吸入后沙丁胺醇的相对肺和全身生物利用度与口咽沉积:新型吸入器技术训练装置的药代动力学评价。

IF 2 4区 医学 Q3 RESPIRATORY SYSTEM
Wesam G Ammari, Mark Sanders
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引用次数: 0

摘要

背景:不理想使用加压计量吸入器(pMDI)仍然是吸入治疗成功的主要障碍。口头吸入器技术培训(VT)不能维持患者对pMDI的良好使用,因此培训工具可能有所帮助。对两种新型pMDI技术培训工具Trainhaler®(THR装置)和fl - tone®CR (FTCR装置)进行评估和比较,分别从Ventolin®Evohaler®(葛兰素史克)单独吸入THR或与FTCR连接的沙丁胺醇的相对肺和全身生物利用度和口咽沉积。方法:16名健康成人使用THR装置或FTCR装置从Ventolin中吸入2 × 100 μg沙丁胺醇(间隔1分钟),进行两期随机交叉研究。7天洗脱期将THR和FTCR方法分开。每位受试者每次吸完后立即用20ml水漱口,测定口咽沉积。分别于吸入前0.5小时及吸入后0.5、1.0、2.0小时采集尿样。然后将尿液汇集至吸入后24小时。测定肺的相对生物利用度(0 ~ 0.5 h尿沙丁胺醇排泄- usal0.5)和全身的相对生物利用度(0 ~ 24小时尿沙丁胺醇及其代谢物- usalmet24)。结果:THR组和FTCR组的USAL0.5均值(标准差[SD])分别为5.70(6.43)和11.39 (9.67)μg。口咽沉积平均(SD)分别为11.11(4.37)和6.09 (1.89)μg。THR和FTCR装置在USAL0.5和口咽沉积方面差异有统计学意义(p)。结论:THR装置和FTCR装置对吸入pMDI输送有积极影响。的确,FTCR装置使肺的相对生物利用度增加了一倍,并最大限度地减少了吸入沙丁胺醇的有害口咽沉积。在实践中,这些pMDI培训师将补充和维持VT。研究注册:该研究已在ISRCTN注册中心注册(参考:ISRCTN88332465-06/12/2017[预期注册])。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Relative Lung and Systemic Bioavailability Along with Oropharyngeal Deposition of Salbutamol Post-Inhalation: A Pharmacokinetic Evaluation of Novel Inhaler Technique Training Gadgets.

Background: Suboptimal use of pressurized metered dose inhaler (pMDI) remains a major barrier to inhaled therapy success. Verbal inhaler technique training (VT) fails to maintain patients' good pMDI use, thus training tools might help. Trainhaler® (THR device) and Flo-Tone® CR (FTCR device), two novel pMDI technique training tools, were evaluated and compared in terms of relative lung and systemic bioavailability and oropharyngeal deposition of salbutamol inhaled from Ventolin® Evohaler® (GlaxoSmithKline) either alone following THR or connected to FTCR. Methods: Sixteen healthy adults inhaled 2 × 100 μg salbutamol puffs (1 minute apart) from Ventolin using the THR device or FTCR device in a two-period, randomized crossover study. A 7-day washout separated THR and FTCR approaches. Immediately after each puff inhalation, each subject gargled with 20 mL water for oropharyngeal deposition determination. Urine samples were collected 0.5 hour (pre-inhalation) and 0.5, 1.0, and 2.0 hours post-inhalation. Urine was then pooled till 24-hour post-inhalation. The relative lung bioavailability (0- to 0.5-hour urinary salbutamol excretion-USAL0.5) and relative systemic bioavailability (0- to 24-hour urinary excretion of salbutamol and its metabolite-USALMET24) were determined. Results: The mean (standard deviation [SD]) USAL0.5 of the THR and FTCR groups was 5.70 (6.43) and 11.39 (9.67) μg, respectively. The mean (SD) oropharyngeal deposition was 11.11 (4.37) and 6.09 (1.89) μg, respectively. The THR and FTCR devices were statistically significantly different in USAL0.5 and oropharyngeal deposition (p < 0.001), whereas there was no statistically significant difference in USALMET24. Conclusion: The THR device and the FTCR device showed positive impact on inhaled pMDI delivery. Indeed, the FTCR device doubled the relative lung bioavailability and minimized the unwanted oropharyngeal deposition of inhaled salbutamol. In practice, these pMDI trainers would complement and maintain VT. Study Registration: The study was registered on the ISRCTN registry (Reference: ISRCTN88332465-06/12/2017 [Prospectively Registered]).

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来源期刊
CiteScore
6.70
自引率
2.90%
发文量
34
审稿时长
>12 weeks
期刊介绍: Journal of Aerosol Medicine and Pulmonary Drug Delivery is the only peer-reviewed journal delivering innovative, authoritative coverage of the health effects of inhaled aerosols and delivery of drugs through the pulmonary system. The Journal is a forum for leading experts, addressing novel topics such as aerosolized chemotherapy, aerosolized vaccines, methods to determine toxicities, and delivery of aerosolized drugs in the intubated patient. Journal of Aerosol Medicine and Pulmonary Drug Delivery coverage includes: Pulmonary drug delivery Airway reactivity and asthma treatment Inhalation of particles and gases in the respiratory tract Toxic effects of inhaled agents Aerosols as tools for studying basic physiologic phenomena.
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