Lehman Laura L, Kleindorfer Dawn O, Khoury Jane C, Alwell Kathleen, Moomaw Charles J, Kissela Brett M, Khatri Pooja
Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229, USA.
J Child Neurol. 2011 Sep;26(9):1121-5. doi: 10.1177/0883073811408091. Epub 2011 May 31.
Intravenous recombinant tissue plasminogen activator is an established therapy for adults with ischemic stroke. In this Greater Cincinnati/Northern Kentucky population-based study, 8% were eligible. However, no established therapy exists for children with acute ischemic stroke. Accordingly, investigators assessed rates of eligibility for recombinant tissue plasminogen activator therapy among children (<18 years of age) in the same population to aid planning of future clinical trials. The investigators identified 29 pediatric ischemic strokes during 3 separate study periods (1993-1994, 1999, and 2005) and determined potential eligibility for recombinant tissue plasminogen activator therapy based on 2007 American Heart Association guidelines for adults. Depending on how relative contraindications were considered, 1 to 3 cases (3%-10%) met eligibility criteria. On the basis of national pediatric stroke incidence rates extrapolated from our population, it is estimated that up to 178 children might be eligible for intravenous recombinant tissue plasminogen activator therapy annually in the United States. Thus, recruitment for clinical studies is likely to be challenging and requires a concerted multicenter effort.
静脉注射重组组织型纤溶酶原激活剂是治疗成人缺血性中风的既定疗法。在这项基于大辛辛那提/北肯塔基人群的研究中,8%的患者符合条件。然而,目前尚无针对儿童急性缺血性中风的既定疗法。因此,研究人员评估了同一人群中儿童(<18岁)接受重组组织型纤溶酶原激活剂治疗的符合条件率,以帮助规划未来的临床试验。研究人员在3个不同的研究期间(1993 - 1994年、1999年和2005年)确定了29例儿童缺血性中风病例,并根据2007年美国心脏协会的成人指南确定了接受重组组织型纤溶酶原激活剂治疗的潜在符合条件情况。根据对相对禁忌症的考虑方式,有1至3例(3% - 10%)符合资格标准。根据从我们的人群中推算出的全国儿童中风发病率,估计美国每年可能有多达178名儿童符合静脉注射重组组织型纤溶酶原激活剂治疗的条件。因此,临床研究的招募工作可能具有挑战性,需要多中心协同努力。