Department of Micro-data Analysis, Dalarna University, Falun, Sweden.
School of Business, Orebro University, Orebro, Sweden.
Acta Neurol Scand. 2019 Jan;139(1):70-75. doi: 10.1111/ane.13020. Epub 2018 Sep 24.
The aim of this retrospective study was to investigate whether patients with Parkinson's disease, who are treated with levodopa-carbidopa intestinal gel (LCIG), clinically worsen during the afternoon hours and if so, to evaluate whether this occurs in all LCIG-treated patients or in a subgroup of patients.
Three published studies were identified and included in the analysis. All studies provided individual response data assessed on the treatment response scale (TRS), and patients were treated with continuous LCIG. Ninety-eight patients from the three studies fulfilled the criteria. t tests were performed to find differences on the TRS values between the morning and the afternoon hours, linear mixed effect models were fitted on the afternoon hours' evaluations to find trends of wearing-off, and patients were classified into three TRS categories (meaningful increase in TRS, meaningful decrease in TRS, non-meaningful increase or decrease).
In all three studies, significant statistical differences were found between the morning TRS values and the afternoon TRS values (P-value <=0.001 in all studies). The linear mixed effect models had significant negative coefficients for time in two studies, and 48 out of 98 patients (49%) showed a meaningful decrease in TRS during the afternoon hours.
The results from all studies were consistent, both in the proportion of patients in the three groups and in the value of TRS decrease in the afternoon hours. Based on these findings, there seems to be a group of patients with predictable "off" behavior in the later parts of the day.
本回顾性研究旨在探讨接受左旋多巴-卡比多巴肠凝胶（LCIG）治疗的帕金森病患者是否在下午出现临床恶化，如果是，评估这种情况是否发生在所有 LCIG 治疗患者中，还是发生在某些亚组患者中。
确定了三项已发表的研究并将其纳入分析。所有研究均提供了在治疗反应量表（TRS）上评估的个体反应数据，且患者接受持续 LCIG 治疗。三项研究中有 98 名患者符合标准。进行 t 检验以发现 TRS 值在上午和下午之间的差异，对下午的评估进行线性混合效应模型拟合以发现进展趋势，并将患者分为三个 TRS 类别（TRS 有显著增加、TRS 有显著减少、TRS 无显著增加或减少）。
在所有三项研究中，上午的 TRS 值与下午的 TRS 值之间存在显著的统计学差异（所有研究的 P 值均<=0.001）。在两项研究中，线性混合效应模型的时间具有显著的负系数，98 名患者中有 48 名（49%）在下午出现了 TRS 的显著减少。
所有研究的结果都是一致的，无论是在三组患者中的比例，还是在下午 TRS 值下降的幅度上。基于这些发现，似乎有一群患者在一天的晚些时候会出现可预测的“关闭”行为。
