盐酸阿戈美拉汀与盐酸帕罗西汀治疗重症抑郁症的疗效和安全性研究

摘要/Abstract

摘要：

目的：研究阿戈美拉汀和帕罗西汀治疗重症抑郁症的疗效，安全性和耐受性。方法：选取医院2017年12月至2019年12月80例诊断为重度抑郁症的患者，依据随机抽签法分为阿戈美拉汀组(40例)与帕罗西汀组(40例)。帕罗西汀组患者接受帕罗西汀20～40 mg·d^-1，而阿戈美拉汀组患者接受阿戈美拉汀25～50 mg·d^-1。通过汉密尔顿抑郁量表(HAM-D17)、汉密尔顿焦虑量表，蒙哥马利-阿斯伯格抑郁量表，希恩残疾量表得分来评估疗效。结果：在治疗后第1周阿戈美拉汀组的MADRS评分明显低于帕罗西汀，差异具有统计学意义(P＜0.05)；在治疗后第4周阿戈美拉汀组的HAM-A评分、MADRS评分明显低于帕罗西汀组，差异具有统计学意义(P＜0.05)；阿戈美拉汀组发生皮肤及其附件不良反应的人数明显少于帕罗西汀组，差异具有统计学意义(P＜0.05)。阿戈美拉汀组的HAM-D17评分、MADRS评分、HAM-A评分、SDS评分、HAMD-17睡眠评分在治疗后8周内的得分与帕罗西汀组对比，差异无统计学意义(P＞0.05)。阿戈美拉汀组在治疗后的第1、2、4、6、8周的显效、有效人数与帕罗西汀组对比，差异无统计学意义(P＞0.05)。阿戈美拉汀组在治疗后的第1周、第4周、第8周的CGI-I改善人数、CGI-S评分与帕罗西汀组对比，差异无统计学意义(P＞0.05)。结论：阿戈美拉汀在治疗8周后显示出与帕罗西汀等效的抗抑郁药疗效，且安全性可接受。

关键词: 阿戈美拉汀, 帕罗西汀, 安全性, 重度抑郁症

Abstract:

Objective：To study the efficacy, safety and tolerance of agomelatine and paroxetine in Chinese Han patients with severe depression. Methods: A total of 80 patients diagnosed with major depression in our hospital from December 2017 to December 2019 were selected and divided into agomelatine group (40 cases) and paroxetine group (40 cases) according to random drawing method. Patients in the paroxetine group received paroxetine 20 to 40 mg·d^-1,while patients in the agomelatine group received agomelatine 25 to 50 mg·d^-1. Efficacy was assessed by ham-D17, Hamilton Anxiety Scale, Montgomery-Asperger Depression Scale, and Sheehan Disability Scale. Results：In the first week after treatment, the MADRS score of agomelatine groupwas significantly lower than that of paroxetine group, the difference was statistically significant (P<0.05). At the fourth week after treatment, the HAM-A score and MADRS score of agomelatine group were significantly lower than those of paroxetine group and MADRS score, the difference was statistically significant (P<0.05). The number of adverse reactions in skin and subcutaneous tissue in agomelatine group was significantly less than that in paroxetine group, the difference was statistically significant (P<0.05). There was no significant difference in the scores of ham-d17, MADRS, HAM-A, SDS and HAMD-17 sleep scores between the two groups within 8 weeks after treatment (P>0.05). There were no statistically significant differences in the number of effective and effective persons in the agomelatine group and the paroxetine group at the 1st, 2nd, 4th, 6th and 8th weeks after treatment (P>0.05). There were no significant differences in the number of CGI-I improvement and CGI-S score between the agomelatine group and the paroxetine group at the 1st, 4th and 8th week after treatment (P>0.05). Conclusion：After 8 weeks of treatment, agomelatine shows the same antidepressant effect as paroxetine, and the safety is acceptable.

Key words: Agomelatine, Paroxetine, Safety, Major depression

中图分类号:

R749

白由竹.

盐酸阿戈美拉汀与盐酸帕罗西汀治疗重症抑郁症的疗效和安全性研究 [J]. 中国药物评价, 2022, 39(2): 180-185.

BAI You-zhu.

Efficacy and Safety of Argometine Hydrochloride and Paroxetine Hydrochloride in Patients with Severe Depression [J]. CHINESE JOURNAL OF DRUG EVALUATION, 2022, 39(2): 180-185.

参考文献

[1] 张德伦，陈林. 阿戈美拉汀与艾司西酞普兰治疗抑郁症有效性与安全性的对照研究[J]. 中国医院药学杂志， 2019, 39(9)：966-968.

[2] 王艾红，谢莹莹，尹安春，等. 抑郁症共病患者干预策略研究进展[J]. 护理学报， 2019, 26(2)：34-38.

[3] 周晶晶，朱彤，杨健. 基于临床特征预判抗抑郁药物疗效反应的相关研究进展[J]. 中国医刊， 2019，54(5)：31-34.

[4] 朱建峰，金卫东. 抗抑郁药物的不良反应[J]. 医药导报， 2018, 37(10)：1198-1202.

[5] 胡茂荣，陈晋东，李乐华，等. 阿戈美拉汀：一种新型抗抑郁药[J]. 中国新药与临床杂志， 2009，2：81-85.

[6] 张德伦，陈林. 阿戈美拉汀与艾司西酞普兰治疗抑郁症有效性与安全性的对照研究[J]. 中国医院药学杂志， 2019, 39(9)：966-968.

[7] 张伟，刘海燕. 高压氧联合阿戈美拉汀治疗老年抑郁症患者68例疗效观察[J]. 中华航海医学与高气压医学杂志，2020，27(3)：275-278.

[8] Looh，Hale A，Haenen H.Determination of the dose of agomelatine, a melatoninergic agonist and selective 5-HT(2C) antagonist, in the treatment of major depressive disorder: a placebo-controlled dose range study[J]. International Clinical Psychopharmacology, 2002, 17(5)：239-247.

[9] None. Antidepressant efficacy of agomelatine: meta-analysis of published and unpublished studies[J]. Bmj, 2014, 348(1)：g1888.

[10] Guaiana G, Gupta S, DC hiodo, et al. Agomelatine versus other antidepressive agents for major depression.[J]. Cochrane Database of Systematic Reviews, 2012, 12(12)：CD008851.

[11] 翟倩，丰雷，张国富，等. 阿戈美拉汀治疗抑郁症的研究进展[J]. 中国药房， 2019, 30(17)：2435-2440.

[12] 倪晓金，倪琴，朱洁，等. 阿戈美拉汀对抑郁症患者睡眠质量及血清褪黑素水平的影响[J]. 临床精神医学杂志， 2020，30(6)：39-41.

[13] Freiesleben SD, Furczyk K. A systematic review of agomelatine-induced liver injury[J]. Journal of Molecular Psychiatry, 2015, 3(1)：4.

[14] 王艳婕，曹威，李庆丽，等. 阿戈美拉汀联合解郁丸治疗对抑郁症患者炎症因子和脑源性神经营养因子的影响[J]. 中国慢性病预防与控制，2020，28(1)：61-63.

[15] 张德伦，陈林. 阿戈美拉汀与艾司西酞普兰治疗抑郁症有效性与安全性的对照研究[J]. 中国医院药学杂志， 2019, 39(9)：966-968.

[16] 邹展平，封敏，费玉娥，等. 阿戈美拉汀治疗首发抑郁症疗效及对肝功能的影响[J]. 浙江临床医学，2021，23(1)：88-89，92.