Riley D K, Pavia A T, Beatty P G, Petersen F B, Spruance J L, Stokes R, Evans T G
Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City 84132.
Am J Med. 1994 Dec;97(6):509-14. doi: 10.1016/0002-9343(94)90345-x.
To evaluate the efficacy of prophylactic low-dose amphotericin B (0.1 mg/kg per day) (LDA) in preventing fungal infections in patients who have had a bone marrow transplant (BMT).
Double-blind, randomized, controlled trial in which patients undergoing bone marrow transplantation received intravenous LDA or similar-appearing placebo from the onset of neutropenia until the absolute neutrophil count remained > 0.5 x 10(9)/L, or until high-dose amphotericin B was initiated. Weekly surveillance cultures were obtained from all patients.
Five of 18 patients (28%) randomized to placebo developed documented systemic fungal infections within the first 30 days after transplantation, compared to none of 17 patients who received LDA (P = 0.045). LDA recipients received fewer days of high-dose amphotericin B (P = 0.04) and fewer days of antibiotics (P = 0.008). There were trends towards fewer days of hospitalization (P = 0.14) and improved survival (P = 0.08); these differences were statistically significant among recipients of allogeneic BMT. No adverse effects occurred with LDA therapy.
LDA appears to be safe and to reduce early systemic fungal infections in BMT recipients. Improved survival was observed among LDA recipients, but this was not directly attributable to the prevention of fungal infection.
评估预防性低剂量两性霉素B（每天0.1mg/kg）（LDA）在预防骨髓移植（BMT）患者真菌感染中的疗效。
双盲、随机、对照试验，骨髓移植患者从中性粒细胞减少开始直至绝对中性粒细胞计数保持>0.5×10⁹/L或开始使用高剂量两性霉素B，接受静脉注射LDA或外观相似的安慰剂。所有患者每周进行监测培养。
随机分配至安慰剂组的18例患者中有5例（28%）在移植后的前30天内发生了有记录的系统性真菌感染，而接受LDA的17例患者中无一例发生（P = 0.045）。接受LDA的患者接受高剂量两性霉素B的天数较少（P = 0.04），使用抗生素的天数也较少（P = 0.008）。住院天数有减少趋势（P = 0.14），生存率有提高趋势（P = 0.08）；这些差异在异基因BMT受者中具有统计学意义。LDA治疗未出现不良反应。
LDA似乎是安全的，可减少BMT受者早期系统性真菌感染。观察到接受LDA的患者生存率有所提高，但这并非直接归因于真菌感染的预防。
