Wallace J D
Clinical/Regulatory Affairs, Athena Neurosciences, Inc., South San Francisco, California.
Neurology. 1994 Nov;44(11 Suppl 9):S60-8; discussion S68-9.
Data from three placebo-controlled and 11 active-controlled studies of tizanidine were combined to permit analysis of the subsets, which were too small to evaluate within the individual studies. Overall analysis of placebo-controlled data confirms the effectiveness of tizanidine in reducing muscle tone in patients with spasticity of spinal cord origin. Subset analyses suggest that patients with more severe spasticity are more likely to respond, but age, sex, and race were not predictive of response. Comparisons of tizanidine with active controls showed no differences in efficacy compared with baclofen or diazepam. However, when compared with controls, patients treated with tizanidine did not experience increased weakness. Furthermore, patients tolerated tizanidine better than the control medications. More patients experienced adverse events during tizanidine treatment than did patients receiving placebo. The most common adverse events reported were dry mouth, somnolence, asthenia, and dizziness. Mild elevations in liver function tests were noted occasionally, but improved in all patients with dose reduction or withdrawal. Three patients from the double-blind database reported formed visual hallucinations. All three cleared; two continued tizanidine, and one discontinued.
来自替扎尼定三项安慰剂对照研究和11项活性对照研究的数据被合并起来，以便对那些在单个研究中规模太小而无法评估的亚组进行分析。安慰剂对照数据的总体分析证实了替扎尼定在降低脊髓源性痉挛患者肌张力方面的有效性。亚组分析表明，痉挛更严重的患者更有可能产生反应，但年龄、性别和种族并不能预测反应情况。替扎尼定与活性对照的比较显示，与巴氯芬或地西泮相比，疗效没有差异。然而，与对照相比，接受替扎尼定治疗的患者并未出现肌无力加重的情况。此外，患者对替扎尼定的耐受性优于对照药物。与接受安慰剂的患者相比，更多患者在替扎尼定治疗期间出现不良事件。报告的最常见不良事件为口干、嗜睡、乏力和头晕。偶尔会发现肝功能检查轻度升高，但所有患者在减量或停药后均有所改善。双盲数据库中有三名患者报告出现了视幻觉。三人的症状均已消除；两人继续使用替扎尼定，一人停药。
