Whone Alan L, Watts Ray L, Stoessl A Jon, Davis Margaret, Reske Sven, Nahmias Claude, Lang Anthony E, Rascol Olivier, Ribeiro Maria J, Remy Philippe, Poewe Werner H, Hauser Robert A, Brooks David J
Faculty of Medicine, Imperial College, Hammersmith Hospital, London, United Kingdom.
Ann Neurol. 2003 Jul;54(1):93-101. doi: 10.1002/ana.10609.
Preclinical studies suggest ropinirole (a D2/D3 dopamine agonist) may be neuroprotective in Parkinson's disease (PD), and a pilot clinical study using (18)F-dopa positron emission tomography (PET) suggested a slower loss of striatal dopamine storage with ropinirole compared with levodopa. This prospective, 2-year, randomized, double-blind, multinational study compared the rates of loss of dopamine-terminal function in de novo patients with clinical and (18)F-dopa PET evidence of early PD, randomized 1 to 1 to receive either ropinirole or levodopa. The primary outcome measure was reduction in putamen (18)F-dopa uptake (Ki) between baseline and 2-year PET. Of 186, 162 randomized patients were eligible for analysis. A blinded, central, region-of-interest analysis showed a significantly lower reduction (p = 0.022) in putamen Ki over 2 years with ropinirole (-13.4%; n = 68) compared with levodopa (-20.3%; n = 59; 95% confidence interval [CI], 0.65-13.06). Statistical parametric mapping localized lesser reductions in (18)F-dopa uptake in the putamen and substantia nigra with ropinirole. The greatest Ki decrease in each group was in the putamen (ropinirole, -14.1%; levodopa, -22.9%; 95% CI, 4.24-13.3), but the decrease was significantly lower with ropinirole compared with levodopa (p < 0.001). Ropinirole is associated with slower progression of PD than levodopa as assessed by (18)F-dopa PET.
临床前研究表明，罗匹尼罗（一种D2/D3多巴胺激动剂）可能对帕金森病（PD）具有神经保护作用，一项使用（18）F-多巴正电子发射断层扫描（PET）的初步临床研究表明，与左旋多巴相比，罗匹尼罗可使纹状体多巴胺储存的丧失更缓慢。这项前瞻性、为期2年的随机、双盲、多国研究比较了初发患者中多巴胺终末功能丧失的速率，这些患者有临床及（18）F-多巴PET证据显示为早期PD，按1:1随机分组接受罗匹尼罗或左旋多巴治疗。主要结局指标是基线与2年PET检查之间壳核（18）F-多巴摄取（Ki）的降低。在186例随机分组患者中，162例符合分析条件。一项盲法、中心、感兴趣区分析显示，与左旋多巴（-20.3%；n = 59；95%置信区间[CI]，0.65 - 13.06）相比，罗匹尼罗治疗2年时壳核Ki的降低显著更低（p = 0.022）（-13.4%；n = 68）。统计参数映射显示，罗匹尼罗治疗时壳核和黑质中（18）F-多巴摄取的降低幅度较小。每组中Ki降低最大的部位均在壳核（罗匹尼罗，-14.1%；左旋多巴，-22.9%；95% CI，4.24 - 13.3），但罗匹尼罗组的降低幅度显著低于左旋多巴组（p < 0.001）。根据（18）F-多巴PET评估，与左旋多巴相比，罗匹尼罗与PD进展更缓慢相关。
