Kjaer M, Brunsgaard N, Jakobsen P, Edwards D M, Strolin-Benedetti M
Department of Oncology, Aalborg Hospital, Denmark.
Anticancer Drugs. 1993 Aug;4(4):437-41. doi: 10.1097/00001813-199308000-00003.
Twenty-six female patients with breast cancer participated in an open, randomized, cross-over study comparing single dose bioavailability of a recently developed oral medroxyprogesterone acetate (MPA) formulation (200 mg sachet where MPA is loaded in a polyvinylpyrrolidone cross-linked polymer, MPA/PVP) with the standard formulation (500 mg tablet). Blood tests were performed under standardized conditions for 120 h in all patients and MPA plasma concentrations determined by means of HPLC. Dose-normalized AUC(0-tz), AUC (0-infinity) and Cmax were all significantly higher for the MPA/PVP formulation than for the standard formulation. The relative bioavailability of the MPA/PVP formulation was on average three times superior to that of the standard formulation. This new MPA formulation might have important clinical implications for the treatment of hormone-sensitive cancer.
26名乳腺癌女性患者参与了一项开放、随机、交叉研究，比较了一种新开发的口服醋酸甲羟孕酮（MPA）制剂（200毫克药囊，其中MPA负载于聚乙烯吡咯烷酮交联聚合物中，MPA/PVP）与标准制剂（500毫克片剂）的单剂量生物利用度。在标准化条件下对所有患者进行了120小时的血液检测，并通过高效液相色谱法测定MPA血浆浓度。MPA/PVP制剂的剂量标准化AUC(0-tz)、AUC(0-无穷大)和Cmax均显著高于标准制剂。MPA/PVP制剂的相对生物利用度平均比标准制剂高两倍。这种新的MPA制剂可能对激素敏感性癌症的治疗具有重要的临床意义。
