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精神分裂症(Schizophrenia)是精神疾病中的一种主要类型,是一组病因未完全阐明的,以基本个性改变,思维、情感、知觉和行为分裂,精神活动与环境不协调为主要特征的一类常见的精神疾病。其临床表现可分为阳性和阴性症状。阳性症状的特点是正常功能的过度发挥或扭曲,如幻觉、妄想、偏执狂;阴性症状则为正常功能的缩减或丧失,如社交障碍、感情淡漠、快感缺失等。患者的症状表现可以是其中一种,也可兼有两种症状表现。欧洲药品监督管理局人用药品委员会曾于1998年发布了治疗精神分裂症药物临床试验的指导原则,并于2011年进行了更新。本文参考欧洲药品监督管理局人用药品委员会2011年2月最新发布的治疗精神分裂症药物临床试验指导原则,分别对精神分裂症药物临床试验考虑要点和一般考虑两部分进行介绍。本部分节录其中治疗精神分裂症药物临床研究的一般考虑、疗效评价、临床药理学、临床有效性等内容,为注册申请人提供参考。
Schizophrenia is one of the major types of mental illness and is characterized by a set of etiologies that are not fully elucidated and are characterized by basic personality changes, mental, emotional, sensory and behavioral divisions, disharmony between mental activity and the environment Common mental illness. The clinical manifestations can be divided into positive and negative symptoms. Positive symptoms are characterized by over-exertion or distortion of normal functions, such as hallucinations, delusions, paranoia; negative symptoms are reduced or lost normal functions such as social disorders, apathy, loss of pleasure and so on. The patient’s symptoms can be one of them, or both. The European Medicines Commission on Human Medicines released the Guiding Principles for the Clinical Trials of Schizophrenia in 1998 and was updated in 2011. In this paper, with reference to the latest clinical trial guidelines for the treatment of schizophrenia issued by the Commission on Drugs for Human Drug Administration of European Medicines and Drug Administration in February 2011, respectively, the clinical trial of schizophrenia drug considerations and general considerations are introduced. This section excerpts the general considerations of the clinical research on the treatment of schizophrenia drugs, evaluation of the efficacy, clinical pharmacology, clinical validity, etc., to provide reference for registered applicants.