Shults C W
Neurology Service, VA Medical Center, San Diego, CA 92161.
Acta Neurol Scand Suppl. 1993;146:36-42.
In patients with early, otherwise untreated Parkinson's disease, the abilities of selegiline (deprenyl) and tocopherol, antioxidative agents that act through complementary mechanisms, to delay the emergence of more severe disability requiring treatment with levodopa were evaluated. Eight hundred subjects were randomly assigned in a two-by-two factorial design to receive selegiline (10 mg per day), tocopherol (2000 IU per day), selegiline and tocopherol, or placebo and were followed up to determine the frequency of development of disability requiring treatment with levodopa, the primary end point. Interim analysis performed by an independent safety monitoring committee prompted a preliminary comparison of the 401 subjects assigned to tocopherol or placebo with the 399 subjects assigned to selegiline, alone or with tocopherol. During an average of 12 months of follow-up, only 97 subjects who received selegiline reached the end point. In contrast, 176 subjects who did not receive selegiline reached the end point during this period (P < 10(-8)). Selegiline was also found to be well tolerated and to have a small, but statistically significant symptomatic benefit. These results indicate that use of selegiline (10 mg per day) in patients with early, otherwise untreated Parkinson's disease, delays the emergence of more severe disability.
在早期未经治疗的帕金森病患者中，对司来吉兰（丙炔苯丙胺）和生育酚这两种通过互补机制发挥作用的抗氧化剂延缓出现需要左旋多巴治疗的更严重残疾的能力进行了评估。800名受试者按二乘二析因设计随机分组，分别接受司来吉兰（每日10毫克）、生育酚（每日2000国际单位）、司来吉兰加生育酚或安慰剂治疗，并进行随访以确定需要左旋多巴治疗的残疾发生频率，这是主要终点。由独立安全监测委员会进行的中期分析促使对分配接受生育酚或安慰剂治疗的401名受试者与分配接受司来吉兰单独治疗或司来吉兰加生育酚治疗的399名受试者进行初步比较。在平均12个月的随访期间，仅97名接受司来吉兰治疗的受试者达到终点。相比之下，在此期间有176名未接受司来吉兰治疗的受试者达到终点（P<10-8）。还发现司来吉兰耐受性良好，且有轻微但在统计学上有显著意义的症状改善。这些结果表明，在早期未经治疗的帕金森病患者中使用司来吉兰（每日10毫克）可延缓更严重残疾的出现。
