长效的早期帕金森病的多巴胺受体激动剂卡麦角林:5年的最终结果,双盲,levodopa-controlled学习。

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Bracco F,等待的人群,Chouza C,杜邦E, Gershanik O,马蒂美索摩根富林明,Montastruc杰

长效的早期帕金森病的多巴胺受体激动剂卡麦角林:5年的最终结果,双盲,levodopa-controlled学习。

中枢神经系统药物。2004;18 (11):733 - 46。

PubMed ID

15330687 (在PubMed

]

文摘

目的:卡麦角林是一个ergoline导数每日一次很长的半衰期,允许政府和潜在的比是可能的持续刺激多巴胺能受体与其他多巴胺受体受体激动剂(DAs)。本研究的目的是评估是否可能带来的优势更持续多巴胺能的影响卡麦角林将转化为延迟性的运动并发症,患者与左旋多巴相比,新诊断帕金森病。研究设计和方法:本研究是一个双盲、多中心试验相比初始卡麦角林和左旋多巴治疗帕金森病。共有419名左旋多巴、DA和selegiline-naive新诊断帕金森氏症患者随机接受卡麦角林(n = 211)或左旋多巴(n = 209)。治疗是一个最佳剂量滴定的24周,然后继续在这个剂量,直到研究端点(确认电动机的并发症)或最多5年。年1 - 5,接收卡麦角林卡麦角林组平均每日剂量范围从2.8 - -2.9毫克,添加了在平均每日剂量左旋多巴在第一年从322毫克到431毫克5年;在同一时期,左旋多巴组接收每日左旋多巴剂量784毫克。因此,患者在卡麦角林组< 50%比左旋多巴组患者左旋多巴。结果:运动并发症显著延迟(p = 0.0175)和发生频率更低比levodopa-treated cabergoline-treated患者患者(22.3% vs 33.7%)。Cox比例风险模型回归分析表明,发展这种并发症是> 50%的相对风险较低(0.46; p < 0.001) in the cabergoline group compared with the levodopa group. In particular, development of dyskinesias was markedly delayed in the cabergoline group and occurred in 9.5% of patients compared with 21.2% in the levodopa group (p < 0.001). Among patients not requiring supplemental levodopa, the frequency of motor complications was three times higher with levodopa (15.5% of 110 patients) than with cabergoline (5.3% of 76 patients). Among patients who did need supplemental levodopa, motor complications were more frequent in the levodopa arm (54.1% of 98 patients) than in the cabergoline arm (31.9% of 135 patients). Consistent improvements relative to baseline in average Unified Parkinson's Disease Rating Scale (UPDRS) daily living activities and motor function sections, and in Clinical Global Impression severity of illness and physician- and patient- rated global improvement scores, were seen in both treatment groups, with maximal effects occurring within 2 years. However, levodopa treatment was associated with a significantly (p < 0.001) greater improvement in motor disability (as measured by the UPDRS motor score) over time, with mean values of 13.8 versus 12.9 in the cabergoline versus levodopa arm recorded at 1 year, 18.6 versus 17.2 at 3 years and 19.2 versus 16.3 at 5 years, respectively. While the overall frequency of adverse events was similar in the two groups, the cabergoline-treated group experienced marginally, but not significantly, higher frequencies of nausea, vomiting, dyspepsia and gastritis (37.4% vs 32.2% in the levodopa group) and of dizziness and postural hypotension (31.3% vs 24% in the levodopa group). Cabergoline-treated patients also experienced a significantly higher frequency of peripheral oedema (16.1% vs 3.4%, respectively; p < 0.0001). The cabergoline and levodopa groups had similar rates of sleepiness (17.5% vs 18.3%, respectively) and hallucinations (4.8% vs 4.4%, respectively); in an elderly population subset, hallucinations were reported in 7.1% and 6.5% of patients taking cabergoline and levodopa, respectively. Adverse events generally occurred more frequently in female patients (with the exception of dyskinesias, hyperkinesias and hallucinations, which occurred more frequently in men) and in the elderly. CONCLUSION: This study showed that, compared with levodopa, initial therapy with cabergoline in patients with Parkinson's disease is associated with a lower risk of response fluctuations at the cost of a marginally reduced symptomatic improvement and some tolerability disadvantages that are mostly limited to a significantly higher frequency of peripheral oedema.

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药物

卡麦角林