咪唑斯汀治疗3293例急性荨麻疹起效时间的临床研究  

Evaluation of onset time of mizolastine in the treatment of 3293 patients with acute urticaria

作　　者：无 林麟（整理者） 

机构地区：[1]咪唑斯汀治疗急性荨麻疹全国多中心临床协作组 [2]不详

出　　处：《中华皮肤科杂志》2007年第9期524-526,共3页Chinese Journal of Dermatology

摘　　要：目的观察咪唑斯汀治疗急性荨麻疹的临床起效时间、疗效以及安全性。方法在全国53所医院开放性临床试验。急性荨麻疹受试者口服咪唑斯汀10 mg,观察2 h。每半小时评价临床症状评分变化以及安全性。结果3293例患者服药后0.5、1、1.5和2 h,风团、红晕和瘙痒症状均有显著改善。服药后0.5 h,起效率和有效率分别为42.12%(1387例)和5.47%(180例);服药后1 h分别为82.20%(2707例)和21.62%(712例);服药后1.5 h,分别为94.26%(3104例)和46.13%(1519例);服药后2 h,分别为97.21%(3201例)和73.16%(2409例)。有127例(3.86%)发生一般不良反应。结论服用咪唑斯汀10 mg能够在2 h内快速、有效缓解急性荨麻疹的病情,安全性高。Objective To study the onset time, efficacy and safety of mizolastine in the treatment of acute urticaria. Methods An open clinical trial was performed in 53 hospitals. All patients with acute urticaria were given a single dose of 10 mg mizolastine, and evaluated for symptom （ e.g. wheal, flare, itching ） scores and adverse effects every half an hour until 2 hrs after the medication. Results A total of 3293 patients were enrolled and completed the trial. After the medication, the response rate and effective rate were 42.12% （1387/3293） and 5.47% （180/3293） respectively at 0.5 h, 82.20% （2707/3293） and 21.62% （ 712/3293 ） respectively at 1 h, 94.26% （ 3104/3293 ） and 46.13% （ 1519/3293 ） respectively at 1.5 h, 97.21% （ 3201/3293 ） and 73.16% （ 2409/3293 ） respectively at 2 h. No serious adverse reaction occurred, but common side effects, including a burning sensation in the stomach, nausea, dizziness, etc, were observed in 3.86% （127/3293） patients. Conclusion Mizolastine can quickly, effectively and safely control the symptom of acute urticaria within 2 hrs after medication.

关 键 词：荨麻疹 咪唑斯汀 临床试验 多中心研究 

分 类 号：R758.24[医药卫生—皮肤病学与性病学]