法国图尔大学中心医院（CHRU）Stephan Ehrmann团队研究了吸入阿米卡星预防呼吸机相关肺炎的效果。2023年10月25日出版的《新英格兰医学杂志》发表了这项成果。

预防性吸入抗生素是否可以降低呼吸机相关肺炎的发病率尚不清楚。

在这项由研究者发起的多中心、双盲、随机、对照、优越性试验中，研究组将接受有创机械通气至少72小时的危重成年人分配为每天一次接受（20毫克/公斤体重）吸入阿米卡星3天，或接受安慰剂治疗3天。主要结局是在28天的随访中首次出现呼吸机相关肺炎。并对安全性进行了评估。

共有850名患者接受了随机分组，847人被纳入分析（417人被分配至阿米卡星组，430人被分配到安慰剂组）。阿米卡星组337名患者（81%）和安慰剂组355名患者（82%）接受了所有三次的每日雾化吸入。

28天时，阿米卡星组62名患者（15%）和安慰剂组95名患者（22%）出现呼吸机相关肺炎（与呼吸机相关肺炎的限制平均生存时间差异为1.5天；P=0.004）。阿米卡星组74名患者（18%）和安慰剂组111名患者（26%）发生了与感染相关的呼吸机相关并发症（危险比为0.66）。阿米卡星组有7名患者（1.7%）和安慰剂组有4名患者（0.9%）出现与试验相关的严重不良反应。

研究结果表明，在接受了至少3天机械通气的患者中，随后3天吸入阿米卡星疗程在28天的随访中减轻了呼吸机相关肺炎的负担。

附：英文原文

Title: Inhaled Amikacin to Prevent Ventilator-Associated Pneumonia | NEJM

Author: anonymous

Issue&Volume: 2023-10-25

Abstract:

Background

Whether preventive inhaled antibiotics may reduce the incidence of ventilator-associated pneumonia is unclear.

Methods

In this investigator-initiated, multicenter, double-blind, randomized, controlled, superiority trial, we assigned critically ill adults who had been undergoing invasive mechanical ventilation for at least 72 hours to receive inhaled amikacin at a dose of 20 mg per kilogram of ideal body weight once daily or to receive placebo for 3 days. The primary outcome was a first episode of ventilator-associated pneumonia during 28 days of follow-up. Safety was assessed.

Results

A total of 850 patients underwent randomization, and 847 were included in the analyses (417 assigned to the amikacin group and 430 to the placebo group). All three daily nebulizations were received by 337 patients (81%) in the amikacin group and 355 patients (82%) in the placebo group. At 28 days, ventilator-associated pneumonia had developed in 62 patients (15%) in the amikacin group and in 95 patients (22%) in the placebo group (difference in restricted mean survival time to ventilator-associated pneumonia, 1.5 days; 95% confidence interval [CI] 0.6 to 2.5; P=0.004). An infection-related ventilator-associated complication occurred in 74 patients (18%) in the amikacin group and in 111 patients (26%) in the placebo group (hazard ratio, 0.66; 95% CI, 0.50 to 0.89). Trial-related serious adverse effects were seen in 7 patients (1.7%) in the amikacin group and in 4 patients (0.9%) in the placebo group.

Conclusions

Among patients who had undergone mechanical ventilation for at least 3 days, a subsequent 3-day course of inhaled amikacin reduced the burden of ventilator-associated pneumonia during 28 days of follow-up.

DOI: 10.1056/NEJMoa2310307

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2310307