摘要

目的：探讨阿戈美拉汀联合第二代抗精神病药物治疗精神分裂症阴性症状和认知功能的疗效和安全性。

方法：一项为期24周的开放性随机对照试验共纳入83名以阴性症状为主的精神分裂症患者。参与者被随机分为两组：实验组接受阿戈美拉汀（25mg/天）联合第二代抗精神病药物治疗，对照组仅接受第二代抗精神病药物。随访评估在第2、4、8、16和24周进行。主要评估工具包括阴性症状评定量表（SANS）、阳性和阴性症状量表（PANSS）、临床总体印象量表（CGI）、重复神经心理状态评定量表（RBANS）、治疗副反应量表（TESS）。

结果：实验组在SANS总分及其情感淡漠、言语贫乏、快感缺失/社交退缩等分量表上均显示显著的时间×组交互作用（p < 0.001, p < 0.01）。PANSS总分、阴性症状及一般精神病理分量表上也表现出类似的显著交互作用（p < 0.01），CGI-E亦显示出显著的交互作用（p < 0.05）。至第24周，实验组在RBANS得分上明显优于对照组，尤其在即时记忆和延迟记忆方面。不良事件的发生率在两组间无显著差异。

结论：阿戈美拉汀联合第二代抗精神病药物有效改善精神分裂症患者的阴性症状和认知功能，且安全性良好。

关键词：关键词：阿戈美拉汀、精神分裂症、阴性症状、认知功能、随机对照试验。

ABSTRACT

Objective: To investigate the efficacy and safety of agomelatine combined with second-generation antipsychotic drugs in the treatment of negative symptoms and cognitive function in schizophrenia.

Methods: A 24-week open-label randomized controlled trial was conducted, enrolling 83 schizophrenia patients primarily exhibiting negative symptoms. Participants were randomly assigned to two groups: the experimental group received agomelatine (25 mg/day) combined with second-generation antipsychotic medication, while the control group received only second-generation antipsychotic drugs. Follow-up assessments were conducted at weeks 2, 4, 8, 16, and 24. The primary assessment tools included the Scale for the Assessment of Negative Symptoms (SANS), Positive and Negative Syndrome Scale (PANSS), Clinical Global Impressions (CGI), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Treatment Emergent Symptom Scale (TESS).

Results: The experimental group showed significant time × group interactions on the total SANS score and subscales, including emotional blunting, poverty of speech, anhedonia/social withdrawal (p < 0.001, p < 0.01). Similar significant interactions were observed in the PANSS total score, negative symptom, and general psychopathology subscales (p < 0.01), and in CGI-E (p < 0.05). By week 24, the experimental group significantly outperformed the control group in RBANS scores, particularly in immediate and delayed memory. The incidence of adverse events was similar between the two groups.

Conclusion  : Agomelatine combined with second-generation antipsychotic drugs effectively improves negative symptoms and cognitive function in patients with schizophrenia, with a good safety profile.

Key words: Keywords: Agomelatine, schizophrenia, negative symptoms, cognitive function, randomized controlled trial.