晚期帕金森病的运动障碍和疼痛：3b期开放标签随机DYSCOVER研究的事后分析

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2024-04-01 Epub Date: 2024-02-12 DOI:10.1007/s40120-024-00583-z

Eric Freire-Alvarez, Paola Vanni, Egon Kurča, Lydia Lopez-Manzanares, Norbert Kovács, Cleanthe Spanaki, Tianming Gao, Lars Bergmann, Olga Sánchez-Soliño

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引用次数: 0

摘要

简介：DYSCOVER研究是一项3b期开放标签随机试验（NCT02799381），该试验评估了左旋多巴-卡比多巴肠道凝胶（LCIG）与优化药物治疗（OMT）在帕金森病（PD）患者中的应用情况，帕金森病患者基线运动障碍负担较重（定义为统一运动障碍评定量表[UDysRS]总分≥30分）。第 12 周时，接受 LCIG 与 OMT 治疗的患者在运动障碍、疼痛和健康相关结果方面均有显著改善。本分析旨在研究运动障碍、疼痛和帕金森病健康相关结果之间的相关性：这项事后分析评估了 UDysRS、King's 帕金森病疼痛量表 (KPPS)、8 项帕金森病问卷 (PDQ-8)、统一帕金森病评定量表第二部分、临床严重性总体印象 (CGI-S) 或变化 (CGI-C) 以及基线和接受 LCIG 或 OMT 治疗 12 周后无运动障碍 "On "时间之间的相关性。相关性通过皮尔逊相关系数进行评估（分类：弱，r = 0.20-0.39；中度，r = 0.40-0.59；强，r ≥ 0.60）：在61名患者中，UDysRS与KPPS评分之间存在中度至高度的显著正相关（基线，r = 0.47；第12周与基线相比的变化[CFB]，r = 0.63；均为p 结论：在高度运动障碍患者中，UDysRS与KPPS评分之间存在显著正相关（基线，r = 0.47；第12周与基线相比的变化[CFB]，r = 0.63；均为p在运动障碍负担较重的患者中，基线时运动障碍、疼痛和健康相关生活质量（HRQoL）之间呈正相关。运动障碍和疼痛的改善与 HRQoL 的改善相关，这表明了麻烦性运动障碍的临床负担：试验注册号：Clinicaltrials.gov 识别码 NCT02799381。

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Dyskinesia and Pain in Advanced Parkinson's Disease: Post Hoc Analysis from the Phase 3b, Open-Label, Randomized DYSCOVER Study.

Introduction: The DYSCOVER study was a phase 3b, open-label, randomized trial (NCT02799381) that evaluated levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) in patients with Parkinson's disease (PD) and a high burden of dyskinesia at baseline (defined as Unified Dyskinesia Rating Scale [UDysRS] total score ≥ 30). At week 12, patients receiving LCIG versus OMT experienced significant improvements in dyskinesia, pain, and health-related outcomes. The objective of this analysis was to examine correlations between dyskinesia, pain, and health-related outcomes in PD.

Methods: This post hoc analysis assessed correlations between UDysRS, King's Parkinson's Disease Pain Scale (KPPS), 8-item Parkinson's Disease Questionnaire (PDQ-8), Unified Parkinson's Disease Rating Scale part II, Clinical Global Impression of Severity (CGI-S) or Change (CGI-C), and "On" time without troublesome dyskinesia at baseline and after 12 weeks of LCIG or OMT. Correlations were assessed by Pearson correlation coefficients (categorization: weak, r = 0.20-0.39; moderate, r = 0.40-0.59; strong, r ≥ 0.60).

Results: Among 61 patients, moderate-to-strong positive and significant correlations were observed between UDysRS and KPPS scores (baseline, r = 0.47; week 12 change from baseline [CFB], r = 0.63; all p < 0.001). UDysRS and KPPS scores had moderate-to-strong positive and highly significant correlations with PDQ-8 scores (baseline, r = 0.45 and 0.46, respectively; CFB, r = 0.54 and 0.64, respectively; all p < 0.001). Moderate positive and significant correlations were observed between UDysRS and CGI-S/CGI-C scores (baseline, r = 0.41; CFB, r = 0.47; all p < 0.001).

Conclusions: In patients with high dyskinesia burden, positive correlations were observed between dyskinesia, pain, and health-related quality of life (HRQoL) at baseline. Improvements in dyskinesia and pain were associated with improvements in HRQoL, demonstrating the clinical burden of troublesome dyskinesia.

Trial registration number: Clinicaltrials.gov identifier NCT02799381.

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

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