Wang J, Jin S, Wu X J, Miao M, Tang X W, He X F, Qiu H Y, Han Y, Wang Y, Li W Y, Li C X, Xue S L, Ma X, Wu D P
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.
Zhonghua Xue Ye Xue Za Zhi. 2022 Oct 14;43(10):848-852. doi: 10.3760/cma.j.issn.0253-2727.2022.10.008.
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. This 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. 30 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. Treatment of invasive fungal illness in conjunction with hematological malignancies showed good efficacy and safety with amphotericin B cholesteryl sulfate complex for injection.
评估注射用两性霉素B胆固醇硫酸酯复合物在血液系统恶性肿瘤合并侵袭性真菌病患者的经验性和诊断性抗真菌治疗中的安全性和有效性。这项单臂临床研究纳入了30例接受血液系统恶性肿瘤合并侵袭性真菌病经验性和诊断驱动抗真菌治疗的患者。主要终点是安全性。缓解率、发热持续时间和治疗完成率均被视为次要目标。最终有30名参与者纳入研究,治疗完成率为80.0%。大多数不良事件为1-2级。输注反应是最常见的不良事件(24/30,80%)。总缓解率为80.0%(24/30)。24例患者(80.0%)发热持续1天。注射用两性霉素B胆固醇硫酸酯复合物联合治疗血液系统恶性肿瘤合并侵袭性真菌病显示出良好的疗效和安全性。