Dimitrakakis C, Keramopoulos D, Vourli G, Gaki V, Bredakis N, Keramopoulos A
Breast Center, Iaso Women's Health Hospital, Marousi, Athens, Greece.
Climacteric. 2005 Dec;8(4):342-51. doi: 10.1080/13697130500345216.
This observational, prospective, open, non-randomized study was designed to assess the safety and efficacy of tibolone for the treatment of climacteric symptoms in women with a history of breast cancer.
A total of 156 women who had been treated for breast cancer and had received tamoxifen for 5 years participated in the study. One month after stopping tamoxifen, 52 women started taking tibolone while the rest served as untreated controls (n = 104). They were followed up (mean duration 61 months) for climacteric symptoms, cancer recurrence rate, breast density, endometrial thickness and adverse events.
There was no difference in cancer recurrence rate between the two groups. Breast density was not affected. Tibolone treatment alleviated climacteric symptoms and positively affected sexual problems. Endometrial thickness was not adversely affected by treatment and there was a low incidence of adverse events.
Tibolone was effective in the treatment of climacteric symptoms and well tolerated in a group of 52 women with a history of breast cancer. The cancer recurrence rate in the tibolone group was comparable to that of untreated controls. It should be noted that the limitations of the study design and the small number of events preclude any definitive conclusions about the effects of tibolone on breast cancer recurrence in general clinical practice. There were no breast-related adverse effects, and overall safety and tolerance were similar to those of the general population of postmenopausal women treated with tibolone.
本观察性、前瞻性、开放性、非随机研究旨在评估替勃龙治疗有乳腺癌病史女性更年期症状的安全性和有效性。
共有156名接受过乳腺癌治疗且已服用他莫昔芬5年的女性参与了该研究。在停止服用他莫昔芬1个月后，52名女性开始服用替勃龙，其余女性作为未治疗对照组（n = 104）。对她们进行随访（平均持续时间61个月），观察更年期症状、癌症复发率、乳腺密度、子宫内膜厚度及不良事件。
两组的癌症复发率无差异。乳腺密度未受影响。替勃龙治疗缓解了更年期症状，并对性问题有积极影响。治疗未对子宫内膜厚度产生不利影响，不良事件发生率较低。
替勃龙对52名有乳腺癌病史的女性治疗更年期症状有效且耐受性良好。替勃龙组的癌症复发率与未治疗对照组相当。应当指出，研究设计的局限性和事件数量较少，使得在一般临床实践中无法就替勃龙对乳腺癌复发的影响得出任何确定性结论。未出现与乳腺相关的不良反应，总体安全性和耐受性与接受替勃龙治疗的绝经后女性总体人群相似。
