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[AHA访谈]SPRINT研究主席Paul Whelton教授分析该研究结果

作者:国际循环网   日期:2015/11/10 16:41:22

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编者按:2015年11月9日,美国心脏协会(AHA)2015科学年会的第5场最新临床试验专题备受关注。这一专题仅展示了收缩压干预试验(SPRINT)一项研究,这项由美国国立卫生研究院(NIH)多个机构合作开展的研究,旨在观察将收缩压降至120 mm Hg以下能否为心血管高危患者带来获益。SPRINT研究主要结果由该研究主席、美国杜兰大学Paul Whelton教授公布,且同时在线发表于《新英格兰医学杂志》。在会议现场,《国际循环》记者有幸采访了Whelton教授。

  编者按:2015年11月9日,美国心脏协会(AHA)2015科学年会的第5场最新临床试验专题备受关注。这一专题仅展示了收缩压干预试验(SPRINT)一项研究,这项由美国国立卫生研究院(NIH)多个机构合作开展的研究,旨在观察将收缩压降至120 mm Hg以下能否为心血管高危患者带来获益。SPRINT研究主要结果由该研究主席、美国杜兰大学Paul Whelton教授公布,且同时在线发表于《新英格兰医学杂志》。在会议现场,《国际循环》记者有幸采访了Whelton教授。

  《国际循环》:自NIH在9月11日宣布决定提前终止SPRINT研究开始,该研究就引起了广泛关注。初步资料显示,与收缩压<140 mm Hg的控制目标相比,将收缩压控制在<120 mm Hg可使心血管事件减少30%,全因死亡率降低25%,提示强化降压对改善患者预后具有积极意义。您认为,这一结果能否颠覆传统的降压目标?

  International Circulation: Dr. Whelton, the SPRINT trial has attracted widespread attention since the NIH announced deciding to stop it early on September 11th. Initial data showed that compared with SBP target <140 mm Hg, SBP <120 mm Hg could reduce 30% of cardiovascular events and 25% of all-cause mortality, which suggested that aggressive BP control had a positive impact on outcome. In your opinion, could these results overthrow the traditional blood pressure target?

  Whelton教授:首先,非常高兴接受本次采访,也非常高兴与非常多优秀的中国同道进行交流。我是Paul Whelton,是SPRINT研究的临床研究委员会主席,也是杜兰大学公共卫生学院的教授。

  SPRINT研究结果发现,与使收缩压<140 mm Hg的标准控制目标相比,将高危高血压人群的收缩压降至低于目前推荐水平即使其<120 mm Hg确实能带来一些显著获益。例如,可使主要终点(心脏病发作、不导致心脏病发作的急性冠状动脉综合征、急性代偿性卒中、急性失代偿性心力衰竭及心血管死亡的复合终点)发生风险降低25%,使全因死亡率降低27%。但是,需要强调的是,将收缩压控制在<120 mm Hg可导致一些不良事件,因此临床实施时需要谨慎和小心。与标准降压组相比,强化降压组的高血压发生率虽然降低,但却会出现因低血压及晕厥而住院,增加骨折及跌倒损伤风险,也有信号提示其可能会导致肾脏疾病。因此,我们需要在积极降压的同时进行密切随访。但总的来说,SPRINT研究表明,对高危高血压患者而言,可能最好将血压降得更低一些。美国及中国的指南制定委员会有必要重视这些证据,并结合其他临床证据或信息,为临床医生及其所服务的患者制定相应的推荐。

  Dr. Whelton: First of all, it is a great pleasure to be with you and so many wonderful colleagues in China. I am Dr. Paul Whelton and I am the chair of the Systolic Blood Pressure Intervention Trial, or SPRINT and I am here in that role. I am also the Show Chwan Professor of Global Public Health at Tulane.

  Our findings in a high risk group of hypertensives, was that taking our patients to a lower pressure than is currently recommended, less than 120 mm Hg systolic blood pressure in comparison to the standard recommendation of less than 140 mm Hg did resolve in some very impressive benefits. 25% reduction in the primary outcome that would have been a first occurrence of either a heart attack, acute coronary syndrome not leading to a heart attack, acute compensated stroke, acute decompensated heart failure, or cardiovascular disease death, 25% reduction for that outcome and also a 27% for all cause mortality. There were some adverse events and we have to be respectful and careful of those. We did not see more hypertension overall in the lower blood pressure group, but we did see some hospitalizations due to low blood pressure and syncope. We did not resolve in fractures or injuries or falls, and we saw some renal disease signals so we have to follow those but overall a very powerful outcome suggesting that a group or a high risk group of hypertensives like SPRINT, it may be better to go to lower pressures. Guidelines committees in the US and of course in China will have to look at this data and put it in the context of all the other information and make recommendations to practitioners and the patients they serve.

  《国际循环》:与SPRINT研究不同,ACCORD并未发现将收缩压降至<120 mm Hg能显著减少主要终点。您对上述两个设计相似的研究所得出的不一致结论作何评价?

  International Circulation: The ACCORD study did not find that systolic blood pressure less than 120 mm Hg could bring significant reduction of primary endpoints. Can you comment on the inconsistent conclusions between SPRINT and ACCORD with similar designs?

  Whelton教授:ACCORD研究虽在很多方面与SPRINT研究存在相似之处,但也有很多不同。SPRINT研究的样本量是ACCORD研究的两倍多,因此研究非常幸运地得到了预期结果,而ACCORD研究则非常不幸地仅得到了所预期的一半事件率。此外ACCORD研究没有较大的统计效力,所得到的结果可信区间范围较宽,研究中的某些获益可能相当于SPRINT研究中的27%。当然,ACCORD研究是析因分析设计,与SPRINT研究相比,其结果解读更加复杂。但是,我认为这两项研究在很大程度上是一致的,只是与ACCCORD研究相比,SPRINT研究规模更大,回答问题的统计学效力更高。

  Dr. Whelton: Well, ACCORD was in many ways similar to SPRINT, but in many ways different to SPRINT. SPRINT had more than double the sample size, we were fortunate in meeting our expectations for event rates and then in ACCORD unfortunately they only got about half the event rate that they expected. They did not have a lot of statistical power. Their confidence intervals were wide and there might have been a benefit as much as 27% in ACCORD so in that sense, quite consistent with SPRINT. Of course ACCORD was a factorial design, which makes it a little more complicated to interpret than SPRINT, so I think they are largely consistent, we just had a bigger trial with more power to answer the question.

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