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临床儿科杂志第 34 卷第 12 期 2016 年 12 月J Clin Pediatr Vol.34 No.12 Dec. 2016 doi:10.3969/j.issn.1000-3606.2016.12.008·论 著·美芬那敏铵糖浆消除或缓解儿童急性上呼吸道感染症状有效性
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和安全性的临床研究
火灾自救房定珠鲍一笑美芬那敏铵糖浆注册研究协作组儿科疾病
大学全文上海交通大学医学院附属新华医院儿童呼吸科（上海 200092）
摘要：目的以愈美甲麻敏糖浆为对照，评价美芬那敏铵糖浆消除或缓解儿童急性上呼吸道感染症状的有效性和安全性。方法应用随机、盲法、平行对照方法，在11个临床研究中心共纳入FAS分析患儿253例，试验组127例，最终纳入符合方案集（PPS）分析118例；对照组126例，纳入PPS分析116例。试验组服用美芬那敏铵糖浆，对照组服用愈美甲麻敏糖浆，遵医嘱连续服用不超过7 d，至少服用3 d。结果入组时两组的年龄、性别、急性上呼吸道感染评分等的差异均无统计学意义（P > 0.05）。试验组急性上呼吸道感染症状缓解中位时间为51.0 h（95% CI：43.0~62.0 h），对照组为56.0 h（95% CI：48.0~64.0 h），差异无统计学意义（P > 0.05）；校正中心和基线影响后，试验组非劣效于对照组；试验组与对照
员工个人工作总结
芋头条组急性上呼吸道感染症状积分差异无统计学意义（F = 0.14，P = 0.710）；急性上呼吸道感染单项症状消失率，两组间差异均无统计学意义（P > 0.05）；两组间依从性评价的差异无统计学意义（P > 0.05）；试验组和对照组均各有7例不良事件，且均有1例判断为药物不良反应，不良反应发生率均为0.8%。结论美芬那敏铵糖浆在治疗儿童急性上呼吸道感染时能有效快速缓解症状，其疗效和安全性非劣效于传统药物愈美甲麻敏糖浆。
关键词：急性上呼吸道感染；愈美甲麻敏；临床研究；儿童
Clinical study on the efficacy and safety of Dextromethorphan Hydrochloride, Chlorphenamine Malente, and Ammonium Chloride Syrup on eliminating or relieving the symptoms of acute upper respiratory infection in children F ANG Dingzhu, BAO Yixiao, Registration Study Group of Dextromethorphan Hydrobromide Chlorphenamine Maleate and Ammonium Chloride Syrup (Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, China) Abstract:Objective To evaluate the efficacy and safety of Dextromethorphan Hydrochloride, Chlorphenamine Malente, and Ammonium Chloride Syrup on eliminating or relieving the symptoms of acute upper respiratory infections in children, by comparing with Guaifenesin, Dextromethorphan Hydrobromide, Methylephedrine Hydrochloride, and Chlorphenamine Maleate Syrup.Methods Random, blind and parallel control method was adopted. A total of 253 pediatric patients were recruit梦英文
ed in 11 clinical rearch centers; 127 patients were assigned in experimental group and finally 118 patients were included in the program t analysis (PPS); 126 patients were assigned into control group and finally 116 patients were included in PPS. The experimental group took Dextromethorphan Hydrochloride, Chlorphenamine Malente, and Ammonium Chloride Syrup and control group took Guaifenesin, Dextromethorphan Hydrobromide, Methylephedrine Hydrochloride, and Chlorphenamine Maleate Syrup. All of the patients took as prescribed at least for 3 days but not more than 7 days. Results There was no significant differences in age, x, and acute upper respiratory tract infection scores between the two groups (P > 0.05). PPS showed the median time of symptom relief of acute upper respiratory tract infection in experimental group was 51.0 h (95%CI: 43.0-62.0 h) and 56.0 h (95%CI: 48.0-64.0 h) in control group. There was no difference between two groups (P > 0.05). After calibration of center and baline effects, the experimental group was not wor than the control group. There was no difference in the score of acute upper respiratory tract infection between two groups (F=0.14, P=0.710). The individual symptoms disappear rate of acute upper respiratory tract infection and the compliance between two groups were similar (P all > 0.05). Both groups had 7 cas of adver events, and one ca of adver drug reactions each. Thus, the adver reaction rates in two groups were 0.8% each.
Conclusions Dextromethorphan Hydrochloride, Chlorphenamine Malente, and Ammonium Chloride Syrup can effectively征兵体检标准
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