摘要
目的评价布洛伪麻那敏干混悬剂治疗头痛、发热并伴有鼻塞、流涕、打喷嚏等症状的成人感冒的有效性和安全性。方法采用多中心、随机、双盲、双模拟阳性药物平行对照试验设计,分别给予对照组和试验组病人口服氨酚伪麻那敏片Ⅱ或布洛伪麻那敏干混悬剂,每日4次,疗程均为3～5d。治疗结束后分别对病人的症状、体征以及实验室指标进行评估和组间比较。结果纳入全分析集(FAS)222例,其中对照组109例,试验组113例。完成符合方案集(PPS)219例,对照组107例,试验组112例。按FAS或PPS分析,对照组总有效率及总显效率均为99.1%,试验组总有效率及总显效率均为100.0%,2组疗效差异无显著意义(P>0.05)。治疗后,2组受试者的第1组症状(发热、头痛)及第2组症状(鼻塞、流涕、打喷嚏)的积分均显著改善(P<0.05),改善程度组间无显著差异(P>0.05)。药物不良反应多表现为嗜睡、困倦、口干和头晕,对照组和试验组不良反应发生率分别为15.4%和8.8%,组间比较无显著差异(P>0.05),且发生程度均为轻度。结论布洛伪麻那敏干混悬剂治疗成人感冒安全、有效。
AIM To evaluate the efficacy and safety of ibuprofen, pseudoephedrine and chlorphenamine for suspension in the treatment of adult cold with symptoms such as headache, fever, associated with stuffy nose, runny nose and sneezing. METHODS The study was designed as a randomized, double-blind, double- dummy, parallel and muhicenter trial. The patients in the control group were administered with paracetamol, pseudoephedrine and chlorphenamine tablets Ⅱ , while the patients in the study group were given ibuprofen, pseudoephedrine and chlorphenamine for suspension. The medicine was taken orally four times per day, with a course of 3 to 5 days for each group. The clinical signs, symptoms and laboratory tests of the patients were evaluated and compared between two groups before and after the treatment. RESULTS Two hundred and twenty- two patients were enrolled in the full analysis set including 109 patients in the control group and 113 patients in the study group. Two hundred and nineteen patients accomplished the per protocol set with 107 patients in the control group and 112 patients in the study group. According to the results of the full analysis set or the per protocol set, the total effective rate and remarkable effective rate of the control troup were same as 99.1%, while those of the study group were 100%; showing no significant difference between the two groups （P 〉 0.05）. After the treatment, the first set of symptoms （fever, headache） and the second set of symptoms （stuffy nose, runny nose, sneezing） in the two groups were significantly improved （P 〈 0.05）, but revealing no significant differences between the two groups （P 〉 0.05）. The common adverse reactions including lethargy, sleepiness, thirsty and dizziness occurred mildly with incidences of 15.4% and 8.8% respectively in the control group and study group, with no significant difference between the two groups （P 〉 0.05）. CONCLUSION Ibuprofen, pseudoephedrine and chlorphenamine for suspension is safe and effective as well as paracetamol, pseudoephedrine and chlorphenamine tablets Ⅱ in treating common cold.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2009年第9期688-692,共5页
Chinese Journal of New Drugs and Clinical Remedies
关键词
感冒
布洛芬
伪麻黄碱
氯苯那敏
对乙酰氨基酚
多中心研究
随机对照试验
双盲法
common cold
ibuprofen
pseudoephedrine
chlorphenamine
paracetamol
multicenter studies
randomized controlled trials
double-blind method
作者简介
林桦（1974-），女，湖南长沙人，主治医师，硕士，主要从事呼吸内科专业临床、科研及教学工作。Phn：86—731—8861—8203。E-mail：victoria1126@sina．com
