Hanna P A, Ratkos L, Ondo W G, Jankovic J
New Jersey Neuroscience Institute, JFK Medical Center, Edison, USA.
J Neural Transm (Vienna). 2001;108(1):63-70. doi: 10.1007/s007020170097.
OBJECTIVE/BACKGROUND: To compare the safety and efficacy of pramipexole and pergolide in the treatment of mild to moderate Parkinson's disease (PD). In contrast to pergolide, a D1 and D2 dopamine agonist, pramipexole is a nonergoline dopamine agonist with D2 and preferential D3 dopamine receptor activity. This selective activity may result in clinically different effects. No prospective head-to-head comparison studies of pergolide and pramipexole have been reported.
Patients with PD who were maintained on an optimal dose of pergolide were converted to pramipexole, typically over a one-month period. Clinical assessments were performed just prior to conversion and after an optimal dose of pramipexole was achieved.
Twenty-five patients were converted from pergolide to pramipexole during the period of July, 1997 to January, 1999. Three patients were lost to follow-up, and one patient died. Of the remaining 21 patients there were 11 men and 10 women, mean age was 67.3 years +/- 10.0 (range 51-84). Mean duration of symptoms prior to conversion was 12.5 years +/- 3.4 (range 5-19). All patients (except one) were on concomitant carbidopa/ levodopa and experienced motor fluctuations. After a mean follow-up of 5.9 +/- 2.9 months on pramipexole, the mean levodopa daily dose was reduced from 618.7mg to 581.2mg (16.5% reduction, p = 0.61). The mean daily doses of pergolide and pramipexole (in milligrams per day) were 2.1 +/- 1.5 (0.15-6) and 3.2 +/- 1.1 (0.75-6) respectively. Thirteen patients (62%) reported overall improvement (subjective global response) on pramipexole as compared to pergolide, 5 (24%) were unchanged and 3 (14%) reported worsening. Eighteen of the 21 patients (86%) remained on pramipexole after the study period. Although there was a slight trend toward improved scores on pramipexole, the difference was not statistically significant.
This open label study failed to provide evidence of superior efficacy of either dopamine agonist. It is possible, however, that while somepatients may benefit more from either pergolide or pramipexole, other patients may obtain additional benefit from other DA agonists or combination therapy. Future randomized, controlled, double-blinded therapeutic trials are needed to determine which, if any, dopamine agonist is superior in the treatment of PD.
目的/背景:比较普拉克索和培高利特治疗轻至中度帕金森病(PD)的安全性和疗效。培高利特是一种D1和D2多巴胺激动剂,而普拉克索是一种具有D2和优先D3多巴胺受体活性的非麦角林多巴胺激动剂。这种选择性活性可能导致临床上不同的效果。尚未有关于培高利特和普拉克索的前瞻性直接比较研究报道。
维持在最佳剂量培高利特治疗的PD患者转换为普拉克索治疗,通常在1个月的时间内完成。在转换前及达到普拉克索最佳剂量后进行临床评估。
1997年7月至1999年1月期间,25例患者从培高利特转换为普拉克索治疗。3例患者失访,1例患者死亡。其余21例患者中,男性11例,女性10例,平均年龄67.3岁±10.0岁(范围51 - 84岁)。转换前症状的平均持续时间为12.5年±3.4年(范围5 - 19年)。所有患者(除1例)均同时服用卡比多巴/左旋多巴并出现运动波动。在普拉克索平均随访5.9±2.9个月后,左旋多巴的平均日剂量从618.7mg降至581.2mg(降低16.5%,p = 0.61)。培高利特和普拉克索的平均日剂量(毫克/天)分别为2.1±1.5(0.15 - 6)和3.2±1.1(0.75 - 6)。与培高利特相比,13例患者(62%)报告使用普拉克索后总体改善(主观整体反应),5例(24%)无变化,3例(14%)报告病情恶化。研究期结束后,21例患者中有18例(86%)继续使用普拉克索。虽然使用普拉克索后评分有轻微改善趋势,但差异无统计学意义。
这项开放标签研究未能提供证据表明两种多巴胺激动剂中哪一种具有更优疗效。然而,有可能一些患者可能从培高利特或普拉克索中获益更多,而其他患者可能从其他多巴胺激动剂或联合治疗中获得额外益处。未来需要进行随机、对照、双盲治疗试验,以确定哪种多巴胺激动剂(如果有的话)在PD治疗中更具优势。