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不同雾化器给予囊性纤维化患者左氧氟沙星的疗效和肺部沉积差异。

Differential Performance and Lung Deposition of Levofloxacin with Different Nebulisers Used in Cystic Fibrosis.

机构信息

Division Cystic Fibrosis, CF Center Westbrandenburg, Campus Potsdam, Clinic Westbrandenburg, 14467 Potsdam, Germany.

Global Medical Affairs, Chiesi Farmaceutici S.p.A., 43122 Parma, Italy.

出版信息

Int J Mol Sci. 2022 Aug 24;23(17):9597. doi: 10.3390/ijms23179597.

Abstract

We compared the performance and levofloxacin (Quinsair) lung deposition of three nebulisers commonly used in CF (I-Neb Advance, eFlow rapid, and LC Plus) with the approved nebuliser Zirela. The delivered dose, delivery rate, and aerosol particle size distribution (APSD) for each device were determined using the methods described in the Pharmacopeia. High-resolution computed tomography scans obtained from seven adult patients with mild CF were used to generate computer-aided, three-dimensional models of their airway tree to assess lung deposition using functional respiratory imaging (FRI). The eFlow rapid and the LC Plus showed poor delivery efficiencies due to their high residual volumes. The I-Neb, which only delivers aerosols during the inspiratory phase, achieved the highest aerosol delivery efficiency. However, the I-Neb showed the largest particle size and lowest delivery rate (2.9 mg/min), which were respectively associated with a high extrathoracic deposition and extremely long nebulisation times (>20 min). Zirela showed the best performance considering delivery efficiency (159.6 mg out of a nominal dose of 240 mg), delivery rate (43.5 mg/min), and lung deposition (20% of the nominal dose), requiring less than 5 min to deliver a full dose of levofloxacin. The present study supports the use of drug-specific nebulisers and discourages the off-label use of general-purpose devices with the present levofloxacin formulation since subtherapeutic lung doses and long nebulisation times may compromise treatment efficacy and adherence.

摘要

我们比较了三种常用于 CF(I-Neb 高级、eFlow 快速和 LC Plus)的雾化器与经批准的雾化器 Zirela 的性能和左氧氟沙星(Quinsair)肺部沉积效果。使用《药典》中描述的方法确定了每种设备的输送剂量、输送速率和气溶胶颗粒大小分布(APSD)。从七名患有轻度 CF 的成年患者中获得的高分辨率计算机断层扫描扫描用于生成气道树的计算机辅助三维模型,以使用功能呼吸成像(FRI)评估肺部沉积。由于高残留量,eFlow 快速和 LC Plus 的输送效率较差。仅在吸气阶段输送气雾剂的 I-Neb 实现了最高的气雾剂输送效率。然而,I-Neb 显示出最大的颗粒大小和最低的输送速率(2.9mg/min),这分别与胸腔外沉积高和雾化时间极长(>20 分钟)相关。考虑到输送效率(240mg 标称剂量中有 159.6mg)、输送速率(43.5mg/min)和肺部沉积(标称剂量的 20%),Zirela 的性能最佳,需要不到 5 分钟即可输送完左氧氟沙星的全剂量。本研究支持使用特定药物的雾化器,并劝阻使用通用设备进行标签外使用,因为治疗剂量不足和雾化时间长可能会影响治疗效果和依从性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d852/9455972/7e6d3feddc51/ijms-23-09597-g001.jpg

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