Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia
Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia
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DOI：
10.1056/nejmoa061094
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发表时间：
2007-01-25
影响因子：
158.5
通讯作者：
Angulo-Gonzalez, David
中科院分区：
文献类型：
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作者：
Cornely, Oliver A.;Maertens, Johan;Angulo-Gonzalez, David
背景：急性髓细胞白血病或骨髓增生异常综合征化疗导致中性粒细胞减少的患者，是难以治疗的，往往是致命的侵袭性真菌infections.METHODS：在这个随机，多中心研究涉及评估谁不知道治疗分配，我们比较了泊沙康唑的疗效和安全性与氟康唑或伊曲康唑作为预防患者长期中性粒细胞减少。患者在每个化疗周期接受预防性治疗，直至中性粒细胞减少症恢复和完全缓解，直至发生侵袭性真菌感染，或长达12周，以先发生者为准。我们比较了泊沙康唑组和氟康唑组或伊曲康唑组在治疗过程中（主要终点）证实或可能的侵袭性真菌感染的发生率;任何原因的死亡和死亡时间是次要终点。结果：共有304例患者被随机分配接受泊沙康唑，298例患者被随机分配接受氟康唑（240）或伊曲康唑（58）。泊沙康唑组7例（2%）和氟康唑或伊曲康唑组25例（8%）报告了严重或可能的侵袭性真菌感染（泊沙康唑组绝对减少，-6%; 95%置信区间，-9.7至-2.5%; P
BACKGROUND:Patients with neutropenia resulting from chemotherapy for acute myelogenous leukemia or the myelodysplastic syndrome are at high risk for difficult-to-treat and often fatal invasive fungal infections.METHODS:In this randomized, multicenter study involving evaluators who were unaware of treatment assignments, we compared the efficacy and safety of posaconazole with those of fluconazole or itraconazole as prophylaxis for patients with prolonged neutropenia. Patients received prophylaxis with each cycle of chemotherapy until recovery from neutropenia and complete remission, until occurrence of an invasive fungal infection, or for up to 12 weeks, whichever came first. We compared the incidence of proven or probable invasive fungal infections during treatment (the primary end point) between the posaconazole and fluconazole or itraconazole groups; death from any cause and time to death were secondary end points.RESULTS:A total of 304 patients were randomly assigned to receive posaconazole, and 298 patients were randomly assigned to receive fluconazole (240) or itraconazole (58). Proven or probable invasive fungal infections were reported in 7 patients (2%) in the posaconazole group and 25 patients (8%) in the fluconazole or itraconazole group (absolute reduction in the posaconazole group, -6%; 95% confidence interval, -9.7 to -2.5%; P