Department of Neurosciences, Institute of Psychiatry, Psychology and Neuroscience and Parkinson's Foundation Centre of Excellence, King's College London, King's College Hospital, London, UK.
Parkinson's Foundation Centre of Excellence, King's College Hospital, London, Dubai, United Arab Emirates.
Sci Rep. 2023 Oct 31;13(1):18681. doi: 10.1038/s41598-023-46003-4.
Advanced Parkinson's Disease (APD) is complicated by the emergence of motor and non-motor fluctuations, which are initially predictable and eventually become unpredictable, in part due to erratic gastric absorption and short half of oral levodopa. Attempts to manage such fluctuations with oral dopaminergic drugs often lead to disabling dyskinesias. Continuous Subcutaneous Apomorphine Infusion (CSAI), despite being approved for the treatment of APD since 1993, was approved in India only in 2019. We studied the safety, tolerability and efficacy of CSAI in Indian patients with APD in a registry design to raise local awareness of this important treatment. We conducted a prospective registry-based observational audit at 10 centers across different states of India. Patients with APD, not responding to or with significant side effects from oral dopaminergic therapy, were assessed at baseline and at month 6 and 12 following CSAI infusion. Fifty-one patients completed the study, CSAI significantly reduced the functional impact of dyskinesia (p < 0.01 at 6 months and p < 0.001 at 12 months). There was a significant improvement in the OFF-state from baseline (p < 0.01 at 6 months and p < 0.001 at 12 months) No discernible side effects were observed apart from mild site reaction (n = 7), nausea (n = 7) skin nodules (n = 2). CSAI demonstrated safety, efficacy, tolerability and improved quality of life in patients with APD, as shown in previous studies. Our study highlighted current existing inequalities in treatment availability, lack of awareness, knowledge gap, affordability and cost remains a concern regarding apomorphine use in Indian PD population.
晚期帕金森病(APD)的复杂性在于运动和非运动波动的出现,这些波动最初是可预测的,最终变得不可预测,部分原因是胃吸收不稳定和口服左旋多巴半衰期短。尝试使用口服多巴胺药物来管理这些波动往往会导致致残性运动障碍。持续皮下给予阿朴吗啡输注(CSAI)自 1993 年以来已被批准用于治疗 APD,但直到 2019 年才在印度获得批准。我们以登记设计的方式研究了 CSAI 在印度 APD 患者中的安全性、耐受性和疗效,以提高对这种重要治疗方法的本地认识。我们在印度不同邦的 10 个中心进行了一项基于前瞻性登记的观察性审计。在基线时以及 CSAI 输注后 6 个月和 12 个月对 APD 患者进行评估,这些患者对口服多巴胺治疗无反应或有明显副作用。51 例患者完成了这项研究,CSAI 显著降低了运动障碍的功能影响(6 个月时 p<0.01,12 个月时 p<0.001)。与基线相比,OFF 状态有显著改善(6 个月时 p<0.01,12 个月时 p<0.001)。除了轻度局部反应(n=7)、恶心(n=7)和皮肤结节(n=2)外,没有观察到明显的副作用。CSAI 在以前的研究中显示了安全性、疗效、耐受性和改善 APD 患者的生活质量。我们的研究强调了目前在治疗可及性、意识、知识差距、负担能力和费用方面存在的不平等,这仍然是影响印度 PD 人群中使用阿朴吗啡的一个问题。