家庭护理拉丁裔患者皮下注射左乙拉西坦。
Subcutaneous Levetiracetam Administration in Latino Patients on Home Care.
发表日期:2023 Oct 31
作者:
Laura Cuellar-Valencia, Angelica Claros-Hulbert, Adriana Ortegon, Juliana Pino, Laura Velandia, Juan Esteban Correa-Morales
来源:
PHARMACOLOGY & THERAPEUTICS
摘要:
背景:左乙拉西坦具有良好的皮下注射药理学特性。然而,其皮下使用仍然被认为是标签外使用,因为这超出了其许可范围。其安全性、耐受性和有效性的证据基础仅限于观察性研究。目的:报告皮下注射左乙拉西坦在拉丁裔家庭护理患者中的安全性和有效性。设计:观察性回顾性病例系列研究。受试者:患有致命疾病的拉丁裔成年人的连续样本。方法:使用具有 4 个领域(选择、确定、因果关系和报告)的案例系列框架来确保报告质量。此外,还收集并报告了之前全面审查中确定的 8 项相关结果。使用不良事件通用术语标准记录不良反应。结果:15 名患有肿瘤和非肿瘤诊断的拉丁裔患者接受皮下注射左乙拉西坦治疗,平均时间为 21 天的家庭护理。由于口服途径的缺失,左乙拉西坦最常采用皮下注射。皮下注射左乙拉西坦的平均剂量为 1200 毫克。只有 1 名患者需要调整剂量,并且只有 2 名患者在治疗试验期间总共经历了 5 次癫痫发作。没有不良反应的报道。结论:皮下注射左乙拉西坦似乎有效且安全。这个家庭护理拉丁裔患者的病例系列扩大了其在家庭护理环境中使用的证据。目前报告的多个病例系列的初步数据值得进行强有力的试验。
Background: Levetiracetam has a favorable pharmacology profile to be used subcutaneously. However, its subcutaneous use is still considered off-label as this is beyond its license. The evidence base for its safety, tolerability, and efficacy is limited to observational studies. Objectives: To report the safety and efficacy of subcutaneous levetiracetam in Latino patients on home care. Design: Observational retrospective case series study. Subjects: Consecutive sample of Latino adults with life-limiting illnesses. Methods: A case series framework with 4 domains (selection, ascertainment, causality, and reporting) to ensure reporting quality was used. Additionally, 8 relevant outcomes established in a previous comprehensive review, were collected and reported. Adverse reactions were documented using the Common Terminology Criteria for Adverse Events. Results: Fifteen Latino patients with oncological and non-oncological diagnoses received subcutaneous levetiracetam for a mean of 21 days on home care. Levetiracetam was most frequently initiated subcutaneously due to loss of the oral route. The average dosage of subcutaneous levetiracetam was 1200 mg. Only 1 patient required a dose adjustment, and only 2 patients experienced a total of 5 seizures during the therapy trial. No adverse reactions were reported. Conclusions: Subcutaneous levetiracetam appears to be effective and safe. This case series of Latino patients in home care expands the evidence of its use in the home care setting. The preliminary data reported by now on multiple case series warrants robust trials.