贵州医科大学学报

2006, (05) 420-423

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盐酸左西替利嗪片治疗慢性特发性荨麻疹的研究
A Random,Double-blind,Double-modeling,and Parallel Control Study on Curative Effect of Levocetirizine to Chronic Idiopathetic Urticaria

程波;刘茁;纪明开;陈颖;张子平;施秀明;
CHENG Bo,LIU Zhuo,JI Ming-kai,CHEN Ying,ZHANG Zi-ping,SHI Xiu-ming(Department of Dermatology,The First Affiliated Hospital of Fujian Medical University,Fuzhou 350005,Fujian,China)

摘要(Abstract):

目的:以盐酸西替利嗪片为阳性对照药,评价盐酸左西替利嗪片治疗慢性特发性荨麻疹的有效性和安全性。方法:试验采用随机、双盲双模拟、平行对照行临床研究。结果:盐酸左西替利嗪对慢性特发性荨麻疹的基本痊愈率、有效率分别为66.67%和88.89%,盐酸西替利嗪基本痊愈率、有效率分别为72.22%和88.89%,两组疗效的差异无统计学意义(P>0.05)。盐酸左西替利嗪的不良反应发生率为5.56%,与盐酸西替利嗪的不良反应发生率(16.67%)的差异无统计学意义(P>0.05)。结论:盐酸左西替利嗪片(5mg)治疗慢性特发性荨麻疹的疗效高、安全性好,其疗效和安全性与盐酸西替利嗪片(10mg)相当。
Objective:To evaluate the effect and safety of the drug,acid hydrochloric levocetirizine,produced by Zhejiang Yongning Pharmaceutics for the treatment of chronic idiopathetic urticaria.Methods:Acid hydrochloric cetirizine was used as positive control,and a random,double-blind,double-modeling,and parallel control study was carried out.Thirty-six patients were divided into groups A and B randomly(18 for each)to receive treatment of clevocetirizine(group A,5 mg/day)and cetirizine(group B,10 mg/day)respectively.The treatment courses of both was 29 days in average.The results of the study were analysed with SAS 6.12 statistical analysis software.Results:The healing and efficency rates of chronic idiopathetic urticaria were 66.67% and 88.89% in group A,and 77.2% and 88.89% in group B.No significant difference was found in curative effect between the two groups(P>0.05).The incidence rates of adverse reaction were 5.56% in group A and 16.67% in group B.the difference was not statistically significant(P>0.05).The main manifestation of adverse reaction was dizziness.Heart rate,breath rate,blood pressure,blood and urine,liver and kidney function of all patients were examined before and after the treatment,and no abnormality of clinical sense was found.No abnormal changes was found in the electrocardiogram parameters of patients(P-R interval,Q-Tc,QRS time limited)either.Conclusions:Acid hydroc levocetirizine(5 mg)has highly curative effect to chronic idiopathetic urticaria with good safety.Its curative effect and safety are equal with acid hydroc cetirizine.

关键词(KeyWords): 荨麻疹;双盲法;左西替利嗪;西替利嗪
urticaria;double-blind method;levocetirizine;cetirizine

Abstract:

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作者(Author): 程波;刘茁;纪明开;陈颖;张子平;施秀明;
CHENG Bo,LIU Zhuo,JI Ming-kai,CHEN Ying,ZHANG Zi-ping,SHI Xiu-ming(Department of Dermatology,The First Affiliated Hospital of Fujian Medical University,Fuzhou 350005,Fujian,China)

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DOI: 10.19367/j.cnki.1000-2707.2006.05.013

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