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用于复杂性肺部疾病的阿米卡星脂质体吸入混悬液

Amikacin Liposome Inhalation Suspension for Complex Lung Disease.

作者信息

Golia Austin, Mahmood Brenden R, Fundora Yaniset, Thornby Krisy-Ann, Chahine Elias B

出版信息

Sr Care Pharm. 2020 Apr 1;35(4):162-170. doi: 10.4140/TCP.n.2020.162.

Abstract

To review the pharmacology, pharmacokinetics, pharmacodynamics, clinical efficacy, safety, administration, and role of amikacin liposome inhalation suspension (ALIS) in treatment of complex (MAC) lung disease.
A PubMed search using the terms "amikacin inhaled," "nebulized," and "liposome suspension" was performed. Selected infectious diseaseconference posters were also examined for relevant information. In addition, pertinent guidelines were reviewed.
Guidelines for the management of nontuberculous mycobacterial infections from the American Thoracic Society/ Infectious Diseases Society of America and the British Thoracic Society were used to summarize guidelinebased therapy (GBT). A phase II and a phase III clinical trial were reviewed to evaluate the role of ALIS in the treatment of MAC lung disease.
ALIS is a new formulation of inhaled amikacin (AMK) indicated for the treatment of MAC lung disease refractory to GBT in adults who are not candidates for intravenous AMK. An ongoing clinical trial has demonstrated that once-daily ALIS plus GBT results in higher rates of culture conversion compared with GBT alone by month 6 among patients with a mean age of 65 years. The most common adverse reactions associated with ALIS were dysphonia, cough, bronchospasm, hemoptysis, and ototoxicity. Nephrotoxicity was uncommon.
ALIS has been shown to increase culture conversion rates when added to GBT in adults with difficult-to-treat MAC lung disease. ALIS is associated with high rates of pulmonary and auditory adverse reactions and a low risk of renal adverse reactions. ALIS may be an attractive treatment option for older adults who are at high risk for nephrotoxicity.

摘要

回顾阿米卡星脂质体吸入混悬液(ALIS)在治疗复杂性非结核分枝杆菌(MAC)肺病中的药理学、药代动力学、药效学、临床疗效、安全性、给药方法及作用。

使用“吸入阿米卡星”“雾化”和“脂质体混悬液”等检索词在PubMed上进行检索。还查阅了选定的传染病会议海报以获取相关信息。此外,对相关指南进行了综述。

采用美国胸科学会/美国传染病学会和英国胸科学会发布的非结核分枝杆菌感染管理指南来总结基于指南的治疗(GBT)。对一项II期和一项III期临床试验进行了综述,以评估ALIS在治疗MAC肺病中的作用。

ALIS是吸入用阿米卡星(AMK)的一种新剂型,适用于对GBT难治且不适合静脉用AMK治疗的成年MAC肺病患者。一项正在进行的临床试验表明,在平均年龄为65岁的患者中,与单用GBT相比,每日一次的ALIS联合GBT在第6个月时培养转阴率更高。与ALIS相关的最常见不良反应为声音嘶哑、咳嗽、支气管痉挛、咯血和耳毒性。肾毒性并不常见。

在难治性MAC肺病成年患者中,ALIS联合GBT已显示可提高培养转阴率。ALIS与较高的肺部和听觉不良反应发生率以及较低的肾脏不良反应风险相关。对于有肾毒性高风险的老年人,ALIS可能是一种有吸引力的治疗选择。

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