注射用两性霉素B胆固醇硫酸酯复合物挽救治疗侵袭性真菌病的安全性和有效性  

Safety and efficacy of amphotericin B colloidal dispersion in the salvage treatment of invasive fungal disease

作　　者：曹易耕 陈兵[2] 史鹏程[3] 杨继龙[4] 何祎 魏嘉璘 庞爱明 杨栋林 马巧玲 张荣莉 翟卫华 陈欣 冯四洲 韩明哲 姜尔烈 CAO Yigeng;CHEN Bing;SHI Pengcheng;YANG Jilong;HE Yi;WEI Jialin;PANG Aiming;YANG Donglin;MA Qiaoling;ZHANG Rongli;ZHAI Weihua;CHEN Xin;FENG Sizhou;HAN Mingzhe;JIANG Erlie(Hematopoietic Stem Cell Transplantation Center,Institute of Hematology&Blood Diseases Hospital,Chinese Academy of Medical Sciences,Tianjin 300020,China)

机构地区：[1]中国医学科学院血液病医院(中国医学科学院血液学研究所)干细胞移植中心,天津300020 [2]南京大学医学院附属鼓楼医院血液科 [3]南方医科大学南方医院血液科 [4]南方医科大学珠江医院血液内科

出　　处：《中国感染与化疗杂志》2023年第4期443-448,共6页Chinese Journal of Infection and Chemotherapy

基　　金：天津市自然科学基金面上项目(TJWJ2022MS001)。

摘　　要：目的评价注射用两性霉素B胆固醇硫酸酯复合物(ABCD)挽救治疗侵袭性真菌病(IFD)的安全性和有效性。方法回顾性收集既往抗真菌治疗失败后在2021年4—8月间接受ABCD治疗的106例患者资料。统计患者基本信息、临床结局以及ABCD相关不良反应指标。结果106例患者中,ABCD相关不良反应主要为输液反应,包括寒颤(60.4%)、发热(54.7%)和畏寒(11.3%)。不良反应多为1~2级。106例患者的ABCD挽救治疗有效率为85.8%(91例,95%CI:77.7%~91.9%)。其中,确诊/临床诊断IFD患者有效率为92.6%(25/27,95%CI:75.7%~99.1%),包括毛霉病(9例)、肺曲霉病(5例)、隐球菌性脑膜脑炎(5例)、马尔尼菲篮状菌病(3例)、肺念珠菌病(2例)患者治疗均有效,3例念珠菌血症患者中的1例治疗有效。7例既往接受过多烯类抗真菌药物治疗的确诊/临床诊断IFD患者挽救治疗均有效。此外,确诊/临床诊断IFD患者6周内均为生存状态。结论ABCD治疗IFD安全可耐受,肾毒性较低,用于既往抗真菌治疗不耐受或无效患者仍可有效。Objective To evaluate the safety and efficacy of amphotericin B colloidal dispersion(ABCD)in the salvage treatment of invasive fungal disease(IFD).Methods A total of 106 patients who received ABCD salvage therapy from April to August 2021 after failure of previous antifungal therapy were reviewed and analyzed retrospectively.The demographic and clinical data and ABCD-related adverse reactions were summarized with descriptive statistics.Results Transfusion reactions were the most common ABCD-related adverse events in the 106 patients,including chills(60.4%),fever(54.7%)and fear of cold(11.3%).Most of the adverse reactions were grade 1 or 2.The efficacy rate of ABCD treatment was 85.8%(91/106,95%CI:77.7%-91.9%)in all of the patients,and 92.6%(25/27,95%CI:75.7%-99.1%)in the patients with proven/probable IFD,including mucormycosis(n=9),invasive pulmonary aspergillosis(n=5),cryptococcal meningitis(n=5),talaromycosis(n=3),pulmonary moniliasis(n=2),and one of three patients with candidemia.ABCD salvage treatment succeeded in all of the seven patients with proven/probable IFD who received prior polyene antifungal therapies.All patients with proven/probable IFD were alive within 6 weeks after ABCD treatment.Conclusions ABCD is safe and well-tolerated in the treatment of IFD with low renal toxicity.ABCD salvage treatment is also effective in patients who are intolerant of or failed to prior antifungal therapy.

关 键 词：侵袭性真菌病 注射用两性霉素B胆固醇硫酸酯复合物 安全性 有效性 

分 类 号：R978.5[医药卫生—药品] R519[医药卫生—药学]