Brooks D J, Agid Y, Eggert K, Widner H, Ostergaard K, Holopainen A
MRC Clinical Sciences Centre and Division of Neuroscience, Faculty of Medicine, Imperial College, Hammersmith Hospital, London, UK.
Eur Neurol. 2005;53(4):197-202. doi: 10.1159/000086479. Epub 2005 Jun 20.
The aim of this study was to evaluate the efficacy of the new optimised levodopa, Stalevo (levodopa, carbidopa and entacapone) in patients with Parkinson's disease experiencing end-of-dose wearing-off. Treatment with Stalevo was compared to treatment with traditional immediate-release levodopa and dopa-decarboxylase inhibitor (DDCI) formulations along with adjunct entacapone (Comtess/Comtan). A European, open, parallel-group, active treatment-controlled phase IIIb study evaluating 176 patients randomised to switch from their current regimen of levodopa/DDCI to either an equivalent dose of Stalevo or levodopa/DDCI plus entacapone. After 6 weeks, treatments were assessed using the Clinical Global Impression of Change, the Unified Parkinson's Disease Rating Scale and a Motor Fluctuations Questionnaire. Over 70% of patients in both the Stalevo and adjunct entacapone arms felt that they were clinically improved and over 80% experienced a reduction in fluctuations. Although there was no significant difference between Stalevo and levodopa/DDCI plus entacapone with regard to motor improvement and side effects, 81% of patients stated that they preferred treatment with Stalevo compared with taking two separate tablets (i.e. levodopa/DDCI and entacapone). Stalevo was well tolerated and safe when substituted for levodopa DDCI preparations.
本研究旨在评估新型优化左旋多巴制剂Stalevo(左旋多巴、卡比多巴和恩他卡朋)对帕金森病患者剂末疗效减退的治疗效果。将Stalevo治疗与传统速释左旋多巴和多巴脱羧酶抑制剂(DDCI)制剂联合恩他卡朋(珂丹/Comtan)治疗进行比较。这是一项欧洲的开放性、平行组、活性药物对照的IIIb期研究,评估了176例患者,这些患者被随机分配,从当前的左旋多巴/DDCI治疗方案转换为等量的Stalevo或左旋多巴/DDCI加恩他卡朋治疗。6周后,使用临床总体印象变化量表、统一帕金森病评定量表和运动波动问卷对治疗效果进行评估。Stalevo组和恩他卡朋联合治疗组均有超过70%的患者感觉临床症状改善,超过80%的患者运动波动减少。虽然在运动改善和副作用方面,Stalevo与左旋多巴/DDCI加恩他卡朋之间没有显著差异,但81%的患者表示,与服用两片单独的药片(即左旋多巴/DDCI和恩他卡朋)相比,他们更喜欢Stalevo治疗。当用Stalevo替代左旋多巴DDCI制剂时,耐受性良好且安全。