Posaconazole gastro-resistant tablets for preventing invasive fungal disease after haematopoietic stem cell transplantation: a propensity-matched cohort study

IF 10.9 1区医学 Q1 INFECTIOUS DISEASES

Clinical Microbiology and Infection Pub Date : 2024-07-26 DOI:10.1016/j.cmi.2024.07.019

Jiaxin Cao , Pan Pan , Dan Feng , Mingyang Wang , Yawei Zheng , Nan Yang , Xin Chen , Weihua Zhai , Rongli Zhang , Qiaoling Ma , Jialin Wei , Donglin Yang , Yi He , Xiaodan Wang , Sizhou Feng , Mingzhe Han , Erlie Jiang , Aiming Pang

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引用次数: 0

Abstract

Objectives

To evaluate posaconazole (POS) gastro-resistant tablets for preventing invasive fungal disease (IFD) in haematopoietic stem cell transplantation (HSCT) patients and analyse POS plasma concentrations.

Methods

A single-arm trial was designed with a historical cohort as a control. Patients aged 13 years and older undergoing HSCT at the HSCT Center of Blood Diseases Hospital, Chinese Academy of Medical Sciences between December 2020 and May 2022 were enrolled, prospectively taking POS gastro-resistant tablets orally from day 1 to day 90 post-transplant and monitoring plasma concentrations. We also identified a retrospective cohort treated with alternative antifungal prophylaxis between January 2018 and December 2020, matched using propensity score methods. The primary outcome was the cumulative incidence of IFD at day 90 post-transplant.

Results

The prospective study involved 144 patients receiving POS gastro-resistant tablets for IFD prevention, contrasting with 287 patients receiving non-POS tablets. By day 90 post-transplant, the POS tablet group exhibited a significantly lower cumulative incidence of IFD (2.81%; 95% CI, 0.09–5.50% vs. 7.69%; 95% CI, 4.60–10.78%; p 0.044). Adverse events were comparable between the groups with liver changes in 33/144 (22.92%) vs. 84/287 (29.27%) (p 0.162), and renal injuries in 15/144 (10.41%) vs. 37/287 (12.89%) (p 0.457). Mean POS plasma concentrations on days 4, 8, 15, and 22 post-administration were 930.97 ng/mL, 1143.97 ng/mL, 1569.8 ng/mL, and 1652.57 ng/mL, respectively.

Discussion

Patients administered POS gastro-resistant tablets for antifungal prophylaxis experienced a lower cumulative incidence of IFD. POS plasma concentrations in HSCT patients stabilized by day 15 of medication.

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用于预防造血干细胞移植后侵袭性真菌病的泊沙康唑胃耐受片：倾向匹配队列研究。

目的评估泊沙康唑（POS）胃耐受片在造血干细胞移植（HSCT）患者中预防侵袭性真菌病（IFD）的作用，并分析POS的血浆浓度：方法：设计了一项单臂试验，以历史队列作为对照。纳入2020年12月至2022年5月在中国医学科学院血液病医院造血干细胞移植中心接受造血干细胞移植的13岁及以上患者，从移植后第1天至90天口服POS胃复安片并监测血浆浓度。我们还确定了 2018 年 1 月至 2020 年 12 月期间接受替代抗真菌预防治疗的回顾性队列，并采用倾向评分法进行匹配。主要结果是移植后第90天IFD的累积发生率：这项前瞻性研究涉及 144 名接受 POS 耐胃酸药片预防 IFD 的患者，与之形成对比的是 287 名接受非 POS 药片的患者。到移植后第 90 天，POS 片组的 IFD 累计发生率明显降低（2.81% [95% CI, 0.09%-5.50%] 对 7.69% [95% CI, 4.60%-10.78%]; P = 0.044）。两组之间的不良反应相当，肝脏变化为 33/144 例（22.92%）对 84/287 例（29.27%）（P = 0.162），肾脏损伤为 15/144 例（10.41%）对 37/287 例（12.89%）（P = 0.457）。用药后第 4、8、15 和 22 天的平均 POS 血浆浓度分别为 930.97 纳克/毫升、1143.97 纳克/毫升、1569.8 纳克/毫升和 1652.57 纳克/毫升：使用 POS 耐胃酸片剂进行抗真菌预防的患者，IFD 的累积发生率较低。造血干细胞移植患者的 POS 血浆浓度在服药第 15 天时趋于稳定。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Microbiology and Infection 医学-传染病学

CiteScore

25.30

自引率

2.10%

发文量

441

审稿时长

2-4 weeks

期刊介绍： Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.