Carbidopa/levodopa dose elevation and safety concerns in Parkinson's patients: a cross-sectional and cohort design
Carbidopa/levodopa dose elevation and safety concerns in Parkinson's patients: a cross-sectional and cohort design
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DOI：
10.1136/bmjopen-2012-001971
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发表时间：
2012-01-01
期刊：
影响因子：
2.9
通讯作者：
Okun, Michael S.
中科院分区：
文献类型：
--
作者：
Brodell, David W.;Stanford, Nicole T.;Okun, Michael S.
目的：Sinemet是一种含有卡比多巴和左旋多巴的复方药物，被认为是治疗帕金森病（PD）的金标准疗法。 1988 年，美国食品和药物管理局 (FDA) 批准了 25/100 卡比多巴/左旋多巴制剂的每日最大剂量限制为 800 毫克（八片）。总体而言，FDA 的批准是一次历史性的成功；然而，药物限制已被硬编码到许多在线医疗记录系统中。本研究通过使用前瞻性收集的患者信息数据库来调查 800 mg 阈值。设计：一项回顾性队列研究：（第一部分）横断面，（第二部分）纵向。设置和参与者：大型学术、三级医疗环境中运动障碍中心的 PD 患者。结果测量：使用低于和高于 800 mg 阈值剂量的卡比多巴/左旋多巴进行分析。然后通过连续两次就诊进行二次分析，以确定超过 800 毫克阈值的影响。在标准化量表上进行比较。 结果：服用低于和高于 800 mg 卡比多巴/左旋多巴阈值的患者的运动、情绪和生活质量评分没有显着差异，但运动障碍持续时间略有恶化，但运动障碍疼痛和残疾没有恶化。在连续两次就诊期间超过 800 mg 阈值的 PD 患者中，抑郁症状和生活质量指标显着改善，并且这些患者的运动波动或运动障碍没有恶化。 结论：数据表明，当 PD 患者超过 800 mg 卡比多巴/左旋多巴阈值时，有可能获得增强的临床获益。许多患者可能需要超过 800 毫克阈值，药房和保险公司应该意识到可能超出批准限制的要求。
Objective: Sinemet, a combination drug containing carbidopa and levodopa is considered the gold standard therapy for the treatment of Parkinson's disease (PD). When approved by the Food and Drug Administration (FDA) in 1988, a maximum daily dosage limit of 800 mg (eight tablets) of the 25/100 carbidopa/levodopa formulation was introduced. Overall, the FDA approval was a historic success; however, the pill limit has been hardcoded into many online medical record systems. This study investigates the 800 mg threshold by using a prospectively collected database of patient information.Design: A retrospective cohort study: (Part I) cross-sectional, (Part II) longitudinal.Setting and participants: PD patients at a Movement Disorders Center in a large academic, tertiary medical setting.Outcome measures: An analysis was performed using carbidopa/levodopa at dosages below and above the 800 mg threshold. A secondary analysis was then performed using two consecutive clinic visits to determine the effects of crossing the 800 mg threshold. Comparisons were made on standardised scales.Results: There was no significant difference in motor, mood and quality-of-life scores in patients consuming below and above the 800 mg carbidopa/levodopa threshold, though a mild worsening in dyskinesia duration was noted without worsening in dyskinesia pain and disability. In PD patients who crossed the 800 mg threshold between two consecutive clinic visits, a significant improvement in depressive symptoms and quality-of-life measures was demonstrated, and in these patients there was no worsening of motor fluctuations or dyskinesia.Conclusions: The data suggest that PD patients have the potential for enhanced clinical benefits when eclipsing the 800 mg carbidopa/levodopa threshold. Many patients will likely need to eclipse the 800 mg threshold and pharmacies and insurance companies should be aware of the requirements that may extend beyond approval limits.