Aerosol amphotericin B inhalations for prevention of invasive pulmonary aspergillosis in neutropenic cancer patients
Aerosol amphotericin B inhalations for prevention of invasive pulmonary aspergillosis in neutropenic cancer patients
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DOI：
10.1007/bf01697981
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发表时间：
1995-12-01
影响因子：
3.5
通讯作者：
Beyer, J
中科院分区：
文献类型：
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作者：
Behre, GF;Schwartz, S;Beyer, J
为了确定两性霉素B雾化吸入预防侵袭性肺曲霉菌病(IPA)的价值，我们启动了一项前瞻性随机多中心试验。计划的意向治疗中期分析包括115例(30%)急性髓系白血病、急性淋巴细胞性白血病/高度恶性非霍奇金淋巴瘤或接受自体干细胞移植的实体瘤患者化疗后中性粒细胞减少。65例患者随机接受两性霉素B气雾剂雾化吸入，每日2次，每次10 mg(A组)，其余50例患者未使用两性霉素B气雾剂(B组)，两性霉素B雾化吸入无严重副作用，但咳嗽(54%)、味道不佳(51%)和恶心(37%)可导致23%(15/65)的患者提前停用两性霉素B气雾剂。A组确诊、可能或可能发生IPA的发生率为5%(3/65)，而B组为12%(6/50)(p>；0.05)。A组65例患者中有5例(8%)出现细菌性肺炎，B组中有1例患者(2%)出现细菌性肺炎(p>；0.05)。因此，在这项中期分析中发现，预防性使用两性霉素B气雾剂没有降低IPA的发生率。由于喷雾剂两性霉素B预防没有严重的副作用，这项研究将继续对总共380名患者进行研究。
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, probable, 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.