Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage.
Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage.
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DOI：
10.1016/j.mjafi.2017.03.010
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发表时间：
2018-04-01
期刊：
影响因子：
--
通讯作者：
Anadure, Ravi
中科院分区：
文献类型：
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作者：
Gupta, Salil;Abbot, A K;Anadure, Ravi
背景：自发性脑出血患者血压升高引起的血肿扩大可能决定预后。本研究的目的是确定急性自发性脑出血降压的安全性和有效性。这个开放标签，一项多中心试验，将年龄≥18岁且在发病72小时内无继发性原因的自发性脑出血患者随机分配至严格BP对照组，如果平均动脉压（MAP）≥ 115 mm Hg和常规BP对照组，如果MAP ≥ 130 mm Hg，则开始治疗。在各自的臂中将MAP再维持72小时，之后两个臂的MAP均低于115 mm Hg。主要结果为90天时的改良兰金量表。结果：118例患者，每组59例。所有患者均可接受随访。基线特征相似。在90天时，两组之间的中位mRS无显著差异。严格对照组（干预安全性）中“不良结局”（mRS 3-6）与“良好结局”（mRS 0-2）的比值比不显著（OR 0. 70 [95% CI 0. 34 - 1. 47] p= 0. 35）。在严格对照组中，以优势比形式进行干预的“良好结局”的有效性并不显著（OR 1.43 [95%CI 0.68-2.99]，p=0.35）。结论：在症状发作后72小时内出现的自发性脑出血患者中，如果MAP超过115 mm Hg，则可以安全降低，但不能改善临床结局。
BACKGROUND: Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage.METHODS: This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130mm of Hg. The MAP was maintained in the respective arm for another 72h after which both arms had MAP below 115mm of Hg. Primary outcome was modified Rankin Scale at 90 days.RESULTS: 118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for "poor outcome" (mRS 3-6) in the tight control arm (safety of the intervention) against "good outcome" (mRS 0-2) was not significant (OR 0.70 [95% CI 0.34-1.47] p=0.35). Efficacy of the intervention in the form of Odds Ratio for "good outcome" in the tight control arm was not significant (OR 1.43 [95% CI 0.68-2.99], p=0.35).CONCLUSION: In patients with spontaneous intracerebral haemorrhage who present within 72h of the onset of symptoms, MAP can be safely lowered if it crosses 115mm of Hg but it does not improve clinical outcome.