JAMA:唑来膦酸治疗间隔是4周好还是12周好

2017-01-04 MedSci MedSci原创

唑来膦酸是第三代亚甲基氨基二膦酸,它可以降低骨转移患者的骨骼相关事件和疼痛的发生率。但是,唑来膦酸的最佳给药间隔仍不明确。近期,一项发表在JAMA杂志上的文章对比研究了每12周使用唑来膦酸与每4周使用唑来膦酸的临床效果。此项研究招募了自2009年5月至2012年4月期间转移性乳腺癌、转移性前列腺癌或具有至少1个骨累及部位的多发性骨髓瘤的患者(n=1822),随访至2014年4月完成。受试患者随机接

唑来膦酸是第三代亚甲基氨基二膦酸,它可以降低骨转移患者的骨骼相关事件和疼痛的发生率。但是,唑来膦酸的最佳给药间隔仍不明确。

近期,一项发表在JAMA杂志上的文章对比研究了每12周使用唑来膦酸与每4周使用唑来膦酸的临床效果。

此项研究招募了自2009年5月至2012年4月期间转移性乳腺癌、转移性前列腺癌或具有至少1个骨累及部位的多发性骨髓瘤的患者(n=1822),随访至2014年4月完成。

受试患者随机接受每4周(n=911)静脉内输注唑来膦酸vs每12周(n=911)静脉内输注唑来膦酸维持治疗2年。

研究主要终点是在随机化分组治疗后2年内具有至少1个骨骼相关事件(定义为临床骨折、脊髓压迫、辐射至骨或涉及骨的手术)的患者的比例,以及组间绝对差为7%作为非劣性。次要终点包括通过疾病分类具有至少1个骨骼相关事件的患者的比例,通过简明疼痛量表评估的疼痛(范围,0-10;分数越高表明疼痛更重),东部合作肿瘤组的性能状态(0-4;分数越高表示残疾越重),下颚骨坏死的发生率,肾功能障碍,骨骼发病率(每年的骨骼相关事件的平均数)以及在553名患者亚组中的骨代谢抑制(通过C-末端端肽水平评估)。

此项研究结果表明,在1822名患者中(中位年龄,65岁;980名妇女[53.8%];855名乳腺癌,689名前列腺癌和278名多发性骨髓瘤患者),共有795名患者完成了2年的研究。

每4周给予唑来膦酸的260名患者(29.5%)及每12周给药组的253名患者(28.6%)在2年内经历至少1次骨骼相关事件(风险差异-0.3%[单侧95%CI,-4%至∞];非劣效性P<0.001)。

对于乳腺癌、前列腺癌或多发性骨髓瘤患者,骨骼相关事件的比例在每4周给药组与每12周给药组之间没有显着差异。

疼痛评分、性能状态评分、颚骨坏死的发生率和肾功能障碍在两种治疗组之间没有显着差异。
两组的骨骼发病率数值相同,但是每12周接受唑来膦酸的患者的骨代谢较大(C末端端肽水平较高)。

此项研究表明:在由于乳腺癌、前列腺癌或多发性骨髓瘤引起骨转移的患者中,与每4周的标准给药间隔相比,每12周使用唑来膦酸不会导致2年内骨骼事件的风险增加。这个较长的间隔可以是可接受的治疗选项。

原始出处:
Himelstein AL, Foster JC, Khatcheressian JL, Roberts JD, Seisler DK, Novotny PJ, Qin R, Go RS, Grubbs SS, O'Connor T, Velasco MR Jr, Weckstein D, O'Mara A, Loprinzi CL, Shapiro CL. Effect of Longer-Interval vs Standard Dosing of Zoledronic Acid on Skeletal Events in Patients With Bone Metastases: A Randomized Clinical Trial. JAMA. 2017 Jan 3;317(1):48-58. doi: 10.1001/jama.2016.19425.

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  1. [GetPortalCommentsPageByObjectIdResponse(id=176820, encodeId=4f391e6820dc, content=内容相当好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c0d1700260, createdName=1de7cc1bm81(暂无匿称), createdTime=Sat Feb 18 13:51:11 CST 2017, time=2017-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170444, encodeId=d2241e04449d, content=如果真是这样,可以尝试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170803/IMG5982F7A3DBB3C1061.jpg, createdBy=0ba51605600, createdName=Jianghuiqin, createdTime=Sun Jan 15 08:33:37 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=169070, encodeId=3a321690e0a2, content=这个会改变临床实践吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Mon Jan 09 11:25:50 CST 2017, time=2017-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168533, encodeId=f5e716853394, content=内容不错,己拜读。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sat Jan 07 11:17:56 CST 2017, time=2017-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379679, encodeId=132613e967969, content=<a href='/topic/show?id=6d8340012ff' target=_blank style='color:#2F92EE;'>#唑来膦酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40012, encryptionId=6d8340012ff, topicName=唑来膦酸)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3307462, createdName=风铃821, createdTime=Fri Jan 06 10:15:00 CST 2017, time=2017-01-06, status=1, ipAttribution=)]
    2017-02-18 1de7cc1bm81(暂无匿称)

    内容相当好

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=176820, encodeId=4f391e6820dc, content=内容相当好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c0d1700260, createdName=1de7cc1bm81(暂无匿称), createdTime=Sat Feb 18 13:51:11 CST 2017, time=2017-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170444, encodeId=d2241e04449d, content=如果真是这样,可以尝试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170803/IMG5982F7A3DBB3C1061.jpg, createdBy=0ba51605600, createdName=Jianghuiqin, createdTime=Sun Jan 15 08:33:37 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=169070, encodeId=3a321690e0a2, content=这个会改变临床实践吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Mon Jan 09 11:25:50 CST 2017, time=2017-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168533, encodeId=f5e716853394, content=内容不错,己拜读。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sat Jan 07 11:17:56 CST 2017, time=2017-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379679, encodeId=132613e967969, content=<a href='/topic/show?id=6d8340012ff' target=_blank style='color:#2F92EE;'>#唑来膦酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40012, encryptionId=6d8340012ff, topicName=唑来膦酸)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3307462, createdName=风铃821, createdTime=Fri Jan 06 10:15:00 CST 2017, time=2017-01-06, status=1, ipAttribution=)]
    2017-01-15 Jianghuiqin

    如果真是这样,可以尝试!

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=176820, encodeId=4f391e6820dc, content=内容相当好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c0d1700260, createdName=1de7cc1bm81(暂无匿称), createdTime=Sat Feb 18 13:51:11 CST 2017, time=2017-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170444, encodeId=d2241e04449d, content=如果真是这样,可以尝试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170803/IMG5982F7A3DBB3C1061.jpg, createdBy=0ba51605600, createdName=Jianghuiqin, createdTime=Sun Jan 15 08:33:37 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=169070, encodeId=3a321690e0a2, content=这个会改变临床实践吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Mon Jan 09 11:25:50 CST 2017, time=2017-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168533, encodeId=f5e716853394, content=内容不错,己拜读。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sat Jan 07 11:17:56 CST 2017, time=2017-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379679, encodeId=132613e967969, content=<a href='/topic/show?id=6d8340012ff' target=_blank style='color:#2F92EE;'>#唑来膦酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40012, encryptionId=6d8340012ff, topicName=唑来膦酸)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3307462, createdName=风铃821, createdTime=Fri Jan 06 10:15:00 CST 2017, time=2017-01-06, status=1, ipAttribution=)]
    2017-01-09 jetleo

    这个会改变临床实践吗?

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=176820, encodeId=4f391e6820dc, content=内容相当好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c0d1700260, createdName=1de7cc1bm81(暂无匿称), createdTime=Sat Feb 18 13:51:11 CST 2017, time=2017-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170444, encodeId=d2241e04449d, content=如果真是这样,可以尝试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170803/IMG5982F7A3DBB3C1061.jpg, createdBy=0ba51605600, createdName=Jianghuiqin, createdTime=Sun Jan 15 08:33:37 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=169070, encodeId=3a321690e0a2, content=这个会改变临床实践吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Mon Jan 09 11:25:50 CST 2017, time=2017-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168533, encodeId=f5e716853394, content=内容不错,己拜读。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sat Jan 07 11:17:56 CST 2017, time=2017-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379679, encodeId=132613e967969, content=<a href='/topic/show?id=6d8340012ff' target=_blank style='color:#2F92EE;'>#唑来膦酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40012, encryptionId=6d8340012ff, topicName=唑来膦酸)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3307462, createdName=风铃821, createdTime=Fri Jan 06 10:15:00 CST 2017, time=2017-01-06, status=1, ipAttribution=)]
    2017-01-07 虈亣靌

    内容不错,己拜读。

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=176820, encodeId=4f391e6820dc, content=内容相当好, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c0d1700260, createdName=1de7cc1bm81(暂无匿称), createdTime=Sat Feb 18 13:51:11 CST 2017, time=2017-02-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=170444, encodeId=d2241e04449d, content=如果真是这样,可以尝试!, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://cacheapi.medsci.cn/resource/upload/20170803/IMG5982F7A3DBB3C1061.jpg, createdBy=0ba51605600, createdName=Jianghuiqin, createdTime=Sun Jan 15 08:33:37 CST 2017, time=2017-01-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=169070, encodeId=3a321690e0a2, content=这个会改变临床实践吗?, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4bfa83595, createdName=jetleo, createdTime=Mon Jan 09 11:25:50 CST 2017, time=2017-01-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=168533, encodeId=f5e716853394, content=内容不错,己拜读。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Sat Jan 07 11:17:56 CST 2017, time=2017-01-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379679, encodeId=132613e967969, content=<a href='/topic/show?id=6d8340012ff' target=_blank style='color:#2F92EE;'>#唑来膦酸#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=40012, encryptionId=6d8340012ff, topicName=唑来膦酸)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3307462, createdName=风铃821, createdTime=Fri Jan 06 10:15:00 CST 2017, time=2017-01-06, status=1, ipAttribution=)]

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