Parkinson-Klinik Ortenau, Kreuzbergstr. 12-16, 77709, Wolfach, Germany.
Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
J Neural Transm (Vienna). 2023 Jun;130(6):821-826. doi: 10.1007/s00702-023-02636-3. Epub 2023 Apr 23.
Parkinson's disease (PD) is a neurodegenerative disorder that leads to the degeneration of dopaminergic neurons resulting in a widespread pathology of motor and non-motor symptoms. Oral levodopa remains the most effective symptomatic treatment of PD, but motor complications such as Off episodes occur over time. The spectrum of manifestation of OFF episodes varies, e.g., early morning akinesia, end-of-dose wearing OFF, delayed ON, suboptimal ON and dose failure. The functional disability substantially impacts the quality of life for PD patients. An innovative on-demand therapy to treat Off episodes was approved for patients receiving oral levodopa/dopa deacarboxylase inhibitor: inhaled levodopa powder (Inbrija®). The pulmonary delivery of inhaled levodopa powder provides a predictable and fast treatment effect, independent of gastrointestinal dysfunctions or food intake, which could affect levodopa absorption. Levodopa is administered with a breath-actuated inhaler device and the approved dose is 84 mg per Off episode. During the pivotal SPAN-PD phase III trial, significant improvement in Unified Parkinson Disease Rating Scale III score was measured 30 min post-dose at week 12. Improvement was already seen for the first measured time point 10 min post-dose. No differences in pulmonary function was observed when using inhaled levodopa powder regularly for up to 12 months. Inhaled levodopa powder was also approved for early morning Off episodes. The aim of this review article is to give an overview of the different clinical studies of the innovative inhaled levodopa powder, a new on-demand therapy to treat Off episodes in PD.
帕金森病(PD)是一种神经退行性疾病,导致多巴胺能神经元退化,从而导致广泛的运动和非运动症状的病理变化。口服左旋多巴仍然是 PD 最有效的对症治疗方法,但随着时间的推移,运动并发症如“OFF”发作会出现。OFF 发作的表现谱多种多样,例如,清晨运动不能、剂量结束时的“OFF”、延迟“ON”、“ON”不佳和剂量失败。功能障碍严重影响 PD 患者的生活质量。一种用于治疗 OFF 发作的创新按需治疗方法已被批准用于接受口服左旋多巴/多巴胺脱羧酶抑制剂的患者:吸入左旋多巴粉(Inbrija®)。吸入左旋多巴粉的肺部输送提供了可预测和快速的治疗效果,独立于胃肠道功能障碍或食物摄入,这可能会影响左旋多巴的吸收。左旋多巴通过呼吸驱动吸入器装置给药,批准剂量为每次 OFF 发作 84mg。在 SPAN-PD 三期关键性试验中,在第 12 周给药后 30 分钟测量到统一帕金森病评定量表 III 评分显著改善。在给药后第一个测量时间点 10 分钟即可观察到改善。在长达 12 个月的时间内定期使用吸入左旋多巴粉时,未观察到肺功能差异。吸入左旋多巴粉也被批准用于治疗清晨 OFF 发作。本文综述的目的是概述创新型吸入左旋多巴粉的不同临床研究,这是一种治疗 PD OFF 发作的新的按需治疗方法。