摘要
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％VS67．47％）。试验组15、30、60和120min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15min时其疗效已经显著优于美敏伪麻溶液。通过5～7d治疗，复方磷酸可待因溶液对于控制咳嗽症状的效果可能优于美敏伪麻溶液。
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 muhicentre, 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 E（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 E（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 min after drug
出处
《国际呼吸杂志》
2011年第9期641-644,共4页
International Journal of Respiration
基金
基金项目：上海市重点学科建设项目资助（B115）
关键词
复方磷酸可待因溶液
美敏伪麻溶液
急性咳嗽
Cofetol cough syrup
Dextromethorphan hydrobromide, chorpheniramine mateate and pseudoe phedrine hydiochloride solution
Acute cough
