Chen Wei-Hsi, Lin Hung-Sheng, Chen Chien-I, Chou Min-Shon, Liou Chia-Wei, Chen Shun-Sheng
Department of Neurology, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan.
Acta Neurol Taiwan. 2011 Sep;20(3):163-71.
Tissue plasminogen activator (tPA) was approved by the Food and Drug Administration for ischemic stroke treatment since 1996 at the United States of America and also 2002 at Taiwan. Since after it is strongly advertised for a promising benefit to early thrombolysis that is further echoed by a recommendation in clinical guidelines from multiple medical associations in worldwide. Because of an overwhelming data of positive benefit collected in the evidence-based medicine database, legal dispute subsequently occurs when tPA is failed to be administrated in appropriate time.
In order to elucidate the legal viewpoint for tPA used in ischemic stroke, a review of the domestic judiciary decrees regarding this issue was conducted. Cases in Taiwan were executed from the open access database of the Judicial Yuan, Taiwan. The background, legal dispute and judgment of each case were analyzed.
Till August, 2010, there were 6 cases in Taiwan. All cases occurred after 2003. The causes of disputes were a loss of chance for thrombolysis due to a delay of diagnosis (4 cases, 67%) and a failure of thrombolytic treatment after a diagnosis of ischemic stroke (2 cases, 23%). All cases were presented to non-neurologists at initial. Five cases expired or terminated into vegetation before litigation.
A failure of early diagnosis or treatment after a diagnosis of ischemic stroke are important for medicolegal dispute in tPA usage, which is expected to become prevalent in Taiwan in future. A fatal or poor outcome may be a triggering factor for litigation. Therefore, an improvement of the knowledge and practice to increase early diagnosis of ischemic stroke is the key factor for reducing medicolegal issue regarding tPA use in ischemic stroke. This is particularly true for non-neurologist physicians.
自1996年起，组织型纤溶酶原激活剂（tPA）在美国被食品药品监督管理局批准用于缺血性卒中治疗，2002年在台湾地区也获批准。自其因对早期溶栓有显著益处而被大力宣传后，全球多个医学协会的临床指南中也有相关推荐。由于循证医学数据库中收集了大量显示其有积极益处的数据，随后当未能及时使用tPA时便引发了法律纠纷。
为阐明tPA用于缺血性卒中的法律观点，对国内关于此问题的司法判决进行了回顾。台湾地区的案例来自台湾地区司法院的公开数据库。分析了每个案例的背景、法律纠纷及判决结果。
截至2010年8月，台湾地区有6起案例。所有案例均发生在2003年之后。纠纷原因包括因诊断延迟导致溶栓机会丧失（4例，67%）以及缺血性卒中诊断后溶栓治疗失败（2例，23%）。所有案例最初均由非神经科医生诊治。5例在诉讼前死亡或呈植物人状态。
缺血性卒中诊断后早期诊断或治疗失败是tPA使用中发生医疗法律纠纷的重要原因，预计未来在台湾地区会更为普遍。致命或不良后果可能是引发诉讼的因素。因此，提高知识水平和实践能力以增加缺血性卒中的早期诊断是减少tPA用于缺血性卒中相关医疗法律问题的关键因素。对于非神经科医生而言尤其如此。
