Behre G F, Schwartz S, Lenz K, Ludwig W D, Wandt H, Schilling E, Heinemann V, Link H, Trittin A, Boenisch O
Department of Hematology/Oncology, University Hospital Göttingen, Germany.
Ann Hematol. 1995 Dec;71(6):287-91. doi: 10.1007/BF01697981.
To determine the value of aerosol amphotericin B inhalations for prevention of invasive pulmonary aspergillosis (IPA), we initiated a prospective randomized multicenter trial. The scheduled intent-to-treat interim analysis included 115 patients (30%) with prolonged neutropenia after chemotherapy for acute myeloid leukemia, acute lymphoblastic leukemia/high-grade non-Hodgkin's lymphoma, or solid tumors undergoing autologous stem cell transplantation. Sixty-five patients had been randomized to receive prophylactic aerosol amphotericin B inhalations at a dose of 10 mg twice daily (group A); for the remaining 50 patients no aerosol amphotericin B prophylaxis was used (group B). No serious side effects from amphotericin B inhalations occurred, but coughing (54%), bad taste (51%), and nausea (37%) caused early cessation of aerosol amphotericin B prophylaxis in 23% (15/65) of courses. In group A, the incidence of proven, probably, or possible IPA was 5% (3/65) as compared with 12% (6/50) in group B (p > 0.05). Microbiologically documented bacterial pneumonias were observed in 5/65 (8%) patients in group A and in 1/50 (2%) patients in group B (p > 0.05). Thus, no reduction in incidence of IPA from use of prophylactic aerosol amphotericin B inhalations was found in this interim analysis. As there were no serious side effects from aerosol amphotericin B prophylaxis, accrual in the study will continue for a total of 380 patients.
为了确定雾化吸入两性霉素B预防侵袭性肺曲霉病（IPA）的价值，我们开展了一项前瞻性随机多中心试验。计划的意向性治疗中期分析纳入了115例患者（占30%），这些患者因急性髓系白血病、急性淋巴细胞白血病/高级别非霍奇金淋巴瘤或接受自体干细胞移植的实体瘤接受化疗后出现长期中性粒细胞减少。65例患者被随机分配接受预防性雾化吸入两性霉素B，剂量为每日两次，每次10mg（A组）；其余50例患者未使用雾化两性霉素B进行预防（B组）。雾化吸入两性霉素B未出现严重副作用，但咳嗽（54%）、味觉不佳（51%）和恶心（37%）导致23%（15/65）的疗程提前停止雾化两性霉素B预防。A组中，确诊、很可能或可能的IPA发生率为5%（3/65），而B组为12%（6/50）（p>0.05）。A组5/65（8%）的患者和B组1/50（2%）的患者观察到微生物学记录的细菌性肺炎（p>0.05）。因此，在本次中期分析中未发现预防性雾化吸入两性霉素B可降低IPA的发生率。由于雾化两性霉素B预防未出现严重副作用，该研究将继续纳入总共380例患者。
