Korth-Bradley J M, Dowell J A, King S P, Liu H, Berger M S
Department of Clinical Pharmacokinetics, Wyeth-Ayerst Research, Philadelphia, Pennsylvania 19101, USA.
Pharmacotherapy. 2001 Oct;21(10):1175-80. doi: 10.1592/phco.21.15.1175.33890.
To determine the pharmacokinetic parameters of the components of gemtuzumab ozogamicin and to assess the possible influence of age and gender on the values.
Phase II, multicenter, open-label, nonrandomized, parallel study
Hospitals and outpatient oncology clinics.
Fifty-eight patients with acute myeloid leukemia in first relapse participated. Demographic data included 29 men and 29 women; 34 were younger than 60 years of age (mean age 53+/-16 yrs).
Patients received gemtuzumab ozogamicin as a single 2-hour infusion of 9 mg/m2. Serial plasma samples were collected over 10 days after the beginning of the infusion.
Plasma concentrations of components of gemtuzumab ozogamicin (hP67.6 antibody, total and unconjugated calicheamicin derivatives) were measured by validated enzyme-linked immunosorbent assays. Pharmacokinetic parameters were determined by noncompartmental methods and comparisons between groups were made by analysis of variance. No significant differences were seen between men and women or between those over 60 and those less than 60 years of age in maximum concentration, time to maximum concentration, area under the curve, clearance, or volume of distribution for components of gemtuzumab ozogamicin.
No differences occur in the pharmacokinetics of the components of gemtuzumab ozogamicin (hP67.6 or calicheamicin) based on gender or age.
确定吉妥珠单抗奥唑米星各成分的药代动力学参数，并评估年龄和性别对这些参数值的可能影响。
II期、多中心、开放标签、非随机、平行研究
医院和门诊肿瘤诊所
58例首次复发的急性髓系白血病患者参与研究。人口统计学数据包括29名男性和29名女性；34名年龄小于60岁（平均年龄53±16岁）。
患者接受单次2小时静脉输注9mg/m²的吉妥珠单抗奥唑米星。输注开始后10天内采集系列血浆样本。
采用经过验证的酶联免疫吸附测定法测量吉妥珠单抗奥唑米星各成分（hP67.6抗体、总加利车霉素衍生物和未结合的加利车霉素衍生物）的血浆浓度。采用非房室方法确定药代动力学参数，并通过方差分析进行组间比较。在吉妥珠单抗奥唑米星各成分的最大浓度、达峰时间、曲线下面积、清除率或分布容积方面，男性与女性之间、60岁以上与60岁以下患者之间均未观察到显著差异。
基于性别或年龄，吉妥珠单抗奥唑米星各成分（hP67.6或加利车霉素）的药代动力学无差异。
