Miller A A, Becher R, Schmidt C G
Innere Klinik und Poliklinik (Tumorforschung), West German Tumor Center, University of Essen Medical School.
J Cancer Res Clin Oncol. 1988;114(2):186-90. doi: 10.1007/BF00417835.
A total of 32 patients with metastatic breast cancer responding with at least disease stabilization to treatment with two commercially available preparations of medroxyprogesterone acetate (MPA) or one preparation of megestrol acetate (MA) were followed for their plasma concentrations. The MPA and MA were measured by HPLC. MPA from Upjohn and Farmitalia was given to 12 patients (median age, 61 years; median follow-up, 20 weeks) and 8 patients (54 years, 16 weeks), respectively, on a schedule of 1000 mg daily i.m. for 10 days followed by 200 mg t.i.d.p.o. for the remainder of the treatment course. The peak concentrations (means, 163 vs 97 ng/ml), the time to peak levels (medians, 3 vs 10 weeks), and the areas under the concentration curves from time 0 to 24 weeks (means, 2400 vs 1868 ng/ml X weeks) were significantly different in the respective treatment groups (t-test; significance level, 0.05). MA from Bristol-Myers was administered orally in one daily dose of 160 mg throughout the treatment course in 12 patients (median age, 51 years; median follow-up, 20 weeks). A mean MA peak concentration of 218 ng/ml was reached after a median of 7 days. Plateau plasma levels were higher for MA than MPA.
共有32例转移性乳腺癌患者,在用两种市售醋酸甲羟孕酮(MPA)制剂或一种醋酸甲地孕酮(MA)制剂治疗后至少病情稳定,对其血浆浓度进行了跟踪监测。MPA和MA通过高效液相色谱法测定。分别给予12例患者(中位年龄61岁;中位随访20周)Upjohn公司和法玛西亚公司生产的MPA,以及8例患者(54岁,16周)MPA,给药方案为每日肌内注射1000mg,共10天,随后在治疗疗程剩余时间口服200mg,每日3次。各治疗组的峰值浓度(均值分别为163 ng/ml和97 ng/ml)、达到峰值水平的时间(中位数分别为3周和10周)以及从0至24周的浓度曲线下面积(均值分别为2400 ng/ml·周和1868 ng/ml·周)存在显著差异(t检验;显著性水平0.05)。在12例患者(中位年龄51岁;中位随访20周)的整个治疗疗程中,给予百时美施贵宝公司生产的MA,每日口服一次,剂量为160mg。中位7天后达到MA平均峰值浓度218 ng/ml。MA的血浆平台期水平高于MPA。