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我国介入心脏病学的新起点 ——国产靶向药物洗脱支架获准上市

2014-03-21 MedSci MedSci原创

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一个医学专科的兴盛，不仅取决于基础研究水平、临床诊疗水平，还要看该专科相关的医疗工业制造水平。中国介入心脏病学始于上世纪80年代，我国首例经皮冠状动脉腔内血管成形术（Percutaneous fransluminal coronary angioplasty，PTCA）于1983年在苏州大学附属第一医院完成，至今已有30年的历史。随着冠心病发生率和死亡率的上升，中国冠心病介入治疗的需求不断增长，其

一个医学专科的兴盛，不仅取决于基础研究水平、临床诊疗水平，还要看该专科相关的医疗工业制造水平。中国介入心脏病学始于上世纪80年代，我国首例经皮冠状动脉腔内血管成形术（Percutaneous fransluminal coronary angioplasty，PTCA）于1983年在苏州大学附属第一医院完成，至今已有30年的历史。随着冠心病发生率和死亡率的上升，中国冠心病介入治疗的需求不断增长，其临床治疗水平也取得了长足的进步。而我国国产冠心病介入材料的发展壮大，则进一步提升了我国介入心脏病学的整体实力。

在第十二届中国介入心脏病学（CIT）大会期间，由中国本土企业上海微创医疗器械（集团）有限公司自主研发的新一代针对冠心病介入治疗使用的Firehawk®（火鹰）冠脉雷帕霉素靶向洗脱支架系统获准上市新闻发布会在上海召开。


罗七一 上海微创医疗器械（集团）有限公司首席技术官致发布会开幕致辞


CIT大会主席高润霖（阜外心血管病医院）对TARGET研究发言

（左起）徐波、高润霖、Dr Martin B. Leon、罗七一

Firehawk®（火鹰）创下了数个中国第一乃至世界第一。首先，它是全球首个单面刻槽工艺支架；其次，它达到了支架有效载药量全球最低的“零冗余”标准；第三，围绕它展开的TARGET系列研究是我国第一个严格遵循国家食品药品监督管理局（CFDA）颁布的《冠脉药物支架临床试验指导原则》进行的上市前研究；第四，它是我国第一个与世界最领先心脏支架雅培XIENCE V支架进行大规模随机入组对照研究证明等效性的国产支架；第五，它是第一个有可能基于支架设计达到缩短介入术后双联抗血小板治疗的冠脉支架。

在火鹰支架获准上市前，由国家心血管病中心阜外心血管病医院牵头发起的针对其临床有效性与安全性进行的TARGET系列研究，验证了它的先进设计理念。作为首个严格遵循国家食品药品监督管理局（CFDA）颁布的《冠脉药物支架临床试验指导原则》进行的上市前研究，将TARGET研究分为首次人体试验（FIM）、随机对照试验（TARGET Ⅰ）和单组目标值试验（TARGETⅡ）进行，共计在全国29家大型心血管病临床中心入组1261例患者。在继承了传统DES优效性能的基础上，该系列研究的TARGET Ⅰ随机对照试验选择了目前全球最具挑战的XIENCE V支架（雅培 美国）进行随机分组对照，两年结果显示同样没有发现支架内血栓形成，其主要观察终点9个月支架内晚期官腔丢失和其他次要观察终点均得到与XIENCE V支架对比的非劣效结论。而入组复杂病例后更加接近真实世界的单组目标值研究TARGET Ⅱ一年结果也只有0.1%（1例）的血栓事件，经分析该例患者发生血栓的原因是氯吡格雷抵抗，更换药物后无血栓情况。

这证明，利用单面刻槽载药工艺的 Firehawk®靶向洗脱支架（TES，Target Eluting Stent）在继承传统DES卓越的有效性并优化载药量后，已经达到了药物支架的安全性能巅峰。该系列研究对于火鹰支架的观察还将持续至5年，相信它将继续改写药物支架的全球数据，将冠心病介入治疗带入中国时代，服务于全球的冠心病患者。



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    2014-07-21 qblt

    #心脏病学#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2018543, encodeId=87ee20185435c, content=<a href='/topic/show?id=ff3c51599b0' target=_blank style='color:#2F92EE;'>#心脏病学#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=51599, encryptionId=ff3c51599b0, topicName=心脏病学)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=640c454, createdName=qblt, createdTime=Mon Jul 21 06:03:00 CST 2014, time=2014-07-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1998716, encodeId=b9dc1998e16e0, content=<a href='/topic/show?id=80936510423' target=_blank style='color:#2F92EE;'>#洗脱支架#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65104, encryptionId=80936510423, topicName=洗脱支架)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e72268, createdName=zhixianchen, createdTime=Thu Apr 17 18:03:00 CST 2014, time=2014-04-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1970396, encodeId=e85919e0396cd, content=<a href='/topic/show?id=6c9425269fd' target=_blank style='color:#2F92EE;'>#介入心脏病学#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25269, encryptionId=6c9425269fd, topicName=介入心脏病学)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4dfa37, createdName=智者为医08, createdTime=Mon May 05 23:03:00 CST 2014, time=2014-05-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1310456, encodeId=631e13104562a, content=<a href='/topic/show?id=f70e8e78941' target=_blank style='color:#2F92EE;'>#药物洗脱支架#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=87789, encryptionId=f70e8e78941, topicName=药物洗脱支架)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智慧医人, createdTime=Sun Mar 23 05:03:00 CST 2014, time=2014-03-23, status=1, ipAttribution=)]
    2014-04-17 zhixianchen

    #洗脱支架#

    0

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    2014-05-05 智者为医08

    #介入心脏病学#

    0

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    2014-03-23 智慧医人

    #药物洗脱支架#

    0