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盐酸左西替利嗪治疗儿童慢性荨麻疹多中心随机对照研究
Efficacy and Safety of Levocetirizine for the Treatment of Childhood Chronic Urticaria: A Randomized,Parallel,Multicenter Study
【摘要】 目的:观察左西替利嗪治疗2~12岁儿童慢性荨麻疹的有效性和安全性。方法:选择2~12岁的慢性荨麻疹患儿为研究对象,进行多中心随机对照临床研究。试验组口服盐酸左西替利嗪,对照组口服氯雷他定,连续28 d。分别于服药前和服药后第7天、第14天、第28天随访,采用荨麻疹严重程度评分观察疗效;同时于服药前和服药后第28天检测肝肾功能、血清总Ig E、血常规和心电图。结果:共有54例患儿完成研究,其中试验组26例,对照组28例。试验组和对照组治疗后第7天的有效率分别为73.08%和39.29%,两组比较差异有统计学意义(χ2=6.234,P<0.05);试验组和对照组治疗后第14天的有效率分别为73.08%和50.00%,第28天有效率分别为84.62%和64.29%,两组比较差异均无统计学意义(χ2分别为3.021、2.901,P>0.05)。试验组不良反应发生率为3.8%,对照组无相关不良反应发生,两组比较差异无统计学意义(P>0.05)。结论:左西替利嗪治疗儿童慢性荨麻疹安全、有效,在治疗早期疗效优于氯雷他定。
【Abstract】 Objective: To investigate the efficacy and safety of levocetirizine for the treatment of children chronic urticaria between 2 ~12years old. Methods: A multicenter,randomized and control study was employed. The children between 2 ~ 12 years old with chronic urticaria were divided into levocetirizine group and loratadine group,levocetirizine or loratadine were taken once daily for 28 days.Compared the efficacy on the 7th day,14 th day and 28 th day after treatment by recording the change of the urticaria severity scores. At the same time,liver and kidney function,serum total Ig E,routine blood and electrocardiogram were recorded before and after treatment on the 28 th day. Results: Fifty-four cases were evaluable for efficacy and safety at the end of the study. The effective rates of levocetirizine group and loratadine group on 7th day were 73. 08% and 39. 29%,there was significant difference between the two groups(χ2= 6. 234,P < 0. 05). The effective rates were 73. 08% and 50. 00% on 14 th day respectively,on 28 th day were 84. 62% and64. 29% respectively,there were no significant differences between the two groups. The rate of adverse reaction for levocetirizine group and loratadine group were 3. 8% and 0% respectively. Conclusion: Levocetirizine and loratadine are effective and safty for the treatment of children chronic urticaria,but levocetirizine was more excellent in the early.
- 【文献出处】 儿科药学杂志 ,Journal of Pediatric Pharmacy , 编辑部邮箱 ,2014年11期
- 【分类号】R758.24
- 【被引频次】2
- 【下载频次】180