Morton and Gloria Shulman Movement Disorders Centre, Toronto Western Hospital, Toronto, Ontario, Canada.
Mov Disord. 2009 Dec 15;24(16):2370-8. doi: 10.1002/mds.22828.
Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism (DATATOP) and Parkinson Research Examination of CEP-1347 Trial (PRECEPT) were two clinical trials of potential disease-modifying agents for Parkinson's disease that used the time to reaching disability sufficient to require dopaminergic therapy as the primary endpoint. To compare the thresholds for initiating dopaminergic treatment for Parkinson's disease between the two studies, conducted fifteen years apart. Baseline and 12-month endpoint characteristics for subjects in the placebo arms of the two studies were compared. DATATOP placebo subjects had slightly higher total Unified Parkinson's Disease Rating Scale (UPDRS) scores at baseline than PRECEPT placebo subjects (26.1 vs. 23.6, P = 0.03). Time to endpoint was not significantly different. Mean total UPDRS scores at endpoint among those subjects reaching endpoint by 12 months were 48.4 in DATATOP and 37.5 in PRECEPT (P < 0.0001). Baseline disease severity and time to disability requiring dopaminergic therapy were similar in the DATATOP and PRECEPT trials. The threshold for starting dopaminergic treatment was lower in PRECEPT than in the earlier DATATOP study. This may relate to changes in philosophies with respect to starting treatment for Parkinson's disease, but the factors underlying this change remain to be elucidated.
Deprenyl 和 Tocopherol 抗氧化治疗帕金森病（DATATOP）和帕金森研究 Cephalon 试验（PRECEPT）是两项针对帕金森病潜在疾病修饰治疗的临床试验，均以达到需要多巴胺治疗的残疾时间作为主要终点。为了比较这两项研究中启动帕金森病多巴胺治疗的阈值，我们对相隔 15 年进行的两项研究进行了比较。比较了两项研究安慰剂组的基线和 12 个月的终点特征。DATATOP 安慰剂组的总统一帕金森病评定量表（UPDRS）评分基线略高于 PRECEPT 安慰剂组（26.1 对 23.6，P = 0.03）。终点时间无显著差异。12 个月时达到终点的受试者的平均总 UPDRS 评分在 DATATOP 为 48.4，在 PRECEPT 为 37.5（P < 0.0001）。DATATOP 和 PRECEPT 试验中基线疾病严重程度和残疾时间至需要多巴胺治疗的时间相似。在 PRECEPT 中开始多巴胺治疗的阈值低于早期的 DATATOP 研究。这可能与开始治疗帕金森病的理念变化有关，但导致这种变化的因素仍有待阐明。
