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一项关于钙通道阻滞剂尼卡地平治疗重度颅脑损伤后血管痉挛的双盲安慰剂对照试验。

A double blind placebo controlled trial of the calcium entry blocking drug, nicardipine, in the treatment of vasospasm following severe head injury.

作者信息

Compton J S, Lee T, Jones N R, Waddell G, Teddy P J

机构信息

Department of Neurological Surgery Radcliffe Infirmary, Oxford, United Kingdom.

出版信息

Br J Neurosurg. 1990;4(1):9-15. doi: 10.3109/02688699009000676.

Abstract

A double blind, placebo controlled trial of nicardipine in the treatment of high Doppler Flow Velocity (DFV) following severe head injury (Glasgow Coma Score (GSC) less than or equal to 8) was performed. Thirty patients with high DFV (greater than or equal to 100 cm/s for 6 h duration) on transcranial Doppler ultrasound, were treated with nicardipine or placebo for 24 h (2.5 mg/h, increasing in steps of 2.5 mg/h at 2 h intervals (maximum rate 7.5 mg/h) depending on response of DFV). DFV was measured hourly for 24 h and then every 12 h for 2 days. Nicardipine significantly reduced DFV below the threshold of 100 cm/s (16/19 cf placebo 3/11, chi-square p less than 0.001). In the nicardipine treated group maximum DFV was significantly reduced (p less than 0.001) and time with DFV below 100 was significantly longer. Rises in DFV were significantly reduced by the drug if the DFV was normal at the time of entry. High DFV returned on cessation of the infusion. No unexpected or adverse side effects were seen. No clinical benefit was demonstrable.

摘要

进行了一项关于尼卡地平治疗重度颅脑损伤(格拉斯哥昏迷评分(GSC)小于或等于8)后高多普勒血流速度(DFV)的双盲、安慰剂对照试验。30例经经颅多普勒超声检查显示DFV高(持续6小时大于或等于100 cm/s)的患者,接受尼卡地平或安慰剂治疗24小时(2.5 mg/h,根据DFV反应每2小时以2.5 mg/h的步长递增(最大速率7.5 mg/h))。每小时测量DFV 24小时,然后每12小时测量2天。尼卡地平显著降低DFV至100 cm/s以下(16/19对比安慰剂3/11,卡方检验p小于0.001)。在尼卡地平治疗组中,最大DFV显著降低(p小于0.001),DFV低于100的时间显著延长。如果入组时DFV正常,药物可显著降低DFV的升高。输注停止后DFV恢复升高。未观察到意外或不良副作用。未显示出临床益处。

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