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[TISC2014]基于循证的卒中治疗及INTERACT-2研究中的积极降压获益

作者:  C.Anderson   日期:2014/7/3 17:11:54

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《国际循环》: 在本届TISC上您有一个有关以循证为基础的卒中患者治疗的讲题。在该领域我们取得了哪些成果和进步?

  <International Circulation>: You gave a speech on evidence based care of the stroke patient at TISC. What are the results and what improvements can we make in this field?

  Dr. Anderson:I wish to highlight that there is more to study beyond drug treatment or surgical treatment related to the care of the patients who have had a stroke. I wanted to emphasize the nursing care option and the organization of the management of physiological variables like oxygen levels, blood pressure, fluids and hydration, mobilization, and in particular, finally enough, what is the best position to nurse the patient’s head. I wanted to emphasize other important options in the care of the patient and to highlight 2 clinical trials. One is being completed and was conducted in the United Kingdom and the other one is a new trial that I am initiating which will involve about 55 centers in China. The first trial, which is unpublished, but the main research that has been announced, it was announced at the European Stroke Conference in Nice, this was called the SO2S study or The stroke oxygen supplementation study. This was a trial that involved over 8,000 patients of a mild to moderate level of disability and it was looking at 2 methods of oxygen supplementation against no treatment, one with continuous low flow oxygen for 72 hours, and the other one was intermittent oxygen flow at night time. Both treatments were neutral, there was no effect on survival or disability and the results were perhaps in some way a bit surprising that the routine use of oxygen when the patient comes to emergency department did not seem to affect the outcome. I was using that to emphasize other aspects of the patients care that may be important and then lead to this new trial that we are launching in a few months called HeadPoST which is The Head Position in acute Stroke Trial. There have been suggestions that the blood flow in the brain might be better in the patient when lying flat if there is swelling in the brain. In particularly if here is a bleed or a hemorrhage in the brain, it is better that they have the head up. There may be differences in the positioning related to oxygenation and risk of pneumonia and I showed that there is a study published from the China National Stroke study that showed that the rates of aspiration and pneumonia in China stroke patients is about 11% i.e. 1 in 10 patients who come to hospital with a stroke get pneumonia. That might have something to do with positioning and nursing care. Then I just put that into the context of the benefits of well organized stroke care in improving patient outcome which is very relevant to China and elsewhere in the world.

  《国际循环》: 在本届TISC上您有一个有关以循证为基础的卒中患者治疗的讲题。在该领域我们取得了哪些成果和进步?

  Anderson教授:我想强调的是,就卒中患者的管理与治疗而言,我们需要对药物及手术治疗外的其他方面进行更多研究。我想强调的是血氧水平、血压、体液及水合作用、动员尤其头部护理等生理问题管理方面的选择与组织实施情况。例如,患者护理过程中一些其他重要因素的两项临床试验,其中之一在英国开展,即将完成;另一项由我发起,中国55家中心也参与。第一项试验名为SO2S(卒中吸氧)研究结果尚未公布,但其主要结果已在尼斯举行的欧洲卒中大会上公布。该研究共入选8000余例轻中度残疾患者,旨在观察与不进行氧疗相比,两种氧疗方法(持续72小时低流量吸氧和晚间间断吸氧)对患者的影响。结果显示,两种氧疗方法对患者生存率及残疾情况均无影响,这在一定程度上有些令人意外,因为通常患者急诊室就诊时会常规应用氧气。因此,患者护理的其他方面可能非常重要,因此我们开展了一项名为HeadPoST(急性卒中头部位置)的新试验。有研究提示,若卒中患者大脑存在肿胀时,平躺时大脑血流可能会更好。但如果存在脑出血则将头抬起来更好。头部位置会影响氧合及肺炎发生风险。此外,中国国家卒中研究发现,中国卒中患者肺炎发生率约为11%,这意味着10例卒中患者中约有1例会发生肺炎。这可能在一定程度上与体位及护理有关。我认为,改善卒中管理将能改善中国及世界其他地区的患者结局。

  <International Circulation>: So when we are talking about studies, most studies have, of course, inclusion and exclusion criteria and they are not going to always cover all patient conditions. What kind of accommodations do you make or recommendations to anticipate that for a study?

  Dr. Anderson:Well the type of trials that I do are fairly pragmatic and relevant to healthcare delivery in different health settings. The type of trials that I do are simple with very broad inclusion criteria and exclusion criteria. I make the procedures fairly simple because when you are doing a trial with several thousand patients and in the case of HeadPoST, I will take about 20,000 patients, to make that affordable and to be able to be conducted in an efficient manner you need to keep all of the procedures very simple. Most of these trials had pretty broad inclusion criteria and probably fairly relevant but there is always the downside to that process is if it is too broad then there may be particular types of patients within that group that has specific, or better benefit, or harm, especially with treatment. The trouble is when you are in your primary studies and you set out on the journey to get an answer, you do not always know which particular types of patients are the best, so my approach is just to keep it very broad and to define the patient carefully so that you can look at separate analysis in a predefined manner.

  《国际循环》:大部分研究都有入选标准和排除标准,并不能涵盖所有患者情况。您对研究的入选标准有何推荐?

  Anderson教授:我所参与的试验相对更贴近临床实际,主要涉及不同医疗机构的医疗服务问题,通常采用较简单和相对广泛的入选及排除标准,这样试验相对就可简化,因而就像在开展HeadPoST研究入选数千例患者的试验一样,便可从近两万例患者中以一种简单而又经济有效的方式进行患者选择。大多数试验的入选标准都相对较为宽泛,但无论如何入选过程都或多或少存在一定的不足。如果入选标准过于宽泛,则可能会突显不出某种治疗方法对特定人群的获益或危害。而问题是,我们开展最初的研究时并不知道哪些类型的患者最能从我们所实施的治疗中获益。在这种情况下,我还是主要采用相对较宽泛的入选标准,并仔细确定患者,以确保能以预先设定的方式单独进行亚组分析。

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