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非囊性纤维化支气管扩张症患者吸入干粉抗生素:一项真实世界研究中的疗效与安全性

Inhaled Dry Powder Antibiotics in Patients with Non-Cystic Fibrosis Bronchiectasis: Efficacy and Safety in a Real-Life Study.

作者信息

Martínez-García Miguel Ángel, Oscullo Grace, Barreiro Esther, Cuenca Selene, Cervera Angela, Padilla-Galo Alicia, de la Rosa David, Navarro Annie, Giron Rosa, Carbonero Francisco, Castro Otero Maria, Casas Francisco

机构信息

Pneumology Department, Hospital Universitario y Politécnico La Fe, 46026 Valencia, Spain.

Centro de Investigación en Red de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, 28029 Madrid, Spain.

出版信息

J Clin Med. 2020 Jul 21;9(7):2317. doi: 10.3390/jcm9072317.

DOI:10.3390/jcm9072317
PMID:32708262
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7408283/
Abstract

BACKGROUND

Nebulised antibiotics are habitually used in patients with bronchiectasis, but the use of dry powder inhaled antibiotics (DPIA) in these patients is extremely limited. This study seeks to analyse the efficacy and safety of DPIA in bronchiectasis patients.

MATERIAL AND METHODS

Multi-centre study of historic cohorts. All the hospital centres in Spain were contacted in order to collect data on patients with a diagnosis of bronchiectasis who had taken at least one dose of DPIA. Its efficacy was analysed in clinical, functional and microbiological terms by comparing the year before and the year after the prescription of DPIA. Adverse effects and variables associated with these effects, or any need to withdraw the drug, were also analysed.

RESULTS

164 patients from 33 Spanish centres were included; 86% and 14% of these were treated with dry powder colistin and tobramycin, respectively. Chronic bronchial infection by was present in 86% of these patients, and DPIA significantly reduced the number of exacerbations, the quantity and purulence of sputum and the isolation of pathogenic microorganisms. The most common adverse effect was cough (40%), particularly in cases of Chronic Obstructive Pulmonary Disease (COPD) and a previous cough and in those patients who had difficulties in handling the device. These factors were associated with a higher level of withdrawal of the treatment. There were no serious adverse effects.

CONCLUSIONS

Our study suggests that DPIA are clinically efficacious and safe for treating bronchiectasis patients. Cough was shown to be the most common side-effect and reason for withdrawal of the treatment.

摘要

背景

雾化抗生素常用于支气管扩张症患者,但干粉吸入抗生素(DPIA)在这些患者中的使用极为有限。本研究旨在分析DPIA在支气管扩张症患者中的疗效和安全性。

材料与方法

对历史队列进行多中心研究。联系了西班牙所有医院中心,以收集诊断为支气管扩张症且至少服用过一剂DPIA的患者的数据。通过比较开具DPIA处方前后一年的情况,从临床、功能和微生物学方面分析其疗效。还分析了不良反应以及与这些反应相关的变量,或是否需要停药。

结果

纳入了来自西班牙33个中心的164例患者;其中86%和14%的患者分别接受了干粉多粘菌素和妥布霉素治疗。这些患者中86%存在慢性支气管感染,DPIA显著减少了病情加重次数、痰液量和脓性以及致病微生物的分离。最常见的不良反应是咳嗽(40%),尤其是慢性阻塞性肺疾病(COPD)患者、既往有咳嗽的患者以及操作设备有困难的患者。这些因素与较高的停药率相关。未出现严重不良反应。

结论

我们的研究表明,DPIA在治疗支气管扩张症患者方面临床有效且安全。咳嗽是最常见的副作用和停药原因。

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本文引用的文献

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RIBRON: The spanish Online Bronchiectasis Registry. Characterization of the First 1912 Patients.RIBRON:西班牙在线支气管扩张症注册中心。首批 1912 名患者的特征。
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Phase I, Dose-Escalating Study of the Safety and Pharmacokinetics of Inhaled Dry-Powder Vancomycin (AeroVanc) in Volunteers and Patients with Cystic Fibrosis: a New Approach to Therapy for Methicillin-Resistant Staphylococcus aureus.吸入型盐酸万古霉素干粉剂(AeroVanc)在健康志愿者和囊性纤维化患者中的安全性和药代动力学的 I 期剂量递增研究:耐甲氧西林金黄色葡萄球菌治疗的新方法。
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吸入用硫酸多粘菌素甲磺酸钠在支气管扩张合并感染患者治疗中的应用:当前证据的叙述性综述
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Inhaled Antibiotics in Non-cystic Fibrosis Bronchiectasis (NCFB): A Systematic Review of Efficacy and Limitations in Adult Patients.非囊性纤维化支气管扩张症(NCFB)吸入抗生素治疗:成年患者疗效与局限性的系统评价
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Safety and Efficacy of Devices Delivering Inhaled Antibiotics among Adults with Non-Cystic Fibrosis Bronchiectasis: A Systematic Review and a Network Meta-Analysis.非囊性纤维化支气管扩张症成人患者吸入性抗生素给药装置的安全性和有效性:一项系统评价和网状荟萃分析
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Cystic fibrosis lung disease and bronchiectasis.
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British Thoracic Society guideline for bronchiectasis in adults.英国胸科学会成人支气管扩张指南。
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RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis.RESPIRE 2 研究:一项比较环丙沙星干粉吸入剂与安慰剂治疗非囊性纤维化支气管扩张症的 III 期、安慰剂对照、随机临床试验。
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RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis.RESPIRE 1:一项 III 期安慰剂对照随机试验,评估吸入环丙沙星干粉治疗非囊性纤维化支气管扩张症的疗效。
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Spanish Guidelines on Treatment of Bronchiectasis in Adults.《西班牙成人支气管扩张症治疗指南》
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