Liposomal amphotericin B in combination with caspofungin for invasive aspergillosis in patients with hematologic malignancies -: A randomized pilot study (Combistrat trial)
Liposomal amphotericin B in combination with caspofungin for invasive aspergillosis in patients with hematologic malignancies -: A randomized pilot study (Combistrat trial)
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DOI：
10.1002/cncr.23109
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发表时间：
2007-12-15
期刊：
影响因子：
6.2
通讯作者：
Mahi, Lamine
中科院分区：
文献类型：
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作者：
Caillot, Denis;Thiebaut, Anne;Mahi, Lamine
背景侵袭性曲霉病（IA）在免疫功能低下的患者中预后不良。作用于不同靶点的药物组合有望提高单独化合物的临床疗效。在一项前瞻性、开放性初步研究中，确诊或可能患有IA的患者被随机分配接受标准剂量（每日3 mg/kg）的脂质体阿替霉素B（Am B）和标准剂量的卡泊芬净联合治疗或高剂量Am B方案（每日10 mg/kg）单药治疗。分析了30例恶性血液病患者（21例男性和9例女性），每组15例患者，联合组的中位治疗持续时间为18天，高剂量单药治疗组的中位治疗持续时间为17天。在治疗结束时，与高剂量单药治疗组（15例患者中的4例; 27%）相比，联合治疗组（15例患者中的10例; 67%）的总体缓解率（部分或完全缓解; P = 0.028）明显更有利。入选后12周的生存率分别为100%和80%。高剂量单药治疗组3例患者发生输注相关反应。接受高剂量单药治疗的17例患者中有4例（23%）和接受联合治疗的15例患者中有1例（7%）的血清肌酐升高2倍;低钾血症
BACKGROUND. invasive aspergillosis (IA) has a poor prognosis in immunocompromised patients. Combinations of drugs that act on different targets are expected to improve the clinical efficacy of separate compounds.METHODS. Patients with proven or probable IA were randomized in a prospective, open pilot study to receive either a combination of liposomal amphotericin B (AmB) at the standard dose (3 mg/kg daily) and caspofungin at the standard dose or monotherapy with a high-dose AmB regimen (10 mg/kg daily).RESULTS. Thirty patients (21 men and 9 women) with hematologic malignancies were analyzed, and there were 15 patients in each arm. The median duration of treatment was 18 days for the combination group and 17 days for the high-dose monotherapy group. At the end of treatment, there were significantly more favorable overall responses (partial or complete responses; P =.028) in the combination group (10 of 15 patients; 67%) compared with the high-dose monotherapy group (4 of 15 patients; 27%). Survival rates at 12 weeks after inclusion were 100% and 80%, respectively. Infusion-related reactions occurred in 3 patients in the high-dose monotherapy group. A 2-fold increase in serum creatinine occurred in 4 of 17 patients (23%) who received high-dose monotherapy and 1 of 15 patient (7%) who received combination therapy; hypokalemia