Article(id=1291404904904512288, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.11.005, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1735574400000, receivedDateStr=2024-12-31, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824522472, onlineDateStr=2026-08-04, pubDate=1750089600000, pubDateStr=2025-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824522472, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824522471, creator=13701087609, updateTime=1785824522471, updator=13701087609, issue=Issue{id=1291404791758975909, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1750089600000', pubDateStr='2025-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824495496, creator='13701087609', updateTime=1785896929934, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708603887542774, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708603887542775, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1522, endPage=1526, ext={EN=ArticleExt(id=1291404905655292705, articleId=1291404904904512288, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of agomelatine combined with paroxetine in the treatment of patients with depression and insomnia, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective To observe the clinical efficacy and safety of agomelatine combined with paroxetine tablets in patients with depression and insomnia, and its effects on neurotransmitter levels and sleep.
Methods The patients with depression and insomnia were divided into control group and treatment group, according to random number table. Control group was treated with paroxetine tablets 20 mg, oral, treatment course was 8 weeks. Treatment group was treated with agomelatine 25 mg and paroxetine tablets 20 mg, once a day, treatment course was 8 weeks. The Hamilton depression rating scale (HAMD), Montreal cognitive assessment scale (MoCA), neurotransmitters [norepinephrine (NE), 5-hydroxytryptamine (5-HT), dopamine (DA)], Pittsburgh sleep quality index (PSQI) and incidence of adverse drug reactions between two groups were compared.
Results Treatment group was enrolled 60 cases; control group was enrolled 60 cases. After 8 weeks of treatment, the HAMD in treatment group and control group were (17.33±1.54) and (21.19±1.87) scores; MoCA were (29.01±0.19) and (28.52±0.21) scores; NE levels were (65.56±4.63) and (53.74±4.52) ng·mL-1; 5-HT levels were (165.82±7.17) and (149.63±8.48) ng·mL-1; DA levels were (582.73±17.52) and (543.85±20.38) ng·mL-1, sleep latency were (1.09±0.12) and (1.53±0.15) scores; sleep efficiency were (1.12±0.17) and (1.58±0.20) scores; hypnotic drug were (1.01±0.13) and (1.42±0.15) scores; subjective sleep quality were (1.14±0.10) and (1.62±0.16) scorse; sleep persistence were (1.16±0.11) and (1.55±0.13) scores; the score for sleep disorders were (1.07±0.14) and (1.52±0.17) scores; daytime functional disorders were (0.99±0.16) and (1.51±0.18) scores, all with statistically significant difference (all P<0.05). The adverse drug reactions in treatment group and control group were 11.67% and 8.33%, with no statistically significant differences (P>0.05).
Conclusion Administration of agomelatine and paroxetine tablets to patients with depression and insomnia can improve depressive symptoms, cognitive function, sleep conditions, regulate the expression of neurotransmitters such as NE and 5-HT, and has good safety.
, authors=Lu-mei WANG
1a, Jing CHEN
1b, Bin WANG
1c, authorsList=Lu-mei WANG, Jing CHEN, Bin WANG, authorCompany=null, correspAuthors=Jing CHEN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404906519319330, articleId=1291404904904512288, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=阿戈美拉汀联合帕罗西汀治疗抑郁症伴失眠患者的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察阿戈美拉汀片联合帕罗西汀片治疗抑郁症伴失眠患者的临床效果和安全性，及其对神经递质水平和睡眠的影响。
方法 将抑郁症伴失眠患者用随机数表法分为对照组和试验组。对照组口服帕罗西汀片，单次剂量20 mg，疗程为8周，试验组口服阿戈美拉汀片25 mg和帕罗西汀片20 mg，每天1次，疗程为8周。比较2组患者的汉密尔顿抑郁量表（HAMD）、蒙特利尔认知评估量表（MoCA）、神经递质[去甲肾上腺素（NE）、5-羟色胺（5-HT）、多巴胺（DA）]、匹兹堡睡眠质量指数（PSQI）以及药物不良反应发生情况。
结果 试验组入组60例，对照组入组60例。治疗8周后，试验组和对照组HAMD分别为（17.33±1.54）和（21.19±1.87）分，MoCA分别为（29.01±0.19）和（28.52±0.21）分，NE水平分别为（65.56±4.63）和（53.74±4.52）ng·mL-1，5-HT水平分别为（165.82±7.17）和（149.63±8.48）ng·mL-1，DA水平分别为（582.73±17.52）和（543.85±20.38）ng·mL-1，睡眠潜伏期分别为（1.09±0.12）和（1.53±0.15）分，睡眠效率分别为（1.12±0.17）和（1.58±0.20）分，催眠药物分别为（1.01±0.13）和（1.42±0.15）分，主观睡眠质量分别为（1.14±0.10）和（1.62±0.16）分，睡眠持续性分别为（1.16±0.11）和（1.55±0.13）分，睡眠紊乱分别为（1.07±0.14）和（1.52±0.17）分，日间功能紊乱分别为（0.99±0.16）和（1.51±0.18）分，在统计学上差异均有统计学意义（P<0.05）。试验组和对照组的药物不良反应发生率分别为11.67%和8.33%，在统计学上差异无统计学意义（P>0.05）。
结论 对抑郁症伴失眠患者予以阿戈美拉汀片联合帕罗西汀片，可以改善抑郁症状、认知功能和睡眠情况，调节NE、5-HT等神经递质表达，且安全性良好。
, authors=王璐眉
1a, 陈晶
1b, 汪斌
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王璐眉（1986-），女，主管药师，主要从事临床药学相关研究和工作
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