鞘内药物递送系统相关的不良事件和并发症：来自制造商和使用者设施设备不良事件数据库（MAUDE）的见解。
Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database.
机构信息
Department of Anesthesiology, University of Minnesota, Minneapolis, MN, USA.
Department of Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.
出版信息
Neuromodulation. 2021 Oct;24(7):1181-1189. doi: 10.1111/ner.13325. Epub 2020 Dec 11.
BACKGROUND
Modern intrathecal drug delivery systems (IDDS) are technologically advanced to deliver medication through various automated and patient-controlled programs. They also are associated with unique complications ranging from post-operative complications, medication-related adverse events (AE), device malfunction, to refill associated AE.
OBJECTIVES
To systematically analyze real-world complications and AE reported on the Food and Drug Administration's Manufacturer and User Facility Device Experience database (MAUDE) associated with IDDS among patients predominantly with chronic pain disorders.
MATERIALS AND METHODS
MAUDE database was sampled for a month four times a year during the study period, February 2018 to February 2019. The database was resampled every six months till August 2020 to evaluate for any additional reported cases during the index months. The two FDA approved IDDS, were included. AE were broadly classified into causes related to catheter malfunction, pump malfunction, biologic, and medication-related AE.
RESULTS
A total of 1001 reports were included in the final analysis. The top three reasons for adverse report are infection/erosion (15.7%, n = 157), motor stall (12.4%, n = 125) and adverse medication reactions (11.8%, n = 119), respectively. There were five deaths among patients with IDDS. Epidural hematoma (n = 3) after IDDS surgery resulted in a death and residual neurological deficits after surgical evacuation. Programming errors, medication concentration discrepancy, and failure to turn on the pump after reprogramming are various preventable causes of medication-related IDDS AEs.
CONCLUSIONS
Analysis of AE associated with IDDS from the MAUDE database provided a real-world perspective different from reported registry complications. Awareness and vigilance of preventable IDDS-related complications is the first step toward mitigating risks to provide safe and effective intrathecal drug delivery for chronic pain management.
背景
现代鞘内药物输送系统（IDDS）技术先进，可通过各种自动化和患者控制程序输送药物。它们还与各种独特的并发症相关，包括术后并发症、药物相关不良事件（AE）、设备故障、再填充相关 AE 等。
目的
系统分析 Food and Drug Administration 的制造商和用户设施设备体验数据库（MAUDE）中与 IDDS 相关的主要患有慢性疼痛障碍的患者报告的真实世界并发症和 AE。
材料和方法
在研究期间，每年四次从 MAUDE 数据库中抽取一个月的数据进行采样，时间为 2018 年 2 月至 2019 年 2 月。每六个月对数据库进行重新采样，直到 2020 年 8 月，以评估索引月份是否有其他报告的病例。仅纳入两种 FDA 批准的 IDDS。AE 被广泛分为与导管故障、泵故障、生物和药物相关 AE 相关的原因。
结果
共有 1001 份报告纳入最终分析。不良报告的前三个原因是感染/侵蚀（15.7%，n=157）、电机失速（12.4%，n=125）和药物不良反应（11.8%，n=119）。在使用 IDDS 的患者中有 5 人死亡。IDDS 手术后的硬膜外血肿（n=3）导致死亡和手术后神经功能缺损残留。编程错误、药物浓度差异以及重新编程后未打开泵是药物相关 IDDS AE 的各种可预防原因。
结论
从 MAUDE 数据库分析与 IDDS 相关的 AE 提供了不同于报告的登记并发症的真实世界视角。提高对可预防 IDDS 相关并发症的认识和警惕是降低风险以提供安全有效的鞘内药物输送治疗慢性疼痛的第一步。
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