美敏伪麻溶液治疗急性上呼吸道感染所致咳嗽133例的疗效和安全性  

Efficacy and safety of dextromethorphan-chlorpheniramine-pseudoephedrine solution in treating cough caused by acute upper respiratory tract infections in 133 patients

作　　者：周敏[1] 戴然然[1] 沈继敏[1] 万欢英[1] 邓伟吾[1] 宋承娟[2] 周新[2] 鲁慧敏[3] 林建海[3] 王赟[4] 陈小东[4] 李向阳[5] 朱惠莉[5] 

机构地区：[1]上海第二医科大学附属瑞金医院呼吸科,上海200025 [2]上海交通大学附属第一人民医院呼吸科,上海200080 [3]上海第二医科大学附属新华医院呼吸科,上海200092 [4]复旦大学附属华山医院呼吸科,上海200040 [5]华东医院呼吸科,上海200040

出　　处：《中国新药与临床杂志》2005年第9期693-696,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:评价美敏伪麻溶液治疗急性上呼吸道感染所致咳嗽的疗效和安全性.方法:262例急性上呼吸道感染病人随机分为2组,试验组133例,男性61例,女性72例,年龄(44±s 13)a,予美敏伪麻溶液10 mL,po,tid;对照组129例,男性54例,女性75例,年龄(46±14)a,予复方磷酸可待因溶液10 mL,po,tid;疗程均为3～5 d,治疗结束后根据咳嗽的频率和程度综合评价疗效,同时根据病人的记录评价安全性.结果:根据符合方案(PP)分析,治疗d 3综合临床有效率试验组为41.2%,对照组为39.1%,2组间差异无显著意义(P=0.59);治疗d 5试验组和对照组综合临床有效率分别为87.8%和79.7%,2组有显著差异(P=0.01).试验组不良反应发生率17.2%,对照组为16.7%,2组间无显著差异(P=0.91).结论:用药3 d后美敏伪麻溶液治疗急性上呼吸道感染引起咳嗽的疗效与复方磷酸可待因溶液相当,d 5优于复方磷酸可待因溶液,其不良反应轻,安全性良好.AIM： To evaluate the efficacy and safety of dextromethorphan-chlorpheniramine-pseudoephedrine solution in upper respiratory tract hundred and sixty-two treating cough infections. patients were caused by acute METHODS ： Two randomly divided into two groups. One hundred and thirty-three patients in trial group （M 61, F 72; age （44 ±s13） a） were administrated with dextromethorphan-chlorpheniraminepseudoephedrine solution 10 mL,po,tid, while the other 129 patients in control group （M 54, F 75 ; age （46 ± 15） a） were administrated with compound codeine phosphate solution, 10 mL,po,tid. The period of the treatment was 3-5 d for each group. And the follow up was carried out with various recorded information including efficacy judged by the frequency and degree scores of cough, and safety judged by the record of those patients. RESULTS： According to per protocol （PP） analysis, on d 3 after treatment, the total clinical effective rates were 41.2 % in the trial group and 39.1% in the control group with no significant difference between the two groups （P = 0.59）. On d 5 after treatment, the total clinical effective rates were 87.8 % in the trial group and 79.7 % in the the control group with significant difference between them （P = 0.01 ）. In addition, the ratio of adverse reactions revealed 17. 2 % and 16. 7 % in trial and control group respectively, showing no statistically significant difference（ P = 0.91 ）. CONCLUSION： Three days after treatment, dextromethorphan-chlorpheniraminepseudoephedrine solution is as effective as compound codeine phosphate solution in treating cough induced by acute upper respiratory tract infections. Five days after treatment, dextromethorphan-chlorpheniramine-pseudoephedrine solution is more effective than compound codeine phosphate solution. The adverse reactions of dextromethorphan-chlorpheniramine-pseudoephedrine solution are slight and it is safety.

关 键 词：呼吸道感染 咳嗽 呼吸系统药 安全 随机对照试验 多中心研究 药物评价 美敏伪麻溶液 

分 类 号：R511.6[医药卫生—内科学] R974[医药卫生—临床医学]