Dipartimento di Ematologia, Oncologia, Anatomia Patologica e Medicina Rigenerative, Azienda Policlinico Umberto I, Sapienza University of Rome Via Benevento 6, 00161 Rome, Italy.
Haematologica. 2012 Apr;97(4):560-7. doi: 10.3324/haematol.2011.053058. Epub 2011 Nov 18.
Posaconazole is effective as primary antifungal prophylaxis of invasive fungal diseases in patients with acute myeloid leukemia.
The impact of primary antifungal prophylaxis administered during front-line chemotherapy for acute myeloid leukemia was evaluated by comparing 58 patients who received oral amphotericin B (control group) to 99 patients who received oral posaconazole (posaconazole group). The primary endpoint was the incidence of proven/probable invasive fungal diseases. Secondary endpoints included incidence of invasive aspergillosis, survival at 4 and 12 months after the diagnosis of acute myeloid leukemia and costs.
Proven/probable invasive fungal diseases were documented in 51.7% of patients in the control group and in 23.2% in the posaconazole group (P=0.0002). Invasive aspergillosis was documented in 43% of patients in the control group and in 15% in the posaconazole group (P=0.002). No survival difference was observed in patients aged over 60 years. In patients aged 60 years or less, a statistically significant survival advantage was observed at 4 months, but no longer at 12 months, in the posaconazole group (P=0.03). It was calculated that in the posaconazole group there was a mean 50% cost reduction for the antifungal drugs.
Primary antifungal prophylaxis with posaconazole during front-line chemotherapy was effective in preventing invasive fungal diseases in a "real-life" scenario of patients with acute myeloid leukemia, resulted in an early but transitory survival advantage in younger patients and was economically advantageous.
泊沙康唑作为急性髓系白血病患者侵袭性真菌感染的一线预防治疗药物，具有确切疗效。
通过比较 58 例接受口服两性霉素 B（对照组）与 99 例接受口服泊沙康唑（泊沙康唑组）的患者，评估急性髓系白血病一线化疗时进行预防性抗真菌治疗的影响。主要终点是确诊/疑似侵袭性真菌感染的发生率。次要终点包括侵袭性曲霉菌病的发生率、急性髓系白血病确诊后 4 个月和 12 个月的生存率以及成本。
对照组患者中有 51.7%确诊/疑似侵袭性真菌感染，泊沙康唑组为 23.2%（P=0.0002）。对照组中有 43%的患者确诊侵袭性曲霉菌病，泊沙康唑组为 15%（P=0.002）。60 岁以上患者的生存率无差异。60 岁及以下患者中，泊沙康唑组在 4 个月时有统计学显著的生存优势，但在 12 个月时无优势（P=0.03）。计算结果表明，在泊沙康唑组中，抗真菌药物的平均成本降低了 50%。
在一线化疗中使用泊沙康唑进行预防性抗真菌治疗，在急性髓系白血病患者的“真实世界”环境中能有效预防侵袭性真菌感染，在年轻患者中产生早期但短暂的生存优势，且具有经济效益。
