Pramipexole vs levodopa as initial treatment for Parkinson disease - A randomized controlled trial
Pramipexole vs levodopa as initial treatment for Parkinson disease - A randomized controlled trial
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DOI：
10.1001/jama.284.15.1931
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发表时间：
2000-10-18
影响因子：
120.7
通讯作者：
Watts, A
中科院分区：
文献类型：
--
作者：
Holloway, R;Shoulson, I;Watts, A
目的比较普拉克索和左旋多巴治疗早期帕金森病(PD)后运动并发症的发生情况。设计多中心、平行分组、双盲、随机对照试验，在美国和加拿大的22个地点建立学术运动障碍诊所。在美国和加拿大的22个地点设立学术运动障碍诊所。3001名早期PD患者需要接受多巴胺治疗以治疗新出现的残疾。干预受试者被随机分配接受普拉克索0.5 mg/d，3次/d左旋多巴安慰剂(n=151)；或卡比多巴/左旋多巴，25/100 mg，每日3次，同时服用普拉克索安慰剂(n=150)。对于残废患者，在前10周内剂量逐渐增加。从第11周到第23.5个月，研究人员被允许添加开放标签的左旋多巴来治疗持续或新出现的残疾。主要结果衡量3种多巴胺能并发症中任何一种首次发生的时间：疲惫、运动障碍或运动波动；统一帕金森病评定量表(UPDRS)评分的变化，基线评估和随访评估；在一个由82名受试者组成的亚组中，在基线和23.5个月的评估中，在多巴胺转运体的单光子发射计算机断层成像上，特异性和不可移位性纹状体碘1232-β-羧甲氧基-3-β-(4-碘苯基)托烷(β-CIT)的摄取率(β-CIT)。结果最初的普拉克索治疗导致疲劳、运动障碍或运动波动的发生率(28%)显著低于左旋多巴(51%)(风险比，0.45；95%可信区间[CI]，0.30-0.66；
Context Pramipexole and levodopa both ameliorate the motor symptoms of early Parkinson disease (PD), but no controlled studies have compared long-term outcomes after initiating dopaminergic therapy with pramipexole vs levodopa.Objective To compare the development of dopaminergic motor complications after initial treatment of early PD with pramipexole vs levodopa.Design Multicenter, parallel-group, double-blind, randomized controlled trial.Setting Academic movement disorders clinics at 22 sites in the United States and Canada.Patients Three hundred one patients with early PD who required dopaminergic therapy to treat emerging disability, enrolled between October 1996 and August 1997.Interventions Subjects were randomly assigned to receive pramipexole, 0.5 mg 3 times per day, with levodopa placebo (n=151); or carbidopa/levodopa, 25/100 mg 3 times per day, with pramipexole placebo (n=150). For patients with residual disability, the dosage was escalated during the first 10 weeks. From week 11 to month 23.5, investigators were permitted to add open-label levodopa to treat continuing or emerging disability.Main Outcome Measures Time to the first occurrence of any of 3 dopaminergic complications: wearing off, dyskinesias, or on-off motor fluctuations; changes in scores on the Unified Parkinson's Disease Rating Scale (UPDRS), assessed at baseline and follow-up evaluations; and, in a subgroup of 82 subjects evaluated at baseline and 23.5 months, ratio of specific to nondisplaceable striatal iodine 1232-beta-carboxymethoxy 3-beta-(4-iodophenyl)tropane (beta-CIT) uptake on single photon emission computed tomography imaging of the dopamine transporter.Results Initial pramipexole treatment resulted in significantly less development of wearing off, dyskinesias, or on-off motor fluctuations (28%) compared with levodopa (51%) (hazard ratio, 0.45; 95% confidence interval [CI], 0.30-0.66; P