NEJM：脑出血急性期强化降压治疗不降低临床死亡率

脑出血的降压治疗一直是学者们争论的焦点，急性期降压对预后的影响尚不明确。来自澳大利亚的Craig S. Anderson等医生研究了脑出血强化降压与临床预后的关系，发表在2013年6月20日的NEJM杂志上。结果显示：脑出血强化降压不改善死亡率及重度残疾率，但改善脑出血后改良Rankin评分。

该研究纳入2839例自发性脑出血伴收缩压增高的患者，入组时间均在起病6小时内，随机分为两组，一组为强化降压组（1小时内目标收缩压为<140 mm Hg），另一组为指南推荐治疗组（目标收缩压为<180 mm Hg），药物选择由临床医师选择。主要终点事件为死亡或重度残疾，重度残疾定义为发病90天后改良的Rankin评分为3到6分，改良的Rankin评分0分表现无症状，5分显示重度残疾，6分代表死亡。采用预先设定的顺序分析方法分析改良的Rankin评分。同时，分析两组患者的严重不良反应发生率。

在有记载主要终点事件的2794例患者中，1382例患者接受强化降压治疗，其中719例(52.0%)出现主要终点事件；1412例接受指南推荐治疗，其中785例(55.6%)出现主要终点事件，强化降压组的优势比为0.87，95%可信区间[CI]为0.75到1.01，P=0.06。顺序分析显示强化降压组明显降低改良Rankin评分，较重残疾的优势比为0.87，95%可信区间CI为0.77到1.00，P=0.04。强化降压组死亡率为11.9%，指南推荐治疗组为12.0%。非致命性不良反应两组发生率分别为23.3%和23.6%。

在脑出血患者中，强化降压并没有明显降低死亡或重度残疾等主要终点事件的发生率。改良Rankin评分的有序分析显示强化降压可改善功能预后。

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.).