverse events between the two groups, with 19.64%(33/168)in the pimecrolimus-treated group and 24.40%(41/168)in the vehicle-treated group(P=0.3568).The most common adverse events were mild-to-moderate local application site reactions, such as erythema, pain, pruritus, burning, and folliculitis. Conclusion Pimecrolimus cream 1% is a safe and effective treatment alternative for Chinese uediatric and adult patients with mild to moderate AD.

Key words: Dermatitis, atopic, Pimecrolimus, Randomized controlled trials