University of Alabama at Birmingham, Birmingham, AL, USA.
Pharmerit International, Bethesda, MD, USA.
Parkinsonism Relat Disord. 2021 May;86:52-57. doi: 10.1016/j.parkreldis.2021.03.009. Epub 2021 Mar 23.
To estimate the impact of carbidopa/levodopa enteral suspension (CLES) on key patient-centered outcomes in patients with advanced Parkinson's disease (PD).
A comprehensive literature review identified relevant studies, from which data were meta-analyzed over 3-month intervals up to 24 months. Patient-centered outcomes of interest included mean (95% CI) changes from baseline (Δ) in quality of life (QoL), measured using PD-specific (PDQ-8, PDQ-39) and generic (EQ-5D) instruments; activities of daily living (ADL), measured in On and Off states using UPDRS Part II; and motor symptoms (i.e., Off time/day and motor examination [measured in On and Off states using UPDRS Part III]).
The pooled meta-analysis included data from 26 studies evaluating 1556 patients on CLES. At 3 months, all outcomes showed significant improvement: QoL (ΔPDQ-39 = -10.26 [-11.54, -8.97], ΔEQ-5D = 15.42 [12.58, 18.26]); ADL (ΔUPDRS II = -4.32 [-5.63, -3.01]); motor symptoms (ΔOff time hours/day = -3.48 [-4.15, -2.82], ΔUPDRS III = -6.20 [-9.88, -2.51]). At 24 months, there were statistically significant mean improvements in QoL (ΔPDQ-39 = -7.74 [-12.40, -3.07], ΔEQ-5D = 11.18 [6.90, 15.45]) and ADL (ΔUPDRS II = -3.88 [-5.34, -2.42]), and Off time (-4.21 [-5.16, -3.26] hours/day).
Impact of CLES on significantly reducing Off time/day was observed to be rapid and durable (i.e., remained consistent across 24 months). Most QoL and ADL measures showed a consistent pattern of improvement with initiation of treatment and remained significantly improved from baseline at 24 months.
评估卡比多巴/左旋多巴肠内混悬液（CLES）对晚期帕金森病（PD）患者关键患者为中心结局的影响。
全面的文献复习确定了相关研究，对这些研究的数据进行了 3 个月间隔的荟萃分析，最长达 24 个月。感兴趣的患者为中心结局包括从基线（Δ）变化的平均（95%CI）质量（QoL）生活，使用 PD 特异性（PDQ-8、PDQ-39）和通用（EQ-5D）工具测量；日常生活活动（ADL），在 ON 和 OFF 状态下使用 UPDRS 第二部分测量；和运动症状（即，每日 OFF 时间和运动检查[在 ON 和 OFF 状态下使用 UPDRS 第三部分测量]）。
汇总的荟萃分析包括来自 26 项研究的数据，评估了 1556 例 CLES 患者。在 3 个月时，所有结局均显示出显著改善：生活质量（ΔPDQ-39=-10.26[-11.54，-8.97]，ΔEQ-5D=15.42[12.58，18.26]）；ADL（ΔUPDRS II=-4.32[-5.63，-3.01]）；运动症状（ΔOFF 时间/小时/天=-3.48[-4.15，-2.82]，ΔUPDRS III=-6.20[-9.88，-2.51]）。在 24 个月时，生活质量（ΔPDQ-39=-7.74[-12.40，-3.07]，ΔEQ-5D=11.18[6.90，15.45]）和 ADL（ΔUPDRS II=-3.88[-5.34，-2.42]）和 OFF 时间（-4.21[-5.16，-3.26]小时/天）均有统计学意义的平均改善。
CLES 对减少每日 OFF 时间的影响是迅速和持久的（即，在 24 个月内保持一致）。大多数 QoL 和 ADL 指标显示出随着治疗开始而持续改善的一致模式，并且在 24 个月时仍明显优于基线。
