a Children and Adolescent Health , Aarhus University Hospital , Aarhus , Denmark.
b Department of Women's and Children's Health , Uppsala University , Sweden.
Leuk Lymphoma. 2019 Jun;60(6):1469-1475. doi: 10.1080/10428194.2018.1538507. Epub 2019 Jan 11.
Acute lymphoblastic leukemia (ALL) is a rare disease in infants. Asparaginase is an essential part of the treatment, and there Acute is a need to evaluate the efficiency and safety of this drug in this age group. We evaluated the pharmacokinetics of intramuscularly administered native asparaginase (Asparaginase Medac) and PEG-asparaginase (Oncaspar) as well as hypersensitivity reactions during treatment in Interfant-06 ( www.clinicaltrials.gov : NCT01025804). All patients without hypersensitivity had sufficiently high enzyme activity levels during treatment with both preparations. Patients with hypersensitivity reactions during treatment, characterized by the presence of either or not of clinical symptoms and no measurable enzyme activity, received ineffective therapy. For optimization of the bad prognosis in infant ALL, therapeutic drug monitoring should be performed for identification of patients who should be switched to a different asparaginase preparation because of inactivation of the drug.
急性淋巴细胞白血病（ALL）在婴儿中较为罕见。门冬酰胺酶是治疗的重要组成部分，因此需要评估该药物在该年龄组中的疗效和安全性。我们在 Interfant-06 研究中评估了肌内给予天然门冬酰胺酶（Asparaginase Medac）和聚乙二醇化门冬酰胺酶（Oncaspar）的药代动力学以及治疗期间的过敏反应（www.clinicaltrials.gov：NCT01025804）。所有无过敏反应的患者在两种制剂治疗期间均具有足够高的酶活性水平。治疗期间发生过敏反应的患者具有以下特征：有或没有临床症状和无法测量的酶活性，接受了无效治疗。为了优化婴儿 ALL 的不良预后，应进行治疗药物监测，以识别因药物失活而应改用不同门冬酰胺酶制剂的患者。
