Use of procalcitonin to shorten antibiotic treatment duration in septic patients - A randomized trial

Use of procalcitonin to shorten antibiotic treatment duration in septic patients - A randomized trial
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DOI:
10.1164/rccm.200708-1238oc
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发表时间:
2008-03-01
影响因子:
24.7
通讯作者:
Pugin, Jerome
Pugin, Jerome
中科院分区:
医学1区
文献类型:
--
作者:
Nobre, Vandack;Harbarth, Stephan;Pugin, Jerome

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基本原理:重症脓毒症患者抗生素治疗的持续时间可能导致抗生素过度使用,增加细菌耐药性的风险。目的:检验一种假设,即与经验规则相比,基于降钙素原(PCT)连续测量的算法可以减少抗生素治疗的持续时间,并且不会导致严重脓毒症和脓毒性休克患者更多的不良结局。方法:在随机分配到干预组的患者中,当PCT水平从初始值下降90%或更多时(如果临床医生同意),但不是在第3天之前(如果基线PCT水平≥ 1 μ g/L),停用抗生素。在对照组患者中,临床医生决定抗生素治疗的持续时间根据经验rules.Measurements和主要结果:分配到PCT组的患者有3.5天短的抗生素治疗的中位持续时间的首次发作的感染比对照组(意向治疗,n = 79,P = 0.15)。在可根据连续PCT测量结果做出决定的患者中,PCT指导导致抗生素治疗持续时间缩短4天(根据方案,n = 68,P = 0.003),总体抗生素暴露量减少(P = 0.0002)。在PCT和对照组中观察到相似的死亡率和原发感染复发率。一个为期2天的重症监护病房住院时间也观察到分配到PCT组(P = 0.03)。结论:我们的研究结果表明,一个协议的基础上连续PCT测量允许减少抗生素治疗时间和暴露在严重脓毒症和脓毒性休克患者没有明显的伤害。在www.clinicaltrials.gov注册的临床试验(NCT 00250666)。
Rationale: The duration of antibiotic therapy in critically ill patients with sepsis can result in antibiotic overuse, increasing the risk of developing bacterial resistance.Objectives: To test the hypothesis that an algorithm based on serial measurements of procalcitonin (PCT) allows reduction in the duration of antibiotic therapy compared with empirical rules, and does not result in more adverse outcomes in patients with severe sepsis and septic shock.Methods: In patients randomly assigned to the intervention group, antibiotics were stopped when PCT levels had decreased 90% or more from the initial value (if clinicians agreed) but not before Day 3 (if baseline PCT levels were = 1 mu g/L). In control patients, clinicians decided on the duration of antibiotic therapy based on empirical rules.Measurements and Main Results: Patients assigned to the PCT group had 3.5-day shorter median duration of antibiotic therapy for the first episode of infection than control subjects (intention-to-treat, n = 79, P = 0.15). In patients in whom a decision could be taken based on serial PCT measurements, PCT guidance resulted in a 4-day reduction in the duration of antibiotic therapy (per protocol, n = 68, P = 0.003) and a smaller overall antibiotic exposure (P = 0.0002). A similar mortality and recurrence of the primary infection were observed in PCT and control groups. A 2-day shorter intensive care unit stay was also observed in patients assigned to the PCT group (P = 0.03).Conclusions: Our results suggest that a protocol based on serial PCT measurement allows reducing antibiotic treatment duration and exposure in patients with severe sepsis and septic shock without apparent harm. Clinical trial registered with www.clinicaltrials.gov (NCT 00250666).