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左旋多巴-卡比多巴-恩他卡朋肠凝胶在晚期帕金森病中的应用:一项多中心真实世界经验。

Levodopa-Carbidopa-Entacapone Intestinal Gel in Advanced Parkinson Disease: A Multicenter Real-Life Experience.

机构信息

Department of Neurology, "George Emil Palade" University of Medicine, Pharmacy, Science and Technology, Târgu Mureş, Romania.

Neurology Department, Emergency Clinical County Hospital, Targu Mures, Romania.

出版信息

Am J Ther. 2024;31(3):e209-e218. doi: 10.1097/MJT.0000000000001707. Epub 2024 Mar 8.

Abstract

BACKGROUND

For Parkinson disease (PD) patients who have been diagnosed with advanced disease that can no longer be effectively controlled with optimized oral or transdermal medications, a range of device-aided therapies (DAT) are available, comprising either deep brain stimulation or infusion therapies providing continuous dopaminergic stimulation. Levodopa-entacapone-carbidopa intestinal gel (LECIG) infusion is the latest DAT for advanced PD (APD) that was approved in Romania in 2021.

STUDY QUESTION

What is the experience to date in real-world clinical practice in Romania regarding the efficacy and tolerability of LECIG in APD?

STUDY DESIGN

A retrospective evaluation of 74 APD patients treated with LECIG at 12 specialized APD centers in Romania.

MEASURES AND OUTCOMES

Demographic data and various clinical parameters were recorded, including Mini Mental State Evaluation score or Montreal Cognitive Assessment Test score. Levodopa-equivalent daily dose and the administered doses of levodopa and other PD medications were evaluated at baseline and after starting LECIG treatment. The efficacy of LECIG in reducing daily hours of off time, motor fluctuations, and dyskinesias were assessed. Any percutaneous endoscopic gastrojejunostomy system or device complications after starting LECIG treatment were noted.

RESULTS

At baseline, patients were taking oral levodopa for a mean of 5.3 times per day, with a high proportion also taking concomitant add-on therapies (dopamine agonists, 86%, monoamine oxidase type-B inhibitors, 53%; catechol-O-methyltransferase inhibitors, 64%). LECIG treatment significantly reduced daily off time versus baseline from 5.7 h/d to 1.7 hours per day ( P < 0.01). Duration and severity of dyskinesias was also significantly reduced versus baseline, and improvements were observed in Hoehn and Yahr Scale scores. LECIG treatment also allowed a significant reduction in the use of concomitant oral medications.

CONCLUSIONS

These findings suggest that LECIG treatment is an effective DAT option in APD that can simplify the treatment regimen.

摘要

背景

对于已经被诊断为无法通过优化的口服或透皮药物有效控制的晚期疾病的帕金森病 (PD) 患者,有一系列设备辅助治疗 (DAT) 可供选择,包括深部脑刺激或提供持续多巴胺能刺激的输注疗法。左旋多巴-恩他卡朋-卡比多巴肠凝胶 (LECIG) 输注是 2021 年在罗马尼亚批准的用于晚期 PD (APD) 的最新 DAT。

研究问题

迄今为止,在罗马尼亚的真实临床实践中,LECIG 在 APD 中的疗效和耐受性如何?

研究设计

对罗马尼亚 12 个专门的 APD 中心的 74 名接受 LECIG 治疗的 APD 患者进行回顾性评估。

测量和结果

记录了人口统计学数据和各种临床参数,包括 Mini Mental State 评估评分或蒙特利尔认知评估测试评分。在开始 LECIG 治疗前和治疗后评估了左旋多巴等效日剂量以及左旋多巴和其他 PD 药物的给药剂量。评估了 LECIG 降低每日无活动时间、运动波动和运动障碍的疗效。注意到开始 LECIG 治疗后任何经皮内镜胃空肠造口术系统或设备并发症。

结果

基线时,患者平均每天口服左旋多巴 5.3 次,很大一部分患者还同时服用辅助添加疗法(多巴胺激动剂,86%;单胺氧化酶 B 抑制剂,53%;儿茶酚-O-甲基转移酶抑制剂,64%)。与基线相比,LECIG 治疗显著降低了每日无活动时间,从 5.7 小时/天降至 1.7 小时/天(P <0.01)。与基线相比,运动障碍的持续时间和严重程度也显著降低,Hoehn 和 Yahr 量表评分也有所改善。LECIG 治疗还显著减少了同时口服药物的使用。

结论

这些发现表明,LECIG 治疗是 APD 的一种有效 DAT 选择,可以简化治疗方案。

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