Kristensen B, Ejlertsen B, Dalgaard P, Larsen L, Holmegaard S N, Transbøl I, Mouridsen H T
Department of Clinical Physiology, Rigshospitalet, Copenhagen, Denmark.
J Clin Oncol. 1994 May;12(5):992-7. doi: 10.1200/JCO.1994.12.5.992.
This trial was undertaken to evaluate the effect of adjuvant tamoxifen on bone metabolism in postmenopausal women undergoing surgery for low-risk breast cancer.
In an open trial, 25 women were randomized to receive tamoxifen 30 mg/d for 2 years, and 25 women constituted the control group. Twenty women treated with tamoxifen and 23 women in the control group provided data for the analysis. Inclusion criteria were operation for low-risk breast cancer and cessation of menstruations for more than 1 year. Exclusion criteria were presence of metastases, disorders of bone metabolism, contraindications against tamoxifen, use of drugs with influence on bone metabolism, ailments that made bone mineral measurements impossible, and age greater than 65 years. Repeated measurements of bone mineral density and content at the lumbar spine and forearms, serum alkaline phosphatase, phosphate, and ionized calcium were performed in all patients.
Lumbar spine bone mineral density increased during the first year in women treated with tamoxifen and then stabilized, compared with decreased bone mineral density in the control group (P = .00074). Bone mineral content at the forearms remained almost stable in tamoxifen-treated women compared with a decrease in the control group (P = .024). Serum alkaline phosphatase, phosphate, and ionized calcium decreased in the tamoxifen group (P < .00001, P = .002, and P = .002, respectively).
Tamoxifen has estrogen-like effects on bone metabolism that result in an increase and stabilization of bone mineral density in the axial skeleton and a stabilization of bone mineral content in the appendicular skeleton.
本试验旨在评估辅助性他莫昔芬对接受低风险乳腺癌手术的绝经后女性骨代谢的影响。
在一项开放性试验中，25名女性被随机分配接受他莫昔芬30mg/d治疗2年，另外25名女性作为对照组。20名接受他莫昔芬治疗的女性和23名对照组女性提供了分析数据。纳入标准为低风险乳腺癌手术且绝经超过1年。排除标准为存在转移、骨代谢紊乱、他莫昔芬禁忌证、使用影响骨代谢的药物、导致无法进行骨矿物质测量的疾病以及年龄大于65岁。对所有患者进行腰椎和前臂骨矿物质密度及含量、血清碱性磷酸酶、磷酸盐和离子钙的重复测量。
与对照组骨矿物质密度降低相比，接受他莫昔芬治疗的女性在第一年腰椎骨矿物质密度增加，随后稳定（P = .00074）。与对照组降低相比，接受他莫昔芬治疗的女性前臂骨矿物质含量几乎保持稳定（P = .024）。他莫昔芬组血清碱性磷酸酶、磷酸盐和离子钙降低（分别为P < .00001、P = .002和P = .002）。
他莫昔芬对骨代谢具有雌激素样作用，可导致中轴骨骼骨矿物质密度增加并稳定，以及四肢骨骼骨矿物质含量稳定。
