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一种创新的皮质类固醇/长效β-激动剂呼气触发式吸入器:促进丙酸氟替卡松/富马酸福莫特罗在肺部的递送,用于哮喘治疗。

An innovative corticosteroid/long-acting β-agonist breath-triggered inhaler: facilitating lung delivery of fluticasone propionate/formoterol fumarate for the treatment of asthma.

机构信息

National Heart and Lung Institute, Imperial College London & Royal Brompton Hospital, London, UK.

Cochin Hospital (APHP), University Paris Descartes, Paris, France.

出版信息

Expert Opin Drug Deliv. 2019 Dec;16(12):1367-1380. doi: 10.1080/17425247.2019.1689957. Epub 2019 Nov 28.

DOI:10.1080/17425247.2019.1689957
PMID:31752560
Abstract

: Incorrect inhaler technique is one reason why the efficacies of inhaled asthma treatments in clinical trials and effectiveness in the real world differ. Inhaler technique is critical for drug delivery to the lungs; incorrect technique negatively impacts asthma control and long-term outcomes. Breath-triggered inhalers (BTIs) can simplify drug administration and are suitable for most patients, including those with reduced inspiratory flow. Until recently, no inhaled corticosteroid/long-acting β-agonist combination BTI was available in Europe. The (fluticasone propionate/formoterol fumarate [FP/FORM]) is the first combination BTI now approved in Europe for asthma maintenance treatment.: We review studies examining the challenges posed to patients by different inhaler types and explore evidence demonstrating the clinical efficacy of FP/FORM administered via a pressurized metered-dose inhaler. We also review the pharmacokinetic/pharmacodynamic studies supporting FP/FORM k-haler use, and consider data showing high lung deposition with the device. Finally, we review patient experiences using the BTI, device characteristics, and health economic aspects.: Despite the availability of therapies, asthma control levels remain low, and there is a clear need for easy-to-use inhalers. Research to increase our understanding of critical errors with each inhaler and how to overcome them is important for improving care. AUC: area under the plasma concentration-time curve from the time of dosing to the last measurable concentration; BDP: beclometasone dipropionate; BTI: breath-triggered inhaler; BUD: budesonide; CI: confidence interval; C maximum observed plasma concentration; DPI: dry powder inhaler; FDC: fixed-dose combination; FEV: forced expiratory volume in 1 s; FORM: formoterol fumarate; FP: fluticasone propionate; HCP: health-care professional; ICS: inhaled corticosteroid; LABA: long-acting β-agonist; OR: odds ratio; PIL: patient information leaflet; pMDI: pressurized metered-dose inhaler; SAL: salmeterol xinafoate.

摘要

不正确的吸入器技术是临床试验中吸入性哮喘治疗效果和实际效果不同的原因之一。吸入器技术对于药物输送到肺部至关重要;不正确的技术会对哮喘控制和长期结果产生负面影响。触发式吸入器(BTI)可以简化药物给药,适用于大多数患者,包括吸气流量降低的患者。直到最近,欧洲还没有可用的吸入性皮质类固醇/长效β-激动剂组合 BTI。(丙酸氟替卡松/富马酸福莫特罗[FP/FORM])是欧洲目前批准用于哮喘维持治疗的第一种组合 BTI。

我们回顾了研究不同吸入器类型给患者带来的挑战,并探讨了 FP/FORM 通过压力定量吸入器给药的临床疗效证据。我们还回顾了支持 FP/FORM k-haler 使用的药代动力学/药效学研究,并考虑了该装置具有高肺部沉积的数据。最后,我们回顾了患者使用 BTI 的经验、设备特点和健康经济学方面。

尽管有治疗方法,哮喘控制水平仍然较低,因此需要易于使用的吸入器。研究增加我们对每种吸入器关键错误的理解以及如何克服这些错误的理解对于改善护理非常重要。AUC:从给药时间到最后可测量浓度的时间的血浆浓度-时间曲线下面积;BDP:倍氯米松二丙酸酯;BTI:触发式吸入器;BUD:布地奈德;CI:置信区间;C max:最大观察到的血浆浓度;DPI:干粉吸入器;FDC:固定剂量组合;FEV 1:1 秒用力呼气量;FORM:富马酸福莫特罗;FP:丙酸氟替卡松;HCP:卫生保健专业人员;ICS:吸入性皮质类固醇;LABA:长效β-激动剂;OR:比值比;PIL:患者信息传单;pMDI:压力定量吸入器;SAL:沙美特罗昔萘酸。

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