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[JAMA最新论文]:基于方案治疗与常规治疗金黄色葡萄球菌菌血症的临床疗效与严重不良事件
2018年10月07日 时讯速递, 进展交流 暂无评论

Original Investigation

September 25, 2018

Effect of Algorithm-Based Therapy vs Usual Care on Clinical Success and Serious Adverse Events in Patients with Staphylococcal Bacteremia: A Randomized Clinical Trial

Thomas L. Holland, Issam Raad, Helen W. Boucher, et al

JAMA. 2018;320(12):1249-1258. doi:10.1001/jama.2018.13155

Abstract

Importance 背景

The appropriate duration of antibiotics for staphylococcal bacteremia is unknown.

葡萄球菌菌血症的适当抗生素疗程并不明确。

Objective 目的

To test whether an algorithm that defines treatment duration for staphylococcal bacteremia vs standard of care provides noninferior efficacy without increasing severe adverse events.

针对葡萄球菌菌血症,与标准治疗相比,验证确定疗程的治疗方案在不增加严重不良事件方面是否非劣效。

Design, Setting, and Participants 设计,场景及研究人群

A randomized trial involving adults with staphylococcal bacteremia was conducted at 16 academic medical centers in the United States (n = 15) and Spain (n = 1) from April 2011 to March 2017. Patients were followed up for 42 days beyond end of therapy for those with Staphylococcus aureus and 28 days for those with coagulase-negative staphylococcal bacteremia. Eligible patients were 18 years or older and had 1 or more blood cultures positive for S aureus or coagulase-negative staphylococci. Patients were excluded if they had known or suspected complicated infection at the time of randomization.

这项有关葡萄球菌菌血症成年患者的随机对照试验于2011年4月至2017年3月在美国和西班牙的16个医学中心进行。金黄色葡萄球菌菌血症患者随访至治疗结束后42天,凝固酶阴性葡萄球菌菌血症患者随访至治疗结束后28天。入选标准为18岁以上成人,一次或一次以上金黄色葡萄球菌或凝固酶阴性葡萄球菌血培养阳性。排除标准包括随机分组时的已知或可疑复杂感染。

Interventions 干预措施

Patients were randomized to algorithm-based therapy (n = 255) or usual practice (n = 254). Diagnostic evaluation, antibiotic selection, and duration of therapy were predefined for the algorithm group, whereas clinicians caring for patients in the usual practice group had unrestricted choice of antibiotics, duration, and other aspects of clinical care.

患者被随机分为治疗方案组(n = 255)或常规治疗组(n = 254)。治疗方案组的诊断评估、抗生素选择及疗程均预先确定,而常规治疗组患者的主管医生可不受限制地确定抗生素的选择、疗程及临床治疗的其他措施。

Main Outcomes and Measures 主要预后指标

Coprimary outcomes were (1) clinical success, as determined by a blinded adjudication committee and tested for noninferiority within a 15% margin; and (2) serious adverse event rates in the intention-to-treat population, tested for superiority. The prespecified secondary outcome measure, tested for superiority, was antibiotic days among per-protocol patients with simple or uncomplicated bacteremia.

联合主要预后终点为(1)临床成功率,由设盲的评估委员会确定,非劣效检验的临界为15%;及(2)意向治疗组的严重不良事件发生率,进行优效检验。预先确定的次要预后终点(采用优效检验)为符合方案集(简单或非复杂性菌血症)的抗生素使用天数。

Results 结果

Among the 509 patients randomized (mean age, 56.6 [SD, 16.8] years; 226 [44.4%] women), 480 (94.3%) completed the trial. Clinical success was documented in 209 of 255 patients assigned to algorithm-based therapy and 207 of 254 randomized to usual practice (82.0% vs 81.5%; difference, 0.5% [1-sided 97.5% CI, −6.2% to ∞]). Serious adverse events were reported in 32.5% of algorithm-based therapy patients and 28.3% of usual practice patients (difference, 4.2% [95% CI, −3.8% to 12.2%]). Among per-protocol patients with simple or uncomplicated bacteremia, mean duration of therapy was 4.4 days for algorithm-based therapy vs 6.2 days for usual practice (difference, −1.8 days [95% CI, −3.1 to −0.6]).

509名患者接受随机分组(平均年龄,56.6 [SD, 16.8] 岁;226名 [44.4%] 女性),其中480名 (94.3%) 患者完成临床试验。方案治疗组255名患者中209名临床治疗成功,常规治疗组254名患者中207名治疗成功(82.0% vs 81.5%;差异,0.5% [单尾 97.5% CI, −6.2% to ∞])。严重不良事件发生率方案治疗组32.5%,常规治疗组28.3%(差异,4.2% [95% CI, −3.8% to 12.2%])。在符合方案患者(简单或非复杂性菌血症)中,抗生素平均疗程为方案组4.4天 vs 常规治疗组6.2天(差异,-1.8 天 [95% CI, -3.1 to -0.6])。

Conclusions and Relevance 结论与意义

Among patients with staphylococcal bacteremia, the use of an algorithm to guide testing and treatment compared with usual care resulted in a noninferior rate of clinical success. Rates of serious adverse events were not significantly different, but interpretation is limited by wide confidence intervals. Further research is needed to assess the utility of the algorithm.

对于葡萄球菌菌血症患者,与常规治疗相比,采用治疗方案指导检验及治疗的临床成功率显示非劣效。严重不良事件发生率无显著差异,但由于可信区间范围很宽,限制了结果的解读。需要进一步研究评估治疗方案的用处。

Trial Registration 试验注册

ClinicalTrials.gov Identifier: NCT01191840

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