盐酸奥洛他定片治疗过敏性鼻炎疗效和安全性的多中心临床研究

目的:观察盐酸奥洛他定片治疗过敏性鼻炎的临床疗效及安全性。方法:采用随机、双盲、双模拟、多中心、平行对照的方法,试验组和对照组各150例,分别采用盐酸奥洛他定片,bid,每次1片;或氯雷他定片,qd,每次1片,2组分别给予盐酸奥洛他定和氯雷他定模拟片,连续给药14 d。疗程结束时以症状体征总积分下降值、综合疗效改善百分率来评估其临床疗效,以不良事件及不良反应、实验室检查等来评估其安全性。结果:共有147例患者纳入疗效分析,试验组(n=73)及对照组(n=74),综合疗效有效率分别为90.41%和83.78%(P>0.05)。35例患者发生54例次不良事件(试验组17人26例次,对照组18人28例次),其中48例次不良事件与药物相关,主要表现为口干、头晕、嗜睡、乏力等,此为相关药物不良反应。而2组间不良事件及不良反应发生率差异无统计学意义(P>0.05)。无严重不良事件发生。结论:盐酸奥洛他定片可有效控制过敏性鼻炎症状,疗效显著,安全性好。

A multicenter clinical trial to evaluate the efficacy and safety of olopatadine hydrochloride tablets in the treatment of allergic rhinitis

OBJECTIVE To evaluate the efficacy and safety of olopatadine hydrochloride tablet in the treatment of allergic rhinitis.METHODS 150 allergic rhinitis patients were enrolled and divided into 2 groups equally in a randomized,double-blind,double-simulation,multicenter,positive-controlled study.The test group received olopatadine hydrochloride tablet,1 tablet twice,per day for 14 days;while the control group was given loratadine tablet,1 tablet per day,then added the olopatadine hydrochloride and loratadine simulation tablet respectively for 14 days.To observe and compare the efficacy and safety of these two drugs,the integrated efficacy index,effective rate,adverse events or adverse reaction and the outcome of laboratory examination were adopted respectively.RESULTS 147 patients were eligible for efficacy analysis(73 in test group and 74 in control group).The effective rates were 90.41% in test group and 83.78% in control group.there was no significant difference between the two groups(P>0.05).There were 54 adverse events developed in 35 patients,and 48 of them is related with the drugs that is called adverse reaction,mainly including dry mouth,dizziness,somnolence and hypodynamia(17 patients in test group and 18 patients in control group).The incidence of adverse events and adverse reaction were no difference between the two groups(P>0.05).CONCLUSION The results of the study indicate that olopatadine hydrochloride tablets could control the symptoms of allergic rhinitis effectively and it is well-tolerated.