伪麻美沙芬滴剂的疗效和安全性

目的 :评价伪麻美沙芬滴剂治疗由感冒等引起的咳嗽和鼻塞症状的疗效和安全性。方法 :本次临床试验采用多中心、随机、对照研究。完成病儿142例 ,其中试验组 71例 ,男性 38例 ,女性 33例 ,年龄为 (16±s 9)mo ,服用伪麻美沙芬滴剂 ;对照组71例 ,男性 4 1例 ,女性 30例 ,年龄为 (18± 10 )mo ,服用美尔伪麻溶液。试验组和对照组均按月龄服药 ,每日 4次 ,疗程均为 5d。结果 :服药 5d后试验组的止咳效果达 75 % ,缓解鼻塞的效果达 87% ,总有效率达 87% ,与对照组比较 ,差异无显著意义 (P>0 .0 5 )。试验组不良反应的发生率为 1% ,与对照组相比无显著意义 (P >0 .0 5 )。结论 :伪麻美沙芬滴剂治疗由普通感冒等引起的咳嗽、鼻塞有明显疗效 ,无明显不良反应。

Effect and safety of pseudoephedrine-dextromethorphan drops

AIM: To evaluate the effect and safety of pseudoephedrine dextromethorphan drops in treating cough and rhinocleisis symptoms caused by common cold. METHODS: A multi center randomized control clinical trial was used. One hundred and forty two patients were divided into two groups. The trial group of seventy one patients (M 38, F 33; age (16± s 9)mo) took psudoehedrine dextromethorphan drops and the control group of seventy one patients (M 41, F 30; age (18±10)mo) took pseudoephedrine, chlorphenamine and dextromethorphan solution. Each patient took medicine according to the age of the moon. The medicine was taken qid for 5 d. RESULTS: The antitussive and releasing rhinocleisis rate after d 5 was 75% and 87%, respectively. The adverse reaction rate of the trial group was 1%, no significant difference between two groups. No serious adverse reactions appeared. CONCLUSION: Pseudophedrine dextromethorphan drops in treating cough and rhinocleisis symptoms caused by common cold is safe and effective without any obvious adverse reactions.