复方甲氧那明治疗感染后咳嗽的有效性和安全性多中心临床研究

目的 评价复方甲氧那明治疗感染后咳嗽的有效性和安全性.方法 采用开放的、前瞻性多中心临床研究.病例选自2009年11月至2010年10月在6家教学医院呼吸科就诊,并被诊断为感染后咳嗽的患者 入选时咳嗽症状积分至少≥2分.治疗用药为复方甲氧那明胶囊(第一三共制药(上海)有限公司生产 商品名:阿斯美)2粒 3次/d 饭后口...

A multicenter study to evaluate the efficacy and safety of compound methoxyphenamine in the treatment of postinfectious cough

Objective To evaluate the efficacy and safety of compound methoxyphenamine in the treatment of postinfectious cough.Methods An open,perspective,multicenter clinical trial was conducted.Subjects who meet with the diagnostic of postinfectious cough and with cough symptom score greater than 2 were recruited by six different teaching hospitals at the department of respiration.The test drug compound methoxyphenamine capsule was produced by Japan's Daiichi Sankyo Pharmaceutical Co.Ltd.Japan (brand name:Asmeton Strong capsule).Two capsules of test drug were orally administrated to subjects after meal 3 times per day for a 7-10 days treatment.The primarily endpoint was the evaluation of cough severity.Results There were 441 subjects randomized to study treatment (FAS),with 162 male and 279 female.The average age for FAS is 45.6,with a age range of 18～70.Cough duration of patients enrolled in the study rangs from 1 to 60 days and average cough duration is 29.8days.Of the 394 patients metting Per protocol set (PP),symptoms were relief (56.090％,221 patients),significantly improved (34.01 ％,134 patients),slightly better (5.08％,20 patients),and not improved (4.82 ％,19 patients).The average cough score of daytime and nocturnality,total cough score,and cough severity score were statistically significantly lower ( P ＜ 0.000 1 ).The total cough score and cough severity score were significantly decreased after 48 hrs treatment ( P ＜ 0.000 1 ).442 patients were totally used for safety analysis,in which 88 patients (20.85％) had minor or milder side-effects and 79 patients (18.72％) were confirmed their side-effects were related to methoxyphenamine treatment.Serious side-effects were not observed during whole study.Conclusions Compound methoxyphenamine resulted in clinically important and statistically significant impróve symptoms of patients with postinfectious cough.In addition,compound methoxyphenamine is associated with minor or milder sideeffects.These results suggested that compound methoxyphenamine as a safe and efficient drug can be widely used in postinfectious cough treatment.