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Lancet Diabetes Endocrinol:地诺单抗联合西那卡塞治疗原发性甲状旁腺功能亢进

2020-07-15 MedSci原创 MedSci原创

原发性甲状旁腺功能亢进的治疗方法很少。本研究目的是评估地诺单抗(denosumab)联合西那卡塞(cinacalcet,拟钙剂)治疗原发性甲状旁腺功能亢进的疗效。

背景:原发性甲状旁腺功能亢进的治疗方法很少。本研究目的是评估地诺单抗(denosumab)联合西那卡塞(cinacalcet,拟钙剂)治疗原发性甲状旁腺功能亢进的疗效。

方法:这是一项随机、单中心、双盲试验,招募年满18岁的原发性甲状旁腺功能亢进患者,随机分组(1:1:1),联合组接受西那卡塞 30mg/日+地诺单抗 60mg/6个月(皮下注射);地诺单抗组接受地诺单抗+安慰剂;安慰剂组接受安慰剂+安慰剂;均持续干预1年。主要结果是1年后用双X射线骨密度仪测量腰椎、全髋关节、股骨颈和前臂远端的骨密度(BMD)的变化。

结果:2017年3月14日-2018年3月16日,招募了285名参与者,联合组、地诺单抗组和安慰剂组分别分到16人、15人和15人,随后联合组有一位患者退出试验。与安慰剂相比,地诺单抗治疗的患者的BMD改善:腰椎(联合组5.4%[95%CI 2.7-8.1]、地诺单抗组6.9%[95%CI 4.2-9.6];p<0·0001),全髋关节(5.0%[3.0-6.9]、4.1%[2.5-5.8];p<0.0001)和股骨颈(4.5% [1.9-7.9],p=0·0008;3.8%[1.4-6.3],p=0·0022)。前臂远端的BMD变化明显。共发生了6例非致死性严重不良事件(联合组2例、地诺单抗组1例、安慰剂组3例)。治疗组之间不良事件的总体发生率无差异,无致命性不良事件。

总结:研究表明,无论是否接受西那卡塞治疗,地诺单抗均可有效改善原发性甲状旁腺功能亢进患者的BMD和骨转换,对于不希望手术的患者来说可能是一种有效的选择。

原始出处:

Leere Julius Simoni,Karmisholt Jesper,Robaczyk Maciej et al. Denosumab and cinacalcet for primary hyperparathyroidism (DENOCINA): a randomised, double-blind, placebo-controlled, phase 3 trial.[J] .Lancet Diabetes Endocrinol, 2020, 8: 407-417.

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encodeId=802f151393325, content=<a href='/topic/show?id=32d33e069ee' target=_blank style='color:#2F92EE;'>#原发性甲状旁腺功能亢进#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=37069, encryptionId=32d33e069ee, topicName=原发性甲状旁腺功能亢进)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d7e10601864, createdName=12498877m101暂无昵称, createdTime=Fri Jul 17 08:32:28 CST 2020, time=2020-07-17, status=1, ipAttribution=)]
    2021-03-16 howi
  5. 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  6. 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  7. 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    2020-07-31 146b6845m33暂无昵称

    厉害

    0

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