| Li Jun,Miao Shipan,Wang Qianqian,Song Suqi,Yuan Xiaoping,Zhang Kai,Effect of different doses of agomelatine on liver function in patients with depressive disorders： a real-world study[J].SICHUAN MENTAL HEALTH,2025,(6):486-490 |
| Effect of different doses of agomelatine on liver function in patients with depressive disorders： a real-world study |
DOI：10.11886/scjsws20250720001 |
| English keywords:Agomelatine Depressive disorder Liver function Dose effect Real-world study |
| Fund projects:安徽省委教育工委高校优秀青年人才支持计划项目（项目编号：gxyqZD2022022）；安徽省转化医学研究院科研基金重点项目（项目名称： 青少年非自杀性自伤干预及机制的转化研究，项目编号：2023zhyx-B18） |
| Author Name | Affiliation | Postcode | | Li Jun | Chaohu Hospital Affiliated to Anhui Medical University, Hefei 238000, China | 238000 | | Miao Shipan | Chaohu Hospital Affiliated to Anhui Medical University, Hefei 238000, China | 238000 | | Wang Qianqian | School of Mental Health and Psychological Sciences, Anhui Medical University, Hefei 238000, China | 238000 | | Song Suqi | Chaohu Hospital Affiliated to Anhui Medical University, Hefei 238000, China | 238000 | | Yuan Xiaoping | Chaohu Hospital Affiliated to Anhui Medical University, Hefei 238000, China | 238000 | | Zhang Kai* | Chaohu Hospital Affiliated to Anhui Medical University, Hefei 238000, China
Anhui Provincial Mental Health Center, Hefei 238000, China | 238000 |
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| Background Agomelatine， a novel antidepressant with dual efficacy in mood improvement and sleep regulation， has been widely utilized in clinical treatment of depressive disorders. The association between agomelatine and hepatic dysfunction has garnered increasing attention， yet there remains limited research on its long-term effect of liver function in real clinical scenarios.Objective To investigate the effect of different doses of agomelatine on liver function in patients with depressive disorders in real clinical scenarios， and to ascertain its safety profile and efficacy differences.Methods A retrospective study was conducted， enrolling 200 patients diagnosed with depressive disorders according to the International Classification of Diseases， tenth edition （ICD-10）， who received agomelatine treatment at the Department of Psychiatry of Chaohu Hospital Affiliated to Anhui Medical University from January 2019 to December 2024. Longitudinal follow-up was performed based on real-world data. Patients were divided into a low-dose group （25 mg/d） （n=121） and a high-dose group （50 mg/d） （n=79） based on their agomelatine dosage. Follow-up assessments were conducted at baseline， the 2nd， 6th， 14th， and 26th weeks after treatment initiation. Liver function indicators， including alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， and total bilirubin （TBIL）， were measured using a fully automated biochemical analyzer. Clinical symptoms were evaluated using the Hamilton Depression Scale-24 item （HAMD-24） and the Hamilton Anxiety Scale （HAMA）.Results No statistically significant time effect， intergroup effect， or time-by-group interaction effect was observed for ALT， AST， or TBIL in either the low-dose or high-dose group （P>0.05）. The time effects for both HAMD-24 and HAMA scores in the two groups were statistically significant （Ftime=430.573， 395.737， P<0.01）. From the end of the 2nd week of treatment onward， the scores at each follow-up time point were significantly lower than those at the baseline period （P<0.01）.Conclusion Both low-dose and high-dose agomelatine may have no significant effect on liver function in patients with depressive disorders， with no difference in liver function impairment was observed between dosage groups. Low-dose and high-dose agomelatine may be equally effective in alleviating depressive and anxiety symptoms in patients with depressive disorders. ［Funded by the Education Work Committee of the Anhui Provincial Committee for Outstanding Young Talents in Colleges and Universities （number， gxyqZD2022022）； the Key Project of Scientific Research Fund of Anhui Institute of Translational Medicine （number， 2023zhyx-B18）］ |
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