盐酸非索非那定胶囊治疗过敏性鼻炎的多中心临床研究

Treatment of allergic rhinitis with fexofenadine hydrochloride: a multicenter clinical trial

目的:评价盐酸非索非那定胶囊治疗过敏性鼻炎的疗效和安全性。方法:本研究采用多中心、随机、双盲、阳性药物平行对照的临床研究方法。受试者144例,随机分成试验组和对照组各72例。试验组口服盐酸非索非那定胶囊60mg, 2次／d;对照组服用盐酸西替利嗪片10 mg,1次／d,总疗程均为14d。结果:治疗后2周,两组患者各项症状明显改善,症状积分及病情分级数均有明显下降;试验组痊愈率为18．46％,有效率为69．23％;对照组痊愈率为28．67％,有效率为65．67％,两组间差异无统计学意义(P>0.05)。综合疗效评价:试验组改善率为70．31％,对照组改善率为71．64％,两组间无统计学差异(P>0．05)。所有患者在治疗过程中均未出现严重药品不良事件,试验组和对照组不良反应发生率分别为10．77％和20．90％。结论:盐酸非索非那定胶囊治疗过敏性鼻炎疗效明确,无明显严重不良反应,患者耐受性好。

Objective： To evaluate effectiveness and safety of fexofenadine hydrochloride in treatment of patients with allergic rhinitis. Methods： A randomized double-blind parallel controlled clinical trial was conducted. Totally 144 patients with allergic rhinitis were randomly divided into 2 groups：72 patients in test group and 72 patients in control group. Patients in test group took fexofenadine hydrochloride 60 mg twice a day for 2 weeks. Patients in control group took cetirizine hydrochloride 10 mg once daily for 2 weeks. Results. All symptoms were improved significantly and symptom scores and illness classification scores were significantly decreased after treatment for 2 weeks in both groups. The cure rate and improvement rate were 18.46% and 69.23% in the test group, while they were 28.67% and 65.67% in the control group, respectively. No statistically significant difference was observed between the two groups. The result of comprehensive effectiveness evaluation was expressed as improvement rate： 70.31% in the test group and 71.64% in the control group. No statistically significant difference in effectiveness was observed between the two groups （P〉0. 05）. There was no severe side effect in the two groups. The adverse drug reactions were mild with incidence of 10. 77 % in the test group and 20.90% in the control group. Conelusion： Fexofenadine hydrochloride has good effects on patients with allergic rhinitis and causes little adverse drug reactions. It is effective and safety to use fexofenadine hydrochloride in the treatment of allergic rhinitis.