BACKGROUND:Posaconazole is approved for invasive fungal infection prophylaxis in patients with hematologic malignancies. Posaconazole suspension is plagued by poor oral absorption and dietary requirements that are difficult for patients to meet. The delayed-release tablet formulation of posaconazole may be taken without regards to meals and has significantly better oral absorption than posaconazole suspension. OBJECTIVES:We sought to determine if a switch to posaconazole tablets improved steady-state drug level attainment for invasive fungal infection prophylaxis in patients with acute myeloid leukemia. METHODS:All adult inpatients with acute myeloid leukemia undergoing chemotherapy, who received posaconazole for invasive fungal infection prophylaxis between 2012 and 2015, were included. The primary outcome was proportion of patients with first posaconazole level greater than 700 ng/mL. Secondary outcomes included proportion of patients with first posaconazole level greater than 1000 ng/mL, invasive fungal infection within 100 days, and adverse drug events. RESULTS:Forty patients received posaconazole tablets and 34 patients received suspension. Posaconazole levels were significantly higher at first measurement in patients receiving tablet than suspension (1296 ng/mL vs. 788 ng/mL, p < 0.01). Thirty-seven patients receiving tablets had a serum drug level greater than 700 ng/mL on first measurement versus 18 receiving suspension (p < 0.01). Patients receiving tablets were also more likely to have a serum drug level over 1000 ng/mL on first measurement (26 vs. 11, p < 0.01). Rates of invasive fungal infection and adverse events were not statistically different. CONCLUSIONS:Patients receiving posaconazole tablets attained significantly higher serum drug levels than those receiving suspension.

译文

背景:泊沙康唑被批准用于血液系统恶性肿瘤患者的侵入性真菌感染预防。泊沙康唑悬浮液的口服吸收不良和饮食需求使患者难以满足。泊沙康唑的缓释片剂可在不考虑进餐的情况下服用,并且口服吸收比泊沙康唑悬浮液要好得多。
目的:我们试图确定使用泊沙康唑片是否可以改善预防急性髓性白血病患者侵袭性真菌感染的稳态药物水平。
方法:纳入2012年至2015年期间接受泊沙康唑预防侵入性真菌感染的所有接受化疗的急性髓性白血病成人患者。主要结局是首次泊沙康唑水平高于700μng/ mL的患者比例。次要结果包括首次泊沙康唑水平大于1000µng / mL,100天内侵袭性真菌感染以及药物不良反应的患者比例。
结果:40例患者接受泊沙康唑片治疗; 34例患者接受悬浮液治疗。首次接受片剂的患者中,泊沙康唑的水平明显高于混悬液(1296 ng / mL vs. 788 ng / mL,p <0.01)。初次测量时有37例接受片剂治疗的患者血清药物水平高于700μng/ mL,而接受悬浮液的有18例患者(p <0.01)。首次服用片剂的患者血清药物水平也更有可能超过1000μng/ mL(26 vs. 11,p <0.01)。侵袭性真菌感染和不良事件的发生率在统计学上没有差异。
结论:接受泊沙康唑片剂的患者血清药物水平明显高于接受悬浮液治疗的患者。

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