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[大学生论坛]:唑来膦酸盐可预防骨质减少症老年女性患者的骨折

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歪歪歪 发表于 2019-1-4 12:38:59 | 显示全部楼层 |阅读模式
本帖最后由 歪歪歪 于 2019-1-4 12:40 编辑

Fracture Prevention withZoledronate in Older Women with Osteopenia
唑来膦酸盐可预防骨质减少症老年女性患者的骨折
BACKGROUND
背景
Bisphosphonates prevent fracturesin patients with osteoporosis, but their efficacy in women with osteopeniais unknown. Most fractures in postmenopausal women occur in those withosteopenia, so therapies that are effective in women with osteopenia are needed.
双膦酸盐可预防骨质疏松症患者的骨折,但其对骨质减少症女性患者的疗效尚不明确。绝经后妇女的大多数骨折发生在骨质减少的患者中,因此针对骨质减少的妇女需要有效的治疗方法。

METHODS
方法
We conducted a 6-year, double-blindtrial involving 2000 women with osteopenia (defined by a T score of −1.0 to −2.5 at eitherthe total hip or the femoral neck on either side) who were 65 years of age orolder. Participants were randomly assigned to receive four infusions of eitherzoledronate at a dose of 5 mg (zoledronate group) or normal saline (placebogroup) at 18-month intervals. A dietary calcium intake of 1 g per day wasadvised, but calcium supplements were not provided. Participants who were notalready taking vitamin D supplements received cholecalciferol before the trialbegan (a single dose of 2.5 mg) and during the trial (1.25 mg per month). Theprimary end point was the time to first occurrence of a nonvertebral orvertebral fragility fracture.
我们进行了一项为期6年的双盲试验,该试验涉及2000名女性患有骨质减少症(参与者为65岁或以上的全髋或股骨颈的T评分为-1.0至-2.5)。参与者被随机分配接受4次输注剂量为5mg唑来膦酸盐(唑来膦酸盐组)或生理盐水(安慰剂组),间隔18个月。建议每日膳食钙摄入量为1克,但不提供钙补充剂。未服用维生素D补充剂的参与者在试验开始前和试验期间皆服用了胆钙化醇(开始前:单剂量2.5mg;试验期间:每月1.25 mg)。主要终点是首次发生非椎体骨折或椎体脆性骨折的时间。

RESULTS
结果
At baseline, the mean (±SD) age was71±5 years, the T score at the femoral neck was −1.6±0.5, and themedian 10-year risk of hip fracture was 2.3%. A fragility fracture occurred in190 women in the placebo group and in 122 women in the zoledronate group(hazard ratio with zoledronate, 0.63; 95% confidence interval, 0.50 to 0.79;P<0.001). The number of women that would need to be treated to prevent theoccurrence of a fracture in 1 woman was 15. As compared with the placebo group,women who received zoledronate had a lower risk of nonvertebral fragilityfractures (hazard ratio, 0.66; P=0.001), symptomatic fractures (hazard ratio,0.73; P=0.003), vertebral fractures (odds ratio, 0.45; P=0.002), and heightloss (P<0.001).
在基线时,平均(±SD)年龄为71±5岁,股骨颈T评分为-1.6±0.5,髋部骨折的中位10年风险为2.3%。安慰剂组190名妇女和唑来膦酸盐组122名妇女发生脆性骨折(与唑来膦酸盐组的风险比,0.63;95%置信区间,0.50至0.79;P <0.001)。每15位妇女中有1位需要治疗以防止骨折。与安慰剂组相比,接受唑来膦酸盐治疗的女性患非椎管脆性骨折的风险较低(风险比,0.66;P = 0.001),症状性骨折(风险比,0.73;P = 0.003),椎体骨折(优势比,0.45;P = 0.002)和身高缩减(P<0.001)。

CONCLUSIONS
结论
The risk of nonvertebral orvertebral fragility fractures was significantly lower in women with osteopeniawho received zoledronate than in women who received placebo.
接受唑来膦酸盐治疗的女性骨质减少症患者发生非椎骨或椎骨脆性骨折的风险明显低于接受安慰剂治疗的女性。



作者:Ian R. Reid, M.D., Anne M. Horne, M.B.,Ch.B., Borislav Mihov, B.Phty., Angela Stewart, R.N., Elizabeth Garratt,B.Nurs., Sumwai Wong, B.Sc., Katy R. Wiessing, B.Sc., Mark J. Bolland, Ph.D.,Sonja Bastin, M.B., Ch.B., and Gregory D. Gamble, M.Sc.
期刊名称:New EnglandJournal of Medicine
发表日期:December 20, 2018
N Engl J Med 2018; 379:2407-2416
DOI: 10.1056/NEJMoa1808082

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