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唑来膦酸用于预防老年骨质减少女性的骨折
Fracture Prevention with Zoledronate in Older Women with Osteopenia


Ian R. Reid ... 其他 • 2018.12.20
NEJM 动画解读

唑来膦酸治疗骨质减少
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唑来膦酸盐减少了低骨量老年女性的骨折风险

 

范东伟†‡,陈仲强1†,李危石1†,李蓉§*,宋纯理†‡*

†‡北京大学第三医院骨科;§北京大学第三医院妇产科;†‡北京大学第三医院骨质疏松和骨代谢疾病中心

*通讯作者

 

低骨量发病较为隐蔽,多数患者缺乏典型的临床症状,往往容易被忽略而错失治疗的最佳时机,当出现骨质疏松或骨折时才被发现,但此时疾病已经进展到较为严重的阶段。

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摘要


背景

双膦酸盐可预防骨质疏松患者的骨折,但它们对骨质减少女性的效果尚不清楚。绝经后女性的骨折大多数发生于骨质减少的女性,因此骨质减少的女性需要有效疗法。

 

方法

我们在年龄≥65岁、骨质减少(定义为全髋或任何一侧股骨颈的T值评分为-2.5~-1.0分)的2,000名女性中,开展了一项为期6年的双盲试验。将参与者随机分组,分别接受每18个月1次,每次5 mg唑来膦酸(唑来膦酸组)或生理盐水(安慰剂组)输入,共输入4次。建议每日通过膳食摄入1 g钙,但未提供钙补充剂。在试验开始之前(单剂2.5 mg)和试验期间(每月1.25 mg),未服用维生素D补充剂的参与者接受胆钙化醇治疗。主要终点为至首次发生非椎骨或椎骨脆性骨折的时间。

 

结果

基线时,参与者平均(±SD)年龄为71岁±5岁,股骨颈的T值评分为-1.6分±0.5分,髋部骨折的中位10年风险为2.3%。安慰剂组190名女性和唑来膦酸组122名女性发生了脆性骨折(使用唑来膦酸的风险比,0.63;95%置信区间,0.50~0.79;P<0.001)。每预防1名女性发生骨折,需要治疗的女性数量为15。与安慰剂组相比,接受唑来膦酸治疗的女性发生非椎骨脆性骨折(风险比,0.66;P=0.001)、有症状的骨折(风险比,0.73;P=0.003)、椎骨骨折(比值比,0.45;P=0.002)和身高缩减的风险较低(P<0.001)。

 

结论

接受唑来膦酸治疗的骨质减少女性发生非椎骨或椎骨脆性骨折的风险显著低于接受安慰剂治疗的女性(由新西兰健康研究理事会[Health Research Council of New Zealand]资助;澳大利亚新西兰临床试验注册号为ACTRN12609000593235)。





作者信息

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.
From the Department of Medicine, Faculty of Medical and Health Sciences, University of Auckland (I.R.R., A.M.H., B.M., A.S., E.G., S.W., K.R.W., M.J.B., G.D.G.), and the Auckland District Health Board (I.R.R., S.B.) — both in Auckland, New Zealand. Address reprint requests to Dr. Reid at the Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand, or at i.reid@auckland.ac.nz.

 

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