Ann Neurol. 1998 Mar;43(3):318-25. doi: 10.1002/ana.410430309.
Deprenyl (selegiline) delays the need for levodopa therapy in patients with early Parkinson's disease, but the value of long-term treatment with this type B monoamine oxidase inhibitor remains unsettled. We examined mortality among the 800 patients with early Parkinson's disease who were not requiring levodopa and who were randomly assigned in the DATATOP trial to receive deprenyl, tocopherol, combined treatments, or placebo. Ascertainment of the vital status of subjects in this double-blinded trial was performed prospectively after the initial randomization, during open-label deprenyl, and after a second independent randomization to continue active deprenyl or switch to matching placebo. The study was conducted at 28 academic medical centers in the United States and Canada. After an average of 8.2 years of observation, the overall death rate of our subjects was 17.1% (137 of 800) or 2.1% per year. The mortality rate was unaffected by deprenyl, tocopherol, or combined treatment assignments and was about that expected for an age- and gender-matched US population without Parkinson's disease. Neither deprenyl, tocopherol, nor their combined treatments affected the duration of life in our early Parkinson's disease patients. The deprenyl-related delay in disability that we reported previously was not associated with a deprenyl-related reduction in mortality.
司来吉兰（丙炔苯丙胺）可延缓早期帕金森病患者对左旋多巴治疗的需求，但这种B型单胺氧化酶抑制剂的长期治疗价值仍未明确。我们在DATATOP试验中，对800例尚未需要左旋多巴治疗的早期帕金森病患者进行了研究，这些患者被随机分配接受司来吉兰、维生素E、联合治疗或安慰剂。在这项双盲试验中，对受试者生命状态的确定是在初始随机分组后、开放标签使用司来吉兰期间以及第二次独立随机分组以继续使用活性司来吉兰或改用匹配安慰剂后进行的前瞻性研究。该研究在美国和加拿大的28个学术医学中心进行。经过平均8.2年的观察，我们的受试者总死亡率为17.1%（800例中的137例），即每年2.1%。死亡率不受司来吉兰、维生素E或联合治疗分配的影响，与年龄和性别匹配的无帕金森病美国人群的预期死亡率相近。司来吉兰、维生素E及其联合治疗均未影响我们早期帕金森病患者的寿命。我们之前报道的司来吉兰相关的残疾延迟与司来吉兰相关的死亡率降低无关。
