Pellkofer M, Paulig M
Med Klin (Munich). 1989 Jan 15;84(1):5-8.
In a double-blind comparative study, the therapeutic efficacy and safety of three centrally effective antispasmodics (Tetrazepam, Baclofen and Tizanidine) in patients suffering from multiple sclerosis with spastic motor disturbances of the lower extremities was to be examined. 47 patients of either sex at the age of 23 until 63 were allocated to one of the three therapies by means of minimization. The duration of treatment was limited to 35 days at a maximum. The dosage was optimized corresponding to the clinical symptoms. The antispasmodic efficacy and safety of the above-mentioned substances was investigated with well-established parameters and methods. The typical laboratory parameters were determined at the beginning and at the end of the study. -With reference to cloni, spasms and the muscular tonus, no systematic differences were found between the treatment groups. A previously existing clonus could not be altered decisively by the administration of the three antispasmodics, whereas the muscular tonus could comparably be decreased with all therapeutic measures. Statistically significant differences between the treatment groups were not observed. The patients of all three groups recorded a subjective sensation of relief with reference to the symptoms of spasms by the medication. As to the residual urinary volume, no relevant differences and alterations were determinated in the course of the treatment as well. With reference to undesired side effects quantitative and qualitative differences could be established, in which Tetrazepam showed the most favourable benefit/risk ratio.
在一项双盲对照研究中,考察了三种中枢作用抗痉挛药(替扎西泮、巴氯芬和替扎尼定)对患有下肢痉挛性运动障碍的多发性硬化症患者的治疗效果和安全性。通过最小化法将47名年龄在23岁至63岁之间的男女患者分配至三种治疗方法之一。治疗时长最长限制为35天。根据临床症状调整剂量。采用成熟的参数和方法研究上述药物的抗痉挛效果和安全性。在研究开始和结束时测定典型的实验室参数。——关于阵挛、痉挛和肌张力,各治疗组之间未发现系统性差异。三种抗痉挛药的使用均无法决定性地改变先前存在的阵挛,而所有治疗措施均可同等程度地降低肌张力。未观察到各治疗组之间存在统计学显著差异。所有三组患者均表示用药后痉挛症状有主观缓解感。关于残余尿量,治疗过程中也未发现相关差异和变化。在不良副作用方面,可确定存在定量和定性差异,其中替扎西泮的效益/风险比最为有利。