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[ESC2008]荆志成教授对话Peters教授:抗凝血药物磺达肝癸钠的应用

作者:国际循环网   日期:2008/9/12 18:46:00

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1 There are some significant disagreement with the grading of the level of evidence and the class of recommendation for fondaparinux between the 2007 AHA/ACC and the 2007 ESC guidelines for the acute use of anticoagulants in patients with non-ST-elevation acute coronary syndromes. why difference in appearance? 在2007年AHA/ACC和2007年ESC有关非ST段抬高型急性冠脉综合征(NSTE-ACS)在患者急性期应用抗凝药的指南上,对磺达肝癸钠的证据水平等级以及推荐级别存在明显差异,为何会产生该差异?

International Circulation: Okay. Thank you very much Professor Peter Steg. I…representing the International Circulation…appreciate your cooperation with us. My first question is there are some significant disagreement regarding the grading of the level of evidence and the class of recommendation for fondaparinux between the 2007 AHA/ACC and the 2007 ESC guidelines for the acute use of anticoagulants in patients with non-ST-elevation acute coronary syndromes. So why the different in appearance? 

《国际循环》:在2007年AHA/ACC和2007年ESC有关非ST段抬高型急性冠脉综合征(NSTE-ACS)在患者急性期应用抗凝药的指南上,对磺达肝癸钠(fondaparinux)的证据水平等级以及推荐级别存在明显差异,为何会产生该差异?

Prof. Peters: Well, there are several explanations in my opinion. One is that the people who write these guidelines are usually also involved in doing the trials with the drugs that are concerned. And in the US, the people who have been investigating enoxaparin, the low molecular weight heparin, have also been most active in drawing up the guidelines. So one of the reasons I believe why enoxaparin is so prominent in the American guideline is that the guideline was written by investigators of enoxaparin. Second, the fondaparinux company is European, so to Americans that is a bit more distant, it is a bit more foreign, so they are not as familiar with it as with enoxaparin or low molecular weight heparins. And I must say that within the evidence there is a lot of room for interpretation. So with the same data, you may select one or the other depending on what you’d like to stress. Do you stress efficacy, or do you stress safety. In the enoxaparin trials, efficacy is usually stressed a lot because it is compared to unfractionated heparin, and it is more efficient. And the downside of bleeding, which is also increased with enoxaparin, is usually not stressed that much, because efficacy as I said, is considered more important in the US than safety at present. In Europe, however, we believe that fondaparinux should be preferred treatment for acute coronary syndrome because of safety concerns. We’ve seen…our group of investigators has seen that bleeding is not a small problem, it leads to mortality. And therefore if there is a drug that reduces bleeding, we believe that it should be selected. So there is national interests, there are conflicts of interests, and there is a matter of opinion, of taste. 

Peters 教授:我看有多种解释。一是指南的撰写者同时也是参与到相关药物的研发中。以美国为例,研发enoxaparin(依诺肝素)的人同时也是在指南编辑中最活跃的人。我想这是依诺肝素(enoxaparin)在指南中居于此等显赫地位的原因之一。另一个原因是磺达肝癸钠(fondaparinux)是欧洲公司的产品,所以对美国人来说更遥远,不像依诺肝素(enoxaparin)或低分子肝素那样为人们熟悉。另外我必须说明一点,所谓提供证据的数据是有很大可以自由解读的空间的,关键看你从那个角度出发,更看重什么因素,疗效还是安全性。在依诺肝素(enoxaparin)的试验中,疗效是被着重强调的,因为与普通肝素(UH)相比是更有效的。同时依诺肝素(enoxaparin)导致流血并没有被强调出来,因为正像我前面说过的,在美国人们相对安全性更看重疗效。在欧洲,恰恰相反,我们认为磺达肝癸钠(fondaparinux)才应该做为治疗急性冠脉综合征(ACS)的推荐药物正是出于安全性方面的考虑。我们的研究者发现,出血并不是小事,它是可能致命的。因此我们认为更应改选择一种减少出血副作用的药物。所以这个问题牵涉到国家利益,利益冲突,而且也是仁者见仁,智者见智的。

International Circulation: Yes, so if safety is more important in Europe, so if fondaparinux got the incidence…got the approval from Europe, is more easy to approve that in America? 

《国际循环》:是的,如果说欧洲更注重安全性的话,那么磺达肝癸钠(fondaparinux)既然已在欧洲通过,在美国通过也就很容易了吧?

Prof. Peters: Yes, yes. I think some of what we’re seeing now is temporary. I think in the end we will probably all agree on the merits of each of these drugs. And what we’ll also play a role is that when these drugs go out of patent, so when they become much cheaper, and when the companies lose interest, then we can make the choices just based on their properties, and not on the other interests that people may have. 

Peters 教授:是的。我想我们现在的一些看法可能都是暂时性的。最终我相信我们会在各种药物的性质各方面都达成共识的。同时,当这些药物的专利期过去以后,它们会更便宜,公司对它们失去兴趣,那时我们也可以发挥作用,只就各种药物本身的品性作出评价判断,而不再被评判者的利益关系所误导。

International Circulation:: And for example, one indication of fondaparinux is for the prophylaxis of deep vein thrombosis which may lead to pulmonary embolism. DVT is a major complication in many patients with big surgery such as abdominal surgery, hip replacement, or knee replacement surgery and more. But in China, seldom to prescribe anticoagulant agents to these patients is because…often due to the physicians’ perceiving the risk of major bleeding in association with anticoagulant therapy as unacceptably high. What is the status of anticoagulant for the prophylaxis of DVT in Europe at present? Would you like to share us your experience of fondaparinux or other anticoagulants for the prophylaxis of deep vein thrombosis?

《国际循环》:磺达肝癸钠的一个适应症是预防深静脉血栓,后者可导致肺栓塞。深静脉血栓也是许多大手术患者的一个主要并发症,如腹部手术、髋关节或膝关节置换。在中国,医生们由于担心抗凝治疗引起大出血的风险将会很高,而很少对上述患者应用抗凝药。欧洲应用抗凝药预防深静脉血栓的情况如何?能否与我们一同分享您在使用磺达肝癸钠等抗凝药预防深静脉血栓方面的经验?

Prof. Peters: Certainly, I must say that DVT is not my expertise. But I know about it because of…our contacts in the hospital with hematologists but also because the drugs that we use in coronary care are the same as that are used for DVT. Now as you mentioned, following surgery for hip, or knee replacement, or fractures, DVT is pretty common. And it is an important component of the care of the patient but my explanation for what you may be seeing in China is we’ve seen the same in Europe, some time ago. The surgeons who do the operation are mainly concerned with bleeding because that’s what they see, that is their responsibility. But after two days or so, after the patient leaves the surgical ward, and their job is finished, they are happy. But then after that, in three to five days, they get their DVT, they get their pulmonary embolism, they get their pulmonary hypertension down the road. And the surgeons don’t see that. They don’t even know about it perhaps. At least it is not their responsibility. The same is happening. I could compare it to that with PCI. PCI doctors in the catheterization laboratory are more concerned with thrombosis because that’s what’s troubling their intervention. If they see occluded arteries, they have a problem. So they give a lot of anticoagulants. And then when the patient leaves the lab and goes back to the ward, and they get bleeding complications, after removal of the sheath or something. The interventional cardiologist does not see that. He just sees what’s happening in the lab. Or it’s a little exaggerated, but it shows the same point that doctors put the weight of the evidence on the part of the care that they are responsible for. So surgeons don’t want the bleeding. They don’t see the thrombosis. But we are convinced now that thrombosis prophylaxis is an important component for the care of surgical patients. They should receive anticoagulants, the duration of that depends on the type of operation and the type of patient. And I believe that fondaparinux is the

版面编辑:张家程



Peters磺达肝癸钠ST段抬高型急性冠脉综合征深静脉血栓荆志成

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