Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database.
Adverse Events and Complications Associated With Intrathecal Drug Delivery Systems: Insights From the Manufacturer and User Facility Device Experience (MAUDE) Database.
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DOI：
10.1111/ner.13325
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发表时间：
2021-10
期刊：
影响因子：
2.8
通讯作者：
Shankar, Hariharan
中科院分区：
文献类型：
--
作者：
Goel, Vasudha;Yang, Yan;Kanwar, Siddak;Banik, Ratan K.;Patwardhan, Amol M.;Ibrahim, Mohab;Sivanesan, Eellan;Shankar, Hariharan
现代鞘内药物递送系统（IDDS）技术先进，可通过各种自动化和患者自控程序递送药物。它们还伴有独特的并发症，从术后并发症、药物相关不良事件（AE）、设备故障到再填充相关不良事件不等。
为了系统地分析美国食品药品监督管理局的制造商和用户设施设备体验数据库（MAUDE）中报告的主要患有慢性疼痛疾病的患者使用IDDS相关的实际并发症和不良事件。
在2018年2月至2019年2月的研究期间，MAUDE数据库每年采样4次，每次采样一个月。该数据库每6个月重新采样一次，直至2020年8月，以评估在索引月份期间是否有任何新增报告病例。纳入了两种经美国食品药品监督管理局批准的IDDS。不良事件大致分为与导管故障、泵故障、生物相关以及药物相关不良事件的原因。
最终分析共纳入1001份报告。不良报告的前三大原因分别是感染/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）。使用IDDS的患者中有5例死亡。IDDS手术后的硬膜外血肿（n = 3）导致死亡以及手术清除后的残余神经功能缺损。编程错误、药物浓度差异以及重新编程后未能打开泵是药物相关IDDS不良事件的各种可预防原因。
对MAUDE数据库中与IDDS相关的不良事件的分析提供了一种不同于已报告的注册并发症的实际视角。对可预防的IDDS相关并发症的认识和警惕是降低风险的第一步，以便为慢性疼痛管理提供安全有效的鞘内药物递送。
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 postoperative complications, medication-related adverse events (AE), device malfunction, to refill associated AE. 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. 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. 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. 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.
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影响因子：
2.8
作者：
Shankar, Hariharan
通讯作者：
Shankar, Hariharan
影响因子：
3.1
作者：
Scanlon, Maura M.;Gazelka, Halena M.;Lamer, Tim J.
通讯作者：
Lamer, Tim J.
DOI：
10.1111/j.1533-2500.2007.00142.x
发表时间：
2007-09-01
期刊：
Pain practice : the official journal of World Institute of Pain
影响因子：
--
作者：
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通讯作者：
Mauck, W David
影响因子：
3.6
作者：
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通讯作者：
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影响因子：
3.1
作者：
Sitzman, B. Todd
通讯作者：
Sitzman, B. Todd