复方盐酸伪麻黄碱缓释胶囊治疗感冒患者鼻部症状的多中心临床研究

An open label multi-center clinical trial to evaluate the efficacy of compound phenylpropanolamine hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold

目的 观察复方盐酸伪麻黄碱缓释胶囊治疗普通感冒和 (或 )流行性感冒患者鼻部症状的临床疗效和安全性。方法 采用开放、多中心临床研究。共纳入受试者 4 19例。合格的受试者每次 1粒、每日 2次、间隔 12h、连服 4d复方盐酸伪麻黄碱缓释胶囊 ,然后观察患者鼻部症状的改善情况。结果 本研究最终有 4 16例患者可供疗效分析和安全性分析。鼻塞症状 1至 4d每日治愈率分别为 7%、31%、6 4 %和 88% ,流涕症状 1至 4d每日治愈率分别为 9%、36 %、6 8%和 89% ,打喷嚏症状 1至 4d每日治愈率分别为 2 0 %、5 1%、76 %和 93% ,流眼泪症状 1至 4d每日治愈率分别为 36 %、6 8%、89%和 96 %。共有 35例患者发生了 4 0次不良反应 ,发生率为 8 4 % (35 /416 ) ,主要为轻、中度嗜睡及口干 ,未出现严重的不良反应。结论 复方盐酸伪麻黄碱缓释胶囊可明显持续控制普通感冒和(或 )流行性感冒的鼻部症状 ,疗效较高 ,耐受性较好。

Objective To evaluate the efficacy and safety of compound phenylpropanolamine hydrochloride (New Contac sustained release capsules) in the treatment of the nasal symptoms associated with common cold or influenza Method Open label multi center clinical trial was adopted: one capsule twice daily with an interval of 12 hours, successively for 4 days to treat the nasal symptoms associated with common cold or influenza Results A total of 416 patients were eligible for efficacy and safety analysis The cure rates for nasal congestion from day 1 to day 4 were 7%, 31%, 64% and 88%, cumulatively; for runny nose were 9%, 36%, 68% and 89%; for sneezing were 20%, 51%, 76% and 93%, and for watery eyes were 36%, 68%, 89% and 96%, respectively. There were no serious adverse events during the study Forty adverse events (AE′s) with an incidence of 8% were developed in 35 patients The most frequent AE′s were drowsiness (24/416,6%) and dry mouth (5/416,1%) All AE′s were in mild or moderate degree Conclusion The results indicated that New Contac sustained released capsule was effective in controlling the nasal symptoms associated with common cold or influenza and it was well tolerated