愈酚伪麻待因口服溶液临床有效性和安全性评价

目的评价愈酚伪麻待因口服溶液的镇咳、祛痰及消除鼻塞等感冒症状的临床有效性和安全性。方法240例有感冒症状患者(试验组120例,对照组120例)采用多中心随机双盲平行对照方法进行临床试验,2组分别服用愈酚伪麻待因口服溶液和复方磷酸可待因溶液,10mL.次-1,3次.d-1,疗程(5±2)d。结果完成试验有效病例227例,其中试验组112例,对照组115例。2组治疗后咳嗽、痰量、鼻塞症状均有显著改善(P<0.001),咳嗽和痰量2组治疗前、后的等级差比较无显著性差异,鼻塞等级差比较有显著性差异,以对照组改善程度较高;不良事件发生率试验组为17.1%,对照组为20.2%,2组不良事件发生率无显著性差异。结论愈酚伪麻待因口服溶液是镇咳、祛痰、消除鼻塞等感冒症状的有效、安全药。

Efficacy and Safety of Guaifenesin- Pseudoephedrine Hydrochloride-Codeine Phosphate Oral Solution

OBJECTIVE:To evaluate the clinical efficacy and safety of guaifenesin,pseudoephedrine hydrochloride- codeine phosphate oral solution in relieving cough,eliminating phlegm,relieving nasal stuffiness and other cold symptoms. METHODS:A total of 240 patients with cold symptoms(120 cases in trial group and another 120 cases in control group) were enrolled in our multicenter,randomized,double-blinded and parallel controlled study and treated with guaifenesin-pseudoephedrine hydrochloride-codeine phosphate oral solutionI or compound codeine phosphate liquor 10mL tid for(5±2)d.RESULTS:227(112 in trial group and 115 in control group) were the valid cases with completed trial.Compared with pre-treatment,both of the 2 groups had a significant improvement in symptoms including cough,expectoration and nasal stuffiness after treatment(P<0.001),and there were no significant differences in order differences of cough and expectoration quantity between 2 groups as compared to pre-treatment,but there was significant difference in grade difference of nasal obstruction,with the control group showing a better improvement.The incidence of adverse events was 17.1% in trial group and 20.2% in control group,and there was no significant difference between 2 groups in incidence of adverse events.CONCLUSIONS:guaifenesin-pseudoephedrine hydrochloride-codeine phosphate oral solution(lianlike)is effective and safe in in relieving cough,eliminating phlegm,relieving nasal stuffiness and other cold symptoms.