摘要
目的 :评价伪麻滴剂治疗病儿由感冒等引起的鼻塞的疗效和安全性。方法 :本次临床试验采用多中心、随机、单盲、对照研究。入选 144例 ,完成141例 ,病儿年龄均 3a以内。其中伪麻滴剂组 72例 (脱落 2例 ) ,男性 38例 ,女性 32例 ,年龄为 ( 18±s10 )mo ,服用伪麻滴剂 ;氨酚伪麻滴剂组 72例 (脱落 1例 ) ,男性 4 1例 ,女性 30例 ,年龄 ( 18± 10 )mo ,服用氨酚伪麻滴剂。 2组均按月龄服药 ,每日 4次 ,疗程均为 3d。观察 2组疗效和不良反应。结果 :伪麻滴剂有明显的缓解鼻塞的效果 ,服药 3d后的缓解鼻塞的有效率达 83%,氨酚伪麻滴剂组的有效率75 %,2组疗效经Ridit分析 ,差异无显著意义 (P >0 .0 5 )。伪麻滴剂组不良反应的发生率为 1%,氨酚伪麻滴剂组为 3%(P >0 .0 5 )。未出现严重及预料之外的不良反应。本次试验期间未发现试验药物对血常规和尿常规有明显影响。结论 :伪麻滴剂对由普通感冒等引起的鼻塞有明显疗效 ,不良反应小。
AIM: To evaluate the effect and safety of pseudophedrine drops in treating rhinocleisis symptoms caused by common cold. METHODS: A multi-center randomized control clinical trial was used. One hundred and forty-four patients were divided into two groups and one hundred and forty-one finished in the end. The pseudoephedrine drops group of seventy patients (M 38,F 32;age(18±s10)mo) took pseudophedrine drops. The pseudoephedine group of senventy-one patients (M 41, F 30;age(18±10) mo)took acetaminophen drops. Each patient took medicine according to the moon's age. The medicine was taken qid for 3 d. RESULTS: The releasing rhinocleisis rate after 3 d was 83% and 75%, respectively. The adverse reaction rate was 1% and 3%, repectively. There are no significant difference between two groups. No serious adverse reactions appeared. CONCLUSION:Pseudophedrine drops in treating rhinocleisis symptoms caused by common cold is safe and effective with rare obvious adverse reactions.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2003年第8期456-458,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
伪麻滴剂
感冒
鼻塞
疗效
不良反应
drug evaluation
safety
common cold
ephedrine
pseudoephedrine
pseudoephedrine drops
