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

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. METHODS: 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. RESULTS: 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. CONCLUSION: Treatment of invasive fungal illness in conjunction with hematological malignancies showed good efficacy and safety with amphotericin B cholesteryl sulfate complex for injection.