泊沙康唑与氟康唑或伊曲康唑预防嗜中性白血球减少症患者。
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科恩OA,梅尔滕斯J,温斯顿DJ,完美的J,乌尔曼AJ,沃尔什TJ, Helfgott D, Holowiecki J, Stockelberg D,吴作栋欧美,Petrini提出M, Hardalo C, Angulo-Gonzalez Suresh R D
泊沙康唑与氟康唑或伊曲康唑预防嗜中性白血球减少症患者。
郑传经地中海J。2007年1月25日,356 (4):348 - 59。
- PubMed ID
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17251531 (在PubMed]
- 文摘
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背景:急性早幼粒细胞白血病的化疗后中性粒细胞减少患者或高危骨髓增生异常综合征是难治性,常常是致命的侵袭性真菌感染。方法:随机、多中心研究涉及评估者不知道治疗任务,我们比较的有效性和安全性泊沙康唑与氟康唑或伊曲康唑作为长期嗜中性白血球减少症患者的预防。患者接受与每个周期的化疗,直到康复预防中性粒细胞减少和完全缓解,直到一个侵入性真菌感染发生,或长达12周,哪个是第一位的。我们比较证明或可能的侵袭性真菌感染的发生率治疗期间(主要终点)泊沙康唑与氟康唑或伊曲康唑组;死于任何原因死亡和时间是次要的结束点。结果:共有304名患者被随机分配接受泊沙康唑,和298名患者被随机分配接受氟康唑(240)或伊曲康唑(58)。证明或可能的侵袭性真菌感染被报道7例(2%),泊沙康唑组和25例(8%),氟康唑或伊曲康唑组(绝对减少泊沙康唑组-6%;95%置信区间,-9.7至-2.5%;P < 0.001),完成统计标准优势。泊沙康唑组显著减少患者侵袭性曲霉病(2(1%)和20 (7%),P < 0.001)。 Survival was significantly longer among recipients of posaconazole than among recipients of fluconazole or itraconazole (P=0.04). Serious adverse events possibly or probably related to treatment were reported by 19 patients (6%) in the posaconazole group and 6 patients (2%) in the fluconazole or itraconazole group (P=0.01). The most common treatment-related adverse events in both groups were gastrointestinal tract disturbances. CONCLUSIONS: In patients undergoing chemotherapy for acute myelogenous leukemia or the myelodysplastic syndrome, posaconazole prevented invasive fungal infections more effectively than did either fluconazole or itraconazole and improved overall survival. There were more serious adverse events possibly or probably related to treatment in the posaconazole group. (ClinicalTrials.gov number, NCT00044486 [ClinicalTrials.gov].).
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