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雾化阿米卡星治疗支气管扩张症加重的前瞻性试验。

A Prospective Trial of Nebulized Amikacin in the Treatment of Bronchiectasis Exacerbation.

机构信息

Department of Respiratory Medicine, Qilu Hospital of Shandong University, Jinan, China.

Department of Respiratory Medicine, Laiwu City People's Hospital, Laiwu, China.

出版信息

Respiration. 2018;95(5):327-333. doi: 10.1159/000486134. Epub 2018 Mar 27.

Abstract

BACKGROUND

Pseudomonas aeruginosa is the most common pathogenic bacteria in bronchiectasis (BE) patients. The availability and security of nebulized amikacin treatment are unknown.

OBJECTIVE

The purpose of this study was to explore the efficiency and adverse effects of nebulized amikacin treatment for 2 weeks, administered as intravenous therapy during exacerbation of BE patients infected with P. aeruginosa.

METHODS

A total of 143 patients with exacerbation of BE were screened between January 2013 and March 2016 at five tertiary hospitals in Shandong Province, China. The BE patients were diagnosed by high-resolution computed tomography scans, and all of them were confirmed to be infected with P. aeruginosa after sputum culture test. Seventy-four patients were assigned to the intervention group and received amikacin nebulization (0.2 g) treatment twice daily for 2 weeks along with intravenous antibiotic therapy. Sixty-nine patients were assigned to the control group and received standard antibiotic therapy alone. The primary outcome was the rate of bacterial eradication from the sputum, and the secondary outcomes were drug resistance and adverse effects.

RESULTS

The bacterial eradication rate of sputum in the intervention group (51.4%) was significantly higher compared to that in the control group (23.2%) (χ2 = 14.211, p = 0.030). Drug sensitivity testing showed that there were 5 drug-resistant cases in the intervention group and 7 in the control group, which was not significantly different. Three patients dropped out of the trial due to adverse effects. None of the patients hat renal injury.

CONCLUSIONS

Nebulized amikacin treatment is a safe treatment for exacerbation of BE and significantly increases the bacterial eradication rate of sputum.

摘要

背景

铜绿假单胞菌是支气管扩张症(BE)患者最常见的致病菌。雾化阿米卡星治疗的可及性和安全性尚不清楚。

目的

本研究旨在探讨在铜绿假单胞菌感染的 BE 患者加重期静脉应用阿米卡星治疗 2 周,然后行雾化治疗的疗效和不良反应。

方法

2013 年 1 月至 2016 年 3 月,在山东省 5 家三级医院筛选出 143 例 BE 加重期患者。BE 患者通过高分辨率 CT 扫描进行诊断,所有患者经痰培养试验均确诊为铜绿假单胞菌感染。将 74 例患者纳入干预组,接受阿米卡星雾化(0.2 g)治疗,每日 2 次,持续 2 周,同时接受静脉抗生素治疗。将 69 例患者纳入对照组,单独接受标准抗生素治疗。主要结局为痰细菌清除率,次要结局为耐药性和不良反应。

结果

干预组(51.4%)的痰细菌清除率显著高于对照组(23.2%)(χ2=14.211,p=0.030)。药敏试验显示,干预组有 5 例耐药病例,对照组有 7 例,差异无统计学意义。由于不良反应,有 3 例患者退出试验。所有患者均未出现肾损伤。

结论

雾化阿米卡星治疗是 BE 加重期的一种安全治疗方法,可显著提高痰细菌清除率。

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