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住院退伍军人事务部患者中艰难梭菌感染早期靶向使用非达霉素与口服万古霉素的比较效果。

Comparative effectiveness of early-targeted use of fidaxomicin versus oral vancomycin among hospitalized veterans' affairs patients with infections due to Clostridioides difficile.

机构信息

Skaggs School of Pharmacy & Pharmaceutical Sciences, University of California San Diego, La Jolla, California, USA.

Samuel S. Stratton Veteran's Affairs Medical Center, Albany, New York, USA.

出版信息

Pharmacotherapy. 2021 Feb;41(2):212-219. doi: 10.1002/phar.2503. Epub 2021 Feb 8.

Abstract

STUDY OBJECTIVES

This study sought to compare real-world effectiveness outcomes between hospitalized patients with Clostridioides difficile infections (CDIs) who received early-targeted fidaxomicin or oral vancomycin at two Veterans Affairs Medical Centers (VAMCs).

DESIGN

A retrospective cohort study was performed among hospitalized patients at two VAMCs from January 2008 until July 2017.

SETTING

Albany and Syracuse VAMCs.

PATIENTS

Patients were included in this analysis if they were age ≥18 years; were hospitalized; had a CDI with a Hines Severity Score Index (SSI) ≥2; received oral vancomycin (January 2008-June 2014 at Albany or Syracuse VAMCs) or fidaxomicin (March 2012-July 2017 at Albany VAMC) within 5 days of positive CDI stool sample for ≥ 48 hours.

INTERVENTION

Receipt of an oral vancomycin- or fidaxomicin-containing CDI regimen.

MEASUREMENTS

The primary outcome was a composite of 30-day mortality and 60-day recurrence.

MAIN RESULTS

The study included 54 oral vancomycin and 38 fidaxomicin recipients. The population was predominantly male (97.8%), and mean ± standard deviation age was 74.6 ± 11.1 years. The composite outcome was significantly different between fidaxomicin and vancomycin recipients (26.3% fidaxomicin vs. 51.9% vancomycin; odds ratio (OR): 0.33, 95% CI: 0.14-0.81, p = 0.01). This finding was maintained in the multivariate analysis after adjustment for confounders (adjusted OR: 0.25, 95% CI: 0.09-0.73, p = 0.01) CONCLUSIONS: This real-world effectiveness study suggests that use of fidaxomicin potentially results in better outcomes relative to oral vancomycin for initial treatment of hospitalized VAMC patients with CDIs.

摘要

研究目的

本研究旨在比较两家退伍军人事务医疗中心(VAMC)住院的艰难梭菌感染(CDI)患者接受早期靶向 fidaxomicin 或口服万古霉素的真实世界疗效结局。

设计

这是一项在两家 VAMC 于 2008 年 1 月至 2017 年 7 月期间住院的患者中进行的回顾性队列研究。

地点

奥尔巴尼和锡拉丘兹 VAMC。

患者

如果患者年龄≥18 岁;住院;艰难梭菌感染 Hines 严重程度评分指数(SSI)≥2;在 CDI 粪便样本阳性后 5 天内接受口服万古霉素(2008 年 1 月至 2014 年在奥尔巴尼或锡拉丘兹 VAMC)或 fidaxomicin(2012 年 3 月至 2017 年 7 月在奥尔巴尼 VAMC)治疗至少 48 小时,则纳入本分析。

干预措施

接受口服万古霉素或 fidaxomicin 治疗的 CDI 方案。

测量

主要结局是 30 天死亡率和 60 天复发的复合结局。

主要结果

该研究包括 54 例口服万古霉素和 38 例 fidaxomicin 治疗患者。该人群主要为男性(97.8%),平均年龄±标准差为 74.6±11.1 岁。 fidaxomicin 和万古霉素组的复合结局有显著差异(26.3% fidaxomicin 与 51.9%万古霉素;比值比(OR):0.33,95%置信区间:0.14-0.81,p=0.01)。在调整混杂因素后,多变量分析仍保持这一发现(调整后的 OR:0.25,95%置信区间:0.09-0.73,p=0.01)。

结论

这项真实世界的疗效研究表明,与口服万古霉素相比, fidaxomicin 用于治疗住院的 VAMC 艰难梭菌感染患者,其初始治疗效果可能更好。

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