注射用两性霉素B胆固醇硫酸酯复合物治疗血液系统恶性肿瘤合并侵袭性真菌病30例临床分析  

Clinical analysis of amphotericin B cholesteryl sulfate complex for injection in the treatment of invasive fungal disease for patients with hematological malignancies in 30 cases

作　　者：王俊[1] 金松[1] 吴小津[1] 苗瞄[1] 唐晓文[1] 何雪峰[1] 仇惠英[1] 韩悦[1] 王荧[1] 李渭阳[1] 李彩霞[1] 薛胜利[1] 马骁[1] 吴德沛[1] Wang Jun;Jin Song;Wu Xiaojin;Miao Miao;Tang Xiaowen;He Xuefeng;Qiu Huiying;Han Yue;Wang Ying;Li Weiyang;Li Caixia;Xue Shengli;Ma Xiao;Wu Depei(National Clinical Research Center for Blood Diseases,Jiangsu Institute of Hematology,the First Affiliated Hospital of Soochow University,Institute of Blood and Marrow Transplantation,Soochow University,Jiangsu 215006,China)

机构地区：[1]国家血液系统疾病临床医学研究中心,江苏省血液研究所,苏州大学附属第一医院血液科,苏州大学造血干细胞移植研究所,苏州215006

出　　处：《中华血液学杂志》2022年第10期848-852,共5页Chinese Journal of Hematology

摘　　要：目的评价注射用两性霉素B胆固醇硫酸酯复合物(ABCD)经验治疗和诊断驱动治疗血液系统恶性肿瘤合并侵袭性真菌病患者的安全性和有效性。方法纳入30例2021年6月至2021年8月在苏州大学附属第一医院与苏州弘慈血液病医院接受ABCD经验治疗和诊断驱动治疗的血液系统恶性肿瘤合并侵袭性真菌病患者。主要研究终点为安全性。次要研究终点包括治疗有效率、发热持续时间和ABCD治疗完成率。结果共纳入30例患者,24例(80.0%)完成了ABCD治疗。不良反应多为1~2级,其中输液反应(24/30,80.0%)为最常见的不良反应。总体治疗有效率为80.0%(24/30)。全部患者中,24例(80.0%)发热持续时间为1 d。结论ABCD治疗血液系统恶性肿瘤合并侵袭性真菌病具有较好的疗效及安全性。Objective To assess the safety and effectiveness of amphotericin B cholesteryl sulfate complex for injection in the context of empirical and diagnostic antifungal therapy for patients with hematological malignancies in addition to invasive fungal illness.MethodsThis single-arm clinical study enrolled 30 patients who received empirical and diagnostic-driven antifungal therapy for hematological malignancies combined with invasive fungal disease.The primary endpoint was safety.Response rate,fever duration,and treatment completion rate were all considered secondary objectives.Results30 participants were eventually enrolled in the study,and the treatment completion rate was 80.0%.Most adverse events were in grades 1-2.Infusion response was the most frequent adverse event(24/30,80%).The overall response rate was 80.0%(24/30).In 24 patients(80.0%),the fever persisted for 1 day.Conclusions Treatment of invasive fungal illness in conjunction with hematological malignancies showed good efficacy and safety with amphotericin B cholesteryl sulfate complex for injection.

关 键 词：侵袭性真菌病 两性霉素B胆固醇硫酸酯复合物 经验治疗 诊断驱动治疗 

分 类 号：R733[医药卫生—肿瘤] R519[医药卫生—临床医学]