EFFICACY AND SAFETY OF FLUCONAZOLE PROPHYLAXIS FOR FUNGAL-INFECTIONS AFTER MARROW TRANSPLANTATION - A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND-STUDY

EFFICACY AND SAFETY OF FLUCONAZOLE PROPHYLAXIS FOR FUNGAL-INFECTIONS AFTER MARROW TRANSPLANTATION - A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND-STUDY
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DOI:
10.1093/infdis/171.6.1545
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发表时间:
1995-06-01
影响因子:
6.4
通讯作者:
BOWDEN, RA
BOWDEN, RA
中科院分区:
医学2区
文献类型:
--
作者:
SLAVIN, MA;OSBORNE, B;BOWDEN, RA

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一项随机、双盲、安慰剂对照试验评估了400 mg/d氟康唑预防骨髓移植后前75天内真菌感染的疗效和毒性。在预防期间,152例氟康唑治疗患者中有10例(7%)发生全身真菌感染,而148例安慰剂治疗患者中有26例(18氟康唑组无白色念珠菌感染,而安慰剂组为18例(P <0.001),除念珠菌外,其他念珠菌感染无显著增加。氟康唑还可明显降低浅表真菌感染的发生率(P < .001),真菌定植(P = 0.037),经验性阿替西霉素B使用(P = 0.005),氟康唑组移植后110天死亡31例,安慰剂组52例,存活率提高(P = 0.004),使用氟康唑未检测到临床显著毒性,预防性氟康唑是安全的,显著减少全身真菌感染,并具有其他益处,包括改善骨髓移植后110天的存活率。
A randomized, double-blind, placebo-controlled trial assessed the efficacy and toxicity of 400 mg/day fluconazole in preventing fungal infections during the first 75 days after marrow transplantation, During prophylaxis, systemic fungal infections occurred in 10 (7%) of 152 fluconazole-treated patients compared with 26 (18%) of 148 placebo-treated patients (P = .004), There were no Candida albicans infections in fluconazole recipients compared with 18 in placebo recipients (P < .001) and no significant increase in Candida infections other than C. albicans, Fluconazole also significantly reduced the incidence of superficial fungal infections (P < .001), fungal colonization (P = .037), and empiric amphotericin B use (P = .005), The probability of survival was improved in fluconazole recipients, in whom 31 deaths occurred up to day 110 after transplantation compared with 52 deaths in placebo recipients (P = .004), No clinically significant toxicity was detected with fluconazole use, Prophylactic fluconazole was safe and significantly reduced systemic fungal infections with other benefits, including improved survival at day 110 after marrow transplantation.