Allain H, Cougnard J, Neukirch H C
Hopital Pontchaillou, Rennes, France.
Acta Neurol Scand Suppl. 1991;136:73-8. doi: 10.1111/j.1600-0404.1991.tb05024.x.
The French selegiline multicenter trial was conducted in 1990 to test the possibility to improve disability of de novo parkinsonian patients (P.P.) during the first three months of treatment with selegiline (S) (10 mg/day) monotherapy. 93 P.P. were included in this double-blind, randomized, placebo controlled, clinical trial, in which 13 centers participated. Both parallel groups were followed up from inclusion (D0) to D30, D60 and D90. Drug efficacy was judged with Hoehn and Yahr (HY), Hamilton Depression Rating Scale (HDRS), Unified Parkinson's Disease Rating Scale (UPDRS), Schwab and England scores, decision to introduce levodopa and selfassessment. Biological and clinical parameters (cardio- vascular, weight, side-effects reports) were assessed for tolerability. 84 P.P. (38 P, 46 S) were evaluable for efficacy at D90. When considering the main parameters, S appears superior to placebo: HY scores (p less than 0.001), global UPDRS scores (p less than 0.001) and UPDRS subscores: mental (p less than 0.001), daily living activities (p less than 0.01), motor activities (p less than 0.01). Depressive scores (HDRS) are significantly improved only at D90 (p = 0.005). Levodopa therapy was introduced in 45% of the cases in S groups versus 18.4% in P group. Global impression of efficacy was largely in favor of S; failure was noted in half of the cases in P group and only in 1/5th of the cases in S group. Side-effects were rare and minor. S 10 mg/day monotherapy is statistically superior to placebo in improving de novo P.P. during the first three months treatment. Motor symptoms rapidly improve; mood is only modified after 3 months. S appears to be well tolerated. S may be considered as a good candidate for the initial treatment of P.P.
1990年进行了法国司来吉兰多中心试验，以测试在司来吉兰（S）（10毫克/天）单药治疗的前三个月内改善初发帕金森病患者（P.P.）残疾状况的可能性。93例P.P.被纳入这项双盲、随机、安慰剂对照的临床试验，有13个中心参与。两个平行组从纳入（D0）开始随访至D30、D60和D90。用霍恩和雅尔（HY）分级、汉密尔顿抑郁评定量表（HDRS）、统一帕金森病评定量表（UPDRS）、施瓦布和英格兰评分、引入左旋多巴的决定以及自我评估来判断药物疗效。评估生物学和临床参数（心血管、体重、副作用报告）以确定耐受性。84例P.P.（38例安慰剂组，46例司来吉兰组）在D90时可进行疗效评估。考虑主要参数时，司来吉兰组优于安慰剂组：HY评分（p小于0.001）、UPDRS总分（p小于0.001）以及UPDRS分项评分：精神状态（p小于0.001）、日常生活活动（p小于0.01）、运动活动（p小于0.01）。抑郁评分（HDRS）仅在D90时显著改善（p = 0.005）。司来吉兰组45%的病例引入了左旋多巴治疗，而安慰剂组为18.4%。疗效总体印象在很大程度上有利于司来吉兰组；安慰剂组半数病例出现治疗失败，而司来吉兰组仅1/5病例出现。副作用罕见且轻微。司来吉兰10毫克/天单药治疗在改善初发P.P.的前三个月治疗中在统计学上优于安慰剂。运动症状迅速改善；情绪仅在3个月后有所改善。司来吉兰耐受性良好。司来吉兰可被视为P.P.初始治疗的良好选择。
