患有侵袭性念珠菌病和/或念珠菌血症的患者接受雷沙康唑治疗后的住院和重症监护病房停留时间：两项随机对照试验的汇总分析。
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.
机构信息
Intensive Care Department, CHU UCL Namur Godinne, UCL Louvain Medical School, 1, Avenue G Therasse, 5530, Yvoir, Belgium.
Department of Health Sciences, University of Genoa, and Istituto Di Ricovero E Cura a Carattere, Ospedale Policlinico San Martino, Genoa, Italy.
出版信息
Crit Care. 2024 Nov 11;28(1):361. doi: 10.1186/s13054-024-05152-2.
BACKGROUND
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).
METHODS
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.
RESULTS
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.
CONCLUSIONS
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).
背景
侵袭性念珠菌病/念珠菌血症（IC/C）与健康经济负担有很大关系，主要是由于住院时间延长所致。每周一次的静脉注射棘白菌素类药物瑞他康唑醋酸酯在治疗 IC/C 方面已被证明不劣于卡泊芬净。本文报告了两项先前发表的临床试验（ReSTORE [NCT03667690]和 STRIVE [NCT02734862]）的事后汇总探索性分析结果，这些试验比较了瑞他康唑与每日静脉注射卡泊芬净的疗效，对于卡泊芬净组中稳定的患者，如果符合相关标准，在接受治疗 3 天或更长时间后可以降阶梯使用氟康唑。
方法
在汇总的改良意向治疗（mITT）人群中（所有符合试验要求且至少接受一剂研究药物的有记录的念珠菌感染患者）对住院和重症监护病房（ICU）的住院时间（LoS）结局进行描述性分析。此外，为了调整基线时治疗组之间接受机械通气比例的不平衡，应用了包含机械通气作为二分类协变量的广义线性模型。还报告了 3 期试验中关于每周瑞他康唑治疗可能更早出院的探索性问题的结果。
结果
共纳入 294 例患者（瑞他康唑 139 例，卡泊芬净 155 例），其中 126 例（43%）有 ICU 入住。在所有分析中，接受瑞他康唑治疗的患者的总 LOS 均短于接受卡泊芬净治疗的患者。瑞他康唑组的平均总 LOS 为 25.2 天，卡泊芬净组为 28.3 天；瑞他康唑组的 ICU LOS 平均为 16.1 天，卡泊芬净组为 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%）。对于每周接受瑞他康唑治疗的 187 例患者（30/187）中的 16%，医生可能会考虑更早出院，平均提前 5-6 天。
结论
与每日静脉注射卡泊芬净相比，瑞他康唑可能使 IC/C 患者的住院和 ICU LOS 更短，同时节省资源使用。需要进一步研究以确认这在实际环境中的效果。
试验注册
NCT03667690（ReSTORE；2018 年 9 月 12 日）；NCT02734862（STRIVE；2016 年 4 月 12 日）。
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