抗生素治疗危重症患者的持续时间：基于临床和 C 反应蛋白的方案与无生物标志物的基于证据的最佳实践策略的随机对照试验。
Duration of antibiotic therapy in critically ill patients: a randomized controlled trial of a clinical and C-reactive protein-based protocol versus an evidence-based best practice strategy without biomarkers.
机构信息
Graduate Program in Health Sciences: Infectious Diseases and Tropical Medicine, Department of Internal Medicine, School of Medicine and Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
Departamento de Clínica Médica, 2° andar Faculdade de Medicina. Av. Alfredo Balena, 190, Santa Efigênia, Belo Horizonte, Minas Gerais, Brazil.
出版信息
Crit Care. 2020 Jun 1;24(1):281. doi: 10.1186/s13054-020-02946-y.
BACKGROUND
The rational use of antibiotics is one of the main strategies to limit the development of bacterial resistance. We therefore sought to evaluate the effectiveness of a C-reactive protein-based protocol in reducing antibiotic treatment time in critically ill patients.
METHODS
A randomized, open-label, controlled clinical trial conducted in two intensive care units of a university hospital in Brazil. Critically ill infected adult patients were randomly allocated to (i) intervention to receive antibiotics guided by daily monitoring of CRP levels and (ii) control to receive antibiotics according to the best practices for rational use of antibiotics.
RESULTS
One hundred thirty patients were included in the CRP (n = 64) and control (n = 66) groups. In the intention-to-treat analysis, the median duration of antibiotic therapy for the index infectious episode was 7.0 (5.0-8.8) days in the CRP and 7.0 (7.0-11.3) days in the control (p = 0.011) groups. A significant difference in the treatment time between the two groups was identified in the curve of cumulative suspension of antibiotics, with less exposure in the CRP group only for the index infection episode (p = 0.007). In the per protocol analysis, involving 59 patients in each group, the median duration of antibiotic treatment was 6.0 (5.0-8.0) days for the CRP and 7.0 (7.0-10.0) days for the control (p = 0.011) groups. There was no between-group difference regarding the total days of antibiotic exposure and antibiotic-free days.
CONCLUSIONS
Daily monitoring of CRP levels may allow early interruption of antibiotic therapy in a higher proportion of patients, without an effect on total antibiotic consumption. The clinical and microbiological relevance of this finding remains to be demonstrated.
TRIAL REGISTRY
ClinicalTrials.gov Identifier: NCT02987790. Registered 09 December 2016.
背景
合理使用抗生素是限制细菌耐药性发展的主要策略之一。因此，我们旨在评估基于 C 反应蛋白（CRP）的方案在减少危重症患者抗生素治疗时间方面的有效性。
方法
这是一项在巴西一所大学医院的两个重症监护病房进行的随机、开放标签、对照临床试验。将感染的成年危重症患者随机分配至（i）干预组，即根据 CRP 水平的每日监测结果接受抗生素治疗；（ii）对照组，即根据抗生素合理使用的最佳实践接受抗生素治疗。
结果
共有 130 名患者纳入 CRP（n=64）和对照组（n=66）。意向性治疗分析中，CRP 组和对照组的指数感染事件的抗生素治疗中位持续时间分别为 7.0（5.0-8.8）天和 7.0（7.0-11.3）天（p=0.011）。两组间累积停药抗生素曲线显示治疗时间存在显著差异，仅 CRP 组的指数感染事件中抗生素暴露更少（p=0.007）。在每组 59 名患者的方案治疗分析中，CRP 组和对照组的抗生素治疗中位持续时间分别为 6.0（5.0-8.0）天和 7.0（7.0-10.0）天（p=0.011）。两组间抗生素总暴露天数和无抗生素天数无差异。
结论
每日监测 CRP 水平可能使更多患者更早地中断抗生素治疗，而不会影响抗生素总用量。这一发现的临床和微生物学相关性仍有待证实。
试验注册
ClinicalTrials.gov 标识符：NCT02987790。注册于 2016 年 12 月 9 日。
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