Siris E, Adachi J D, Lu Y, Fuerst T, Crans G G, Wong M, Harper K D, Genant H K
Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.
Osteoporos Int. 2002 Nov;13(11):907-13. doi: 10.1007/s001980200125.
Raloxifene reduces the risk of new vertebral fractures, but its effect on the severity of these new fractures has not been determined. The MORE (Multiple Outcomes of Raloxifene Evaluation) trial studied the effects of placebo, raloxifene 60 or 120 mg/day in 7,705 postmenopausal women with osteoporosis. Radiologists assessed new vertebral fractures from radiographs and graded the fracture severity as normal (no fracture) or mild, moderate or severe. New clinical vertebral fractures were defined as new vertebral fractures associated with symptoms, such as back pain, and confirmed in radiographs. In the total study population, the majority (76.4%) of the women who experienced clinical vertebral fractures were diagnosed with new moderate/severe vertebral fractures. In turn, women with moderate/severe vertebral fractures in the overall population were more likely to experience clinical symptoms suggestive of fracture than were women who had new mild-only vertebral fractures. The incidence of new mild-only and moderate/severe fractures was the same in women without prevalent vertebral fractures, but the incidence of new moderate/severe fractures was 2 to 3 times higher than that for new mild-only fractures in women with prevalent vertebral fractures. Raloxifene 60 mg/day decreased the risk of at least 1 new moderate/severe vertebral fracture by 61% in women without prevalent vertebral fractures [RR 0.39 (95% CI 0.17, 0.69)], and by 37% in women with prevalent vertebral fractures [RR 0.63 (95% CI 0.49, 0.83)] at 3 years. The risk reductions for at least 1 new moderate/severe vertebral fracture were not significantly different between the raloxifene doses, in women with and without prevalent vertebral fractures. The effects of raloxifene on significantly decreasing the risk of new moderate/severe vertebral fractures may explain the risk reduction for new painful clinical vertebral fractures observed with raloxifene, and is particularly important in postmenopausal women with severe osteoporosis who are at higher risk for moderate or severe fractures.
雷洛昔芬可降低新发椎体骨折的风险，但其对这些新发骨折严重程度的影响尚未确定。MORE（雷洛昔芬疗效多终点评估）试验研究了安慰剂、60毫克/天或120毫克/天雷洛昔芬对7705名绝经后骨质疏松症女性的影响。放射科医生通过X光片评估新发椎体骨折情况，并将骨折严重程度分为正常（无骨折）或轻度、中度或重度。新发临床椎体骨折定义为与背痛等症状相关且经X光片证实的新发椎体骨折。在整个研究人群中，发生临床椎体骨折的女性多数（76.4%）被诊断为新发中度/重度椎体骨折。相应地，总体人群中患有中度/重度椎体骨折的女性比仅患有新发轻度椎体骨折的女性更有可能出现提示骨折的临床症状。在无既往椎体骨折的女性中，新发单纯轻度骨折和中度/重度骨折的发生率相同，但在有既往椎体骨折的女性中，新发中度/重度骨折的发生率比新发单纯轻度骨折高2至3倍。60毫克/天雷洛昔芬使无既往椎体骨折的女性发生至少1次新发中度/重度椎体骨折的风险在3年内降低了61%[相对危险度0.39（95%可信区间0.17，0.69）]，使有既往椎体骨折的女性该风险降低了37%[相对危险度0.63（95%可信区间0.49，0.83）]。在有和无既往椎体骨折的女性中，雷洛昔芬不同剂量组之间，至少1次新发中度/重度椎体骨折的风险降低无显著差异。雷洛昔芬显著降低新发中度/重度椎体骨折风险的作用可能解释了雷洛昔芬观察到的新发疼痛性临床椎体骨折风险降低情况，这在骨折风险较高的严重骨质疏松绝经后女性中尤为重要。
