Northwestern University Feinberg School of Medicine, USA.
The University of Iowa, USA.
Parkinsonism Relat Disord. 2019 May;62:201-209. doi: 10.1016/j.parkreldis.2018.12.025. Epub 2019 Jan 31.
To determine the feasibility, safety and tolerability of lumbar punctures (LPs) in research participants with early Parkinson disease (PD), subjects without evidence of dopaminergic deficiency (SWEDDs) and healthy volunteers (HC).
Cerebrospinal fluid (CSF) analysis is becoming an essential part of the biomarkers discovery effort in PD with still limited data on safety and feasibility of serial LPs in PD participants.
DESIGN/METHODS: Parkinson's Progression Marker Initiative (PPMI) is a longitudinal observation study designed to identify PD progression biomarkers. All PPMI participants undergo LP at baseline, 6, 12 months and yearly thereafter. CSF collection is performed by a trained investigator using predominantly atraumatic needles. Adverse events (AEs) are monitored by phone one week after LP completion. We analyzed safety data from baseline LPs.
PPMI enrolled 683 participants (423 PD/196 HC/64 SWEDDs) from 23 study sites. CSF was collected at baseline in 97.5% of participants, of whom 5.4% underwent collection under fluoroscopy. 23% participants reported any related AEs, 68% of all AE were mild while 5.6% were severe. The most common AEs were headaches (13%) and low back pain (6.5%) and both occurred more commonly in HC and SWEDDs compared to PD participants. Factors associated with higher incidence of AEs across the cohorts included female gender, younger age and use of traumatic needles with larger diameter. AEs largely did not impact compliance with the future LPs.
LPs are safe and feasible in PD research participants. Specific LP techniques (needle type and gauge) may reduce the overall incidence of AEs.
确定腰椎穿刺（LP）在早期帕金森病（PD）患者、无多巴胺能缺乏证据的研究参与者（SWEDD）和健康志愿者（HC）中的可行性、安全性和耐受性。
脑脊液（CSF）分析已成为 PD 生物标志物发现工作的重要组成部分，但在 PD 参与者中进行连续 LP 的安全性和可行性数据仍然有限。
设计/方法：帕金森病进展标志物倡议（PPMI）是一项纵向观察性研究，旨在确定 PD 进展的生物标志物。所有 PPMI 参与者在基线、6、12 个月和此后每年进行 LP。CSF 采集由经过培训的调查员使用主要无创伤性的针进行。通过电话在 LP 完成后一周监测不良事件（AE）。我们分析了基线 LP 的安全性数据。
PPMI 从 23 个研究地点招募了 683 名参与者（423 名 PD/196 名 HC/64 名 SWEDD）。97.5%的参与者在基线时采集了 CSF，其中 5.4%在透视下采集。23%的参与者报告了任何相关的 AE，68%的 AE 为轻度，5.6%为重度。最常见的 AE 是头痛（13%）和腰痛（6.5%），HC 和 SWEDD 参与者比 PD 参与者更常见。与各队列 AE 发生率较高相关的因素包括女性、年龄较小以及使用较大直径的创伤性针。AE 并未明显影响未来 LP 的依从性。
LP 在 PD 研究参与者中是安全且可行的。特定的 LP 技术（针的类型和规格）可能会降低 AE 的总体发生率。
