苯磺贝他斯汀与氯雷他定治疗过敏性鼻炎:多中心随机双盲临床试验

Bepotastine Besilate versus Loratatine in the Treatment of Allergic Rhinitis:A Multicenter Randomized Double-Blind Comparison Clinical Trial

目的对苯磺贝他斯汀治疗过敏性鼻炎的有效性和安全性进行评价,并与氯雷他定做比较。方法采用多中心、随机、双盲、平行对照的临床试验,试验组过敏性鼻炎患者120例,每日用苯磺贝他斯汀片10mg,早晚各一次。对照组过敏性鼻炎患者120例,每日用氯雷他定片10mg,每日1次。两组均连续用药14d。疗效评价以治疗的总有效率作为主要指标,症状积分下降指数和鼻腔检查积分下降指数作为次要指标。结果治疗后,苯磺贝他斯汀受试者总有效率为91.4%,氯雷他定组为91.2%,P=0.984;药物不良反应总发生率分别为16.1%,25.4%。经统计学检验,两组差异均无显著统计学意义。其中苯磺贝他斯汀组嗜睡发生率为4.2%;氯雷他定组为14.4%,P=0.012。结论苯磺贝他斯汀治疗过敏性鼻炎与氯雷他定一样安全有效,且苯磺贝他斯汀组的嗜睡发生率低于氯雷他定组。

Objective To evaluate the efficacy and safety of bepotastine besilate in the treatment of allergic rhinitis. Methods A multi-center, randomized, double-blind, parallel controlled clinical trial was performed. Patients received 10rag bepotastine besilate tablet packaged in capsule twice per day in the study group or 10mg loratatine tablet packaged in capsule after breakfast, placebo of the same weight as 10mg loratatine tablet packaged in capsule after supper in the control group for 14 days. 120 cases were enrolled in each group. Total effective rate was defined as primary outcome of efficacy and SSR1 of each nasal symptom （sneezing, nasal discharge, nasal itch, nasal obstruction） and scores of nasal cavity examination as secondnry outcome. Results The total effective rate 91.4% and 91.2% in bepotastine and loratadine group respectively （P = 0. 984）. The adverse reaction rate were 16. 1%, 25.4% n bepotastine and loratadine group respectively. The differences were not statistically significant. The incidence of drowsiness was 4.2% and 14.4% in bepotastine group and loratadine group respectively （P = 0.012 ）.Conclusions Bepotastine besilate was effective in the treatment of allergic rhinitis. The efficacy and safety of bepotastine besilate was similar to loratadine, but incidence of drowsiness was lower than loratadine.