Bateman Brian T, Schumacher H Christian, Boden-Albala Bernadette, Berman Mitchell F, Mohr J P, Sacco Ralph L, Pile-Spellman John
Columbia Presbyterian Medical College for Physicians and Surgeons, Columbia University, New York, NY, USA.
Stroke. 2006 Feb;37(2):440-6. doi: 10.1161/01.STR.0000199851.24668.f1. Epub 2006 Jan 5.
The prospective trials evaluating the safety and efficacy of intravenous tissue plasminogen activator have generally been conducted at academic medical centers and community hospitals with an institutional commitment to stroke care. Relatively little is known about the safety of this therapy as it is used in the community. We therefore examined outcomes in acute stroke patients treated with thrombolysis using the largest discharge database available in the United States for the years 1999 to 2002.
Data were derived from the Nationwide Inpatient Sample for the years 1999 to 2002. Using the appropriate International Classification of Disease-Clinical Modification, 9th revision, codes, patients admitted through the emergency room with a primary diagnosis of acute ischemic stroke were selected for analysis. From these patients, those coded as receiving thrombolysis were identified. Multivariate logistic regression was performed on the thrombolysis and nonthrombolysis cohorts to identify independent predictors of in-hospital mortality from among those clinical elements available in the database.
We identified 2594 patients treated with thrombolysis from a group of 248,964 patients admitted through the emergency room with a primary diagnosis of acute ischemic stroke. The thrombolysis cohort had a higher in-hospital mortality rate compared with the nonthrombolysis patients (11.4% versus 6.8%). The rate of intracerebral hemorrhage was 4.4% for the thrombolysis cohort and 0.4% for nonthrombolysis patients. Multivariate logistic regression showed advanced age, Asian/Pacific Islander race, congestive heart failure, and atrial fibrillation/flutter to be independent predictors of in-hospital mortality after thrombolysis. Thrombolysis volume, overall ischemic stroke volume, and teaching status were not significant predictors of in-hospital mortality after thrombolysis.
Thrombolysis, as it is used in the community, has a safety profile that is similar to that observed in the large, prospective clinical trials.
评估静脉注射组织型纤溶酶原激活剂安全性和有效性的前瞻性试验通常在对中风护理有机构承诺的学术医疗中心和社区医院进行。对于这种疗法在社区中的使用安全性,人们了解相对较少。因此,我们利用美国1999年至2002年最大的出院数据库,研究了接受溶栓治疗的急性中风患者的预后情况。
数据来源于1999年至2002年的全国住院患者样本。使用适当的《国际疾病分类-临床修订版》第9版编码,选择通过急诊室入院且主要诊断为急性缺血性中风的患者进行分析。从这些患者中,识别出编码为接受溶栓治疗的患者。对溶栓和未溶栓队列进行多变量逻辑回归分析,以从数据库中可用的临床因素中确定住院死亡率的独立预测因素。
我们从一组通过急诊室入院且主要诊断为急性缺血性中风的248,964名患者中,识别出2594名接受溶栓治疗的患者。与未溶栓患者相比,溶栓队列的住院死亡率更高(11.4%对6.8%)。溶栓队列的脑出血发生率为4.4%,未溶栓患者为0.4%。多变量逻辑回归显示,高龄、亚太岛民种族、充血性心力衰竭和心房颤动/扑动是溶栓后住院死亡率的独立预测因素。溶栓量、总体缺血性中风量和教学状态不是溶栓后住院死亡率的显著预测因素。
在社区中使用的溶栓疗法,其安全性与大型前瞻性临床试验中观察到的相似。