Effect of nicardipine prolonged-release implants on cerebral vasospasm and clinical outcome after severe aneurysmal subarachnoid hemorrhage -: A prospective, randomized, double-blind phase IIa study
Effect of nicardipine prolonged-release implants on cerebral vasospasm and clinical outcome after severe aneurysmal subarachnoid hemorrhage -: A prospective, randomized, double-blind phase IIa study
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DOI：
10.1161/01.str.0000254601.74596.0f
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发表时间：
2007-02-01
期刊：
影响因子：
8.3
通讯作者：
Vajkoczy, Peter
中科院分区：
文献类型：
--
作者：
Barth, Martin;Capelle, Hans-Holger;Vajkoczy, Peter
背景和目的-本研究的目的是研究尼卡地平缓释植入剂（NPRI）对严重蛛网膜下腔出血后脑血管痉挛和临床结局的影响。方法：32例严重蛛网膜下腔出血并接受动脉瘤夹闭术的患者被纳入这项单中心、随机、双盲试验。16例患者接受了NPRI植入基底脑池，与暴露的近端血管直接接触;在16例对照患者中，基底脑池被打开并冲洗，但没有留下植入物。在术前和第8 +/- 1天进行血管造影。计算机断层扫描成像分析与手术无关的局部梗死的发生率。使用改良的兰金和国立卫生研究院卒中量表评估患者结局。结果：植入NPRI后，近端血管段的血管造影性血管痉挛发生率显著降低（对照组为73%，NPRI组为7%）。大多数远端血管节段也存在显著差异。计算机断层扫描显示迟发性缺血性病变的发生率较低（对照组为47%，NPRI组为14%）。NPRI组表现出更有利的改良兰金和国立卫生研究院卒中量表，以及死亡发生率显著降低（对照组38%，NPRI组6%）。结论：植入NPRI可降低脑血管痉挛和迟发性缺血性功能障碍的发生率，并改善严重蛛网膜下腔出血后的临床结局。（中风。2007;38：330-336）。
Background and Purpose-The purpose of this study was to investigate the effect of nicardipine prolonged-release implants (NPRIs) on cerebral vasospasm and clinical outcome after severe subarachnoid hemorrhage. Methods-Thirty-two patients with severe subarachnoid hemorrhage and undergoing aneurysm clipping were included into this single center, randomized, double-blind trial. Sixteen patients received NPRIs implanted into the basal cisterns in direct contact to the exposed proximal blood vessels; in 16 control patients, the basal cisterns were opened and washed out only without leaving implants. Angiography was performed preoperatively and at day 8 +/- 1. Computed tomography imaging was analyzed for the incidence of territorial infarcts unrelated to surgery. Patient outcome was assessed using the modified Rankin and National Institute of Health Stroke scales. Results-The incidence of angiographic vasospasm in proximal vessel segments was significantly reduced after implantation of NPRIs (73% control versus 7% NPRIs). Significant differences occurred also for the majority of distal vessel segments. Computed tomography scans revealed a lower incidence of delayed ischemic lesions (47% control versus 14% NPRIs). The NPRI group demonstrated more favorable modified Rankin and National Institute of Health Stroke scales as well as a significantly lower incidence of deaths (38% control versus 6% NPRIs). Conclusions-Implantation of NPRIs reduces the incidence of cerebral vasospasm and delayed ischemic deficits and improves clinical outcome after severe subarachnoid hemorrhage. (Stroke. 2007;38:330-336.)