Occurrence of Adverse Events in Long-Term Intrathecal Baclofen Infusion: A 1-Year Follow-Up Study of 158 Adults
Occurrence of Adverse Events in Long-Term Intrathecal Baclofen Infusion: A 1-Year Follow-Up Study of 158 Adults
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DOI：
10.1016/j.apmr.2013.12.019
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发表时间：
2014-06-01
影响因子：
4.3
通讯作者：
Jourdan, Claire
中科院分区：
文献类型：
--
作者：
Borrini, Leo;Bensmail, Djamel;Jourdan, Claire
目的：评估成人鞘内巴氯芬（ITB）治疗相关不良事件（AE）的频率和类型以及相关风险因素。设计：一项前瞻性、观察性成人队列研究，随访时间为2010年1月1日至12月31日。设置：一所大学医院的神经康复科。参与者：所有连续成人受试者（N=158）通过泵接受ITB，在研究期间植入或随访。干预：不适用。主要结局指标：AE的频率和类型。结果：2010年，158例受试者接受了ITB therapy随访，其中128例在2010年之前植入（非手术受试者），30例在2010年植入（手术受试者）。在这30例受试者中，20例为“新植入”，10例为“置换”。“最常见的病理性疾病是脊髓损伤（42%）和多发性硬化症（28%）。28例受试者（18%）共发生38起AE。ITB治疗的AE发生率为0.023/月。53%的不良事件与外科手术相关，29%与器械相关（主要是导管功能障碍），18%与巴氯芬不良反应相关。与手术切口相关的AE（瘢痕并发症和聚集）在置换术中比新植入的受试者更常见（P=.009）。未发现AE的发生与受试者特征（年龄、步态能力、脊髓与脑痉挛、ITB therapy随访持续时间）之间存在显著相关性。近一半的AE为严重AE，平均延长住院时间16天。无不良事件引起长期发病或死亡。结论：在这个队列中，不良事件发生率相对较低。这必须与ITB therapy预期的临床、功能和生活质量改善相平衡。(C)2014年美国康复医学大会
Objective: To assess the frequency and types of adverse events (AEs) related to intrathecal baclofen (ITB) therapy in adults, and associated risk factors.Design: A prospective, observational cohort study of adults followed up from January 1 to December 31, 2010.Setting: A neurologic rehabilitation department in a university hospital.Participants: All consecutive adult subjects (N=158) receiving ITB via a pump, either implanted or followed up during the study period.Intervention: Not applicable.Main Outcome Measures: Frequency and type of AEs.Results: In 2010, 158 subjects were followed up for ITB therapy, of whom 128 were implanted before 2010 (nonsurgical subjects), and 30 underwent implantation in 2010 (surgical subjects). Of these 30 subjects, 20 were "newly implanted" and 10 were "replacements." The most frequent pathologic disorders were spinal cord injury (42%) and multiple sclerosis (28%). Twenty-eight subjects (18%) experienced a total of 38 AEs. The rate of AEs was .023 per month of ITB treatment. AEs were related to the surgical procedure in 53% of cases, to the device in 29% (predominantly catheter dysfunctions), and to adverse effects of baclofen in 18%. AEs related to the surgical incision (scar complications and collections) were more frequent in replacement than newly implanted subjects (P=.009). No significant association between occurrence of an AE and subject characteristics (age, gait capacity, spinal vs cerebral spasticity, duration of ITB therapy follow-up) was found. Nearly half of the AEs were serious, extending admission time by a mean of 16 days. No AE induced long-term morbidity or death.Conclusions: The AE rate was relatively low in this cohort. This has to be balanced against the clinical, functional, and quality-of-life improvements, which are expected from ITB therapy. (C) 2014 by the American Congress of Rehabilitation Medicine