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尼卡地平治疗蛛网膜下腔出血的随机试验:血管造影及经颅多普勒超声结果。合作动脉瘤研究报告。

A randomized trial of nicardipine in subarachnoid hemorrhage: angiographic and transcranial Doppler ultrasound results. A report of the Cooperative Aneurysm Study.

作者信息

Haley E C, Kassell N F, Torner J C

机构信息

Department of Neurology, University of Virginia Health Sciences Center, Charlottesville.

出版信息

J Neurosurg. 1993 Apr;78(4):548-53. doi: 10.3171/jns.1993.78.4.0548.

DOI:10.3171/jns.1993.78.4.0548
PMID:8450327
Abstract

Calcium antagonist drugs were proposed for use in patients with recent aneurysmal subarachnoid hemorrhage (SAH) because of their ability to block the effects of a wide variety of vasoconstrictor substances on cerebral arteries in vitro. It was suggested that these agents might, therefore, be useful in ameliorating cerebral vasospasm and its ischemic consequences which frequently complicate SAH. This hypothesis was tested in an arm of a randomized double-blind placebo-controlled trial of high-dose intravenous nicardipine in patients with recently ruptured aneurysms. Participating investigators were required to send selected copies of all admission and follow-up angiograms obtained between Days 7 and 11 following hemorrhage (the peak period of risk for vasospasm) to the Central Registry of the Cooperative Aneurysm Study for blinded interpretation and review for the presence and severity of angiographic vasospasm. In centers with transcranial Doppler ultrasound (TCD) capabilities, middle cerebral artery (MCA) mean flow velocities were measured and recorded. Angiograms obtained between Days 7 and 11 were available for 103 (23%) of 449 patients receiving nicardipine and 121 (26%) of 457 receiving placebo. There was a balance of prognostic factors for vasospasm between the groups. Fifty-one percent of placebo-treated patients had moderate or severe vasospasm on "Day 7-11 angiograms" compared to 33% of nicardipine-treated patients. This difference is statistically significant (p < 0.01). Sixty-seven (49%) of 137 placebo-treated patients examined with TCD between Days 7 and 11 had mean MCA flow velocities exceeding 120 cm/sec compared to 26 (23%) of 112 nicardipine-treated patients (significant difference, p < 0.001). These data suggest that high-dose intravenous nicardipine reduces the incidence and severity of delayed cerebral arterial narrowing in patients following aneurysmal SAH.

摘要

钙拮抗剂类药物被提议用于近期发生动脉瘤性蛛网膜下腔出血(SAH)的患者,因为它们在体外能够阻断多种血管收缩物质对脑动脉的作用。因此有人提出,这些药物可能有助于改善常使SAH复杂化的脑血管痉挛及其缺血性后果。在一项针对近期动脉瘤破裂患者的大剂量静脉注射尼卡地平的随机双盲安慰剂对照试验中,对这一假设进行了验证。参与研究的调查人员需要将在出血后第7天至第11天(血管痉挛风险高峰期)获得的所有入院和随访血管造影照片的选定副本发送至合作动脉瘤研究中心登记处,以便进行盲法解读,并审查血管造影血管痉挛的存在情况和严重程度。在具备经颅多普勒超声(TCD)功能的中心,测量并记录大脑中动脉(MCA)的平均血流速度。在接受尼卡地平治疗的449例患者中,有103例(23%)在第7天至第11天获得了血管造影照片;在接受安慰剂治疗的457例患者中,有121例(26%)获得了血管造影照片。两组之间血管痉挛的预后因素保持平衡。在“第7 - 11天血管造影照片”上,51%接受安慰剂治疗的患者出现中度或重度血管痉挛,而接受尼卡地平治疗的患者这一比例为33%。这一差异具有统计学意义(p < 0.01)。在第7天至第11天接受TCD检查的137例接受安慰剂治疗的患者中,有67例(49%)MCA平均血流速度超过120 cm/秒,而在112例接受尼卡地平治疗的患者中,这一比例为26例(23%)(差异显著,p < 0.001)。这些数据表明,大剂量静脉注射尼卡地平可降低动脉瘤性SAH患者延迟性脑动脉狭窄的发生率和严重程度。

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