Johnell Olaf, Cauley Jane A, Kulkarni Pandurang M, Wong Mayme, Stock John L
Department of Orthopedics, Universitetssjukhuset MAS, SE-20502 Malmo, Sweden.
J Fam Pract. 2004 Oct;53(10):789-96.
We examined whether past use of hormone therapy influences the effects of raloxifene on the risk of new vertebral fracture, cardiovascular events, or breast cancer.
The Multiple Outcomes of Raloxifene Evaluation (MORE) trial examined vertebral fracture incidence as the primary endpoint, breast cancer incidence as a secondary endpoint. Cardiovascular events were collected as secondary safety endpoints.
The MORE trial enrolled 7705 postmenopausal women. Of the 7682 women who reported their previous HT use status, 29% used HT before screening.
Separate logistic regression models analyzed the relationships between prior HT use and the risk of vertebral fracture, cardiovascular events, or breast cancer. Interaction terms with P<.10 were considered to be statistically significant. Confidence intervals for relative risks (RR) were calculated using the Mantel-Haenszel method.
Raloxifene 60 mg/d, the clinically approved dose for osteoporosis prevention and treatment, reduced the risk of vertebral fractures by 54% (RR=0.46) and 29% (RR=0.71) in women with and without prior HT use, respectively (interaction P=.05). A lower incidence of invasive breast cancer in women with prior HT use (RR=0.23) and in women without prior HT use [RR=0.31; interaction P=.60] was observed in women receiving raloxifene (pooled doses). Irrespective of prior HT use, women treated with raloxifene (pooled doses) had no change in incidence of cardiovascular events (interaction P=.56).
The risk of vertebral fractures was lower in women treated with raloxifene, regardless of prior HT use, but there was a suggestion that the effect was greater in women who had used HT. Women randomized to receive raloxifene exhibited a decreased incidence of invasive breast cancer, compared with women receiving placebo. No change occurred in the incidence of cardiovascular events, regardless of prior HT use.
我们研究了既往使用激素疗法是否会影响雷洛昔芬对新发椎体骨折风险、心血管事件或乳腺癌的影响。
雷洛昔芬评估多项结果（MORE）试验将椎体骨折发生率作为主要终点，乳腺癌发生率作为次要终点。心血管事件作为次要安全性终点进行收集。
MORE试验纳入了7705名绝经后女性。在报告了既往激素疗法使用情况的7682名女性中，29%在筛查前使用过激素疗法。
采用单独的逻辑回归模型分析既往激素疗法使用与椎体骨折、心血管事件或乳腺癌风险之间的关系。P<0.10的交互项被认为具有统计学意义。使用Mantel-Haenszel方法计算相对风险（RR）的置信区间。
雷洛昔芬60mg/d是预防和治疗骨质疏松症的临床批准剂量，在既往使用过激素疗法和未使用过激素疗法的女性中，分别将椎体骨折风险降低了54%（RR=0.46）和29%（RR=0.71）（交互作用P=0.05）。在接受雷洛昔芬（合并剂量）治疗的女性中，既往使用过激素疗法的女性（RR=0.23）和未使用过激素疗法的女性[RR=0.31；交互作用P=0.60]的浸润性乳腺癌发病率均较低。无论既往是否使用过激素疗法，接受雷洛昔芬（合并剂量）治疗的女性心血管事件发生率均无变化（交互作用P=0.56）。
无论既往是否使用过激素疗法，接受雷洛昔芬治疗的女性椎体骨折风险较低，但有迹象表明，使用过激素疗法的女性效果更佳。与接受安慰剂治疗的女性相比，随机接受雷洛昔芬治疗的女性浸润性乳腺癌发病率降低。无论既往是否使用过激素疗法，心血管事件发生率均无变化。
