两性霉素B脂质体挽救性治疗80例血液病患者侵袭性真菌病临床疗效分析

Clinical efficacy and safety of liposomal amphotericin B in the salvage treatment of invasive fungal disease in patients with hematological diseases

目的探究两性霉素B脂质体(Liposomal amphotericin B,L-AmB)在血液病患者中挽救性治疗侵袭性真菌病(invasive fungal disease,IFD)的疗效及安全性。方法回顾性收集既往抗真菌治疗失败后2023年6月至2023年12月期间于苏州弘慈血液病医院血液科接受L-AmB治疗的80例血液病患者资料。统计患者基本信息、临床疗效,应用Logistic回归分析影响L-AmB疗效的因素。结果80例血液病患者中,确诊IFD 9例(11.2%),临床诊断IFD 43例(53.8%),拟诊IFD 28例(35.0%)。L-AmB挽救性治疗有效率为77.5%,中位每日剂量3(1~5)mg·kg^(-1)·d^(-1),中位用药疗程14(8,25)d。多因素Logistic回归分析显示:疾病缓解状态(OR=4.337,95%CI 1.167~16.122,P=0.029)和用药疗程(OR=1.127,95%CI 1.029~1.234,P=0.010)是影响L-AmB疗效的独立因素。L-AmB相关输液反应包括发热和寒战(5.0%)。低钾血症发生率为28.8%,主要为1~2级。肾毒性发生率为11.3%,主要为1~2级。结论L-AmB治疗既往抗真菌治疗不耐受或无效的IFD患者安全有效,不良反应率低。

Objective:To investigate the efficacy and safety of liposomal amphotericin B(L-AmB)for the salvage treatment of invasive fungal disease(IFD)in patients with hematological diseases.Methods:Data were retrospectively collected from 80 patients with hematological issues treated with L-AmB between June 2023 and December 2023 after failure of previous antifungal therapy.Baseline patient information,clinical efficacy,and factors affecting the efficacy of L-AmB were analyzed by logistic regression.Moreover,adverse effects associated with L-AmB were evaluated.Results:Among the 80 patients,9(11.2%)had proven IFD,43(53.8%)had probable IFD,and 28(35.0%)had possible IFD.The efficacy rate of L-AmB salvage therapy for IFD was 77.5%,with a median daily dose of 3(range:1-5)mg·kg^(-1)·d^(-1) and a median dosing course of 14(range:8-25)days.Multivariate logistic regression analysis showed that the disease remission status(OR=4.337,95%CI 1.167-16.122,P=0.029)and duration of medication(OR=1.127,95%CI 1.029-1.234,P=0.010)were independent factors affecting the efficacy of L-AmB.The incidence of infusion reactions associated with L-AmB,including fever and chills,was 5.0%.The incidence of hypokalemia was 28.8%(predominantly grades 1-2),and the incidence of nephrotoxicity was 11.3%(predominantly grades 1-2).Conclusion:L-AmB is safe and effective in the treatment of patients with IFD who are intolerant to or who have experienced no effect of previous antifungal therapy,with a low rate of adverse reactions.