Ohman J, Heiskanen O
Department of Neurosurgery, Helsinki University Central Hospital, Finland.
J Neurosurg. 1989 Jan;70(1):55-60. doi: 10.3171/jns.1989.70.1.0055.
A total of 216 patients with a ruptured aneurysm of the anterior part of the circle of Willis were enrolled into this prospective randomized study of timing of the operation after aneurysmal subarachnoid hemorrhage (SAH). Only patients in clinical Grades I to III (according to the classification of Hunt and Hess) who were admitted and randomly assigned to a treatment group within 72 hours after the SAH were included in the trial. The patients were randomly assigned to one of three operation groups: acute surgery (AS: 0 to 3 days after the SAH; day of SAH = Day 0), intermediate surgery (IS: 4 to 7 days after the SAH), or late surgery (LS: 8 days to an indefinite time after the SAH). Three patients (4.3%) in the IS group and six patients (8.6%) in the LS group died before surgery was undertaken. At 3 months post-SAH, 65 patients (91.5%) from the AS group were classified as independent compared to 55 (78.6%) from the IS group and 56 (80.0%) from the LS group. The management mortality rate in the AS group was 5.6% compared to 12.9% in the LS group. Of the 216 patients enrolled in the timing study, 159 were randomly assigned to an independent double-blind placebo-controlled trial of nimodipine in Grade I to III patients. A total of 79 patients received nimodipine and 80 placebo. When the nimodipine group and the no-nimodipine group (the 80 placebo-treated patients plus the 52 patients who were not entered into the nimodipine trial) were analyzed separately, a significant difference was seen in the outcome of the no-nimodipine group (dependent AS vs. dependent IS, p = 0.01). Nimodipine treatment was associated with a significant reduction of delayed ischemic deterioration (all operation group combined, nimodipine vs. no nimodipine p = 0.01; LS with nimodipine vs. LS with no nimodipine, p = 0.03).
共有216例 Willis 环前部动脉瘤破裂患者被纳入这项关于动脉瘤性蛛网膜下腔出血（SAH）后手术时机的前瞻性随机研究。仅纳入临床分级为 I 至 III 级（根据 Hunt 和 Hess 分类法）且在 SAH 后72小时内入院并随机分配至治疗组的患者。患者被随机分配至三个手术组之一：急诊手术（AS：SAH 后0至3天；SAH 当天 = 第0天）、中期手术（IS：SAH 后4至7天）或延期手术（LS：SAH 后8天至不确定时间）。IS 组有3例患者（4.3%）和 LS 组有6例患者（8.6%）在手术前死亡。SAH 后3个月时，AS 组65例患者（91.5%）被分类为独立状态，而 IS 组为55例（78.6%），LS 组为56例（80.0%）。AS 组的治疗死亡率为5.6%，而 LS 组为12.9%。在纳入手术时机研究的216例患者中，159例被随机分配至一项针对 I 至 III 级患者的尼莫地平独立双盲安慰剂对照试验。共有79例患者接受尼莫地平治疗，80例接受安慰剂治疗。当分别分析尼莫地平组和非尼莫地平组（80例接受安慰剂治疗的患者加上未纳入尼莫地平试验的52例患者）时，非尼莫地平组的结局存在显著差异（依赖 AS 与依赖 IS，p = 0.01）。尼莫地平治疗与延迟性缺血性恶化的显著减少相关（所有手术组合并，尼莫地平组与非尼莫地平组，p = 0.01；接受尼莫地平治疗的 LS 组与未接受尼莫地平治疗的 LS 组，p = 0.03）。
