Fernandez-Gotico Hannah, Lightfoot Tiffany, Meighan Melissa
Questions or comments about this article may be directed to Hannah Fernandez-Gotico, MS RN-BC CPHQ at
J Neurosci Nurs. 2017 Feb;49(1):31-36. doi: 10.1097/JNN.0000000000000247.
The approved treatment by the Food and Drug Administration for acute ischemic stroke is intravenous tissue-type plasminogen activator (IV tPA). After IV tPA administration, patients are monitored for adverse events using an American Heart Association/American Stroke Association guideline instituted in 1996. There is limited evidence describing the safest and most efficient method to monitor patients during the first 24 hours after tPA administration. Although the overall rates of adverse events have been reported, the time when patients may be at most risk for an event has not been studied. The purpose of this study was to identify the time of adverse event occurrences in the first 24 hours after IV tPA administration.
This was a descriptive, retrospective chart review study of patients admitted to an integrated health system and treated with IV tPA for acute stroke between July 2010 and July 2012. Charts were reviewed for adverse events using the Institute for Healthcare Improvement's Global Trigger Tool for Measuring Adverse Events. Possible chart indicators of adverse events or "triggers" included neurological decline, vital signs elevated above specified parameters, and emergent imaging. Adverse events included episodes of neurological decline, angioedema, allergic reactions, bleeding, and intracerebral hemorrhage (ICH). The timing of each detected event was determined, and descriptive statistics were used for data analysis.
Fourteen adverse events (2.8%) were detected in a population of 498 patients. Reactions consisted of allergic reaction (n = 1), angioedema (n = 1), neurological decline without ICH (n = 1), gastrointestinal bleeding (n = 1), bleeding gums (n = 1), and high-risk ICH (n = 9). Thirteen of the 14 adverse events (92.9%) occurred within the first 12 hours after IV tPA administration.
Close monitoring during the first 12 hours after IV tPA treatment may be essential. However, close monitoring after 12 hours may not contribute significantly to improved patient outcomes. Larger studies may provide evidence for the safest and most efficient monitoring protocol for patients treated with IV tPA for ischemic stroke.
美国食品药品监督管理局批准用于急性缺血性卒中的治疗方法是静脉注射组织型纤溶酶原激活剂（IV tPA）。在静脉注射IV tPA后，根据1996年制定的美国心脏协会/美国卒中协会指南对患者进行不良事件监测。关于在注射tPA后的头24小时内监测患者的最安全、最有效的方法，证据有限。虽然已报告了不良事件的总体发生率，但尚未研究患者发生事件风险最高的时间。本研究的目的是确定静脉注射tPA后24小时内不良事件发生的时间。
这是一项描述性回顾性图表审查研究，研究对象为2010年7月至2012年7月期间入住综合医疗系统并接受IV tPA治疗急性卒中的患者。使用医疗改进研究所的全球不良事件触发工具对图表进行不良事件审查。不良事件或“触发因素”的可能图表指标包括神经功能减退、生命体征高于指定参数以及紧急影像学检查。不良事件包括神经功能减退发作、血管性水肿、过敏反应、出血和脑出血（ICH）。确定每次检测到的事件的时间，并使用描述性统计进行数据分析。
在498例患者中检测到14例不良事件（2.8%）。反应包括过敏反应（n = 1）、血管性水肿（n = 1）、无ICH的神经功能减退（n = 1）、胃肠道出血（n = 1）、牙龈出血（n = 1）和高危ICH（n = 9）。14例不良事件中有13例（92.9%）发生在静脉注射tPA后的前12小时内。
静脉注射tPA治疗后的前12小时内进行密切监测可能至关重要。然而，12小时后进行密切监测可能对改善患者预后的贡献不大。更大规模的研究可能为接受IV tPA治疗缺血性卒中的患者提供最安全、最有效的监测方案的证据。
