OBJECTIVE: We investigated the analgesic efficacy of two therapeutic strategies (opioid with oxycodone- prolonged-release (PR) and higher dose of levodopa/benserazide) compared with placebo in patients with PCP.
METHODS: OXYDOPA was a randomized, double-blind, double-dummy, placebo-controlled, multicenter parallel-group trial run at 15 centers within the French NS-Park network. PD patients with PCP (≥30 on the Visual Analogue Scale [VAS]) were randomly assigned to receive oxycodone-PR (up to 40 mg/day), levodopa/benserazide (up to 200 mg/day) or matching placebo three times a day (tid) for 8 weeks at a stable dose, in add-on to their current dopaminergic therapy. The primary endpoint was the change in average pain intensity over the previous week rated on VAS from baseline to week-10 based on modified intention-to-treat analyses.
RESULTS: Between May 2016 and August 2020, 66 patients were randomized to oxycodone-PR (n = 23), levodopa/benserazide (n = 20) or placebo (n = 23). The mean change in pain intensity was -17 ± 18.5 on oxycodone-PR, -8.3 ± 11.1 on levodopa/benserazide, and -14.3 ± 18.9 in the placebo groups. The absolute difference versus placebo was -1.54 (97.5% confidence interval [CI], -17.0 to 13.90; P = 0.8) on oxycodone-PR and +7.79 (97.5% CI, -4.99 to 20.58; P = 0.2) on levodopa/benserazide. Similar proportions of patients in each group experienced all-cause adverse events. Those leading to study discontinuation were most frequently observed with oxycodone-PR (39%) than levodopa/benserazide (5%) or placebo (15%).
CONCLUSIONS: The present trial failed to demonstrate the superiority of oxycodone-PR or a higher dose of levodopa in patients with PCP, while oxycodone-PR was poorly tolerated. © 2024 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
目的:我们研究了两种治疗策略(阿片类药物联合羟考酮缓释(PR)和更高剂量的左旋多巴/苄丝肼)与安慰剂在PCP患者中的镇痛效果。
方法:OXYDOPA是随机的,双盲,双假人,安慰剂对照,多中心平行组试验在法国NS-Park网络内的15个中心进行。患有PCP的PD患者(视觉模拟评分[VAS]≥30)被随机分配接受羟考酮PR(最多40mg/天),左旋多巴/苄丝肼(高达200毫克/天)或匹配的安慰剂,每天三次(tid),以稳定的剂量持续8周,作为他们目前多巴胺能治疗的补充。主要终点是根据改良的意向治疗分析,在VAS上从基线到第10周的前一周平均疼痛强度的变化。
结果:在2016年5月至2020年8月之间,66例患者随机接受羟考酮-PR(n=23),左旋多巴/苄丝肼(n=20)或安慰剂(n=23)。羟考酮-PR的疼痛强度平均变化为-17±18.5,左旋多巴/苄丝肼-8.3±11.1,安慰剂组的-14.3±18.9。与安慰剂相比,绝对差异为-1.54(97.5%置信区间[CI],羟考酮PR为-17.0至13.90;P=0.8),左旋多巴/苄丝肼为+7.79(97.5%CI,-4.99至20.58;P=0.2)。每组中相似比例的患者经历了全因不良事件。与左旋多巴/苄丝肼(5%)或安慰剂(15%)相比,羟考酮PR(39%)最常观察到导致研究中止的那些。
结论:本试验未能证明羟考酮-PR或更高剂量的左旋多巴在PCP患者中的优越性,而羟考酮-PR的耐受性较差。©2024作者(S)。由WileyPeriodicalsLLC代表国际帕金森症和运动障碍协会出版的运动障碍。