Efficacy of pramipexole, a novel dopamine agonist, as monotherapy in mild to moderate Parkinson's disease
Efficacy of pramipexole, a novel dopamine agonist, as monotherapy in mild to moderate Parkinson's disease
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普拉克索（一种新型多巴胺激动剂）单药治疗轻至中度帕金森病的疗效
DOI：
10.1212/wnl.49.3.724
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发表时间：
1997
期刊：
影响因子：
9.9
通讯作者：
J. Friedman
中科院分区：
文献类型：
--
作者：
K. Shannon;J. Bennett;J. Friedman
共有 335 名早期帕金森病 (PD) 患者参加了一项多中心、随机、双盲试验，旨在评估普拉克索的疗效和安全性。仅限未接受左旋多巴治疗的特发性 PD 患者进入。普拉克索按照剂量递增方案给药，最高为 4.5 mg/d。在为期 7 周的剂量递增阶段，每位受试者的研究药物剂量逐渐调整至其最大耐受剂量。随后进行为期 24 周的维持治疗。维持期间的平均每日剂量为3.8 mg。与安慰剂相比，普拉克索显着降低了帕金森病症状和体征的严重程度，通过第 24 周统一帕金森病评定量表第二部分（日常生活活动）和第三部分（运动检查）与基线相比的下降来衡量（p ≤ 0.0001）。活性药物组和安慰剂组之间的差异在第 3 周（1.5 mg/d）的剂量递增间隔中出现，并在整个维持阶段持续存在（p ≤ 0.0001）。大多数患者完成了研究（普拉克索 83%，安慰剂 80%）。在不良事件评估中，与安慰剂患者相比，普拉克索治疗组更频繁地出现恶心、失眠、便秘、嗜睡和幻视。血压或脉搏率没有出现临床上显着的变化。总体而言，这些结果表明普拉克索治疗早期帕金森病是安全有效的。
A total of 335 patients with early Parkinson's disease (PD) were enrolled in a multicenter, randomized, double-blind trial designed to assess the efficacy and safety of pramipexole. Entry was restricted to patients with idiopathic PD who were not receiving levodopa. Pramipexole was administered according to an ascending dose schedule up to 4.5 mg/d. During the 7-week dose-escalation phase, each subject was titrated to his or her maximally tolerated dose of study medication. This was followed by a 24-week period of maintenance therapy. The mean daily dose during the maintenance period was 3.8 mg. Pramipexole significantly reduced the severity of PD symptoms and signs compared with placebo, as measured by decreases in parts II (Activities of Daily Living) and III (Motor Examination) of the Unified Parkinson's Disease Rating Scale at week 24 compared with baseline (p ≤ 0.0001). Differences between the active drug and placebo groups emerged at week 3 (1.5 mg/d) in the ascending-dose interval and persisted throughout the maintenance phase (p ≤ 0.0001). The majority of patients completed the study (pramipexole 83%, placebo 80%). In the assessment of adverse events, nausea, insomnia, constipation, somnolence, and visual hallucinations occurred more frequently in the pramipexole treatment group compared with placebo patients. No clinically significant changes were noted in blood pressure or pulse rate. Overall, these results indicate that pramipexole is safe and effective in the treatment of early PD.