盐酸氨溴索雾化吸入与静脉注射的临床药代动力学和药效学研究
投稿时间:2015-03-09  修订日期:2015-05-19  点此下载全文
引用本文:陈楠,李晓华,刘平,司倩,王金亮,乔海灵.盐酸氨溴索雾化吸入与静脉注射的临床药代动力学和药效学研究[J].医学研究杂志,2016,45(1):113-116
DOI: 10.11969/j.issn.1673-548X.2016.01.028
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作者单位E-mail
陈楠 450000 南方医科大学附属郑州人民医院药学部  
李晓华 450000 南方医科大学附属郑州人民医院药学部  
刘平 450000 南方医科大学附属郑州人民医院药学部  
司倩 450000 南方医科大学附属郑州人民医院药学部  
王金亮 450000 南方医科大学附属郑州人民医院呼吸内科  
乔海灵 450000 南方医科大学附属郑州人民医院呼吸内科 qiaohl@zzu.edu.cn 
基金项目:常州四药临床药学科研基金资助项目(CZSYJJ11013)
中文摘要:目的 研究盐酸氨溴索雾化吸入与静脉两种给药途径的临床药代动力学研究,评价盐酸氨溴索经雾化吸入给药的有效性。方法 抽取12例存在黏痰不易排出症状的呼吸系统疾病的男性病例(肝肾功能正常)随机分为两组,分别采用初始为盐酸氨溴索雾化和洗脱后静脉注射治疗,以及初始为盐酸氨溴索静脉推注和洗脱后雾化治疗。通过高效液相层析法测定在痰液中及血液中的相应药代动力学参数,如药物浓度-时间曲线下面积AUC(血浆)/AUC(痰液)、达峰浓度、达峰时间,结合临床疗效考察药动学与药效学的相关性。结果 两种给药方式血浆的Tmax、Cmax、AUC基本一致,但是雾化给药方式痰液的Tmax、Cmax、AUC均高于静脉注射方式,雾化吸入治疗的临床好转速率优于静脉注射治疗。结论 盐酸氨溴索经雾化吸入给药较静脉注射给药有更好的临床治疗效果。
中文关键词:盐酸氨溴索  雾化吸入  静脉注射  药代动力学  临床疗效
 
Clinical Pharmacokinetic and Pharmacodynamic Study of Ambroxol Inhalation and Intravenous Treatment
Abstract:Objective To study the clinical pharmacokinetic of ambroxol hydrochloride inhalation and intravenous administration routines and evaluate the effectiveness of ambroxol administration. Methods Twelve male patients with symptoms of phlegm difficult to discharge of respiratory disease (normal liver and kidney function) were randomly divided into two groups, treated using initially atomized ambroxol then intravenous injection treatment after elution for a week, and ambroxol initial intravenous injection then atomized ambroxol treatment after elution. We determined the corresponding pharmacokinetic parameters by HPLC in sputum and blood, such as the drug concentration-time curve area under the AUC (plasma)/AUC (sputum), peak concentration, time to peak and investigating the relevance of pharmacokinetics and pharmacodynamics by combining clinical efficacy. Results The Tmax, Cmax and AUC of plasma in the administration ways were basically the same, but the Tmax, Cmax, AUC of the sputum in atomization administration were higher than that in intravenous injection, the clinical improvement rate of inhalation therapy was superior to that of intravenous treatment. Conclusion Ambroxol hydrochloride administered via inhalation had a better clinical effect compared with intravenous administration.
keywords:Ambroxol hydrochloride  Inhalation  Intravenous injection  Pharmacokinetic  Clinical effectiveness
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