滴通鼻炎水喷雾剂治疗伤风鼻塞(急性鼻炎)的临床研究

目的:对滴通鼻炎水喷雾剂治疗伤风鼻塞(急性鼻炎)的临床疗效和安全性做出客观评价。方法:采用随机、盲法、阳性药平行对照、多中心试验的设计方法。本试验共入组伤风鼻塞患者88例,其中试验组66例,对照组22例,分别使用滴通鼻炎水喷雾剂,外用喷鼻,一次1~2揿,一日3~4次;鼻炎滴剂(喷雾型),外用喷鼻,一次1~2揿,一日3~4次。疗程均为5 d。用伤风鼻塞(急性鼻炎)临床疗效判定标准、局部症状、体征疗效和鼻塞缓解时间及维持时间评定疗效,一般体格检查、不良事件评定安全性。结果:88例患者治疗5 d后伤风鼻塞(急性鼻炎)的临床疗效:试验组的痊愈率为24.24%,显效率为31.82%,有效率37.88%,无效率6.06%;对照组的痊愈率为4.55%,显效率为36.36%,有效率36.36%,无效率22.73%。经CMH检验,两组的差异有统计学意义(P<0.05),试验组优于对照组。经秩和检验,两组的鼻塞缓解时间差异无统计学意义。经t检验,两组的鼻塞缓解维持时间差异有统计学意义(P<0.05),试验组优于对照组。两组治疗前后的体温、呼吸、心率、收缩压、舒张压等生命体征检查比较上,差异均无统计学意义。两组均无不良事件发生。结...

Safety and effectiveness of Ditong liquid nasal spray in patients with acute rhinitis

Objective: To investigate the safety and effectiveness of Ditong liquid nasal spray in the treatment of symptoms of cold and stuffy noses(acute rhinitis).Methods: In a randomized,blinded,parallel controlled,multi-center safety/efficacy study,88 patients with symptoms of cold and stuffy noses were enrolled.The patients were treated by either Ditong liquid nasal spray,1~2 squirts in each nostril,3~4 times daily for 5 days(n=66),or rhinitis drop(spray) 1~2 squirts in each nostril,3~4 times daily for 5 days(con...