Ann Neurol. 1996 Jan;39(1):29-36. doi: 10.1002/ana.410390106.
In the controlled trial Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP), 310 of the 800 enrolled subjects did not reach the primary end point of disability requiring levodopa therapy during 21 +/- 4 (mean +/- SD) months of observation or need early initiation of deprenyl (selegiline) during a 2-month withdrawal of experimental treatments. While maintaining the blindness of their original deprenyl and tocopherol treatment assignments, these 310 subjects were administered deprenyl 10 mg/day (open label) and were monitored systematically at 1- to 3-month intervals for up to 18 months (12 +/- 5 mo). During this extended trial, the 189 subjects who had been assigned originally to active deprenyl tended to reach the end point of disability faster than the 121 subjects who had not been assigned originally to deprenyl (hazard ratio, 1.43; 95% CI, 0.98, 2.09; p = 0.065). However, the differential rates of reaching the end point may have been due in part to the more severe baseline impairment of deprenyl-assigned subjects, who benefited originally from deprenyl but who were more likely to require levodopa during this extended period of observation. Prior treatment with deprenyl did not lead to superior survival with respect to the end point of disability requiring levodopa, suggesting that the initial advantages of deprenyl were not sustained.
在帕金森病的司来吉兰与维生素E抗氧化治疗（DATATOP）对照试验中，800名入组受试者中有310名在21±4（均值±标准差）个月的观察期内未达到需要左旋多巴治疗的残疾主要终点，或在2个月的实验治疗撤药期内无需提前开始使用司来吉兰（Selegiline）。在保持其最初司来吉兰和维生素E治疗分配的盲态的情况下，这310名受试者接受10毫克/天的司来吉兰（开放标签）治疗，并每隔1至3个月进行系统监测，最长监测18个月（12±5个月）。在这项延长试验中，最初被分配接受活性司来吉兰治疗的189名受试者比最初未被分配接受司来吉兰治疗的121名受试者更倾向于更快达到残疾终点（风险比，1.43；95%置信区间，0.98，2.09；p = 0.065）。然而，达到终点的差异率可能部分归因于最初接受司来吉兰治疗的受试者基线损伤更严重，他们最初从司来吉兰中获益，但在延长的观察期内更有可能需要左旋多巴治疗。就需要左旋多巴的残疾终点而言，先前使用司来吉兰治疗并未带来更好的生存率，这表明司来吉兰最初的优势并未持续。
