Buongiorno Maríateresa, Antonelli Francesca, Cámara Ana, Puente Victor, de Fabregues-Nebot Oriol, Hernandez-Vara Jorge, Calopa Matilde, Pascual-Sedano Berta, Campolongo Antonia, Valldeoriola Francesc, Tolosa Eduardo, Kulisevsky Jaime, Martí Maria Jose
Parkinson's Disease and Movement Disorders Unit, Neurology Service, Hospital Clínic, University of Barcelona, Spain; Instituto de Investigaciones Biomédicas August Pi I Sunyer - IDIBAPS, Barcelona, Spain; CIBERNED Carlos III Health Institute, Spain.
Neurology Service, Institut Municipal d'Investigacio Medica, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
Parkinsonism Relat Disord. 2015 Aug;21(8):871-6. doi: 10.1016/j.parkreldis.2015.05.014. Epub 2015 May 19.
Continuous infusion of levodopa/carbidopa intestinal gel (LCIG) is an effective treatment for patients with advanced Parkinson Disease (PD) that cannot be further improved by oral therapy.
We conducted an observational, prospective, and multicenter study to collect, in a large sample of PD treated with LCIG, long-term information about the outcome and safety of the treatment. The assessments were performed before LCIG, 1, 3, 6 months after, and ever since, every 6 months.
We studied 72 patients with a mean observation time of 22 months and a maximum of 48 months. During follow-up 28 patients discontinued the treatment, especially for lack of efficacy or adverse events related to the drug. We obtained a significant improvement of motor and non-motor fluctuations, mean off time and some non-motor symptoms. A significant increase in the percentage of time with dyskinesias was found in patients having less than 50% of the day with dyskinesias before LCIG. However, patients having already many dyskinesias before LCIG experienced a significant decrease of the troublesome dyskinesias, meaning that outcomes might be different depending on specific clinical characteristics. Adverse effects were in general minor but one case of intestinal perforation and one of abdominal cellulite were observed.
We confirmed that LCIG is a very effective treatment option for advanced PD; however considering the findings that dyskinesia can increase and the potential for serious side effects, we suggest the necessity for development of guidelines that better define the profile of responders.
持续输注左旋多巴/卡比多巴肠凝胶(LCIG)是治疗晚期帕金森病(PD)患者的一种有效方法,这些患者无法通过口服疗法得到进一步改善。
我们进行了一项观察性、前瞻性多中心研究,以收集大量接受LCIG治疗的PD患者的治疗结局和安全性的长期信息。评估在LCIG治疗前、治疗后1、3、6个月以及此后每6个月进行一次。
我们研究了72例患者,平均观察时间为22个月,最长为48个月。在随访期间,28例患者停止了治疗,尤其是因为缺乏疗效或与药物相关的不良事件。我们在运动和非运动波动、平均关期时间以及一些非运动症状方面取得了显著改善。在LCIG治疗前异动症时间不足全天50%的患者中,发现异动症时间百分比显著增加。然而,在LCIG治疗前已有许多异动症的患者中,麻烦的异动症显著减少,这意味着结局可能因特定临床特征而异。不良反应总体较轻,但观察到1例肠穿孔和1例腹部蜂窝织炎。
我们证实LCIG是晚期PD非常有效的治疗选择;然而,考虑到异动症可能增加以及存在严重副作用的可能性,我们建议有必要制定更好地界定反应者特征的指南。