在抑郁患者的标准医疗实践中使用阿戈美拉汀：法国多中心观察性研究的 1 年结果。
Agomelatine in Standard Medical Practice in Depressed Patients: Results of a 1-Year Multicentre Observational Study In France.
机构信息
Centre Hospitalier Sainte-Anne (GHU Paris Psychiatrie et Neurosciences), INSERM U1266 and Paris-Descartes University, Paris, France.
Centre Hospitalier Universitaire de Rouen, Unité de Biostatistiques, Rouen, France.
出版信息
Clin Drug Investig. 2020 Nov;40(11):1009-1020. doi: 10.1007/s40261-020-00957-9.
BACKGROUND AND OBJECTIVES
Non-interventional studies are a valuable source of evidence that is complementary to traditional randomised, blinded and controlled clinical trials, for evaluating antidepressants in a real-world setting. The aim of the present study was to document the use of agomelatine in current medical practice and evaluate its effectiveness and safety in outpatients prescribed agomelatine to treat their current depressive episode.
METHODS
This 12-month observational French study included patients initiating agomelatine treatment. The intensity and severity of depression were assessed using the 17-item Hamilton Depression Rating Scale (HAM-D17) total score and the Clinical Global Impression-Severity of Illness (CGI-S) scale. Patients' quality of life and functioning were measured using the Quality of Life in Depression Scale and the Sheehan Disability Scale, respectively. The safety measures included emergent adverse events and biological samplings, with a focus on liver acceptability.
RESULTS
A total of 1484 patients (70% of women; 49.6 ± 15.4 years of age) were enrolled in the study. Most patients (62.3%) were treated with agomelatine for at least 6 months and 28.8% were treated for at least 1 year. Mean HAM-D17 total score and mean CGI-S scores decreased by 13.6 ± 8.1 and 2.1 ± 1.5 points, respectively, from baseline to last visit on agomelatine. Rates of responders (i.e. with a decrease in HAM-D17 total score by at least 50%) and remitters (HAM-D total score < 7) at the last visit were 90.7% and 56.0%, respectively. The mean HAM-D total score decreased after agomelatine withdrawal (- 4.1 ± 6.7) until the last visit. The quality of life and daily functioning of patients improved, while the numbers of days lost and underproductive days decreased over the follow-up period. Safety findings were in accordance with the known information regarding agomelatine.
CONCLUSION
In the current medical practice, this study confirms the effectiveness and good tolerability of agomelatine administered for a treatment period in agreement with guideline recommendations.
TRIAL REGISTRATION NUMBER
ISRCTN53570733 on 27 August 2010.
背景和目的
非干预性研究是一种有价值的证据来源，与传统的随机、盲法和对照临床试验相辅相成，可在真实环境中评估抗抑郁药的疗效。本研究旨在记录在当前的医疗实践中使用阿戈美拉汀的情况，并评估其在治疗当前抑郁发作的门诊患者中的疗效和安全性。
方法
这是一项为期 12 个月的法国观察性研究，纳入了开始使用阿戈美拉汀治疗的患者。使用 17 项汉密尔顿抑郁量表（HAM-D17）总分和临床总体印象-疾病严重程度（CGI-S）量表评估抑郁的严重程度和强度。使用抑郁患者生活质量量表和 Sheehan 残疾量表分别评估患者的生活质量和功能。安全性措施包括新发不良事件和生物样本检测，重点关注肝脏可接受性。
结果
共有 1484 例患者（70%为女性；年龄 49.6±15.4 岁）入组本研究。大多数患者（62.3%）接受阿戈美拉汀治疗至少 6 个月，28.8%的患者接受治疗至少 1 年。与基线相比，阿戈美拉汀治疗的最后一次就诊时 HAM-D17 总分和 CGI-S 评分分别平均下降 13.6±8.1 和 2.1±1.5 分。最后一次就诊时的应答率（即 HAM-D17 总分至少下降 50%）和缓解率（HAM-D 总分<7）分别为 90.7%和 56.0%。阿戈美拉汀停药后 HAM-D 总分（-4.1±6.7）直至最后一次就诊仍继续下降。随访期间，患者的生活质量和日常功能得到改善，缺勤天数和生产力低下天数减少。安全性发现与阿戈美拉汀的已知信息一致。
结论
在当前的医疗实践中，本研究证实了阿戈美拉汀的有效性和良好耐受性，其治疗时间与指南推荐一致。
试验注册
ISRCTN53570733，2010 年 8 月 27 日。
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