中华皮肤科杂志 ›› 2012, Vol. 45 ›› Issue (4): 231-233.

• 论著 • 上一篇    下一篇

苯磺贝他斯汀片治疗慢性荨麻疹的多中心随机双盲对照研究

李丽1,何志新1,刘玲玲2,赵广3,顾军4,顾恒5,王宝玺6   

  1. 1. 北京协和医院
    2. 北京大学第一医院皮肤科
    3. 中国人民解放军空军总医院皮肤科 100142
    4. 上海第二军医大学附属长海医院皮肤科
    5. 中国医学科学院皮肤病医院（研究所）
    6. 南京 中国医学科学院北京协和医学院皮肤病研究所
  • 收稿日期:2011-11-22 修回日期:2011-12-18 出版日期:2012-04-15 发布日期:2012-03-30
  • 通讯作者: 王宝玺 E-mail:wangbx1583@263.net

Bepotastine besilate for the treatment of chronic urticaria: a multicenter, double-blind, randomized, parallel-controlled study

  • Received:2011-11-22 Revised:2011-12-18 Online:2012-04-15 Published:2012-03-30
  • Contact: WHANG Baoxi E-mail:wangbx1583@263.net

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摘要：

目的 探讨苯磺贝他斯汀治疗慢性荨麻疹的疗效和安全性。方法 采用多中心、随机双盲对照临床试验。慢性荨麻疹患者随机分为两组，一组接受苯磺贝他斯汀片20 mg/d治疗，另一组接受氯雷他定10 mg/d治疗，共治疗4周。分别在治疗前和治疗后第1周、第2周和第4周随访，对瘙痒、最大风团直径和风团数量进行评价及疗效评估。结果 随机入组240例慢性荨麻疹患者，共227例纳入疗效分析。治疗后4周苯磺贝他斯汀组的总有效率（基愈 + 显效）为74.6%，氯雷他定组的总有效率为77.9%，两组比较差异无统计学意义（P > 0.05）。苯磺贝他斯汀不良事件发生率为12.8%，氯雷他定组为17.9%，两组差异无统计学意义（P > 0.05），两种药物的不良反应主要为轻至中度嗜睡、口干和头晕。结论 苯磺贝他斯汀治疗慢性荨麻疹安全有效，其疗效和不良反应发生率与氯雷他定差异无统计学意义。

关键词: 氯雷他定

Abstract:

Objective To evaluate the efficacy and safety of bepotastine besilate in the treatment of chronic urticaria. Methods A randomized, double-blind, parallel-controlled clinical study was conducted in 5 centers. Patients were randomly assigned to 2 groups to be treated with bepotastine besilate 20 mg or loratadine 10 mg once a day, respectively, for 4 weeks. Visits were scheduled before and after 1, 2 and 4 weeks of treatment. Itching degree, number of wheals and diameter of the largest wheal were recorded for efficacy evaluation. Results Totally, 240 patients were enrolled and 227 patients completed the study. The response rate was 74.6% and 77.9% respectively in bepotastine besilate- and loratadine-treated patients, respectively（P > 0.05）. No significant difference was observed in the incidence of adverse reactions between bepotastine besilate- and loratadine-treated patients （12.8% vs. 17.9%, P > 0.05）. The main side effects were mild to moderate drowsiness, dry mouth, dizziness. Conclusion Bepotastine besilate is effective and safe for the treatment of chronic urticaria, with an efficacy and safety profile similar to that of loratadine.

Key words: loratadine