Ellis M, Spence D, de Pauw B, Meunier F, Marinus A, Collette L, Sylvester R, Meis J, Boogaerts M, Selleslag D, Krcmery V, von Sinner W, MacDonald P, Doyen C, Vandercam B
European Organisation for Research and Treatment of Cancer (EORTC), Invasive Fungal Infections Cooperative Group, Brussels, Belgium.
Clin Infect Dis. 1998 Dec;27(6):1406-12. doi: 10.1086/515033.
This is the first completed prospective randomized clinical efficacy trial of antifungals in the treatment of invasive aspergillosis (IA) and the first to compare the clinical efficacy of two dosages of liposomal amphotericin B (L-AmB) for IA in neutropenic patients with cancer or those undergoing bone marrow transplantation. Eighty-seven of 120 patients were eligible and evaluable. Clinical responses were documented for 26 (64%) of 41 patients receiving 1 mg/(kg.d) (L-AmB-1) and 22 (48%) of 46 receiving 4 mg/(kg.d) (L-AmB-4). Radiologic response rates were similar: 24 (58%) of the L-AmB-1 recipients and 24(52%) of the L-AmB-4 recipients. The six-month survival rates were 43% (L-AmB-1) and 37% (L-AmB-4). These differences were not significant. The numbers of deaths directly due to IA at 6 months were similar: 9 (22%) of 41 L-AmB-1 recipients and 9 (20%) of 46 L-AmB-4 recipients. No other variable independently influenced survival, apart from central nervous system IA. L-AmB is effective in treating approximately 50%-60% of patients who have IA. A 1-mg/(kg.d) dosage is as effective as a 4-mg/(kg.d) dosage, and no advantages to use of the higher, more expensive, dosage has been observed.
这是第一项完成的抗真菌药物治疗侵袭性曲霉病（IA）的前瞻性随机临床疗效试验，也是第一项比较两种剂量的两性霉素B脂质体（L-AmB）对癌症中性粒细胞减少患者或接受骨髓移植患者IA临床疗效的试验。120例患者中有87例符合条件且可进行评估。接受1mg/（kg·d）（L-AmB-1）的41例患者中有26例（64%）记录到临床反应，接受4mg/（kg·d）（L-AmB-4）的46例患者中有22例（48%）记录到临床反应。放射学反应率相似：L-AmB-1组接受者中有24例（58%），L-AmB-4组接受者中有24例（52%）。六个月生存率分别为43%（L-AmB-1）和37%（L-AmB-4）。这些差异不显著。6个月时直接死于IA的人数相似：41例L-AmB-1接受者中有9例（22%），46例L-AmB-4接受者中有9例（20%）。除中枢神经系统IA外，没有其他变量独立影响生存率。L-AmB对约50%-60%患有IA的患者有效。1mg/（kg·d）的剂量与4mg/（kg·d）的剂量效果相同，未观察到使用更高、更昂贵剂量的优势。
