CAJ | 학술논문

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 饭后口服总疗程7～10 d.主要疗效评价指标:咳嗽严重程度评价.结果共入组441例(全分析集,FAS),其中男性162例女性279例.年龄18～70岁平均年龄45.6岁.入选患者咳嗽时间1～60 d 平均29.8 d.纳入疗效分析的共394例(符合方案集 PP) 治疗后痊愈221例占56.09％显效134例占34.01％进步20例,占5.08％,无效19例占4.82％,总有效率为90.10％.治疗后日间咳嗽评分、夜间咳嗽评分以及咳嗽总评分值与治疗前相比差异均有统计学意义 P＜0.000 1.治疗后咳嗽症状的严重度评分和治疗前相比明显降低差异有统计学意义P＜0.000 1.从用药后的第2天开始咳嗽的严重程度评分和咳嗽总评分就开始有显著降低,P值均＜0.000 1.纳入安全性分析共422例 88例发生不良事件发生率为20.85％不良反应均为轻中度反应本研究中无严重不良事件发生.其中研究者判定和药物肯定有关及可能有关的定义为不良反应发生例数为79例发生率为18.72％.结论复方甲氧那明治疗感染后咳嗽的临床疗效显著起效时间快不良反应轻该药可以在临床上推广应用.
목적 평개복방갑양나명치료감염후해수적유효성화안전성.방법 채용개방적、전첨성다중심림상연구.병례선자2009년11월지2010년10월재6가교학의원호흡과취진,병피진단위감염후해수적환자 입선시해수증상적분지소≥2분.치료용약위복방갑양나명효낭(제일삼공제약(상해)유한공사생산 상품명:아사미)2립 3차/d 반후구복 총료정7～10 d.주요료효평개지표:해수엄중정도평개.결과 공입조441례(전분석집,FAS),기중남성162례 녀성279례.년령18～70세 평균년령45.6세.입선환자해수시간1～60 d 평균29.8 d.납입료효분석적공394례(부합방안집 PP) 치료후전유221례 점56.09％ 현효134례 점34.01％ 진보20례,점5.08％,무효19례 점4.82％,총유효솔위90.10％.치료후일간해수평분、야간해수평분이급해수총평분치여치료전상비차이균유통계학의의 P＜0.000 1.치료후해수증상적엄중도평분화치료전상비 명현강저 차이유통계학의의P＜0.000 1.종용약후적제2천개시 해수적엄중정도평분화해수총평분취개시유현저강저,P치균＜0.000 1.납입안전성분석공422례 88례발생불량사건 발생솔위20.85％ 불량반응균위경중도반응 본연구중무엄중불량사건발생.기중연구자판정화약물긍정유관급가능유관적정의위불량반응 발생례수위79례 발생솔위18.72％.결론 복방갑양나명치료감염후해수적림상료효현저 기효시간쾌 불량반응경 해약가이재림상상추엄응용.
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.