喹硫平单药治疗精神分裂症急性发作的疗效和安全性研究

目的评价喹硫平600～750mg/d单药治疗精神分裂症急性发作的疗效和安全性。方法采用多中心、前瞻性、单组、开放性研究。对124例精神分裂症急性发作的住院患者予喹硫平600～750mg/d单药治疗,观察时间为24周。疗效指标为阳性与阴性综合征量表（PANSS）评分变化,蒙哥马利抑郁量表（MADRS）、Pittsburgh睡眠质量指数（PSQI）及大体评定量表（GAS）的评分。安全性指标包括不良事件的评估、实验室检查和生命体征等。结果终点时PANSS总分减分值为54.47,与基线相比差异有统计学意义（P〈0.01）。研究终点时,患者的有效率为77.4%（96/124）,缓解率为58.1%（72/124）。MADRS、PSQI和GAS各时点评分改变与基线的差异均有统计学意义（P均小于0.01）。PANSS总分、阳性、阴性及兴奋因子分自第1周起即明显下降,减分值分别为10.33、3.52、2.11及3.33（P均小于0.01）;此后访视点各评分继续减少。最常见的不良事件为便秘（23.3%）、一过性肝功能异常（14.7%）、心动过速（12.4%）、嗜睡（10.9%）和失眠（10.1%）,无药物相关的严重不良事件发生。结论喹硫平600～750mg/d单药治疗急性精神分裂症安全有效,可改善激越、阳性症状、阴性症状、抑郁症状、睡眠和总体功能。

Effectiveness and safety of mono-therapy quetiapine in acute schizophrenia

Objective：Evaluate mono-therapy quetiapine with 600-750 mg daily in the treatment of acute schizophrenia.Methods：In this multicenter,prospective,one-arm,open-label trial 124 patients with acute schizophrenia were given mono-therapy quetiapine（600-750 mg daily）for 24 weeks.The endpoints were the before-after changes in the total score and sub-scale scores of the Positive and Negative Symptom Scale（PANSS）,the Montgomery-Asberg Depression Rating Scale（MADRS）,the Pittsburgh Sleep Quality Index（PSQI）and the Global Assessment Scale（GAS）.Safety was evaluated by monitoring vital signs,doing lab tests and administering an adverse events rating scale.Results：At the end of the study the mean PANSS score had dropped 54.5 points（P〈0.01）,77.4%（96/124）of participants had met criteria for clinical effectiveness,and 58.1%（72/124）met criteria for remission.Changes in MADRS,PSQI and GAS scores from baseline were also statistically significant（P〈0.01）.The PANSS total score,and the excitement,positive syndrome and negative syndrome subscale scores dropped significantly from baseline by the end of the first week（10.33,3.52,2.11 and 3.33 respectively;all Ps0.01）,and continued to drop thereafter.The most common adverse effects were constipation（23.3%）,abnormal liver function（14.7%）,tachycardia（12.4%）,somnolence（10.9%）and insomnia（10.1%）.There were no severe adverse events related to study treatment.Conclusion：Mono-therapy with quetiapine at a daily dose of 600-750mg is effective and safe in the treatment of acute schizophrenia,producing improvements in agitation,positive symptoms,negative symptoms,depressive symptoms,sleep and overall functioning.