Glasmacher A, Molitor E, Hahn C, Bomba K, Ewig S, Leutner C, Wardelmann E, Schmidt-Wolf I G, Mezger J, Marklein G, Sauerbruch T
Medizinische Klinik und Poliklinik, Rheinische Friedrich-Wilhelms-Universität, Bonn, Germany.
Leukemia. 1998 Sep;12(9):1338-43. doi: 10.1038/sj.leu.2401137.
The efficacy of antifungal prophylaxis with itraconazole capsules and its serum concentrations were evaluated in patients intensively treated for acute leukaemia. A consecutive group of patients without systemic antifungal prophylaxis (January 1993 to August 1994, period 1) was compared with another consecutive group of patients (period 2) who received itraconazole capsules (September 1994 to April 1995 400 mg/day, from May 1995 onwards 600 mg/day). All patients admitted with acute leukaemia and standard or high-dose chemotherapy were included into the study. Clinical endpoint was mortality from proven fungal infection. Seventy-six patients and 148 courses of cytotoxic chemotherapy were analysed in the control group as well as 47 patients and 112 treatment courses in the intervention group. Antifungal prophylaxis led to a significant decrease of mortality from invasive fungal infections (8.8%-0.9%, P = 0.005). The median trough concentration of itraconazole of all measurements was 520 ng/ml (range 230-793) in patients who received 400 mg/day and 760 ng/ml (370-1200) in patients receiving a dosage of 600 mg/day (P = 0.002). These findings suggest that itraconazole is an effective drug for antifungal prophylaxis but also that a considerable number of patients do not reach the desired trough levels (>500 ng/ml) with itraconazole capsules.
在接受强化治疗的急性白血病患者中，评估了伊曲康唑胶囊的抗真菌预防效果及其血清浓度。将一组未接受全身抗真菌预防的连续患者（1993年1月至1994年8月，第1阶段）与另一组连续患者（第2阶段）进行比较，后者接受伊曲康唑胶囊治疗（1994年9月至1995年4月，400毫克/天，从1995年5月起600毫克/天）。所有因急性白血病入院并接受标准或高剂量化疗的患者均纳入研究。临床终点为确诊真菌感染导致的死亡率。对照组分析了76例患者和148个疗程的细胞毒性化疗，干预组分析了47例患者和112个疗程。抗真菌预防使侵袭性真菌感染导致的死亡率显著降低（8.8%-0.9%，P = 0.005）。接受400毫克/天的患者所有测量中伊曲康唑的中位谷浓度为520纳克/毫升（范围230-793），接受600毫克/天剂量的患者为760纳克/毫升（370-1200）（P = 0.002）。这些发现表明伊曲康唑是一种有效的抗真菌预防药物，但也有相当数量的患者使用伊曲康唑胶囊未达到所需的谷浓度（>500纳克/毫升）。
