Patients with AL or MDS undergoing chemotherapy were randomized to open-label micafungin 100 mg intravenously daily or posaconazole suspension 400 mg orally twice daily until neutrophil recovery, up to 28 days. Patients were followed for 12 weeks. The primary endpoint was prophylaxis failure (premature discontinuation due to infection, intolerance, adverse event, or death). Time to failure and survival were calculated by Kaplan-Meier analysis.
From March 2011 to May 2016, 113 patients who received at least 2 doses of prophylaxis were analyzed (58 patients randomized to micafungin and 55 to posaconazole). Prophylaxis failure occurred in 34.5% and 52.7% of patients on micafungin and posaconazole, respectively (P = 0.0118). The median number of days on prophylaxis was 16 [interquartile range (IQR) 12-20] for micafungin and 13 [IQR 6-16] for posaconazole (P = 0.01). Micafungin failures were largely due to antifungal treatment; posaconazole failures were mostly due to gastrointestinal intolerance or adverse effects. IFI incidence and survival were similar between study arms.
Our data support micafungin as alternative antifungal prophylaxis in patients with AL and MDS.
接受化疗的AL或MDS患者随机接受开放标签米卡芬净100mg,每日静脉注射或口服泊沙康唑悬浮液400mg,每日两次,直至中性粒细胞恢复。长达28天。患者随访12周。主要终点是预防失败(由于感染而过早停药,不容忍,不良事件,或死亡)。通过Kaplan-Meier分析计算失败时间和生存期。
从2011年3月至2016年5月,对113名接受至少2剂预防的患者进行了分析(58名患者随机接受米卡芬净治疗,55名患者接受泊沙康唑治疗)。使用米卡芬净和泊沙康唑的患者中,有34.5%和52.7%的患者发生了预防失败,分别(P=0.0118)。米卡芬净的预防天数中位数为16[四分位数间距(IQR)12-20],泊沙康唑为13[IQR6-16](P=0.01)。米卡芬净失败主要是由于抗真菌治疗;泊沙康唑失败主要是由于胃肠道不耐受或不良反应。研究组之间的FI发生率和生存率相似。
我们的数据支持米卡芬净作为AL和MDS患者的替代抗真菌预防。