Allain H, Pollak P, Neukirch H C
Clinique Neurologique, Centre Hospitalier Regional et Universitaire de Grenoble, France.
Mov Disord. 1993;8 Suppl 1:S36-40. doi: 10.1002/mds.870080508.
The French Selegiline Multicenter Trial was carried out in 1990 to investigate whether the disability of de novo patients with parkinsonism could be improved during the first 3 months by monotherapy with selegiline (10 mg/day). A double-blind, randomized, placebo-controlled clinical trial was conducted over 3 months with 93 patients from 13 centers. Symptomatology was assessed on various disease rating scales, including Hoehn and Yahr, Hamilton Depression Rating Scale, Unified Parkinson's Disease rating scale, and Schwab and England scores, as well as self-assessment. Biological and clinical parameters were measured for tolerability, and efficacy was investigated with special reference to the point at which therapy with L-dopa had to be started. Selegiline was significantly superior to placebo on the various motor rating scores, and depressive scores were significantly improved at the end of 3 months. Adverse effects were rare and minor. Therefore, selegiline could be the therapy of choice for the treatment of de novo parkinsonian patients.
1990年开展了法国司来吉兰多中心试验，以研究帕金森病初发患者的残疾状况在最初3个月内是否可通过司来吉兰单药治疗（10毫克/天）得到改善。对来自13个中心的93例患者进行了为期3个月的双盲、随机、安慰剂对照临床试验。通过各种疾病评定量表对症状进行评估，包括霍恩和雅尔分级、汉密尔顿抑郁评定量表、统一帕金森病评定量表、施瓦布和英格兰评分以及自我评估。测量生物学和临床参数以评估耐受性，并特别参照开始使用左旋多巴治疗的时间点来研究疗效。在各项运动评分上，司来吉兰显著优于安慰剂，且3个月末抑郁评分有显著改善。不良反应罕见且轻微。因此，司来吉兰可能是治疗帕金森病初发患者的首选疗法。
