米卡芬净在中国侵袭性真菌感染患者中的有效性和耐受性：一项回顾性、多中心研究。

Effectiveness and Tolerability of Micafungin in Chinese Patients with Invasive Fungal Infections: A Retrospective, Multicenter Study.

机构信息

Fujian Institute of Hematology, Fujian Provincial Key Laboratory on Hematology, Fujian Medical University Union Hospital, Fujian, China.

Sichuan Provincial Peoples' Hospital, Sichuan, China.

出版信息

Adv Ther. 2018 Sep;35(9):1400-1410. doi: 10.1007/s12325-018-0762-5. Epub 2018 Aug 13.

DOI:10.1007/s12325-018-0762-5

PMID:30105657

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6133133/

Abstract

INTRODUCTION

Invasive fungal infections (IFIs) are a significant health problem in immunocompromised patients, resulting in substantial morbidity, mortality, and healthcare costs. Micafungin is a broad-spectrum echinocandin with activity against Candida and Aspergillus spp. This was a multicenter, non-comparative, retrospective observational study that evaluated the effectiveness and tolerability of intravenously administered micafungin for treating IFIs caused by Candida and Aspergillus spp.

METHODS

Adult patients in China who had received at least one dose of intravenously administered micafungin were eligible. Retrospective data (May 2008-April 2015) were extracted from patients' medical files and recorded using electronic data capture. The primary endpoint was overall success rate (patients with complete or partial response). Subgroup analyses determined effectiveness according to diagnostic certainty, fungal species, type of IFI, duration of micafungin treatment, and daily dose of micafungin. Tolerability, including the incidence of adverse events (AEs), was also assessed.

RESULTS

Overall, 2555 patients who received at least one dose of micafungin were identified. The mean duration of treatment and mean daily dose were 10.2 days and 133.0 mg, respectively. The overall success rate was 60.8%; this was significantly higher in patients who received treatment for at least 1 week (range 67.9-71.6% [mean 69.2%]) compared with less than 1 week (47.8%; P < 0.0001), and those who received 50-100 mg (65.7%) compared with other daily doses (range 42.9-60.1% [mean 59.0%]; P = 0.0011). Success rates in Candida- and Aspergillus-infected patients were similar (61.9% and 56.8%, respectively). AEs and adverse drug reactions were observed in 36.2% and 4.5% of patients, respectively. The majority of AEs were mild, while discontinuation due to AEs was low (2.3%).

CONCLUSION

Micafungin is effective and well tolerated for the treatment of patients with IFIs in China, as demonstrated in Candida- and Aspergillus-infected adults. Subgroup analyses highlighted the potential benefits of treating IFIs with micafungin for a minimum of 1 week.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT02678598.

FUNDING

Astellas Pharma Inc.

摘要

简介

侵袭性真菌感染（IFI）是免疫功能低下患者的一个重大健康问题，可导致发病率、死亡率和医疗保健费用显著增加。米卡芬净是一种广谱棘白菌素，对念珠菌和曲霉菌属具有活性。这是一项多中心、非对照、回顾性观察性研究，评估了静脉内给予米卡芬净治疗由念珠菌和曲霉菌属引起的 IFI 的疗效和耐受性。

方法

在中国，至少接受过一次静脉内给予米卡芬净的成年患者符合入组条件。从患者的病历中提取回顾性数据（2008 年 5 月至 2015 年 4 月），并使用电子数据捕获进行记录。主要终点为总缓解率（完全或部分缓解的患者比例）。根据诊断确定性、真菌种类、IFI 类型、米卡芬净治疗持续时间和米卡芬净每日剂量进行亚组分析，以确定疗效。还评估了耐受性，包括不良事件（AE）的发生率。

结果

共纳入 2555 例至少接受过一次米卡芬净治疗的患者。治疗的平均持续时间和平均每日剂量分别为 10.2 天和 133.0mg。总缓解率为 60.8%；与治疗少于 1 周的患者（范围 67.9-71.6%[平均 69.2%]）相比，治疗至少 1 周的患者（71.6%）显著更高（P<0.0001），与接受 50-100mg 剂量的患者（65.7%）相比，接受其他剂量（范围 42.9-60.1%[平均 59.0%]）的患者更低（P=0.0011）。念珠菌和曲霉菌感染者的缓解率相似（分别为 61.9%和 56.8%）。分别有 36.2%和 4.5%的患者出现 AE 和药物不良反应。大多数 AE 为轻度，而因 AE 停药的比例较低（2.3%）。