Parkinson and Movement Disorders Unit, Study Center on Neurodegeneration (CESNE), Department of Neuroscience, University of Padua, Padova, Italy.
Parkinson Institute, ASST G. Pini-CTO, Milan, Italy.
J Neurol. 2022 Oct;269(10):5606-5614. doi: 10.1007/s00415-022-11269-7. Epub 2022 Jul 25.
Levodopa/carbidopa intestinal gel (LCIG) is an effective treatment in patients with advanced Parkinson's disease (PD) with consolidated evidence of clinical efficacy. However, only few studies have assessed long-term safety, causes of discontinuation, mortality, and relative predictors.
We conducted a retrospective analysis of 79 PD patients treated with LCIG between 2005 and 2020 in two Italian Neurological Centers, recording all adverse events (AEs), including weight loss (WL). Kaplan-Meier curve was used to estimate the time to discontinuation and survival. Cox proportional hazard model was employed to identify predictors of discontinuation and mortality, while Pearson's correlation was used to analyze predictors of WL.
The average follow-up was 47.7 ± 40.5 months and the median survival from disease onset was 25 years. There were three cases of polyradiculoneuropathy Guillain-Barre syndrome-like, all occurred in the early years of LCIG treatment. Twenty-five patients died (32%), 18 on LCIG (including one suicide) and seven after discontinuation. The mean WL was 3.62 ± 7.5 kg, which correlated with levodopa dose at baseline (p = 0.002), levodopa equivalent daily dose (LEDD) baseline (p = 0.017) and off-duration (p = 0.0014), but not dyskinesia. Peristomal complications emerged as a negative predictor of discontinuation (p = 0.008).
LCIG has a relatively satisfactory long-term safety profile and efficacy and a relatively low rate of discontinuation. Peristomal complications may represent a predictor of longer duration of therapy. According to the mortality analysis, LCIG patients show a long lifespan. Delaying the initiation of LCIG does not affect the sustainability of LCIG therapy.
左旋多巴/卡比多巴肠凝胶（LCIG）在有巩固的临床疗效证据的晚期帕金森病（PD）患者中是一种有效的治疗方法。然而，只有少数研究评估了长期安全性、停药原因、死亡率和相对预测因素。
我们对 2005 年至 2020 年在意大利两个神经病学中心接受 LCIG 治疗的 79 例 PD 患者进行了回顾性分析，记录了所有不良反应（AE），包括体重减轻（WL）。Kaplan-Meier 曲线用于估计停药和生存时间。Cox 比例风险模型用于确定停药和死亡率的预测因素，而 Pearson 相关分析用于分析 WL 的预测因素。
平均随访时间为 47.7±40.5 个月，从疾病发病到中位生存时间为 25 年。有三例格林-巴利综合征样多神经根神经病，均发生在 LCIG 治疗的早期。25 例患者死亡（32%），18 例在 LCIG 治疗中（包括 1 例自杀），7 例在停药后死亡。平均 WL 为 3.62±7.5kg，与基线时的左旋多巴剂量（p=0.002）、基线时的左旋多巴等效日剂量（LEDD）（p=0.017）和停药时的时间（p=0.0014）相关，但与运动障碍无关。造口周围并发症是停药的负面预测因素（p=0.008）。
LCIG 具有相对满意的长期安全性和疗效，停药率相对较低。造口周围并发症可能是延长治疗时间的预测因素。根据死亡率分析，LCIG 患者的寿命较长。延迟 LCIG 的开始并不影响 LCIG 治疗的可持续性。
