EHJ：如何提高冠状动脉支架评估审批效率？

2015-07-14 大鹏译医学论坛网

近期《欧洲心脏病学杂志》(Eur Heart J)近期发表了一项有关冠状动脉支架评估审批的报告，该文由欧洲心脏病学会(ESC)/欧洲经皮心血管介入学会(EAPCI)专家特别小组撰写，以下为该文要点： 1.由于医疗更新换代较快，冠脉支架产品的“寿命”较短，一般支架在上市后5年后即被淘汰; 2.专家组强调应尽可能加速支架等设备的上市前审批流程，以便患者能最快的获得最先进的治疗。 3.专家组认为，

近期《欧洲心脏病学杂志》(Eur Heart J)近期发表了一项有关冠状动脉支架评估审批的报告，该文由欧洲心脏病学会(ESC)/欧洲经皮心血管介入学会(EAPCI)专家特别小组撰写，以下为该文要点：

1.由于医疗更新换代较快，冠脉支架产品的“寿命”较短，一般支架在上市后5年后即被淘汰;

2.专家组强调应尽可能加速支架等设备的上市前审批流程，以便患者能最快的获得最先进的治疗。

3.专家组认为，及时审阅并答复已提交文件是成功审批流程必不可少的环节，推荐审阅过程有健全的监控机制，并在3到6个月完成。

4.专家组指出，在理想的条件下，医疗设备应分为常规设备(完备医疗标准下的替代治疗)与新型设备(无完备的医疗标准)。但这种分类较为困难，而且为了避免歧义，专家组认为统一评估路径更可取。

5.专家组承认上市后监测在整个临床冠脉支架评估体系中的重要性，而且有人担心支架等设备在上市后的故障相关不良事件发生情况被低估。

6.专家组推荐统一审批流程，这需要人们根据系统性回顾数据制定质量参数，并保证上市前及上市后设备批准所使用参数的一致性。

7.专家组建议在临床试验早期，研究者应采用客观的评价指标评估支架性能。

8.在公示制度方面，专家组有以下建议：为所有申请欧洲统一(CE)认证的临床试验建立系统公示登记制度;在可公开访问的网站上，公示负责条件性CE认证及完整CE认证相关指定机构的决策过程;公示所有以完整CE认证为目的的上市后监测研究结果;建立一个公开访问的中央数据库，该数据需纳入所有得到CE认证的冠脉支架，及其相关试验证据。

9.专家组推荐：为了支持CE市场申请，相关医疗器械的临床研究样本量至少为欧洲患者的一半。

10.支架等医疗设备使用说明应提供关于适应证及禁忌证的明确指导。

原始出处：

Byrne RA, Serruys PW, Baumbach A, et al.Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions Task Force on the Evaluation of Coronary Stents in Europe: Executive Summary. Eur Heart J 2015;Jun 13:[Epub ahead of print].

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2016-03-24 忠诚向上

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好好看下！

130 0
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2016-03-24 忠诚向上

好好看下！

160 0
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2016-03-24 忠诚向上

好好看下！

115 0
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2016-03-24 忠诚向上

好好看下！

126 0
[GetPortalCommentsPageByObjectIdResponse(id=73255, encodeId=35f6e32558a, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73256, encodeId=e322e325681, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=196, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73257, encodeId=6e78e32573c, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73258, encodeId=b537e3258b0, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73259, encodeId=64a7e3259a8, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=160, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73260, encodeId=5e65e326000, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73261, encodeId=f20ce3261ef, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73262, encodeId=d63ae326281, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=173, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73263, encodeId=9d7be3263a8, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1693857, encodeId=2886169385eba, content=<a href='/topic/show?id=30ab30866f0' target=_blank style='color:#2F92EE;'>#冠状动脉支架#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30866, encryptionId=30ab30866f0, topicName=冠状动脉支架)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ad0e29466742, createdName=xiaoyeshuang, createdTime=Wed Feb 24 14:59:00 CST 2016, time=2016-02-24, status=1, ipAttribution=)]
2016-03-24 忠诚向上

好好看下！

173 0
[GetPortalCommentsPageByObjectIdResponse(id=73255, encodeId=35f6e32558a, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=137, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73256, encodeId=e322e325681, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=196, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73257, encodeId=6e78e32573c, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73258, encodeId=b537e3258b0, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=130, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73259, encodeId=64a7e3259a8, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=160, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73260, encodeId=5e65e326000, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73261, encodeId=f20ce3261ef, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73262, encodeId=d63ae326281, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=173, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=73263, encodeId=9d7be3263a8, content=好好看下！, beContent=null, objectType=article, channel=null, level=null, likeNumber=70, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45101626056, createdName=忠诚向上, createdTime=Thu Mar 24 07:45:00 CST 2016, time=2016-03-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1693857, encodeId=2886169385eba, content=<a href='/topic/show?id=30ab30866f0' target=_blank style='color:#2F92EE;'>#冠状动脉支架#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=30866, encryptionId=30ab30866f0, topicName=冠状动脉支架)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=ad0e29466742, createdName=xiaoyeshuang, createdTime=Wed Feb 24 14:59:00 CST 2016, time=2016-02-24, status=1, ipAttribution=)]
2016-03-24 忠诚向上

好好看下！

70 0
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2016-02-24 xiaoyeshuang

#冠状动脉支架#

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