富马酸氯马斯汀注射液治疗急性荨麻疹多中心随机双盲对照研究  

Clemastine fumarate injection for the treatment of acute urticaria： a multicenter, double-blind, randomized,parallel-group, controlled study

作　　者：陈奇权 翟志芳[1] 涂亚庭[2] 赵旭传[3] 鲁建云[4] 白莉[5] 谢红付[6] 郝飞[1] 

机构地区：[1]第三军医大学第一附属医院皮肤科,重庆400038 [2]华中科技大学同济医学院附属协和医院 [3]青岛市市立医院 [4]中南大学湘雅三医院 [5]山西医科大学第一医院 [6]中南大学湘雅医院

出　　处：《中华皮肤科杂志》2015年第7期467-470,共4页Chinese Journal of Dermatology

摘　　要：目的评价富马酸氯马斯汀注射液治疗急性荨麻疹的有效性和安全性。方法选择急性荨麻疹患者为研究对象，采用多中心随机双盲研究设计，试验组肌内注射富马酸氯马斯汀注射液（2mg／次），对照组肌内注射马来酸氯苯那敏注射液（10mg／次），均每12h1次，共2次，观察24h。评价疗前及疗后症状体征总积分、各时间点总有效率、各症状体征改善率和基本缓解率，观察不良反应。结果入组144例患者，试验组和对照组各72例，138例纳入疗效分析。试验组有效率为78．87％（56／71），对照组有效率为77．61％（52／67），两组比较差异无统计学意义（r=0．02，P〉0．05）；首次注射后1h，两组瘙痒、风团大小和数量及风团水肿程度改善率差异均无统计学意义（均P〉O．05）；两组各症状体征的基本缓解率在各时间点比较差异均无统计学意义（均P〉0．05）。两组常见的不良反应有嗜睡、口干、头痛、头晕等，其中试验组嗜睡的发生率为11．11％（8／72），对照组为20．14％（15／72），差异有统计学意义（r=4．451，P〈0．05）。结论富马酸氯马斯汀注射液可有效控制急性荨麻疹症状，且其嗜睡的发生率低于马来酸氯苯那敏。Objective To evaluate the efficacy and safety of clemastine fumarate injection for the treatment of acute urticaria. Methods A muhicenter, double-blind, randomized, parallel-group, controlled study was conducted. Totally, 144 patients with acute urticaria were randomly and equally divided into 2 groups： test group treated with intramuscular injection of clemastine fumarate 2 mg every 12 hours for 24 hours, control group treated with intramuscular injection of chlorphenamine maleate 10 mg every 12 hours for 24 hours. Patients were evaluated for symptom and sign scores before, and at 0.5, 1, 2, 4, 12 and 24 hours after the start of treatment. The total response rate as well as improvement rates and partial remission （ I〉 90% ） rates for each symptom and sign were calculated at the above time points. Adverse reactions were recorded. Statistical analysis was carried out by a noninferiority trial, Wilcoxon rank sum test, chi-square test, analysis of variance, and a nonparameter test with SAS software. Results A total of 144 patients were enrolled into this study and 138 patients completed it. There was no significant difference in the response rate between the test group and control group （78.87% （56/71） vs. 77.61% （52/67）, X2 = 0.02, P〉 0.05）. No significant difference was observed between the two groups in improvement rates for itch or size, number and edema degree of wheals at 1 hour after the initial injection （ all P 〉 0.05 ）, or in partial remission rates for any symptom or sign, at any of the time points （all P 〉 0.05 ）. Common adverse reactions included dry mouth, headache, dizziness, etc. The incidence of lethargy was significantly lower in the test group than in the control group （ 11.11% （8/72） vs. 20.14% （15/72）,x2= 4.451, P 〈 0.05 ）. Conclusions Clemastine fumarate injection is effective for the treatment of acute urticaria, with lower incidence of letharzv comnared with chlorohenamine maleate iniection.

关 键 词：荨麻疹 氯马斯汀 氯苯那敏 随机对照试验 治疗结果 

分 类 号：R758.24[医药卫生—皮肤病学与性病学]