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ESC 2013:早期强化降压治疗改善急性脑出血的功能转归

2013-06-07 NEJM 丁香园

一项大型随机试验的结果表明,早期强化降血压治疗可改善急性脑出血(ICH)患者的功能转归。与指南推荐的标准治疗相比,接受强化降压治疗的患者其改良Rankin量表(mRS)评分分布明显改善,残疾量度水平也明显降低[比值比(OR),0.87;P=0.04]。然而,这项早期INTERACT2试验仅仅显示出死亡和残疾的主要终点方面的轻度、非显著性的减少(OR,0.87;P<0.06)。 研究者仍然相信上述

一项大型随机试验的结果表明,早期强化降血压治疗可改善急性脑出血(ICH)患者的功能转归。与指南推荐的标准治疗相比,接受强化降压治疗的患者其改良Rankin量表(mRS)评分分布明显改善,残疾量度水平也明显降低[比值比(OR),0.87;P=0.04]。然而,这项早期INTERACT2试验仅仅显示出死亡和残疾的主要终点方面的轻度、非显著性的减少(OR,0.87;P<0.06)。

研究者仍然相信上述发现有一定的临床意义,有理由在临床实践中对多数急性脑出血患者采取早期强化降压治疗方案,特别是在与指南推荐治疗相比不过度影响安全性的前提下。

悉尼大学卒中内科与临床神经科学教授、澳大利亚悉尼乔治全球健康研究所的Anderson博士表示:“急性脑出血患者接受降压治疗是安全的,因此对多数患者采取早期强化持续性降压治疗,以期获得更高的康复几率。说到底,这也是患者及家属希望我们做的。”该研究的首席研究员,悉尼大学临床神经科学及卒中医学教授Craig Anderson博士在5月29日的欧洲卒中年会(ESC)上做了上述报告,研究结果同时发表于新欺凌医学杂志。

INTERACT2研究设计

第二次急性脑出血强化降压试验INTERACT2是一项共纳入2,839例患者的多国、多中心、前瞻性、开放标签、终点设盲的随机化试验。入组患者均在出现自发性脑出血后6 h内入院,均表现为收缩压升高(150~220 mmHg),平均年龄为63.5岁,其中63%为男性,68%为中国人,高血压患者占72%。

受试患者汇集后随机分组,分别接受强化(n=1,399)或指南推荐(n=1,430)的降压治疗。强化治疗旨在迅速(1 h内)将收缩压降至140 mmHg以下。而指南推荐治疗的目标是将收缩压降至180 mmHg以下,且不限制时间。

研究设计中并未规定使用哪些降压药物,因此参与试验的141家医院使用了多种降压药物。90%的强化治疗组患者接受了静脉给药,而这一比例在指南推荐治疗组仅为43%。与指南推荐治疗组相比,强化治疗组患者更倾向于接受静脉团注+输液(18% vs. 30%)和多药联合治疗(8% vs. 27%)。在欧洲一些地区最常用药物是乌拉地尔,一种α受体阻断剂,但在美国并非如此。

关键结果

不良结局的主要指标定义为90天mRS评分为3~6分,研究发现强化治疗组和指南推荐治疗组达到这一终点的患者分别有719例(52%)和785例(55.6%)。mRS评分为6分意味着死亡,3~5分表示明显残疾。针对mRS的顺序分析显示,与指南推荐的降血压途径相比,强化治疗组患者的评分更低,有更多患者在有某种程度残疾的情况下仍能达到生活自理(强化治疗组和指南推荐治疗组中分别有48%和44%的患者mRS评分为0~2分)。

研究中采用欧洲生活质量五维度问卷对受试者的健康相关生活质量予以评估。结果显示,强化治疗组患者在行动能力(64% vs. 67%;P=0.13)、自我照顾(47% vs. 52%;P=0.02)、日常活动(61% vs. 66%;P=0.006)、疼痛或不适(40% vs. 45%;P=0.01),以及焦虑或抑郁(34% vs. 38%;P=0.05)这五个方面均优于指南推荐治疗组患者。

Anderson医生观察到,“以前我从未在临床试验中看到这样的结果,在临床试验中很难看到这样显著的改变,当我看到患者在日常行动方面的获益如此之明显时我震惊了,当患者在家治疗时,日常活动会是一个非常重要的功能恢复指标。强化治疗组和指南推荐治疗组的非致死性严重不良事件发生率相似(23.3% vs. 23.6%)。“重要的是,当我们试图找出强化降压治疗带来的危险时,我们未发现任何额外风险,”Anderson博士报道说。

现行实践受到的影响

“如果关于主要转归的试验结果并不像一些人期望的那么显眼,至少其安全性数据可以让从业者感到安心。”克利夫兰诊所基金会的Jennifer Frontera博士在NEJM期刊的随刊述评中指出。两组在神经病学恶化、脑出血扩大、缺血性卒中、心血管事件或严重症状性低血压等方面均无显著差异,她强调。

正在进行中的ATACH II(急性脑出血抗血压治疗)试验或将有望为脑出血后早期降压治疗的获益提供更多证据。ATACH II试验的降压目标、主要和次要终点均与INTERACT2试验相似。这两项试验的关键差异在于,前者将尼卡地平作为唯一的试验降压药物。该试验有望在2016年得出结果。

INTERACT2研究报道的主讲人、英国诺丁汉大学卒中研究室主任Philip Bath博士透露,要修订指南还为时过早,特别是考虑到若干项重要试验仍在进行之中,其中就包括他本人所主持的ENOS(一氧化氮对卒中的疗效)试验。Bath 博士说,“我认为近期随机试验数据或比指南更加重要,因此我焦急地盼望着新的数据出现。我们不需要等太久,在未来的1、2年内一定会有新数据出现。”

研究参与者法国巴黎狄德罗-索邦大学的神经病学教授Christian Stapf博士评论道,作为一名科学家,他赞同“需要得到更多数据后才能改变临床实践”。但作为一名医生他同时指出:“目前我并未发现强化降压有导致任何风险的预兆,因此没有理由反对强化降压,除非对治疗有益。”Anderson博士在发布会上进一步评论道:“ICH是破坏性最大的卒中类型,而我们首次提出迅速强化降压而不是任何特异性治疗有助于ICH患者康复,这就是本项试验带来的关键信息。”对于卒中领域而言这无疑是个好消息,Anderson 医生说,“临床指南和实践都将有可能因此而改变”。

澳大利亚国立卫生与医学研究委员会赞助了INTERACT2。本篇报道所涉及的专家均无利益冲突披露。

Rapid Blood-Pressure Lowering in Patients with Acute Intracerebral Hemorrhage
Background
Whether rapid lowering of elevated blood pressure would improve the outcome in patients with intracerebral hemorrhage is not known.
Methods
We randomly assigned 2839 patients who had had a spontaneous intracerebral hemorrhage within the previous 6 hours and who had elevated systolic blood pressure to receive intensive treatment to lower their blood pressure (with a target systolic level of <140 mm Hg within 1 hour) or guideline-recommended treatment (with a target systolic level of <180 mm Hg) with the use of agents of the physician's choosing. The primary outcome was death or major disability, which was defined as a score of 3 to 6 on the modified Rankin scale (in which a score of 0 indicates no symptoms, a score of 5 indicates severe disability, and a score of 6 indicates death) at 90 days. A prespecified ordinal analysis of the modified Rankin score was also performed. The rate of serious adverse events was compared between the two groups.
Results
Among the 2794 participants for whom the primary outcome could be determined, 719 of 1382 participants (52.0%) receiving intensive treatment, as compared with 785 of 1412 (55.6%) receiving guideline-recommended treatment, had a primary outcome event (odds ratio with intensive treatment, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P=0.06). The ordinal analysis showed significantly lower modified Rankin scores with intensive treatment (odds ratio for greater disability, 0.87; 95% CI, 0.77 to 1.00; P=0.04). Mortality was 11.9% in the group receiving intensive treatment and 12.0% in the group receiving guideline-recommended treatment. Nonfatal serious adverse events occurred in 23.3% and 23.6% of the patients in the two groups, respectively.
Conclusions
In patients with intracerebral hemorrhage, intensive lowering of blood pressure did not result in a significant reduction in the rate of the primary outcome of death or severe disability. An ordinal analysis of modified Rankin scores indicated improved functional outcomes with intensive lowering of blood pressure. (Funded by the National Health and Medical Research Council of Australia; INTERACT2 ClinicalTrials.gov number, NCT00716079.)

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