Maricic Michael, Adachi Jonathan D, Sarkar Somnath, Wu Wentao, Wong Mayme, Harper Kristine D
Section of Rheumatology, Southern Arizona Veterans Affairs Health Care System, 3601 S Sixth Ave, Tucson, AZ 85723, USA.
Arch Intern Med. 2002 May 27;162(10):1140-3. doi: 10.1001/archinte.162.10.1140.
Raloxifene hydrochloride therapy reduces the risk for vertebral fractures at 3 years, but the effects on clinical vertebral fractures in the first year are not known.
The Multiple Outcomes of Raloxifene Evaluation (MORE) Trial enrolled 7705 women with osteoporosis, defined by prevalent vertebral fractures and/or a bone mineral density (BMD) T score at or below -2.5, who were treated with placebo or raloxifene at a dosage of 60 or 120 mg/d for 3 years. New clinical vertebral fractures were defined as incident vertebral fractures associated with signs and symptoms suggestive of vertebral fractures, such as back pain, and were diagnosed by means of postbaseline adjudicated spinal radiographs. Scheduled spinal radiographs were obtained at baseline and at 2 and 3 years. In addition, unscheduled spinal radiographs were obtained in women who reported signs or symptoms suggestive of vertebral fracture, and these radiographs subsequently underwent adjudication. If an adjudicated fracture was identified, this was also considered a clinical fracture.
At 1 year, raloxifene, 60 mg/d, decreased the risk for new clinical vertebral fractures by 68% (95% confidence interval [CI], 20%-87%) compared with placebo in the overall study population, and by 66% (95% CI, 23%-89%) in women with prevalent vertebral fractures, who are at greater risk for subsequent fracture. The risk for clinical vertebral fractures in the raloxifene, 60 mg/d, group was decreased by 46% (95% CI, 14%-66%) at 2 years and by 41% (95% CI, 17%-59%) at 3 years. The cumulative incidence of new clinical vertebral fractures was lower in the group receiving raloxifene, 60 mg/d, compared with placebo (P<.001). We found no significant differences in the risk reductions for clinical vertebral fractures between the raloxifene groups at 1, 2, or 3 years.
The early risk reduction for new clinical vertebral fractures with 1 year of raloxifene treatment was similar to that reported with other antiresorptive agents.
盐酸雷洛昔芬治疗3年可降低椎体骨折风险，但对第1年临床椎体骨折的影响尚不清楚。
雷洛昔芬评估多结局（MORE）试验纳入了7705例骨质疏松症女性患者，这些患者通过存在椎体骨折和/或骨密度（BMD）T值等于或低于-2.5来定义，她们接受安慰剂或剂量为60或120mg/d的雷洛昔芬治疗3年。新的临床椎体骨折定义为与椎体骨折的体征和症状相关的新发椎体骨折，如背痛，并通过基线后经判定的脊柱X线片进行诊断。在基线以及第2年和第3年进行预定的脊柱X线片检查。此外，对报告有椎体骨折体征或症状的女性进行非预定的脊柱X线片检查，这些X线片随后进行判定。如果确定有经判定的骨折，这也被视为临床骨折。
在第1年，与安慰剂相比，雷洛昔芬60mg/d在总体研究人群中使新临床椎体骨折风险降低了68%（95%置信区间[CI]，20%-87%），在有椎体骨折病史、后续骨折风险更高的女性中降低了66%（95%CI，23%-89%）。雷洛昔芬60mg/d组的临床椎体骨折风险在第2年降低了46%（95%CI，14%-66%），在第3年降低了41%（95%CI，17%-59%）。与安慰剂相比，接受雷洛昔芬60mg/d组的新临床椎体骨折累积发生率更低（P<0.001）。我们发现雷洛昔芬组在第1、2或3年时临床椎体骨折风险降低方面没有显著差异。
雷洛昔芬治疗1年对新临床椎体骨折的早期风险降低效果与其他抗吸收药物报道的相似。
