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一项比较7天与14天抗生素治疗非复杂性革兰阴性血流感染的随机临床试验结果的期望排序分析的必要性。

A Desirability of Outcome Ranking Analysis of a Randomized Clinical Trial Comparing Seven Versus Fourteen Days of Antibiotics for Uncomplicated Gram-Negative Bloodstream Infection.

作者信息

Howard-Anderson Jessica, Dai Weixiao, Yahav Dafna, Hamasaki Toshimitsu, Turjeman Adi, Koppel Fidi, Franceschini Erica, Hill Carol, Sund Zoë, Chambers Henry F, Fowler Vance G, Boucher Helen W, Evans Scott R, Paul Mical, Holland Thomas L, Doernberg Sarah B

机构信息

Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.

The Biostatistics Center and Department of Biostatics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Washington, District of Columbia, USA.

出版信息

Open Forum Infect Dis. 2022 Apr 9;9(6):ofac140. doi: 10.1093/ofid/ofac140. eCollection 2022 Jun.

Abstract

BACKGROUND

Although a short course (7 days) of antibiotics has been demonstrated to be noninferior to a conventional course (14 days) in terms of mortality and infectious complications for patients with a Gram-negative bacterial bloodstream infection (GNB), it is unknown whether a shorter treatment duration can provide a better overall clinical outcome.

METHODS

We applied a bloodstream infection-specific desirability of outcome ranking (DOOR) analysis to the results of a previously completed, randomized controlled trial comparing short versus conventional course antibiotic therapy for hospitalized patients with uncomplicated GNB. We determined the probability that a randomly selected participant in the short course group would have a more desirable overall outcome than a participant in the conventional duration group. We performed (1) partial credit analyses allowing for calculated and variable weighting of DOOR ranks and (2) subgroup analyses to elucidate which patients may benefit the most from short durations of therapy.

RESULTS

For the 604 patients included in the original study (306 short course, 298 conventional course), the probability of having a more desirable outcome with a short course of antibiotics compared with a conventional course was 51.1% (95% confidence interval, 46.7% to 55.4%), indicating no significant difference. Partial credit analyses indicated that the DOOR results were similar across different patient preferences. Prespecified subgroup analyses using DOOR did not reveal significant differences between short and conventional courses of therapy.

CONCLUSIONS

Both short and conventional durations of antibiotic therapy provide comparable clinical outcomes when using DOOR to consider benefits and risks of treatment options for GNB.

摘要

背景

尽管对于革兰氏阴性菌血流感染(GNB)患者,已证明短疗程(7天)抗生素在死亡率和感染并发症方面不劣于传统疗程(14天),但尚不清楚较短的治疗持续时间是否能提供更好的总体临床结局。

方法

我们将血流感染特异性结局期望排名(DOOR)分析应用于一项先前完成的随机对照试验结果,该试验比较了住院的无并发症GNB患者短疗程与传统疗程抗生素治疗。我们确定了短疗程组中随机选择的参与者比传统疗程组参与者具有更理想总体结局的概率。我们进行了(1)允许对DOOR排名进行计算和可变加权的部分信用分析,以及(2)亚组分析,以阐明哪些患者可能从短疗程治疗中获益最多。

结果

对于纳入原始研究的604例患者(306例短疗程,298例传统疗程),与传统疗程相比,短疗程抗生素治疗获得更理想结局的概率为51.1%(95%置信区间,46.7%至55.4%),表明无显著差异。部分信用分析表明,不同患者偏好下的DOOR结果相似。使用DOOR进行的预设亚组分析未显示短疗程与传统疗程治疗之间存在显著差异。

结论

在使用DOOR考虑GNB治疗方案的益处和风险时,短疗程和传统疗程抗生素治疗均能提供相当的临床结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3353/9125302/97c58986fbc5/ofac140_fig1.jpg

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