Department of Gastroenterological Surgery, Seizan-Kai Kawaminami Hospital, Kawaminami-cho, Kawaminami 18150-47, Koyu-gun, Miyazaki, 889-1301, Japan.
Department of Gastroenterology and Minimally Invasive Surgery, Juntendo University Hospital, Tokyo, Japan.
BMC Neurol. 2021 Jun 25;21(1):242. doi: 10.1186/s12883-021-02269-7.
Levodopa-carbidopa intestinal gel (LCIG) treatment, a unique drug delivery system for patients with advanced Parkinson's disease (PD), is covered by health insurance in Japan since September 2016. Various LCIG procedure/device-associated adverse events (AEs) have been reported; however, reports on their treatment have been limited. This is the first multicenter study to clarify the frequency and timing of device-related AEs.
Between September 2016 and December 2018, 104 patients introduced to the LCIG treatment for advanced PD in 11 hospitals were included. The patients' characteristics, AEs incidence, AEs time, and tube exchange time were investigated.
The median follow-up period was 21.5 months. Minor AE cases were 29.4%, whereas major AE cases were 43.1%. Majority of major AEs (n = 55, 94.8%) were managed with endoscopic treatment, such as tube exchange. Few severe AEs required surgical treatment (n =3, 5.2%). The mean (range) exposure to percutaneous endoscopic gastrojejunostomy (PEG-J) was 14.7 (0-33) months. One year after the LCIG treatment introduction, 55 patients (54.0%) retained the original PEG-J tube. The mean PEG-J tube exchange time was 10.8 ± 7.0 months in all patients, 11.6 ± 4.7 and 10.5 ± 7.7 months in patients with scheduled exchange and who underwent exchange due to AEs, respectively.
Some device-related AEs occurred during the LCIG treatment; however, only few were serious, most of which could be treated with simple procedures or tube replacement with endoscopy. Therefore, the LCIG treatment is feasible and safe and is a unique treatment option for PD, requiring endoscopists' understanding and cooperation.
左旋多巴-卡比多巴肠凝胶（LCIG）治疗是一种为晚期帕金森病（PD）患者提供的独特药物输送系统，自 2016 年 9 月起在日本获得医疗保险覆盖。已经报告了各种与 LCIG 程序/设备相关的不良事件（AE）；然而，关于其治疗的报告有限。这是第一项阐明与设备相关的 AE 频率和时间的多中心研究。
在 2016 年 9 月至 2018 年 12 月期间，将 11 家医院引入 LCIG 治疗的 104 例晚期 PD 患者纳入本研究。调查了患者的特征、AE 发生率、AE 时间和管交换时间。
中位随访时间为 21.5 个月。轻微 AE 病例占 29.4%，而严重 AE 病例占 43.1%。大多数严重 AE（n=55，94.8%）采用内镜治疗，如管交换。少数严重 AE 需要手术治疗（n=3，5.2%）。经皮内镜胃空肠造口术（PEG-J）的平均（范围）暴露时间为 14.7（0-33）个月。在 LCIG 治疗开始后 1 年，55 例患者（54.0%）保留了原始的 PEG-J 管。所有患者的 PEG-J 管更换时间平均为 10.8±7.0 个月，计划更换和因 AE 更换的患者分别为 11.6±4.7 和 10.5±7.7 个月。
在 LCIG 治疗过程中发生了一些与设备相关的 AE；然而，只有少数是严重的，大多数可以通过简单的程序或内镜下更换管来治疗。因此，LCIG 治疗是可行和安全的，是 PD 的一种独特治疗选择，需要内镜医生的理解和合作。
