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基于细菌载量缩短支气管扩张症静脉抗生素治疗的可行性:概念验证随机对照试验。

Feasibility of shortening intravenous antibiotic therapy for bronchiectasis based on bacterial load: a proof-of-concept randomised controlled trial.

机构信息

MRC Centre for Inflammation Research, Queen's Medical Research Institute, Edinburgh, UK

P. Bedi and M.K. Cartlidge are joint first authors.

出版信息

Eur Respir J. 2021 Dec 16;58(6). doi: 10.1183/13993003.04388-2020. Print 2021 Dec.

Abstract

BACKGROUND

There is a lack of evidence to guide the duration of intravenous antibiotics for bronchiectasis exacerbations.

AIMS

The aim of this study was to assess whether it is feasible, based on bacterial load, to shorten intravenous antibiotics during exacerbations and whether 14 days of treatment is superior.

METHODS

We recruited participants requiring intravenous antibiotics for exacerbations. Participants were randomised into two groups: to receive antibiotics for 14 days (14-day group) or to have a shorter duration of treatment based on bacterial load (bacterial load-guided group (BLGG)). Bacterial load was checked on days 0, 7, 10, 14 and 21. If the bacterial load was <10 CFU·mL on day 7 or day 10 in the BLGG, antibiotics were stopped the following day.

RESULTS

A total of 47 participants were in the 14-day group and 43 were in the BLGG. 88% of participants in the BLGG were able to stop antibiotics by day 8 and potentially 81% of participants in the 14-day group could have stopped antibiotics at day 8. There was a nonsignificant trend for increased clinical improvement by day 21 in the 14-day group compared to the BLGG. However, overall group data showed the median (interquartile range) time to next exacerbation was 27.5 days (12.5-60 days) in the 14-day group and 60 days (18-110 days) in the in BLGG (p=0.0034). In a Cox proportional hazard model, participants in the 14-day group were more likely to experience exacerbations (HR 1.80, 95% CI 1.16-2.80, p=0.009) than those in the BLGG, and those with mild bronchiectasis were less likely to experience exacerbations than patients with more severe bronchiectasis (HR 0.359, 95% CI 0.13-0.99, p=0.048).

CONCLUSIONS

Bacterial load-guided therapy is feasible in most exacerbations requiring intravenous antibiotics. There was a nonsignificant trend for increased clinical improvement by day 21 with 14 days of antibiotics compared with bacterial load-guided therapy but paradoxically there was a prolonged time to next exacerbation in the BLGG.

摘要

背景

目前尚无证据指导支气管扩张症加重期静脉用抗生素的使用时间。

目的

本研究旨在评估根据细菌负荷缩短支气管扩张症加重期静脉用抗生素的使用时间是否可行,以及 14 天的治疗是否更优。

方法

我们招募了需要静脉用抗生素治疗的支气管扩张症加重期患者。参与者被随机分为两组:接受 14 天的抗生素治疗(14 天组)或根据细菌负荷进行更短时间的治疗(细菌负荷指导组(BLGG))。细菌负荷在第 0、7、10、14 和 21 天进行检测。如果 BLGG 组在第 7 天或第 10 天的细菌负荷<10CFU·mL,则次日停止抗生素治疗。

结果

共有 47 名参与者进入 14 天组,43 名参与者进入 BLGG 组。BLGG 组 88%的患者可在第 8 天停止抗生素治疗,而 14 天组潜在 81%的患者可在第 8 天停止抗生素治疗。第 21 天,14 天组的临床改善程度较 BLGG 组有增加的趋势,但无统计学意义。然而,整体组数据显示,14 天组的下一次加重中位(四分位距)时间为 27.5 天(12.5-60 天),BLGG 组为 60 天(18-110 天)(p=0.0034)。在 Cox 比例风险模型中,14 天组的患者比 BLGG 组更有可能发生加重(HR 1.80,95%CI 1.16-2.80,p=0.009),轻度支气管扩张症患者比重度支气管扩张症患者更不容易发生加重(HR 0.359,95%CI 0.13-0.99,p=0.048)。

结论

在大多数需要静脉用抗生素治疗的支气管扩张症加重期患者中,细菌负荷指导治疗是可行的。与细菌负荷指导治疗相比,14 天抗生素治疗在第 21 天的临床改善程度略有增加,但 BLGG 组的下一次加重时间反而延长。

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