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替扎尼定治疗脊髓损伤患者痉挛的疗效与安全性。北美替扎尼定研究组。

Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. North American Tizanidine Study Group.

作者信息

Nance P W, Bugaresti J, Shellenberger K, Sheremata W, Martinez-Arizala A

机构信息

Section of Physical Medicine and Rehabilitation, University of Manitoba, Winnipeg, Canada.

出版信息

Neurology. 1994 Nov;44(11 Suppl 9):S44-51; discussion S51-2.

PMID:7970010
Abstract

Tizanidine, an imidazoline that acts as an agonist at alpha 2-adrenergic receptors, has been shown to be effective in reducing spasticity caused by MS. This multicenter study (14 sites) assessed the efficacy and safety of oral tizanidine in patients who had spinal cord injury of > 12 months' duration. Of the 124 patients admitted to the study, 78 completed it. Tizanidine was titrated to an optimized dosage in each patient to a maximum of 36 mg/d. Muscle tone, assessed by Ashworth score, was significantly reduced (p = 0.0001) by tizanidine treatment in comparison with placebo. Video motion analysis of the pendulum test showed improvement in the tizanidine-treated patients vs placebo (p = 0.04) and showed a significant correlation with the Ashworth score (p < 0.001). No significant alterations in muscle strength or vital signs were noted in either treatment group. The most common adverse events during tizanidine treatment were somnolence, xerostomia, and fatigue. It was concluded that, overall, tizanidine is effective in reducing spasticity in patients with spinal cord injury.

摘要

替扎尼定是一种咪唑啉类药物,可作为α2肾上腺素能受体激动剂,已被证明能有效减轻多发性硬化症引起的痉挛。这项多中心研究(14个地点)评估了口服替扎尼定对脊髓损伤超过12个月患者的疗效和安全性。在124名入选该研究的患者中,78名完成了研究。替扎尼定在每位患者中滴定至最佳剂量,最大剂量为36毫克/天。与安慰剂相比,通过Ashworth评分评估的肌张力经替扎尼定治疗后显著降低(p = 0.0001)。摆锤试验的视频运动分析显示,与安慰剂相比,替扎尼定治疗的患者有改善(p = 0.04),且与Ashworth评分有显著相关性(p < 0.001)。两个治疗组的肌肉力量或生命体征均未发现明显变化。替扎尼定治疗期间最常见的不良事件是嗜睡、口干和疲劳。研究得出结论,总体而言,替扎尼定对减轻脊髓损伤患者的痉挛有效。

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Efficacy and safety of tizanidine in the treatment of spasticity in patients with spinal cord injury. North American Tizanidine Study Group.替扎尼定治疗脊髓损伤患者痉挛的疗效与安全性。北美替扎尼定研究组。
Neurology. 1994 Nov;44(11 Suppl 9):S44-51; discussion S51-2.
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Tizanidine treatment of spasticity caused by multiple sclerosis: results of a double-blind, placebo-controlled trial. US Tizanidine Study Group.替扎尼定治疗多发性硬化所致痉挛:一项双盲、安慰剂对照试验的结果。美国替扎尼定研究组
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A double-blind, placebo-controlled trial of tizanidine in the treatment of spasticity caused by multiple sclerosis. United Kingdom Tizanidine Trial Group.替扎尼定治疗多发性硬化所致痉挛的双盲、安慰剂对照试验。英国替扎尼定试验组。
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Adv Ther. 1998 Jul-Aug;15(4):241-51.

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