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[ARVO2012]IVAN研究的主要结果概要
——Simon Harding教授专访

IVAN Results Summary——Simon Harding教授专访

  作者:  SimonHarding  2012/5/7 16:58:00
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内容概要:Prof Harding:IVAN研究是一项在英国实施的大型研究,共有608例患者参加。本研究的目的是比较两种不同的抗VEGF药物及两种不同给药方式在新生血管性或湿性年龄相关性黄斑变性(AMD)中的治疗效果。药物为贝伐单抗和雷珠单抗,这两种药物可以通过连续每月注射,或者临床医师依据患者情况进行按需注射两种方式治疗湿性AMD。

  <International OphthalmologyTimes>: Can you give us a brief summary of the Inhibition of VEGF in Age-related choroidal Neovascularization (IVAN) Study so that our readers can understand the background of this trial?

  《国际眼科时讯》:为使我们的读者对本次采访背景有所了解,您能给我们简单总结一下IVAN研究的要点吗?

  Dr Harding: The IVAN Study is a large study conducted in the United Kingdom with 608 patients who all agreed to participate in a trial comparing two forms of an anti-VEGF drug for neovascular or wet age-related macular degeneration and also to compare two ways in which those drugs are given. The two drugs are Avastin and Lucentis and they can either be given continuously as an injection every month or given discontinuously where the clinician decides if the patient requires the treatment and then the patient receives the injection on an as-needed basis.

  Prof  Harding:IVAN研究是一项在英国实施的大型研究,共有608例患者参加。本研究的目的是比较两种不同的抗VEGF药物及两种不同给药方式在新生血管性或湿性年龄相关性黄斑变性(AMD)中的治疗效果。药物为贝伐单抗和雷珠单抗,这两种药物可以通过连续每月注射,或者临床医师依据患者情况进行按需注射两种方式治疗湿性AMD。

  <International OphthalmologyTimes>:Compared to CATT, what were the differences in findings?

  《国际眼科时讯》:与CATT研究相比,IVAN研究中有哪些不同的发现?

  Dr Harding: The IVAN Study had some important differences to the CATT study. The principle difference was that in the IVAN Study we were allowed to treat patients with better levels of vision and we also conducted a factorial design which meant that we got two studies for the price of one, as it were. It also meant that we only needed to include 600 patients rather than 1200 patients. There were also a couple of other important differences. We measured cost. We looked at the cost of patients having adverse events; we looked at the cost of them coming to hospital as well as the cost of the drug itself. We also had a different as-needed treatment arm where we gave courses of three injections rather than one and waiting to see the kind of response the patients experienced.

  Prof  Harding:IVAN研究与CATT研究相比有一些重要区别。其中主要的不同点在于,IVAN研究纳入了视力水平更高的患者,并且本研究采用析因设计,这就意味着我们用一项研究的代价可以进行两项研究,也意味着我们只需要纳入600例患者,而不是1200例。同时,这两项研究还有一些其他重要区别。在IVAN研究中,我们对治疗所需费用进行评估,关注了出现不良事件的患者的总费用,包括患者来医院的开销及药物本身的花费。另外,我们的按需治疗采用的是一种不同的方案,即起始对患者进行连续三次注射而不是一次,再观察患者对治疗的反应。
  
  <International OphthalmologyTimes>: What were the differences in adverse events between the IVAN Study and CATT?

  《国际眼科时讯》:IVAN与CATT研究中,在不良事件方面的结果有什么不同?
  
  Dr Harding:  In the CATT study there were two important adverse events that occurred. Firstly, people were more likely to have a heart attack or stroke if they received Avastin compared to Lucentis. Secondly, there were some differences that we can’t really explain in terms of the other serious adverse events. In IVAN, the results were quite different in terms of heart attack and stroke, because they were more likely in people who received Lucentis as opposed to Avastin. What we have presented here at ARVO2012 is a meta-analysis where we have combined the data from the CATT and the IVAN and that made the effect go away. So we are pretty sure that, at least for the arteriothrombotic events of heart attack and stroke that the difference appears to be absent. That leaves us with the issue of the serious adverse events and in the IVAN Study we found a similar result to the CATT study. So we are left with one of the two main causes of concern that may still need some further research.

  Prof  Harding:在CATT研究中,有两项主要不良事件发生。首先,接受贝伐单抗治疗的患者与接受雷珠单抗治疗的患者相比,前者更容易患心肌梗死或卒中。其次,对于“其他严重不良事件”这部分,两种药物还存在一些我们解释的差异。在IVAN研究中,心肌梗死或卒中的结果有很大区别,因为结果显示在接受雷珠单抗治疗的患者中更容易发生心肌梗死或卒中。在2012年ARVO年会上,我们报告的一项结合CATT及IVAN研究数据的荟萃分析中,这一差异就不存在了。所以,我们非常肯定的是,两项研究至少在心肌梗死或卒中这2项动脉血栓栓塞事件上不存在差异。另外,在IVAN中发生的严重不良事件与CATT研究类似。目前,我们所关心的两项主要问题中剩下一项(编辑注:即严重不良事件的差异及其原因),而且需要进一步的研究。
  
  <International OphthalmologyTimes>: We know that Avastin and Lucentis have different molecular structures and that Avastin has a longer half-life which may explain the incidence of adverse events in patients. What is your comment on this safety issue?

  《国际眼科时讯》:我们知道,贝伐单抗的分子结构与雷珠单抗不同,贝伐单抗的半衰期更长似乎可以解释患者中不良事件的发生率。您如何看待这个安全问题?
  
  Dr Harding: I think you are suggesting that there is a difference between Avastin and Lucentis in terms of adverse events, but now I don’t think we have really shown that. The combined results of IVAN and CATT really show that there is very little concern about adverse events.

  Prof Harding:我认为,您只是假设贝伐单抗与雷珠单抗的不良事件存在差异,但目前我们并没有明确证据显示结果如此。IVAN与CATT研究结果综合起来表明,不良事件并未引起太多担忧。
  
  <International OphthalmologyTimes>:A key issue in China is that Lucentis is registered for wet AMD but Avastin is not. What are your thoughts on this situation?

  《国际眼科时讯》:在中国的一个关键问题是,雷珠单抗是经过注册的用于治疗湿性AMD的药物,而贝伐单抗并未被批准治疗AMD,您如何看待这一情况?
  
  Dr Harding:  It is very interesting that only Lucentis is licensed for use in China. We have a similar situation in the United Kingdom where Lucentis is licensed for the treatment of wet or neovascular AMD but Avastin isn’t. Now that we have the results of these two studies that show that the two drugs are very similar if not equivalent, it is now up to our government and our regulatory agencies to decide whether they are going to approve the use of Avastin. I imagine the same issue exists in China that the regulatory approval agencies are going to have to make a decision as to whether they are going to allow the use of Avastin.

  Prof  Harding:在英国我们存在类似的情况,雷珠单抗是获得批准的治疗湿性或者新生血管性AMD的药物,而贝伐单抗未获批准。既然我们两项研究结果显示两种药物的治疗效果非常相似,而价格不同,现在该我们的政府及管理机构决定是否批准贝伐单抗的使用了。我想在中国情况也是一样的,相关部门正在决定是否批准贝伐单抗的使用。
  



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