Alexieva-Figusch J, Blankenstein M A, Hop W C, Klijn J G, Lamberts S W, de Jong F H, Docter R, Adlercreutz H, van Gilse H A
Eur J Cancer Clin Oncol. 1984 Jan;20(1):33-40. doi: 10.1016/0277-5379(84)90031-2.
Megestrol acetate (MA) is of therapeutic value in breast cancer patients. This study was designed to evaluate the effects of different dosages of MA on endocrine events potentially influenced by the drug in relation to plasma level of MA and clinical effects in patients with advanced breast cancer. Eighteen postmenopausal patients were randomly distributed over six groups to receive daily 90, 180 or 270 mg of MA (niagestin) orally in a cross-over study consisting of 3 periods of 6 weeks. Complete remission was observed in 1 patient, partial remission in 9, no change in 4 and failure in 4 patients. During the 18 weeks of treatment plasma levels of MA gradually increased, irrespective of the dose administered. Significant rises of the basal and TRH-stimulated plasma PRL and basal insulin levels were observed, whereas LH and FSH, estradiol, SHBG and the pituitary-adrenal axis were suppressed. None of these metabolic effects showed a correlation with the clinical response. We concluded that treatment of metastatic breast cancer with 180 mg MA/day is effective and causes minimal adverse effects.
醋酸甲地孕酮（MA）对乳腺癌患者具有治疗价值。本研究旨在评估不同剂量的MA对晚期乳腺癌患者中可能受该药物影响的内分泌事件的作用，这些事件与MA的血浆水平及临床疗效相关。在一项由3个为期6周的阶段组成的交叉研究中，18名绝经后患者被随机分为6组，分别口服每日90、180或270mg的MA（妇宁片）。观察到1例患者完全缓解，9例部分缓解，4例无变化，4例治疗失败。在18周的治疗期间，MA的血浆水平逐渐升高，与给药剂量无关。观察到基础及促甲状腺激素释放激素刺激后的血浆催乳素水平和基础胰岛素水平显著升高，而促黄体生成素、促卵泡生成素、雌二醇、性激素结合球蛋白及垂体-肾上腺轴受到抑制。这些代谢效应均与临床反应无关。我们得出结论，每天用180mg MA治疗转移性乳腺癌是有效的，且不良反应最小。
