Sweeney Jared F, Chen John, Darwish Bassem, Holden Devin, Barnes Erin, Varelas Panayiotis
Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.
Department of Pharmacy, Albany Medical Center, Albany, NY, USA.
Neurocrit Care. 2025 Apr;42(2):595-609. doi: 10.1007/s12028-024-02175-z. Epub 2024 Dec 23.
Intrathecal nicardipine (ITN) is an investigational therapy for cerebral vasospasm (CVS) and delayed cerebral ischemia (DCI) in patients with aneurysmal subarachnoid hemorrhage (aSAH). The objective of this scoping review was to characterize the current state of the literature and map the current available evidence, examine research methodology, clarify key concepts and definitions in the literature, report procedural characteristics, identify and analyze knowledge gaps, and serve as a precursor for future systematic reviews, meta-analyses, and randomized controlled trials. An electronic search for studies on ITN for the treatment of CVS and DCI in patients with aSAH was conducted in accordance with published standards. A total of 390 studies were identified by the search. After inclusion criteria were applied, 20 studies were identified for analysis. The identified studies included a total of 976 patients with aSAH who received ITN for the treatment of CVS and DCI. One randomized controlled trial, two prospective observational studies, nine retrospective observational studies, seven retrospective case series, and one case report met inclusion criteria. Study designs, drug administration, dosing regimens, drug concentrations, pharmacokinetics, patient selection, duration of therapy, outcome measures, adverse event monitoring, and definitions of CVS and DCI used are synthesized and discussed. Despite advances in the care of patients with aSAH, CVS and DCI remain leading causes of morbidity and mortality, and ITN represents a potential therapy to help prevent and treat this disease process. With one published randomized controlled trial on one method of administration, one trial underway on a second method of administration, and numerous heterogeneous and primarily retrospective studies published to date, future study with an emphasis on homogenizing study design and outcomes measured is needed to better understand this potential therapy.
鞘内注射尼卡地平（ITN）是一种用于治疗动脉瘤性蛛网膜下腔出血（aSAH）患者脑血管痉挛（CVS）和迟发性脑缺血（DCI）的研究性疗法。本范围综述的目的是描述当前文献的状态并梳理现有证据，审视研究方法，阐明文献中的关键概念和定义，报告程序特征，识别和分析知识空白，并作为未来系统评价、荟萃分析和随机对照试验的先导。按照已发表的标准，对关于ITN治疗aSAH患者CVS和DCI的研究进行了电子检索。检索共识别出390项研究。应用纳入标准后，确定了20项研究进行分析。纳入的研究共包括976例接受ITN治疗CVS和DCI的aSAH患者。一项随机对照试验、两项前瞻性观察性研究、九项回顾性观察性研究、七项回顾性病例系列研究和一项病例报告符合纳入标准。对研究设计、药物给药、给药方案、药物浓度、药代动力学、患者选择、治疗持续时间、结局指标、不良事件监测以及所使用的CVS和DCI定义进行了综合和讨论。尽管aSAH患者的护理取得了进展，但CVS和DCI仍然是发病和死亡的主要原因，而ITN是一种有助于预防和治疗这一疾病过程的潜在疗法。目前已有一项关于一种给药方法的随机对照试验发表，另一项关于第二种给药方法的试验正在进行中，并且迄今已发表了许多异质性且主要为回顾性的研究，未来需要开展侧重于使研究设计和测量结局同质化的研究，以更好地了解这种潜在疗法。
