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[ADA2012]从ORIGIN研究结果的解读2型糖尿病治疗策略
——俄勒冈州健康医学大学Matthew C.Riddle教授访谈
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作者:M.C.Riddle 2012/6/18 16:13:00    加入收藏
内容概要:Riddle教授:首先我想要说,作为研究参与者,我们同样对这项研究的开展方式感到非常高兴。这项研究是一个很大的项目,我们每个人都投入了很大的精力,能够顺利完成使我们松一口气。

  <International Diabetes>: You have just presented the results and your interpretation of the ORIGIN trial. There has been a lot of talk around this conference that this is a beautiful trial but I feel that some members of the audience may have been a little disappointed. What would you say to those people?
  Prof Riddle:First of all I would say that we, the investigators, are very happy with the way the trial was conducted as well. It was a big project and we are relieved it is over because we put a lot of energy into it. To answer your question directly, I think that the trial accomplished its goal. We really wanted to know what the effects were of early basal insulin treatment because there were conflicting hypotheses and conflicting ideas as to what the effect of insulin is in patients with heart disease. There is one view based on physiological evidence which believes that insulin replacement in people who are insulin deficient ought to correct many metabolic abnormalities and there is evidence that it might reduce heart disease. Then there is also a lot of evidence which is mainly from epidemiological studies, not scientific studies but based on analysis of large complicated data bases, suggesting that insulin is harmful and might cause heart disease or cause more heart attacks and that it might cause more cancer. So the community has been confused by conflicting hypotheses. The study was meant to resolve the question, does insulin given to people with high risk for heart disease protect them against events? Does it cause more events or does it have a neutral effect so we can only focus on its glucose lowering power to protect against the complications of diabetes? I think the study answers the question.

  《国际糖尿病》:您刚才的演讲为我们展示了ORIGIN试验的结果。本届大会中,人们一直在赞赏这项研究的设计非常漂亮,但我们看到有些听众似乎对这项研究有些许失望。您想对这些听众说些什么吗?
  Riddle教授:首先我想要说,作为研究参与者,我们同样对这项研究的开展方式感到非常高兴。这项研究是一个很大的项目,我们每个人都投入了很大的精力,能够顺利完成使我们松一口气。我可以直接的回答你的问题,我个人认为这项研究的结果达到了预期目标。学界关于胰岛素对心脏病患者的影响方面存在着两种相互对立的假设和观点,因此我们非常渴望知道早期基础胰岛素治疗对心脏病的影响。一种基于生理学研究证据的观点认为,胰岛素缺乏的患者接受胰岛素替代治疗可以纠正多种代谢异常,而且有证据显示,这样做可以减少心脏病发作。但另一方面,同样还有很多的研究证据(主要是来自流行病学研究,并非基于科学研究,而是基于大规模的复杂数据库分析结果)显示,胰岛素治疗有害,可能会导致心脏病或心脏性猝死,还可能会导致肿瘤发生率增高。因此,学界对这些相互矛盾的学说非常困惑。这项研究就是要解决这个问题,明确高危心脏病患者接受胰岛素治疗后能否预防心脏事件?胰岛素治疗是否会增加事件风险,抑或作用中性?如果结果是这样的,我们仅仅需要将关注点放在胰岛素降糖对糖尿病并发症的保护作用上。我想这个研究回答已经了这个问题。

  <International Diabetes>: Do you believe the reason that you saw no difference in cardiovascular events was because insulin does not have much of an influence on cardiovascular events or was there some other confounding factor such as the level of medical attention people are now receiving, the amount of statins, a lack of events and so on?
  Prof Riddle:No. I don’t think there is any confounding by other current factors. A better way to talk about it is that we have only tested the question over a seven year span of time which sounds like a pretty long time but we also know that diabetic complications take ten or twenty or more years to develop. It may be too short to see an effect if the beneficial effect is on the gradual development of structural changes in the blood vessel walls, coronary plaque and the changes that occur in the development of coronary heart disease. It turns out that other treatments for heart disease work even if the heart is very abnormal in its structure. So aspirin treatment reduces clots and heart attacks even in patients who have advanced heart disease. Similarly statin treatment lowers cholesterol, stabilizes plaques and prevents heart attacks even in the short-run in people with established heart disease. So I think that one possibility is that both what glucose control and maybe separately, insulin replacement do, is to slow the preliminary changes in heart abnormalities that lead to the adverse later events. So it is a time question.

  《国际糖尿病》:本研究中,不同研究组之间心血管事件的发生率没有显著差异,您认为这一结果是由于胰岛素的确对心血管事件没有产生显著影响,还是因为研究存在其他一些混杂因素(如目前受试者所接受的医疗治疗水平,如他汀类药物治疗,研究中总事件数少等)所导致的?
  Riddle教授:我认为这项研究中不存在其他的混杂因素。我想对于这个结果,最好的解释是这项研究的持续时间是7年,听起来似乎时间很长,但我们都知道糖尿病并发症的发生要10年,20年甚至更长时间。想要看到胰岛素对缓慢发生的血管壁结构改变、动脉粥样硬化斑块以及冠心病发生发展过程中的变化等方面的影响,7年时间还是太短了。即使心脏的结构已经很不正常,已有的其他治疗措施依然会非常有效。即使患者的心脏病已经发展到进展期,阿司匹林仍然可以降低血栓和心脏性猝死事件发生率。与之相似,在已确诊的心脏病患者中,即使短期应用他汀类治疗也可以降低胆固醇水平、稳定斑块和预防心脏性猝死发生。因此,我认为有一种可能是,血糖控制或者更具体地说,胰岛素替代治疗的作用是延缓初始心脏异常改变这些初始心脏异常改变最终导致不良心脏事件。因此,这个问题的解释是“时间问题”。

  <International Diabetes>:So as far as cardiovascular events and mortality is concerned, we have not found the answer yet? Is it still too early to know what effect this intervention is going to have on those events?
  Prof Riddle:Yes. We know we are going to be doing at least a short-term follow-up but we hope to follow-up for many years in the same patients without any further treatment to see what happens to them over the years to come.

  《国际糖尿病》:那么,可以说在胰岛素对心血管事件和死亡率的影响这个问题上,我们还没有找到答案。可不可以理解成,现在对胰岛素能否影响这些事件下结论为时尚早?
  Riddle教授: 是的。我们至少要对该人群继续进行一个短期的随访观察,但我们希望能对这批患者开展长期的随访,不增加其他治疗,来观察若干年后的情况。

  <International Diabetes>:Do you think there might be a more obvious effect later on down the road?
  Prof Riddle: It is very possible and I hope we find out.

  《国际糖尿病》:您是否认为这样随访观察下去,随着时间的延长可以观察到更加明显的效果?
  Riddle教授:非常有可能,我希望能够看到。

  <International Diabetes>: What we do know however is that there are no safety concerns giving basal insulin glargine for this period of six or seven years?
  Prof Riddle: I wouldn’t go so far as to say no safety concerns because the insulin has to be used carefully and we used it carefully in this study. If it is used correctly then I believe it is as safe as other treatments and I think that is what we showed.

  《国际糖尿病》:那么,目前我们可以明确的是,基础胰岛素(甘精胰岛素)治疗6年或7年时间,没有发现明显的安全性问题,是这样吗?
  Riddle教授:我认为还不能说没有安全性问题,因为胰岛素的使用必须十分谨慎,我们在研究中也是这样做的。如果能够正确使用,我想胰岛素和其他的治疗措施一样安全,我们的研究也充分体现了这一点。

  <International Diabetes>:One of the concerns many people might raise is that you brought glucose levels down so low with insulin especially so early that they might have expected to see more hypoglycemia. You said you used t

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网站用户: 殷学 时间:2012/9/23 11:42:00
ORIGIN研究给临床带来很好的启发,对于给病人更加积极的早期应用胰岛素保护胰岛功能带来新的证据。

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