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目的:评价左西替利嗪治疗常年性过敏性鼻炎的有效性和安全性。方法:本研究采用多中心随机、双盲、阳性药物平行对照临床试验,选取年龄为18～65a常年性过敏性鼻炎病人144例。随机分成2组,试验组(72例)给予左西替利嗪片(5mg,po,qd);对照组(72例)给予西替利嗪片(10mg,po,qd),均连续14d。结果:完成病例共140例,2组各70例。以症状积分下降指数计算,治疗7d和14d后试验组和对照组的有效率分别89%,83%和94%,93%,2组比较均无统计学差异(P>0.05)。试验组与对照组均未发现严重不良反应的病例,不良反应发生率分别为11%和18%,其中试验组困倦发生率为6%,对照组困倦发生率为11%。结论:左西替利嗪是一种安全、有效的治疗常年性过敏性鼻炎药物,与西替利嗪的疗效相似。
Objective: To evaluate the efficacy and safety of levocetirizine in the treatment of perennial allergic rhinitis. Methods: In this study, a multicenter randomized, double-blind, positive-drug parallel controlled clinical trial was conducted in 144 patients with 18-65 years of perennial allergic rhinitis. The rats in the control group (72 cases) were given cetirizine tablets (10 mg, po, qd) for 14 days. The rats in the experimental group (72 cases) were treated with levocetirizine tablets (5 mg, po, qd) Results: A total of 140 cases completed, two groups of 70 cases. The symptom score decreased index, the treatment of 7d and 14d after the test group and the control group were 89%, 83% and 94%, 93%, respectively, there was no significant difference between the two groups (P> 0.05). No serious adverse reactions were found in the experimental group and the control group. The incidence of adverse reactions were 11% and 18% respectively, in which the incidence of drowsiness in the experimental group was 6% and that in the control group was 11%. CONCLUSION: Levocetirizine is a safe and effective drug for the treatment of perennial allergic rhinitis, and its efficacy is similar to that of cetirizine.