左西替利嗪治疗过敏性鼻炎72例的临床随机对照研究

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。

Clinical randomized controlled trials of levocetirizine in treatment of 72 patients with anaphylactic rhinitis

AIM: To evaluate the efficacy and safety of levocetirizine and cetirizine in the treatment of perennial allergic rhinitis. METHODS: One hundred and forty-four patients between 18-65 a were randomly divided into treatment group and control group in a multi-center,double-blind,randomized active-controlled trial. Seventy-two patients in treatment group were treated with levocetirizine tablets(5 mg,po,qd),72 patients in control group were treated with cetirizine tablets(10 mg,po,qd),all together for 14 d. RESULTS: Seventy patients of the either two groups were completed with the trial.The total clinical effective rates were 89 % and 83 % for the treatment group after 7 d and 14 d,and those of the control group were (94 %) and 93 %, respectively. There was no statistical difference in the symptom integral lowering index (P>0.05). No severe adverse reactions occurred both in treatment group and control group.The incidence of adverse reaction rates 11 % were for levocetirizine and (18 %) in cetirizine. The oscitancy rate of treatment group was 6 %,and 11 % for control group.There was no clinical diversification correlatively. CONCLUSION: Levocetirizine is effective and safe in the treatment of perennial allergic rhinitis, nearly similar to cetirizine.