愈酚伪麻待因口服溶液治疗咳嗽的临床疗效观察和安全性评价

Guaiacol-Pseudoephedrine-Codeine Phosphate Solution for Cough:Observation of Curative Effect and Safety

目的:观察愈酚伪麻待因口服溶液(联力克)治疗咳嗽的临床有效性并进行安全性评价。方法:采用随机、双盲、多中心平行对照临床试验,将60例以干咳为主要症状的患者随机分为联力克组和复方磷酸可待因溶液(联邦止咳露)组,2组用法用量相同,观察2组治疗后咳嗽、咳痰和鼻塞症状的改善及不良反应情况。结果:2组在治疗后咳嗽症状均较治疗前有显著性改善(P<0.01),但组间比较无显著性差异(P=0.464)。联力克组治疗后与治疗前比较具有明显的祛痰作用(P<0.01)。2组不良反应发生率分别为25%、20%,无显著性差异(P=0.605)。结论:联力克治疗咳嗽的疗效与安全性与联邦止咳露相当,且祛痰作用更好。

OBJECTIVE： To evaluate the efficacy and safety of guaiacol - pseudoephedrine- codeine phosphate solution （lianlike） for cough. METHODS： The study was a randomized, doubleblind, parallel contrast clinical trial, a total of 60 patients who were characterized chiefly by nonproductive cough in symptoms were randomly assigned to receive lianlike（trial group） or compound codeine phosphate solution （antieol, control group）, the direction and dosage for the two groups were the same, the main outcome measures were improvement of the symptoms such as cough, expectoration, snuffles and adverse reactions. RESULTS： There were significant improvement in cough in both groups（P 〈 0.01）after treatment, but no significant difference were noted between 2 groups（P= 0.464） . Lianlike was effective in eliminating phlegm（P 〈0.01） . Incidences of adverse reactions were 25% and 20% in trial group and control group respectively, and there was no significant statistical difference between 2 groups（P = 0.605） .CONCLUSION： Lianlike is equivalent to anticol in efficacy and safety, but is more effective in eliminating phlegm.