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[ESC2012]TRILOGY试验的积极意义——Matthew Roe博士专访

作者:  M.Roe   日期:2012/9/20 18:05:11

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以往的研究显示,有些研究被发表在《新英格兰医学杂志》上,药物治疗的ACS患者是高危患者,这些患者相对较为常见,但是以往对这些患者未开展研究。这是由于介入科医生很自然地会开展针对PCI患者的心血管研究。

  <International Circulation> : First we would like to congratulate you on your trial.  Why was there a need for such a trial?
《国际循环》:首先就TRILOGY试验的结果恭喜你。为什么要开展该项试验?
Dr. Roe: As we showed with previous analyses, some of them in reference in the New England Journal paper, these medically managed patients are at high risk and are relatively prevalent, but they have never been studied before. This is because it is natural for an interventional cardiologist to perform cardiovascular research focusing on patients who receive PCI. These patients are easy to find: they are in the cath lab.  Logistically, locating patients was more difficult and so conducting this trial was not easy.  We had to reconfigure the research at many sites, but it was an important study to do because this is a group of patients who have the most events. They are also  most deserving of new treatments as event rates have gone down in PCI treated patients that only show marginal benefit now s in terms of trying to further reducing the risk. In this trial, we are studying a whole new group of patients who have never been studied and trying to understand, and reduce, their risk.
MT Roe博士:以往的研究显示,有些研究被发表在《新英格兰医学杂志》上,药物治疗的ACS患者是高危患者,这些患者相对较为常见,但是以往对这些患者未开展研究。这是由于介入科医生很自然地会开展针对PCI患者的心血管研究。这样的患者很容易找到,他们就在导管室里。从后勤上来讲,找到患者更为困难,因此开展这样的试验并不容易。我们在多家中心开展了TRILOGY试验的重组工作,这是一项重要的试验,因为所纳入的患者是事件发生数最多的这一群患者。这些患者也是最应当接受新型治疗的患者,因为PCI治疗的患者事件率已经下降,在此基础上进一步降低的风险的努力有一些效果,但是差异未达到统计学显著性。TRILOGY试验针对的是从没有被研究过的患者群,目的是了解并降低心血管风险。
 International Circulation : What was some of the strengths of this trial?
《国际循环》:TRILOGY试验的优势是什么?
Dr. Roe: The first strength was that it was worldwide, with 52 countries, including China, were more than 300 patients were enrolled.  The second was that we studied therapy for an unprecedented duration of time, and third we individualized the dose of the antiplatelet agent, which has never been done. The forth stength was that this was a truly an academic-industry partnership. It was an academically led and run trial, coordinated by our organization, the Duke Clinical Research Institute, working together with our sponsors, Eli Illy and Daiichi, but it was run by the academic group. I think that it was a testament to the sponsor’s commitment. We had a great collaboration with more than 50 physicians worldwide working on the committees together.
MT Roe博士:首先,TRILOGY试验是一项国际性研究,有52个国家参与,包括中国在内,入选了300多例患者。其次,该试验观察的治疗时间长于以往。第三,给予了个体化剂量的抗血小板治疗,这是前所未有的。第四,该试验是学术机构和工业联合发起的。学术机构领导并负责试验的进行,由美国杜克大学临床研究院协调整个试验,由美国礼来公司和日本三共公司资助了这项试验。但是试验的开展是由学术机构来完成的。我认为,这实现了赞助商的承诺。试验委员会的50多位来自全球的专家开展了非常好的合作。

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