Rosenbaum D, Zabramski J, Frey J, Yatsu F, Marler J, Spetzler R, Grotta J
Department of Neurology, University of Texas Medical School, Houston 77030.
Stroke. 1991 Apr;22(4):437-41. doi: 10.1161/01.str.22.4.437.
We performed a feasibility and safety study (phase II) of nicardipine, a calcium antagonist, in 57 patients. The objectives of the study were to begin therapy as early as possible (less than or equal to 12 hours) after the onset of ischemic stroke and to administer as high a dose as possible. All patients received an intravenous infusion of nicardipine for 72 hours, starting with a dose of 3 mg/hr and increasing to a maximum dose of 7 mg/hr. Upward titration of the dose was limited by a 10% decrease in blood pressure or a 20 beats/min increase in pulse. Intravenous therapy was followed by 30 days of oral therapy. The mean +/- SD interval from onset of stroke to commencement of therapy was 9.1 +/- 5.4 hours. Adverse reactions consisted primarily of hypotension requiring discontinuation of therapy in four patients. Score on a graded neurologic examination increased from 41/100 at baseline to 64/100 at 3 months for the 41 patients completing follow-up. There was no correlation between the dose of nicardipine administered and outcome, but the 11 patients starting therapy less than or equal to 6 hours after onset did better than those starting therapy 6-12 hours after onset. Further study of very early therapy with nicardipine is justified.
我们对57例患者进行了钙拮抗剂尼卡地平的可行性和安全性研究（II期）。该研究的目的是在缺血性卒中发作后尽早（≤12小时）开始治疗，并给予尽可能高的剂量。所有患者接受尼卡地平静脉输注72小时，起始剂量为3毫克/小时，最大剂量增至7毫克/小时。剂量向上滴定受血压下降10%或脉搏增加20次/分钟限制。静脉治疗后进行30天的口服治疗。从卒中发作到开始治疗的平均±标准差间隔为9.1±5.4小时。不良反应主要包括低血压，4例患者因低血压需要停止治疗。完成随访的41例患者在分级神经学检查中的评分从基线时的41/100增加到3个月时的64/100。给予的尼卡地平剂量与预后之间无相关性，但在卒中发作后≤6小时开始治疗的11例患者比在发作后6 - 12小时开始治疗的患者预后更好。对尼卡地平极早期治疗进行进一步研究是合理的。
