国际呼吸杂志
國際呼吸雜誌
국제호흡잡지
INTERNATIONAL JOURNAL OF RESPIRATION
2011年
9期
641-644
,共4页
顾宇彤%白春学%文富强%周建英%李静%赵乃青%陈淑靖%计海婴%田攀文%赵琼%涂海燕%余勇夫
顧宇彤%白春學%文富彊%週建英%李靜%趙迺青%陳淑靖%計海嬰%田攀文%趙瓊%塗海燕%餘勇伕
고우동%백춘학%문부강%주건영%리정%조내청%진숙정%계해영%전반문%조경%도해연%여용부
复方磷酸可待因溶液%美敏伪麻溶液%急性咳嗽
複方燐痠可待因溶液%美敏偽痳溶液%急性咳嗽
복방린산가대인용액%미민위마용액%급성해수
Cofetol cough syrup%Dextromethorphan hydrobromide,chorpheniramine mateate and pseudoc phedrine hydiochloride solution%Acute cough
目的 以美敏伪麻溶液(惠菲宁)为阳性对照,对复方磷酸可待因溶液(奥亭止咳露)治疗急性咳嗽的有效性和安全性进行评价.方法以由急性上呼吸道感染,急性气管/支气管炎、慢性支气管炎急性加重和上气道咳嗽综合征引起的咳嗽患者为研究对象,采用多中心、分层区段随机、拟双盲对照的临床试验方法,观察两组患者首次服药0、15、30、60和120min以及治疗前后咳嗽、痰黏度和排痰难易程度总积分(TSS).结果符合方案集4个中心治疗结束时试验组症状总分较对照组低[(1.082±1.590)分vs(1.699±1.866)分],试验组症状总分下降较对照组明显[(6.412±1.978)分vs(4.313±2.347)分],治疗有效性(痊愈和显效)试验组优于对照组[(68.60%和13.95%)vs(44.58%和22.89%)](P值均<0.05),4个中心试验组总有效率高于对照组(82.56%vs 67.47%).试验组15、30,60和120 min时TSS均低于对照组(P值均<0.05).治疗后咳嗽程度改善试验组优于对照组(P<0.05),而两组痰黏度和排痰难易程度改善差异无统计学意义(P>0.05).全分析集与符合方案集结果一致.研究期间两组均无严重不良事件发生,两组不良事件发生率以及合并用药的比例差异均无统计学意义(P>0.05).结论复方磷酸可待因溶液对于控制咳嗽症状具有起效快的特点,并且在服药15 min 时其疗效已经显著优于美敏伪麻溶液.通过5～7 d治疗,复方磷酸可待凶溶液对于控制咳嗽症状的效果可能优于美敏伪麻溶液.
目的 以美敏偽痳溶液(惠菲寧)為暘性對照,對複方燐痠可待因溶液(奧亭止咳露)治療急性咳嗽的有效性和安全性進行評價.方法以由急性上呼吸道感染,急性氣管/支氣管炎、慢性支氣管炎急性加重和上氣道咳嗽綜閤徵引起的咳嗽患者為研究對象,採用多中心、分層區段隨機、擬雙盲對照的臨床試驗方法,觀察兩組患者首次服藥0、15、30、60和120min以及治療前後咳嗽、痰黏度和排痰難易程度總積分(TSS).結果符閤方案集4箇中心治療結束時試驗組癥狀總分較對照組低[(1.082±1.590)分vs(1.699±1.866)分],試驗組癥狀總分下降較對照組明顯[(6.412±1.978)分vs(4.313±2.347)分],治療有效性(痊愈和顯效)試驗組優于對照組[(68.60%和13.95%)vs(44.58%和22.89%)](P值均<0.05),4箇中心試驗組總有效率高于對照組(82.56%vs 67.47%).試驗組15、30,60和120 min時TSS均低于對照組(P值均<0.05).治療後咳嗽程度改善試驗組優于對照組(P<0.05),而兩組痰黏度和排痰難易程度改善差異無統計學意義(P>0.05).全分析集與符閤方案集結果一緻.研究期間兩組均無嚴重不良事件髮生,兩組不良事件髮生率以及閤併用藥的比例差異均無統計學意義(P>0.05).結論複方燐痠可待因溶液對于控製咳嗽癥狀具有起效快的特點,併且在服藥15 min 時其療效已經顯著優于美敏偽痳溶液.通過5～7 d治療,複方燐痠可待兇溶液對于控製咳嗽癥狀的效果可能優于美敏偽痳溶液.
목적 이미민위마용액(혜비저)위양성대조,대복방린산가대인용액(오정지해로)치료급성해수적유효성화안전성진행평개.방법이유급성상호흡도감염,급성기관/지기관염、만성지기관염급성가중화상기도해수종합정인기적해수환자위연구대상,채용다중심、분층구단수궤、의쌍맹대조적림상시험방법,관찰량조환자수차복약0、15、30、60화120min이급치료전후해수、담점도화배담난역정도총적분(TSS).결과부합방안집4개중심치료결속시시험조증상총분교대조조저[(1.082±1.590)분vs(1.699±1.866)분],시험조증상총분하강교대조조명현[(6.412±1.978)분vs(4.313±2.347)분],치료유효성(전유화현효)시험조우우대조조[(68.60%화13.95%)vs(44.58%화22.89%)](P치균<0.05),4개중심시험조총유효솔고우대조조(82.56%vs 67.47%).시험조15、30,60화120 min시TSS균저우대조조(P치균<0.05).치료후해수정도개선시험조우우대조조(P<0.05),이량조담점도화배담난역정도개선차이무통계학의의(P>0.05).전분석집여부합방안집결과일치.연구기간량조균무엄중불량사건발생,량조불량사건발생솔이급합병용약적비례차이균무통계학의의(P>0.05).결론복방린산가대인용액대우공제해수증상구유기효쾌적특점,병차재복약15 min 시기료효이경현저우우미민위마용액.통과5～7 d치료,복방린산가대흉용액대우공제해수증상적효과가능우우미민위마용액.
Objective To evaluate the efficacy and safety of Cofetol cough syrup in treating acute cough with dextromethorphan hydrobromide, chorpheniramine mateate and pseudoe phedrine hydiochloride solution as positive control. Methods The patients with acute upper airway infection, acute tracheitis/ bronchitis, exacerbation of chronic bronchitis and upper airway cough syndrome were enrolled into the multiccntre, zonation random and quasi-double blind, controlled clinical study. The total scores of symptoms such as cough, sputum viscosity and the difficulty of eliminating sputum were compared between pre-and post-treatment while recorded at 0, 15, 30, 60 and 120 min after fist drug administration. Results The total score of symptom(TSS) in trial group, was lower than control group [(1. 082±1. 590) scores vs (1. 699±1. 866) scores] at the end of treatment in 4 centers' Per Protocol. TSS declined for trial group was more than control group [(6. 412± 1. 978) scores vs (4. 313 ± 2. 347) scores]. The effective rates of treatment (recovery and excellence) in trial group were better than control group [(68.60% and 13.95%) vs (44.5% and 22.89)](P<0.05), The overall effective rate in trial group was higher than control group (82.5% vs 67. 47%). TSS for trial group was lower than it for control group at 15, 30, 60 and 120 min (P< 0.05). The improvement of cough symptom after treatment in trial group was better than it in control group ( P< 0. 05). There were no statistical significance in the improvement of sputum viscosity and the difficulty of eliminating sputum ( P >0.05).Full Analysis Set and Per Protocol showed the same result. There was no severe adverse event in the study. There were no statistical significance in the adverse reaction rate and drug combination proportion of trial and control groups ( P >0.05), Conclusions Cofetol cough syrup has a quick effect on controlling cough symptom and its effect is better than control solution from 15 rain after drug administration.Cofetol cough syrup may have a better effective than dextromethorphan hydrobromide, chorpheniramine mateate and pscudoe phedrine hydiochloride solution on controlling cough symptom after 5-7 days treatment.
