Poewe Werner, Bergmann Lars, Robieson Weining Z, Antonini Angelo
Medical University of Innsbruck, Innsbruck, Austria.
AbbVie Inc., North Chicago, IL, United States.
Front Neurol. 2020 Jun 19;11:419. doi: 10.3389/fneur.2020.00419. eCollection 2020.
Levodopa-carbidopa intestinal gel (LCIG) is a long-term therapy for motor fluctuations in patients with advanced Parkinson's disease (PD). The aim of this analysis was to identify the baseline characteristics that predict "Off" time reduction in advanced PD patients treated with LCIG under routine clinical care in the GLORIA registry. Patients were followed under routine care for 24 months (M) with delivery of LCIG via percutaneous gastrojejunostomy. Analysis of covariance (ANCOVA) and logistic regression were performed to identify baseline characteristics that predict "Off" time reduction. Compared to baseline, 86% (n/N = 131/152; mean ± SD baseline "Off" time: 3.4 ± 2.2 h) of M24 completers had ≥ 1 h reduction in "Off" time and 64% (n/N = 97/152; mean ± SD baseline "Off" time: 7.6 ± 2.9 h) had ≥ 3 h "Off" time reduction at M24. Most baseline characteristics were similar across responder subgroups; however, patients with ≥ 3 h "Off" time improvement had more "Off" time and less time with dyskinesia at baseline compared to patients with <3 h "Off" time reduction. Despite having less improvement in absolute "Off" h at M24, patients with <3 h "Off" time reduction experienced a 33% median reduction in "Off" time and a 44% median reduction in dyskinesia duration at M24, which was similar to the dyskinesia improvement observed among patients with ≥ 3 h "Off" time improvement (50% median reduction). Baseline "Off" time was both the best predictor of and the only significant factor associated with "Off" time improvement ( <0.0001). LCIG treatment led to clinically meaningful improvements in "Off" time in 86% of advanced PD patients and those with greater "Off" time are likely to experience the largest absolute reduction in hours "Off."
左旋多巴-卡比多巴肠凝胶（LCIG）是治疗晚期帕金森病（PD）患者运动波动的一种长期疗法。本分析的目的是确定在GLORIA注册研究的常规临床护理下，接受LCIG治疗的晚期PD患者中预测“关”期时间减少的基线特征。患者在常规护理下随访24个月，通过经皮胃空肠造口术给予LCIG。进行协方差分析（ANCOVA）和逻辑回归以确定预测“关”期时间减少的基线特征。与基线相比，24个月时完成治疗的患者中有86%（n/N = 131/152；平均±标准差基线“关”期时间：3.4±2.2小时）的“关”期时间减少≥1小时，64%（n/N = 97/152；平均±标准差基线“关”期时间：7.6±2.9小时）在24个月时“关”期时间减少≥3小时。大多数基线特征在反应者亚组中相似；然而，与“关”期时间减少<3小时的患者相比，“关”期时间改善≥3小时的患者在基线时“关”期时间更多，异动症时间更少。尽管在24个月时绝对“关”期小时数改善较少，但“关”期时间减少<3小时的患者在24个月时“关”期时间中位数减少33%，异动症持续时间中位数减少44%，这与“关”期时间改善≥3小时的患者中观察到的异动症改善情况（中位数减少50%）相似。基线“关”期时间既是“关”期时间改善的最佳预测指标，也是与之相关的唯一显著因素（<0.0001）。LCIG治疗使86%的晚期PD患者的“关”期时间有临床意义的改善，且“关”期时间越长的患者可能经历的绝对“关”期小时数减少幅度越大。
