使用雷扎芬净治疗侵袭性念珠菌病和/或念珠菌血症患者的住院时间和重症监护室停留时间:两项随机对照试验的汇总分析

IF 8.8 1区 医学 Q1 CRITICAL CARE MEDICINE
Patrick M. Honoré, Matteo Bassetti, Oliver A. Cornely, Herve Dupont, Jesús Fortún, Marin H. Kollef, Peter Pappas, John Pullman, Jose Vazquez, Inga Bielicka, Sara Dickerson, Nick Manamley, Taylor Sandison, George R. Thompson
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引用次数: 0

摘要

侵袭性念珠菌病/念珠菌血症(IC/C)主要因住院时间延长而造成巨大的医疗经济负担。在 IC/C 的治疗中,每周一次静脉滴注的棘白菌素类药物醋酸雷沙芬净已被证明不劣于卡泊芬净。本文报告了对之前发表的两项临床试验(ReSTORE [NCT03667690]和 STRIVE [NCT02734862])中住院和重症监护室(ICU)停留时间(LoS)的事后汇总探索性分析,这两项试验比较了雷沙芬净和每日静脉注射的卡泊芬净(卡泊芬净组中符合相关标准的稳定期患者可在 3 天或更长时间后减量至氟康唑)。LoS结果在汇总的修正意向治疗(mITT)人群中进行了描述性分析(所有符合试验要求、有记录的念珠菌感染并至少接受了一剂研究药物的患者)。此外,为了调整治疗组间基线时接受机械通气比例的不平衡,还应用了以机械通气为二元协变量的广义线性模型。此外,还报告了对第 3 期试验中一个探索性问题的答复,即每周使用雷沙芬净可能会提前出院。共纳入 294 例患者(雷沙芬净 139 例,卡泊芬净 155 例),其中 126 例(43%)曾入住 ICU。在所有分析中,接受雷沙芬净治疗的患者的LoS在数量上短于卡泊芬净。雷沙芬净和卡泊芬净的平均总住院时间分别为 25.2 天和 28.3 天,ICU 住院时间分别为 16.1 天和 21.6 天。调整机械通气状态后,ICU LoS 的差异为 4.1 天,相对差异为 24%(95% CI -11%,72%)。16%的患者(30/187)在每周使用雷沙芬净后,医生会考虑提前出院,平均提前5-6天。与每日静脉滴注卡泊芬净相比,雷沙芬净可缩短IC/C患者的住院和重症监护室等待时间,同时节省资源使用。要在实际环境中证实这一点,还需要进一步的研究。试验注册。NCT03667690(ReSTORE;2018年9月12日);NCT02734862(STRIVE;2016年4月12日)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Length of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials
Invasive candidiasis/candidemia (IC/C) is associated with a substantial health economic burden driven primarily by prolonged hospital stay. The once-weekly IV echinocandin, rezafungin acetate, has demonstrated non-inferiority to caspofungin in the treatment of IC/C. This paper reports a post hoc pooled exploratory analysis of length of stay (LoS) for hospital and intensive care unit (ICU) stays in two previously published clinical trials (ReSTORE [NCT03667690] and STRIVE [NCT02734862], that compared rezafungin with daily IV caspofungin (stable patients in the caspofungin group who met relevant criteria could step down to fluconazole after 3 days or more). LoS outcomes were analysed descriptively in the pooled modified intention to treat (mITT) population (all patients who had a documented Candida infection in line with trial requirements and received at least one dose of study drug). In addition, to adjust for an imbalance between treatment groups in the proportion receiving mechanical ventilation at baseline, a generalised linear model with mechanical ventilation as a binary covariate was applied. Responses to an exploratory question in the phase 3 trial on possible earlier discharge with weekly rezafungin are also reported. 294 patients were included (rezafungin 139, caspofungin 155), of whom 126 (43%) had ICU admission. Patients treated with rezafungin had a numerically shorter LoS than with caspofungin in all analyses. Mean total LoS was 25.2 days, vs 28.3 days with caspofungin, and mean ICU LoS was 16.1 vs 21.6 days for rezafungin and caspofungin, respectively. After adjustment for mechanical ventilation status the difference in ICU LoS was 4.1 days, a relative difference of 24% (95% CI -11%, 72%). Physicians would have considered earlier discharge for 16% of patients (30/187) with weekly rezafungin, an average of 5–6 days earlier. Rezafungin may enable shorter hospital and ICU LoS in IC/C compared with daily IV caspofungin, with accompanying savings in resource use. Further research is needed to confirm this in the real-world setting. Trial registration. NCT03667690 (ReSTORE; September 12, 2018); NCT02734862 (STRIVE; April 12, 2016).
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来源期刊
Critical Care
Critical Care 医学-危重病医学
CiteScore
20.60
自引率
3.30%
发文量
348
审稿时长
1.5 months
期刊介绍: Critical Care is an esteemed international medical journal that undergoes a rigorous peer-review process to maintain its high quality standards. Its primary objective is to enhance the healthcare services offered to critically ill patients. To achieve this, the journal focuses on gathering, exchanging, disseminating, and endorsing evidence-based information that is highly relevant to intensivists. By doing so, Critical Care seeks to provide a thorough and inclusive examination of the intensive care field.
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