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左旋多巴/卡比多巴肠凝胶:晚期帕金森病的综述

Foslevodopa/Foscarbidopa: A Review in Advanced Parkinson's Disease.

作者信息

Blair Hannah A

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

CNS Drugs. 2025 Jun;39(6):621-632. doi: 10.1007/s40263-025-01179-3. Epub 2025 Apr 8.

Abstract

Foslevodopa/foscarbidopa [PRODUODOPA (EU); VYALEV (USA, Canada, Japan)] is a soluble formulation of levodopa and carbidopa prodrugs for 24-h continuous subcutaneous (SC) infusion. It is approved for the treatment of motor fluctuations in patients with advanced Parkinson's disease (PD). Administered via an ambulatory infusion pump, it allows for personalized dosing based on individual needs. In a randomized, double-blind, double-dummy trial, continuous SC infusion of foslevodopa/foscarbidopa provided a significant and clinically meaningful increase in hours of 'on' time without troublesome dyskinesia and a reduction in hours of 'off' time compared with oral immediate-release levodopa/carbidopa. The benefits of foslevodopa/foscarbidopa were maintained over the longer term (up to 124 weeks). Continuous SC infusion of foslevodopa/foscarbidopa was generally well tolerated, including over the longer term. However, infusion site events were common, necessitating regular monitoring, cannula replacement, infusion site rotation and aseptic techniques. Although further long-term data are required, foslevodopa/foscarbidopa represents a promising non-surgical alternative to the available device-aided therapies for patients with advanced PD whose motor fluctuations are inadequately controlled by other oral PD medications.

摘要

左旋多巴/卡比多巴前药复方制剂[普洛多帕(欧盟);维力维(美国、加拿大、日本)]是左旋多巴和卡比多巴前体药物的一种可溶制剂,用于24小时持续皮下输注。它被批准用于治疗晚期帕金森病(PD)患者的运动波动。通过便携式输液泵给药,它可根据个体需求进行个性化给药。在一项随机、双盲、双模拟试验中,与口服速释左旋多巴/卡比多巴相比,持续皮下输注左旋多巴/卡比多巴前药复方制剂可显著且在临床上有意义地增加“开”期时间,且无麻烦的异动症,并减少“关”期时间。左旋多巴/卡比多巴前药复方制剂的益处可长期维持(长达124周)。左旋多巴/卡比多巴前药复方制剂的持续皮下输注总体耐受性良好,包括长期使用。然而,输注部位事件很常见,需要定期监测、更换套管、轮换输注部位并采用无菌技术。尽管还需要进一步的长期数据,但对于运动波动未被其他口服帕金森病药物充分控制的晚期帕金森病患者,左旋多巴/卡比多巴前药复方制剂是现有设备辅助治疗的一种有前景的非手术替代方案。

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