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[ADA2015]化繁为简:改变胰岛素治疗延迟现状
——加拿大西安大略大学Stewart B. Harris教授访
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作者:S.B.Harris 2015/6/17 10:43:00    加入收藏
内容概要:在ADA 2015年会上,来自加拿大西安大略大学的Stewart B. Harris教授以“Deceptively Simple Insulin Titration—Strategies to Demystify Insulin Therapy(令人迷惑的简单胰岛素滴定——阐明胰岛素治疗的策略)”为题进行了报告。报告结束后,Harris教授接受《国际糖尿病》记者采访,详细阐述了其简单胰岛素注射的理念,并表达了未来胰岛素发展的个人观点。

  <International Diabetes>: So which factors will influence the effectiveness of insulin therapy?

  Dr. Harris: Right. So one of the big challenges we have in the acceptance of insulin therapy in practice both by practitioners who might not be as familiar with insulin therapy, but especially by patients, is the complexity of the regimes. So what I really try to focus on in my presentation today was that: keep it simple. So start at a very simple low dose of basal insulin, slowly up titrate until you’re maxed out on your basal and then use the same process to introduce your prandial insulins in a stepwise approach. I think we’re long – we’re moving away from the era where we automatically put patients on complex insulin regimes, NDI regime therapy. It’s not to say we don’t think that will work. But it’s the way we get there. So start on your basal. Introduce a single meal prandial insulin. When you need to add it to a second meal, use the same process. Start on a low dose of insulin. Two units of a prandial insulin, a Gilliananalogue prandial insulin to reduce risk of hypoglycemia and then introduce it to a second meal and then introduce it to a third meal. In fact many of the studies that I talked about today show that you don’t even need to go to three meal prandial insulins a day, that the majority of your patients will get to target either on basal insulin or basal plus one or basal plus two. At least two thirds can get to basal – can get to optimal glycemic targets with addition of one or two prandial insulins a day.

   《国际糖尿病》:哪些因素会影响胰岛素治疗的有效性?

 
  临床实践中对胰岛素治疗不太熟悉的医务人员以及患者(尤其是患者)接受胰岛素治疗所面临的一个最大挑战就是胰岛素治疗的复杂性。我今天的演讲中真正想强调的就是保持胰岛素治疗的简单性。因此,我建议胰岛素治疗应从应用非常简单的小剂量基础胰岛素开始,缓慢进行剂量滴定直至发挥基础胰岛素的最大效果,若还不能实现血糖控制目标则加用餐时胰岛素,并按照同样的过程来逐渐滴定餐时胰岛素的用量。
 
  我认为,现在已经不是将患者置于复杂胰岛素治疗——每日多次注射胰岛素(MDI)治疗的时代了。但是,这并不是说我们认为MDI就没有其用武之地。只是说,我们需要从基础胰岛素开始启动胰岛素治疗,在血糖控制不佳时按照上述方案逐渐进行剂量滴定及药物添加。在单纯基础胰岛素剂量滴定血糖仍控制不佳后,于某一餐时加用餐时胰岛素,若效果还不佳再进一步于第二餐时加用餐时胰岛素,如此往复。MDI只是剂量滴定及药物添加方案反复实施后形成的最终治疗方案。
 
  餐时胰岛素的用量可从2U开始,一般会选择餐时胰岛素类似物来降低低血糖风险,然后在血糖控制不佳时选择在第二餐时加用,第二餐加用后仍无法实现良好的血糖控制时再在第三餐时加用。实际上,今天所说到的很多研究均显示,我们可能并不需要每天应用三次餐时胰岛素,大部分患者在应用基础胰岛素、基础胰岛素+一次或两次餐时胰岛素后即可实现良好的血糖控制。至少2/3的患者应用基础胰岛素+一次或两次餐时胰岛素后即可实现最佳血糖控制目标。
 

  <International Diabetes>:Thank you. So in Canada or in the U.S., which?conditions?causedelayed-treatment for patients who need insulin treatment? How to achieve optimized insulin treatment by simple insulin titration?

  Dr. Harris: Right. So studies around the world now – and we’ve done it in Canada, there’s studies in the U.S., recent studies in the U.K show that in general there is tremendous delay in the introduction of insulin into the regime, and on average you could say, if you were to summarize the literature, the mean anyone sees is about 9.5% when patients are finally getting put on insulin. So quite a bit of delay – the clinical inertia around delay – and they already have established complications. So I think one of the challenges in introducing insulin therapy is that clinicians think it’s complicated. Endocrinologists are very comfortable using insulin therapy but often it’s late until the patients are seeing the endocrinologists so we need simpler protocols such as the protocols I reviewed today. That will broaden the healthcare provider that’s comfortable in using insulin. So both endocrinologists and primary care physicians and internists could use simpler protocols that may allow for us to introduce insulin at an earlier stage of the disease and the hope is with simpler titration protocols reducing the complexity, empowering patients to self-titrate, that these will help make an impact in the clinical inertia around the delay of insulin therapy.

  《国际糖尿病》:在加拿大或美国,哪些情况可导致需要胰岛素治疗的患者出现胰岛素治疗延迟?应如何通过简单的胰岛素滴定来实现最佳胰岛素治疗?
 
  现在世界各地(包括美国及加拿大)都在开展这方面的研究。美国开展的近期研究显示,通常情况下,胰岛素治疗的起始时间存在显著延迟。回顾相关文献,可见约有9.5%的患者最终需要接受胰岛素治疗。胰岛素治疗存在非常严重的临床惯性延迟,很多患者在接受胰岛素治疗时已经出现了明确的糖尿病并发症。所以,我认为启动胰岛素治疗所面临的一大挑战就是临床医生认为胰岛素治疗太过复杂。
 
  虽然内分泌医生对应用胰岛素治疗比较得心应手,但通常情况下患者在到内分泌专科医生处就诊时其糖尿病已经到了晚期。所以,我们需要更简单的胰岛素治疗方案。这种方案将有助于让更多医务人员更有把握应用胰岛素,内分泌专家、初级保健医生、内科医生都可以应用更简单的胰岛素治疗方案,从而有助于在疾病较早期阶段就启动胰岛素治疗。我们希望这种更简单的滴定胰岛素治疗方案能够降低,胰岛素治疗的复杂性,让患者能够进行胰岛素的自我剂量滴定,从而有助于影响延迟胰岛素治疗的临床惯性。

  <International Diabetes>:Great, thank you so much. So the last question would be: in your opinion, which is the future of insulin preparation? Will human insulin be completely replaced by insulin analogs in future?And also what is the prospect of inhaled insulin?

  Dr. Harris: Right. So we’re at a very interesting time in our insulin therapeutic options. We’ve certainly seen that over the last decade the evolution of analogue insulins have made insulin a safer therapy. At the end of the day, it’s all about keeping our patients safe and so if we have an insulin therapy that reduces their risk of hypoglycemia as we get closer to target that is always going to be the preferred insulin. So I see the day where insulin analogues will preferentially be used around the world over regular insulin – regular human insulin and intermediate insulin, again PHB, because it’s a safer medication. There’s reduced risk for hypoglycemia. And what we’re seeing in the evolution of insulins is we now have the introduction of the second generation of basal analogue insulins that have an even safer profile compared to the first generation like glargine or Levemir, by reducing nocturnal hypoglycemia by another 25% against the so-called gold standard: glargine insulin. So we see that with toshiyo, we see that with degludec, it’s similar kind of findings coming out of the bill data, the new Lilly PEGylated basal lispro insulin, and we’re now soon – trials are underway now testing the second generation of fast-acting analogue insulins that again – their major benefit is reduced risk for hypoglycemia. So I would hope that in the future we will see only analogue insulins being used because of their safety profile. If they’re safer we can be more aggressive, hence we can get more patients to get to the recommend target safely. In terms of inhaled insulin, it’s early days to know where and how inhaled insulin is going to fit into the whole insulin paradigm. Certainly anything you can do to reduce the number of injections patients require is going to be a potentially benefit. I can see in my own practice using inhaled insulin for patients who are very reluctant to go onto a second or third needle, injectable therapy, but would be willing to take more insulin if they could get it in the inhaled version. So that’s where I think its niche will be, at least initially as we gain experience in using it.

 
  《国际糖尿病》:胰岛素制剂的未来发展方向如何?未来胰岛素类似物能否完全取代人胰岛素?您如何评价吸入型胰岛素的应用前景?
 
  目前,胰岛素治疗选择正处于一个非常有趣的时代。我们的确发现,过去10年间胰岛素类似物的改进已经让胰岛素变得更安全。之所以这样做,都是为了让患者更安全。如果一种胰岛素能够降低血糖发生风险,并尽可能地达到血糖控制目标,则其就是可被首选应用的胰岛素。因此,与常规胰岛素(常规人胰岛素及中效胰岛素)相比,未来胰岛素类似物将在世界各地得到优先应用,这主要是因为其更安全,能降低低血糖风险。
 
  就胰岛素的进步而言,目前第二代基础胰岛素类似物已经上市,与第一代基础胰岛素类似物相比,其更安全。目前已经上市的第二代基础胰岛素类似物有德谷胰岛素、聚乙二醇化的基础赖脯胰岛素,相关临床试验正在就第二代长效胰岛素类似物进行评估。结果发现,其最主要的好处是可降低低血糖风险。因此,我希望未来我们仅应用胰岛素类似物,因为他们的安全性更好。如果它们是更安全的,我们就可以更积极地应用,从而让更多患者安全实现血糖控制达标。
 
  就吸入型胰岛素而言,目前尚处于早期阶段,我们需要进一步研究来确定其在整个胰岛素治疗领域中的地位以及如何将其整合至整个胰岛素治疗范式中。当然,任何能够减少所需胰岛素注射次数的方案也都有潜在益处。从我自己的临床实践经验来看,对不愿意注射第二针或第三针胰岛素的患者可以选择应用吸入型胰岛素;但若应用吸入型胰岛素,其所需的胰岛素剂量会更高。至少目前从我们应用的经验来看,吸入型胰岛素的应用情况是这样的。
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