A RANDOMIZED TRIAL OF 2 DOSES OF NICARDIPINE IN ANEURYSMAL SUBARACHNOID HEMORRHAGE - A REPORT OF THE COOPERATIVE ANEURYSM STUDY
A RANDOMIZED TRIAL OF 2 DOSES OF NICARDIPINE IN ANEURYSMAL SUBARACHNOID HEMORRHAGE - A REPORT OF THE COOPERATIVE ANEURYSM STUDY
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DOI：
10.3171/jns.1994.80.5.0788
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发表时间：
1994-05-01
影响因子：
4.1
通讯作者：
GERMANSON, TP
中科院分区：
文献类型：
--
作者：
HALEY, EC;KASSELL, NF;GERMANSON, TP
高剂量静脉尼卡地平已被证明可降低蛛网膜下腔出血（SAH）患者的血管造影和症状性血管痉挛的发生率，但治疗可能因副作用而复杂化，包括低血压或肺水肿/氮质血症。从1989年8月至1991年1月，21个神经外科中心的365名患者进入一项随机双盲试验，比较SAH后持续静脉输注高剂量（0.15 mg/kg/hr）尼卡地平与低50%剂量（0.075 mg/kg/hr）尼卡地平长达14天。在研究期间，184名患者被随机分配接受高剂量尼卡地平治疗，181名患者接受低剂量尼卡地平治疗。在患者年龄、入院时的神经系统状况或初次计算机断层扫描时的血凝块数量和分布方面没有显著差异。高剂量组患者接受计划剂量的比例明显低于低剂量组（80% +/- 0.2% vs. 86% +/-0.2%，p < 0.05），主要是因为不良医疗事件后提前终止治疗。两组中症状性血管痉挛的发生率均为31%，总体3个月结局几乎相同。这些数据表明，从临床的角度来看，高剂量和低剂量尼卡地平治疗的结果几乎是等同的，但低剂量尼卡地平给药的副作用较少。
High-dose intravenous nicardipine has been shown to reduce the incidence of angiographic and symptomatic vasospasm in patients with aneurysmal subarachnoid hemorrhage (SAH), but treatment may be complicated by side effects, including hypotension or pulmonary edema/azotemia. From August, 1989, to January, 1991, 365 patients at 21 neurosurgical centers were entered into a randomized double-blind trial comparing high-dose (0.15 mg/kg/hr) nicardipine with a 50% lower dose (0.075 mg/kg/hr) administered by continuous intravenous infusion for up to 14 days following SAH. Patients in all neurological grades were eligible for the study.During the study period, 184 patients were randomly assigned to receive high-dose nicardipine and 181 to receive the low dose. There were no significant differences in patient age, admission neurological condition, or amount and distribution of blood clot on initial computerized tomography scan. Patients in the high-dose group received a significantly smaller proportion of the planned dose than those in the low-dose group (80% +/- 0.2% vs. 86% +/- 0.2%, p < 0.05), largely because of premature treatment termination after adverse medical events. The incidence of symptomatic vasospasm was 31% in both groups, and the overall 3-month outcomes were nearly identical. These data suggest that, from a clinical standpoint, the results of high-dose and low-dose nicardipine treatment are virtually equivalent, but administration of low-dose nicardipine is attended by fewer side effects.