阿戈美拉汀治疗抑郁症伴睡眠障碍的疗效和安全性的系统评价

目的:基于荟萃分析(Meta分析)方法,系统评价阿戈美拉汀对抑郁症伴睡眠障碍患者的睡眠改善效果及其安全性,为临床治疗提供循证参考。方法:检索PubMed、the Cochrane Library、EMBase、中国知网、万方数据库和维普数据库,纳入从建库至2020年4月公开发表的关于阿戈美拉汀治疗抑郁症伴睡眠障碍患者的中英文文献研究组患者单独使用阿戈美拉汀口服治疗,对照组患者单独使用5-羟色胺再摄取抑制类抗抑郁药(米氮平、帕罗西汀或艾司西酞普兰等)治疗或阿戈美拉汀联合其他药物治疗],提取汉密尔顿抑郁量表(Hamilton depression scale,HAMD)评分和匹茨堡睡眠质量指数(Pittsburgh sleep quality index,PSQI)相关数据,采用Rev Man 5.3软件进行文献质量评价和Meta分析。结果:共纳入8项研究,合计332例患者。Meta分析结果显示,抑郁症伴睡眠障碍患者单独使用阿戈美拉汀治疗后,其HAMD评分(SMD=-5.31,95%CI=-6.28~-4.33,P<0.00001)、PSQI总分(SMD=-3.66,95%CI=-4.16~-3.17,P<0.00001)均较治疗前明显降低,差异均有统计学意义。结论:阿戈美拉汀对抑郁症伴睡眠障碍患者的抑郁症状和失眠症状均有较好的改善作用,但受纳入研究的质量和样本量限制,该结论需大样本、多中心、长时间的随访结果进行验证。

Systematic Review of Efficacy and Safety of Agomelatine in the Treatment of Patients with Depression and Sleep Disorders

OBJECTIVE:To systematically evaluate the improvement effect and safety of agomelatine in patients with depression and sleep disorders based on the Meta-analysis method,so as to provide evidence-based reference for clinical treatment.METHODS:PubMed,the Cochrane Library,EMBase,CNKI,Wanfang database and VIP database were retrieved to collect the Chinese and English literature of agomelatine in the treatment of patients with depression and sleep disorders published from the establishment of the database to Apr.2020.The study group was treated with agomelatine alone,while the control group received serotonin reuptake inhibitor antidepressants(mirtazapine,paroxetine or escitalopram)alone or agomelatine in combination with other medications.Hamilton Depression Scale(HAMD)score and Pittsburgh Sleep Quality Index(PSQI)were extracted,and RevMan 5.3 software was used for literature quality evaluation and Meta-analysis.RESULTS:Totally 8 literature were collected,including 332 patients.Meta-analysis results showed that the HAMD score(SMD=-5.31,95%CI=-6.28--4.33,P<0.00001)and PSQI total score(SMD=-3.66,95%CI=-4.16--3.17,P<0.00001)of patients with depression and sleep disorders with treatment of agomelatine alone were significantly lower than those before treatment,with statistically significant difference.CONCLUSIONS:The improvement of agomelatine in patients with depression and sleep disorders is significant.However,due to the limitation of the quality and sample size of the included studies,the conclusion needs to be verified by the results of large sample,multi-center and long-term follow-up.