阿戈美拉汀单药治疗抑郁症疗效和安全性的多中心开放性研究

Efficacy and safety of agomelatine monotherapy for depression:A multicenter and open-label clinical trial

目的目的探讨阿戈美拉汀单药治疗抑郁症的疗效和安全性。方法选取85例抑郁症患者接受可变剂量(25~50 mg/d)阿戈美拉汀治疗9周。采用汉密尔顿抑郁量表(HAMD-17)、临床总体印象量表(CGI)、抑郁症状快速评估量表(QIDS-SR)、阿森斯失眠量表(AIS)、亚利桑那性体验量表(ASEX)评估疗效,席汉残疾量表(SDS)和简明幸福与生活质量满意度问卷(Q-LES-Q-SF)评估社会功能和生活质量。采用不良事件记录表、实验室检查、生命体征等评估安全性。结果阿戈美拉汀单药治疗抑郁症9周的有效率为73.53%,缓解率为39.71%。与基线相比,治疗后第9周末的抑郁症状、睡眠症状、躯体症状、性功能、社会功能和生活质量均有所改善(P<0.01)。阿戈美拉汀治疗后不良反应有失眠、焦虑和转氨酶升高,程度均为轻度。结论阿戈美拉汀单药治疗对抑郁症患者的核心症状、睡眠症状、躯体症状、性功能均有效,安全性高,耐受性良好。

Objective To evaluate the clinical efficacy and safety of agomelatine monotherapy on depression.Methods A total of 85 patients with depression were selected and received a flexible dosage(25~50 mg/d)of agomelatine for 9 weeks.They were assessed with Hamilton Depression Rating Scale 17-item(HAMD-17),Clinical Global Impressions Scale(CGI),Quick Inventory of Depressive Symptomatology(QIDS-SR),Athens Insomnia Scale(AIS),Arizona Sexual Experience Scale(ASEX),Sheehan Disability Scale(SDS)and Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form(Q-LES-Q-SF).Safety was assessed by using adverse events,laboratory tests,and the vital signs.Results The effective rate and the remission rate of agomelatine monotherapy for depression were 73.53%and 39.71%respectively after 9 weeks of treatment.After 9 weeks of treatment,the depressive symptoms,sleep symptoms,somatic symptoms,sexual dysfunction,social function and quality of life all improved significantly compared with those at the baseline(P<0.01).There were some mild adverse reactions during agomelatine treatment,including insomnia,anxiety and transaminase elevation.Conclusion Agomelatine monotherapy is effective in the treatment of core symptoms,sleep symptoms,somatic symptoms,and sexual dysfunction in patients with depression.It is a safe and well tolerated antidepressant.