ACC 2018:CECCY研究:β受体阻滞剂对化疗心肌毒性是否有预防价值仍有待进一步探讨

2018-03-15 大连医科大学附属第一医院 夏云龙 中国医学论坛报今日循环

随着肿瘤心脏病学这一学科的初步建立和蓬勃发展,人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变。ACC2018上,巴西学者公布的一项题为Carvedilol for PrEvention of Chemotherapy Related CardiotoxicitY(CECCY)的前瞻性、随机、双盲、安慰剂对照研究结果备受瞩目,该研究旨在探讨以卡维地洛为代表的β

随着肿瘤心脏病学这一学科的初步建立和蓬勃发展,人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变。ACC2018上,巴西学者公布的一项题为Carvedilol for PrEvention of Chemotherapy Related CardiotoxicitY(CECCY)的前瞻性、随机、双盲、安慰剂对照研究结果备受瞩目,该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用。

研究简介

2013年4月至2017年1月期间,CECCY研究共计纳入了200例因HER2阴性乳腺癌接受化疗的成年患者。

其标准化疗方案为:环磷酰胺600 mg/m2、阿霉素60 mg/m2,每21天,×4周期;序贯以紫杉醇80 mg/m2,每7天,×8周期。

排除标准包括:不能规律评估心功能者,既往放化疗史,入组时已有心衰症状,既往心肌病、冠心病或中-重度瓣膜病史,日常应用ACEI(ARB)或β受体阻滞剂,有β受体阻滞剂应用禁忌以及HER2阳性患者。

卡维地洛以口服方式给药,起始剂量为3.125 mg,每日两次,能耐受者逐渐递增至目标最大剂量25 mg,每12小时一次。

随访时长为6个月,于每次阿霉素化疗后约19天左右进行,测量工具包括超声心动图、心肌肌钙蛋白I(cTnI)及B型脑钠肽(BNP)。研究的主要终点事件为超声心动图测量的左室射血分数较基线下降超过10%,次级终点事件包括cTnI、BNP水平升高以及心室舒张功能障碍。

随访结果显示,卡维地洛组与安慰剂组在主要终点事件发生率方面并无显著统计学差异(卡维地洛14.5%vs安慰剂13.5%,P=1.00),但卡维地洛组cTnI升高(P=0.003)及心室舒张功能障碍(P=0.039)的发生率较安慰剂组明显减少。此外,卡维地洛组化疗后左室舒张末期内径的增加幅度较安慰剂组也有减小趋势[卡维地洛(44.1±3.64)to(45.2±3.2)vs安慰剂(44.9±3.6)to(46.4±4.0)mm,P=0.057)]。

研究点评

作为迄今为止最大规模的探究β受体阻滞剂用于预防化疗相关心肌毒性的前瞻性临床试验,CECCY研究的结果似乎有些令人失望。

阿霉素相关心肌毒性在临床上主要表现为左室收缩功能下降和左心室扩张,而本研究既未发现卡维地洛对LVEF和左室内径具有统计学意义的保护作用,也未能直接提示卡维地洛对于阿霉素所致心功能不全的有效改善。但笔者认为,以此判定β受体阻滞剂对化疗心肌毒性缺乏预防价值为时尚早。

已有多项研究提示,阿霉素对心功能的损害可能从影响左室的松弛功能开始,逐渐发展至心室收缩功能下降,最终导致症状性心衰。

本研究在乳腺癌化疗患者中观察到了卡维地洛对心室舒张功能的保护作用,或可提示该类药物对于延缓症状性心衰发生的积极作用。

而作为体现心肌损伤的敏感指标,cTnI水平的变化在两组中具有显著差异。结构决定功能,心肌完整性的破坏是心肌功能受损和心脏功能异常的重要病理学基础,从这个角度来说,卡维地洛对于心肌的保护作用显然对保留患者的心室功能有所助益。

再者,阿霉素心肌毒性所致心功能不全的病程常以年计算,具有进行性、不可逆的特点,本研究的随访时限仅有半年,相对较短,以此盖棺定论不够严谨。

从机制上说,β受体阻滞剂固有的负性肌力作用也可能在测量中一定程度上抵消其对左室收缩功能有限的保护作用,这或许也是本研究未观察到卡维地洛与安慰剂在LVEF指标变化方面存在显著差别的原因之一。

然而,除具有其它β受体阻滞剂的药理学作用外,卡维地洛还兼具部分α受体阻滞和抗氧应激化特性。鉴于阿霉素等药物所致心肌毒性与氧化应激密切相关,卡维地洛的确最有希望成为预防化疗致心肌功能不全的理想药物。

但究竟这一理论猜想能否带来现实获益还需要更多的临床试验、更长时间的有效随访和更细致的基础实验研究加以验证。我们相信,随着各国学者对肿瘤治疗相关心血管损伤的深入研究,肿瘤心脏病学的多项未解之谜将会被不断揭开!

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    2018-12-09 仁医06
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target=_blank style='color:#2F92EE;'>#CEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4444, encryptionId=453d444478, topicName=CEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cbfc17510252, createdName=liye789132257, createdTime=Sat Mar 17 11:46:00 CST 2018, time=2018-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296570, encodeId=b33f2965e09f, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Thu Mar 15 22:57:06 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296565, encodeId=2fa72965657c, content=随着肿瘤心脏病学这一学科的初步建立和蓬勃发展.人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变.ACC2018上.巴西学者公布的一项题为CarvedilolforPrEventionofChemotherapyRelatedCardiotoxicitY(CECCY)的前瞻性.随机.双盲.安慰剂对照研究结果备受瞩目.该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用., beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Thu Mar 15 22:49:07 CST 2018, time=2018-03-15, status=1, ipAttribution=)]
    2018-03-18 zhyy88
  4. 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content=随着肿瘤心脏病学这一学科的初步建立和蓬勃发展.人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变.ACC2018上.巴西学者公布的一项题为CarvedilolforPrEventionofChemotherapyRelatedCardiotoxicitY(CECCY)的前瞻性.随机.双盲.安慰剂对照研究结果备受瞩目.该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用., beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Thu Mar 15 22:49:07 CST 2018, time=2018-03-15, status=1, ipAttribution=)]
    2018-03-23 大爰

    学习并分享!!

    0

  5. 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target=_blank style='color:#2F92EE;'>#CEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4444, encryptionId=453d444478, topicName=CEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cbfc17510252, createdName=liye789132257, createdTime=Sat Mar 17 11:46:00 CST 2018, time=2018-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296570, encodeId=b33f2965e09f, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Thu Mar 15 22:57:06 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296565, encodeId=2fa72965657c, content=随着肿瘤心脏病学这一学科的初步建立和蓬勃发展.人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变.ACC2018上.巴西学者公布的一项题为CarvedilolforPrEventionofChemotherapyRelatedCardiotoxicitY(CECCY)的前瞻性.随机.双盲.安慰剂对照研究结果备受瞩目.该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用., beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Thu Mar 15 22:49:07 CST 2018, time=2018-03-15, status=1, ipAttribution=)]
    2018-03-19 大爰

    学习了谢谢分享!!

    0

  6. 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content=随着肿瘤心脏病学这一学科的初步建立和蓬勃发展.人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变.ACC2018上.巴西学者公布的一项题为CarvedilolforPrEventionofChemotherapyRelatedCardiotoxicitY(CECCY)的前瞻性.随机.双盲.安慰剂对照研究结果备受瞩目.该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用., beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Thu Mar 15 22:49:07 CST 2018, time=2018-03-15, status=1, ipAttribution=)]
    2018-03-17 liye789132257
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target=_blank style='color:#2F92EE;'>#CEC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4444, encryptionId=453d444478, topicName=CEC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cbfc17510252, createdName=liye789132257, createdTime=Sat Mar 17 11:46:00 CST 2018, time=2018-03-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296570, encodeId=b33f2965e09f, content=不错的文章值得推荐, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=04f22055142, createdName=131****2916, createdTime=Thu Mar 15 22:57:06 CST 2018, time=2018-03-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=296565, encodeId=2fa72965657c, content=随着肿瘤心脏病学这一学科的初步建立和蓬勃发展.人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变.ACC2018上.巴西学者公布的一项题为CarvedilolforPrEventionofChemotherapyRelatedCardiotoxicitY(CECCY)的前瞻性.随机.双盲.安慰剂对照研究结果备受瞩目.该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用., beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Thu Mar 15 22:49:07 CST 2018, time=2018-03-15, status=1, ipAttribution=)]
    2018-03-15 131****2916

    不错的文章值得推荐

    0

  10. 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content=随着肿瘤心脏病学这一学科的初步建立和蓬勃发展.人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变.ACC2018上.巴西学者公布的一项题为CarvedilolforPrEventionofChemotherapyRelatedCardiotoxicitY(CECCY)的前瞻性.随机.双盲.安慰剂对照研究结果备受瞩目.该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用., beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo7cJ6ejWUr2nIia8qOvAKNdLHr32Df6G8iaoaOx6pHaoiacwp26DaslxZHCGbibZhhCGven4rvmWP60GahtzgFjgCjR/0, createdBy=6b111703011, createdName=有备才能无患, createdTime=Thu Mar 15 22:49:07 CST 2018, time=2018-03-15, status=1, ipAttribution=)]
    2018-03-15 有备才能无患

    随着肿瘤心脏病学这一学科的初步建立和蓬勃发展.人们对肿瘤治疗相关心肌毒性的关注重点已逐渐从呼吁重视和及时预警向早期干预和合理防治转变.ACC2018上.巴西学者公布的一项题为CarvedilolforPrEventionofChemotherapyRelatedCardiotoxicitY(CECCY)的前瞻性.随机.双盲.安慰剂对照研究结果备受瞩目.该研究旨在探讨以卡维地洛为代表的β受体阻滞剂对蒽环类药物相关心肌毒性的预防作用.

    0