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目的观察非索伪麻缓释胶囊治疗变应性鼻炎的疗效和安全性。方法变应性鼻炎患者240例,采用随机、双盲双模拟、多中心、平行对照的方法,随机分为治疗组和对照组各120例,分别采用非索伪麻缓释胶囊,每次1粒,bid,po;或氯雷他定伪麻黄碱缓释片,每次1片,bid,po,连续用药7～14 d。疗程结束时以综合疗效改善百分率、症状体征总积分下降值来评估其临床疗效,以不良事件、实验室检查等来评估其安全性。结果共有224例患者纳入疗效分析,治疗组(113例)及对照组(111例)的综合疗效改善百分率分别为92.92%和95.50%(P>0.05)。29例患者发生45例次不良反应(治疗组13例21例次,对照组16例24例次),主要表现为口干、头晕、嗜睡、乏力等。两组间不良反应发生率差异无显著性(P>0.05)。无一例严重不良事件发生。结论非索伪麻缓释胶囊可有效控制变应性鼻炎症状,疗效显著,安全性好。
Objective To observe the efficacy and safety of non-cable pseudoephedrine sustained release capsules in the treatment of allergic rhinitis. Methods A total of 240 patients with allergic rhinitis were randomly divided into treatment group (120 cases) and control group (120 cases) with randomized, double-blind double simulations, multiple centers and parallel control. Tablets, bid, po; or loratadine pseudoephedrine sustained-release tablets, each 1, bid, po, continuous medication 7 ~ 14 d. At the end of the course of treatment, the clinical curative effect was evaluated by the percentage of the improvement of comprehensive curative effect and the decrease of the total score of the symptoms and signs, and the safety was evaluated by adverse events, laboratory tests and the like. Results A total of 224 patients were included in the efficacy analysis. The overall improvement rates of the treatment group (113 cases) and the control group (111 cases) were 92.92% and 95.50%, respectively (P> 0.05). There were 45 adverse reactions in 29 patients (21 in treatment group, 21 in control group and 24 in control group). The main symptoms were dry mouth, dizzy, drowsiness, fatigue and so on. There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). None of the serious adverse events occurred. Conclusion Non-cable pseudoephedrine sustained release capsules can effectively control the symptoms of allergic rhinitis, with significant curative effect and good safety.