Ciccone Alfonso
Stroke Unit, Department of Neurosciences, Niguarda Hospital, Milan, Italy.
Lancet Neurol. 2003 Jun;2(6):375-8. doi: 10.1016/s1474-4422(03)00412-5.
Thrombolysis with intravenous alteplase for acute ischaemic stroke, which is already in clinical use in the USA and Canada, has recently been approved in the European Union. Until now, the use of alteplase has been limited to research or "off label" therapy in most of Europe. Despite the growing importance of this therapy and the many guidelines for use and comments on its effects, there is a lack of information about informed consent. The process of obtaining informed consent in the therapeutic decision process allows the patients to express their point of view on the risk-to-benefit ratio of thrombolytic therapy, on the different outcomes of stroke, and on the effect of thrombolysis. The discussion between the clinician and the patient or patient's family, during the process of obtaining consent to thrombolysis, can be problematic because therapy has to be given with extreme urgency. In this article, I highlight the importance of obtaining informed consent, help set out the process, and analyse the situations in which obtaining consent to thrombolysis may be legally and ethically avoided.
静脉注射阿替普酶治疗急性缺血性中风在美国和加拿大已应用于临床,最近在欧盟也获得了批准。到目前为止,在欧洲大部分地区,阿替普酶的使用仅限于研究或“未按药品说明书”治疗。尽管这种治疗方法的重要性日益增加,且有许多使用指南及其疗效评价,但关于知情同意的信息却很匮乏。在治疗决策过程中获得知情同意的程序,能让患者就溶栓治疗的风险效益比、中风的不同转归以及溶栓效果表达自己的观点。在获得溶栓同意的过程中,临床医生与患者或患者家属之间的讨论可能会出现问题,因为治疗必须极其紧急地进行。在本文中,我强调了获得知情同意的重要性,阐述了相关程序,并分析了在哪些情况下可以在法律和伦理层面避免获得溶栓同意。