Biglan Kevin M, Holloway Robert G, McDermott Michael P, Richard Irene H
University of Rochester, Department of Neurology, Rochester, NY 14620, USA.
Neurology. 2007 Jul 10;69(2):187-95. doi: 10.1212/01.wnl.0000265593.34438.00.
The CALM-PD trial evaluated the development of motor complications in subjects with early Parkinson disease (PD) randomized to initial treatment with either pramipexole or levodopa. A secondary finding of the trial was a higher than anticipated development or worsening of somnolence and edema and development of hallucinations.
To investigate risk factors for somnolence, edema, and hallucinations in patients with early PD initiating dopaminergic therapy.
This was a secondary analysis of data from the CALM-PD trial. Baseline patient characteristics were evaluated for their associations with the development or worsening of somnolence and edema and the development of hallucinations using Cox proportional hazards regression models.
Kaplan-Meier estimates of the 4-year incidence of the development or worsening of somnolence and edema and the development of hallucinations were 35%, 45%, and 17%. Initial pramipexole treatment (hazard ratio [HR] 2.22, 95% CI 1.41, 3.50, p < 0.001), male gender (HR 1.79, 95% CI 1.09, 2.93, p = 0.02), and >5 systems with a comorbid illness (HR 1.62, 95% CI 1.04, 2.51, p = 0.03) were associated with somnolence. Initial pramipexole treatment (HR 3.18, 95% CI 1.95, 5.18, p < 0.0001), female gender (HR 1.46, 95% CI 0.94, 2.27, p = 0.09), and comorbid cardiac disease (HR 1.59, 95% CI 1.02, 2.47, p = 0.04) were associated with edema. Age > or =65 (HR 2.06, 95% CI 0.98, 4.32, p = 0.06), Mini-Mental State Examination score >28 (HR 0.42, 95% CI 0.19, 0.91, p = 0.03), and >5 systems with a comorbid illness (HR 3.42, 95% CI 1.59, 7.38, p = 0.002) were associated with hallucinations.
Comorbid illnesses are important and overlooked risk factors for the development of somnolence, edema, and hallucinations. When initiating therapy with pramipexole, patients should be counseled about and monitored for somnolence and edema. Slight decrements in cognitive function and older age are associated with an increased risk of hallucinations.
CALM-PD试验评估了早期帕金森病（PD）患者随机接受普拉克索或左旋多巴初始治疗后运动并发症的发生情况。该试验的一个次要发现是嗜睡、水肿的发生或加重以及幻觉的出现高于预期。
研究早期PD患者开始多巴胺能治疗时嗜睡、水肿和幻觉的危险因素。
这是对CALM-PD试验数据的二次分析。使用Cox比例风险回归模型评估基线患者特征与嗜睡和水肿的发生或加重以及幻觉发生之间的关联。
嗜睡和水肿的发生或加重以及幻觉发生的4年发生率的Kaplan-Meier估计值分别为35%、45%和17%。初始普拉克索治疗（风险比[HR]2.22，95%置信区间1.41，3.50，p<0.001）、男性（HR 1.79，95%置信区间1.09，2.93，p = 0.02）以及合并症累及>5个系统（HR 1.62，95%置信区间1.04，2.51，p = 0.03）与嗜睡相关。初始普拉克索治疗（HR 3.18，95%置信区间1.95，5.18，p<0.0001）、女性（HR 1.46，95%置信区间0.94，2.27，p = 0.09）以及合并心脏病（HR 1.59，95%置信区间1.02，2.47，p = 0.04）与水肿相关。年龄≥65岁（HR 2.06，95%置信区间0.98，4.32，p = 0.06）、简易精神状态检查表评分>28分（HR 0.42，95%置信区间0.19，0.91，p = 0.03）以及合并症累及>5个系统（HR 3.42，95%置信区间1.59，7.38，p = 0.002）与幻觉相关。
合并症是嗜睡、水肿和幻觉发生的重要且被忽视的危险因素。开始使用普拉克索治疗时，应向患者提供有关嗜睡和水肿的咨询并进行监测。认知功能略有下降和年龄较大与幻觉风险增加相关。
