Chinese General Practice ›› 2026, Vol. 29 ›› Issue (21): 2967-2974.DOI: 10.12114/j.issn.1007-9572.2025.0374

• Article • Previous Articles    

Evaluation of the Efficacy, Safetyand Economy of Different Amphotericin B Formulationsin Invasive Fungal Disease: a Retrospective Cohort Study

  

  1. 1. Department of Clinical Pharmacy, the First Hospital of Hebei Medical University, Shijiazhuang 050000, China
    2. Technology Innovation Center for Artificial Intelligencein Clinical Pharmacy of Hebei Province, the First Hospital of Hebei Medical University, Shijiazhuang 050000, China
    3. Quality Management Office, the First Hospital of Hebei Medical University, Shijiazhuang 050000, China
  • Received:2025-08-04 Revised:2025-11-12 Published:2026-07-20 Online:2026-06-03
  • Contact: ZHOU Chunhua, YU Jing
  • About author:

    LIU Shuai and YUAN Shizhao are co-first authors

两性霉素B治疗侵袭性真菌病的疗效、安全性及经济性评价:一项回顾性队列研究

  

  1. 1.050000 河北省石家庄市,河北医科大学第一医院临床药学部
    2.050000 河北省石家庄市,河北医科大学第一医院临床药学人工智能技术创新中心
    3.050000 河北省石家庄市,河北医科大学第一医院质量管理办公室
  • 通讯作者: 周春华, 于静
  • 作者简介:

    刘帅与苑世朝为共同第一作者

    本文首次刊登于Precision Medication 2025年第3期(https://doi.org/10.1016/j.prmedi.2025.100048)

    作者贡献:

    刘帅、苑世朝负责研究的实施,撰写论文,进行数据的收集与整理,统计学处理,图、表的绘制与展示;刘琰进行论文的修订、负责文章的质量控制与审查;贾硕贤、赵岩、王紫怡进行数据的收集与整理,统计学处理;周春华、于静对文章整体负责,监督管理。

  • 基金资助:
    河北省自然科学基金(H2022206548); 河北省2024年度医学科学研究课题计划(20241797)

Abstract:

Background

Fungal infections have become an increasingly severe public health challenge worldwide.Amphotericin B is widely used in antifungal therapy and is available in four formulations: Amphotericin B Deoxycholate, Liposomal Amphotericin B, Amphotericin B Colloidal Dispersion, and Amphotericin B Lipid Complex. Despite having the same active ingredient, these different formulations may exhibit variations in efficacy, safety and cost-effectiveness.

Objective

This study aims to investigate the differences in efficacy, safety, and cost-effectiveness among different formulations of amphotericin B in patients with invasive fungal disease (IFD).

Methods

This retrospective observational study enrolled 71 IFD patients treated with amphotericin B at the First Hospital of Hebei Medical University from June 2023 to March 2025, who were divided into the AMB-D group (n=20), L-AMB group (n=20) and ABCD group (n=31) by the formulation type. The primary outcome was the effective remission rate of IFD, which was analyzed with Kaplan-Meier survival curves and the Log-rank test along with the impact of adverse events on survival. The incidences of renal injury, hepatic injury, hypokalemia and thrombocytopenia were compared to assess medication safety, and pharmacoeconomics was evaluated by analyzing total cost, daily average cost and cost-effectiveness.

Results

A total of 71 patients were included in the study, with a median age of 64.0 (54.0, 71.0) years. Among them, 50 were males (70.4%) and 21 were females (29.6%). The complete response rate, partial response rate, and non-response rate of the included patients were 26.8% (19/71), 38.0% (27/71), and 35.2% (25/71), respectively. There were no statistically significant differences in the overall response rate and non-response rate among the AMB-D group, L-AMB group, and ABCD group (P>0.05). Stratified analysis showed that the overall response rates differed significantly among the three groups in patients aged 61-83 years, females, and those with a tentative diagnosis (P<0.05). In addition, the overall response rate and complete response rate differed significantly among the three groups when the treatment duration was less than 3 days (P<0.05); the overall response rate differed significantly among the three groups when the treatment duration exceeded 7 days (P<0.05). Adverse events occurred in 49 of the 71 patients (69.0%), with the most common events being renal injury (31cases, 43.7%), hepatic injury (18 cases, 25.4%), hypokalemia (9 cases, 12.7%), and thrombocytopenia (17 cases, 23.9%). Survival analysis revealed no statistically significant differences in survival time among the three groups for patients who developed renal injury, hepatic injury, hypokalemia, or thrombocytopenia (P>0.05). There were statistically significant differences in the total cost and daily cost among the three groups (P<0.01), with the L-AMB group showing the highest cost-effectiveness ratio.

Conclusion

Amphotericin B formulations exhibit marked variations in efficacy and economy profiles, necessitating individualized selection guided by specific clinical characteristics. Rigorous monitoring of renal function remains imperative throughout the therapeutic course.

Key words: Invasivefungaldisease, Amphotericin B, Nephrotoxicity, Formulations, Retrospective cohort study

摘要:

背景

真菌感染已成为全球范围内日益严峻的公共卫生挑战。两性霉素B被广泛用于抗真菌治疗,该药包括4种剂型:两性霉素B脱氧胆酸盐、脂质体两性霉素B、两性霉素B胶体分散体以及两性霉素B脂质复合物。尽管不同剂型有效成分相同,但其在疗效、安全性和经济性方面可能存在差异。

目的

本研究旨在探讨不同剂型的两性霉素B在侵袭性真菌病(IFD)患者中的疗效、安全性及经济性差异。

方法

本研究为回顾性观察研究,纳入2023年6月—2025年3月河北医科大学第一医院接受两性霉素B治疗的71例IFD患者为研究对象,根据使用制剂类型分为两性霉素B脱氧胆酸盐组(AMB-D组,20例)、脂质体两性霉素B组(L-AMB组,20例)以及两性霉素B胶体分散体组(ABCD组,31例),收集患者临床数据资料,主要结局为IFD的有效缓解率。采用Kaplan-Meier生存曲线和Log-rank检验评估不同两性霉素B剂型的有效缓解率和不良事件对生存的影响。通过比较3组间肾损伤、肝损伤、低钾血症和血小板减少症发生率,评估用药安全性。通过比较总费用、日均费用和成本-效果分析评估药物经济性。

结果

共纳入71例患者,中位年龄为64.0(54.0,71.0)岁,其中男50例(70.4%),女21例(29.6%)。纳入患者的完全缓解率为26.8%(19/71)、部分缓解率为38.0%(27/71)、无效缓解率为35.2%(25/71)。AMB-D组、L-AMB组和ABCD组有效缓解率和无效缓解率比较,差异均无统计学意义(P>0.05);分层分析显示,3组中年龄61~83岁、女性、诊断确定性为拟诊患者的有效缓解率比较,差异均有统计学意义(P<0.05)。此外,在用药<3 d时,3组有效缓解率和完全缓解率比较,差异均有统计学意义(P<0.05);在用药>7 d时,3组有效缓解率比较差异有统计学意义(P<0.05)。71例患者中,49例(69.0%)患者出现不良事件,其中肾损伤31例(43.7%),肝损伤18例(25.4%),低钾血症9例(12.7%)和血小板减少症17例(23.9%)。生存分析结果显示,3组发生肾损伤、肝损伤、低钾血症和血小板减少症患者的生存时间比较,差异均无统计学意义(P>0.05)。3组总费用和日均费用比较,差异均有统计学意义(P均<0.01);且L-MBL组成分/效果值最高。

结论

两性霉素B不同剂型在疗效和经济性方面存在显著差异,因此需要根据患者的具体临床特征进行个体化选择。在整个治疗过程中,对肾功能进行严格监测仍至关重要。

关键词: 侵袭性真菌病, 两性霉素B, 肾毒性, 剂型, 回顾性队列研究

CLC Number: