White M H, Bowden R A, Sandler E S, Graham M L, Noskin G A, Wingard J R, Goldman M, van Burik J A, McCabe A, Lin J S, Gurwith M, Miller C B
Infectious Disease Service, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Clin Infect Dis. 1998 Aug;27(2):296-302. doi: 10.1086/514672.
We conducted a prospective, randomized, double-blind study comparing amphotericin B colloidal dispersion (ABCD) with amphotericin B in the empirical treatment of fever and neutropenia. Patients with neutropenia and unresolved fever after > or = 3 days of empirical antibiotic therapy were stratified by age and concomitant use of cyclosporine or tacrolimus. Patients were then randomized to receive therapy with ABCD (4 mg/[kg.d]) or amphotericin B (0.8 mg/[kg.d]) for < or = 14 days. A total of 213 patients were enrolled, of whom 196 were evaluable for efficacy. Fifty percent of ABCD-treated patients and 43.2% of amphotericin B-treated patients had a therapeutic response (P = .31). Renal dysfunction was less likely to develop and occurred later in ABCD recipients than in amphotericin B recipients (P < .001 for both parameters). Infusion-related hypoxia and chills were more common in ABCD recipients than in amphotericin B recipients (P = .013 and P = .018, respectively). ABCD appeared comparable in efficacy with amphotericin B, and renal dysfunction associated with ABCD was significantly less than that associated with amphotericin B. However, infusion-related events were more common with ABCD treatment than with amphotericin B treatment.
我们进行了一项前瞻性、随机、双盲研究，比较两性霉素B胶体分散体（ABCD）与两性霉素B在发热伴中性粒细胞减少症经验性治疗中的效果。在接受≥3天经验性抗生素治疗后仍有中性粒细胞减少症且发热未缓解的患者，按年龄以及是否同时使用环孢素或他克莫司进行分层。然后将患者随机分为接受ABCD（4mg/[kg·d]）或两性霉素B（0.8mg/[kg·d]）治疗≤14天。总共招募了213例患者，其中196例可评估疗效。接受ABCD治疗的患者中有50%以及接受两性霉素B治疗的患者中有43.2%有治疗反应（P = 0.31）。与接受两性霉素B的患者相比，接受ABCD的患者发生肾功能障碍的可能性较小且发生时间较晚（两个参数的P均<0.001）。与接受两性霉素B的患者相比，接受ABCD的患者中与输液相关的低氧血症和寒战更为常见（分别为P = 0.013和P = 0.018）。ABCD在疗效上似乎与两性霉素B相当，且与ABCD相关的肾功能障碍明显少于与两性霉素B相关的肾功能障碍。然而，与两性霉素B治疗相比，ABCD治疗时与输液相关的事件更为常见。
