H. Lundbeck A/S, Copenhagen, Denmark.
Int J Psychiatry Clin Pract. 1997;1(3):197-202. doi: 10.3109/13651509709024726.
Sertindole is a new limbic-selective antipsychotic agent which has recently received marketing authorization in several countries across Europe for the treatment of schizophrenia. The experience gained in around 2200 patients treated with sertindole in controlled clinical trials has enabled optimal targeting of sertindole to those patient groups who will benefit most and who are least likely to experience adverse effects. Ultimately, it is how a new medicinal product is used in clinical practice, how it performs in everyday life, and how the patient who takes it feels and functions that determine the real benefit/risk ratio of a new medicinal product. The European Post-marketing Observational Serdolect® project (EPOS) is a post-marketing, referenced, observational, cohort, safety study in the treatment of schizophrenic patients initiated earlier this year. It is planned to recruit over 12 000 patients in two cohorts in centres throughout Europe. The aims are to provide a full safety evaluation of sertindole under marketed conditions at the relevant clinical dosage, and further, to provide epidemiological data on schizophrenic patients receiving sertindole or other treatment under the usual clinical conditions in Europe. At the moment, the study is the only one of its kind to be undertaken in schizophrenia and will provide important new data for psychiatrists around the world.
赛乐特是一种新型的边缘选择性抗精神病药物，最近已在欧洲多个国家获得上市许可，用于治疗精神分裂症。在大约 2200 名接受赛乐特对照临床试验治疗的患者中获得的经验，使赛乐特能够针对最有可能受益和最不可能出现不良反应的患者群体进行最佳靶向治疗。最终，决定一种新药的实际效益/风险比的是新药品在临床实践中的使用方式、在日常生活中的表现以及服用它的患者的感受和功能。今年早些时候启动的赛乐特上市后观察性研究（EPOS）是一项上市后、参照性、观察性、队列、安全性研究，旨在治疗精神分裂症患者。该研究计划在欧洲各地的中心招募超过 12000 名患者，分为两个队列。目的是在相关临床剂量下，对赛乐特在上市条件下的全面安全性进行评估，并进一步提供在欧洲通常临床条件下接受赛乐特或其他治疗的精神分裂症患者的流行病学数据。目前，该研究是在精神分裂症中开展的唯一此类研究，将为世界各地的精神科医生提供重要的新数据。
