摘要
Abstract
Objective To compare the clinical efficacy and safety of agomelatine tablet and venlafaxine sustained-release tablet in the treatment of patients with perimenopausal depression.Methods Patients with perimenopausal depression were divided into control group and treatment group according to random number table method.The control group was given venlafaxine sustained-release tablet 75 mg,taken orally in the morning or before going to bed,once a day,and the treatment group was given agomelatine 25 mg orally before bed,once a day.Both groups were treated for 3 months.The clinical efficacy,depression severity[Montgomery-Åsberg Depression Rating Scale(MADRS)],neurotransmitters[norepinephrine(NE),5-hydroxytryptamine(5-HT),dopamine(DA)],reproductive endocrine hormones[follicle stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2),testosterone(T)],Pittsburgh Sleep Quality Index(PSQI)and safety were compared between the two groups of patients.Results There were no shedding cases,and 57 patients in control group and 57 patients in treatment group were enrolled.After treatment,the total effective rates in treatment group and control group were 96.49％(55 cases/57 cases)and 91.23％(52 cases/57 cases)respectively(P＞0.05).At 3 months after treatment,NE levels in treatment group and control group were(135.78±15.56)and(128.33±13.41)ng·L-1,5-HT levels were(285.41±27.47)and(270.29±25.71)ng·L-1,DA levels were(36.04±5.37)and(33.89±5.01)ng·L-1,FSH levels were(4.11±0.93)and(3.58±0.84)U·L-1,LH levels were(5.18±1.01)and(4.54±0.83)U·L-1,E2 levels were(86.91±11.23)and(98.09±13.41)mmol·L-1,T levels were(1.35±0.34)and(1.06±0.31)mmol·L-1,MADRS scores were(29.41±2.77)and(35.63±2.91)points,and PSQI scores were(6.21±1.28)and(7.85±1.87)points respectively,the differences of above indexes were statistically significant between two groups(all P＜0.05).The adverse drug reactions in treatment group were mainly vomiting and dizziness,and those in control group were mainly dizziness,vomiting and hypertension.The total incidence rates of adverse drug reactions in treatment group and control group were 5.26％and 17.54％,respectively(P＜0.05).Conclusion Agomelatine and venlafaxine sustained-release tablet have shown significant efficacy in the treatment of perimenopausal depression,but the former one is more advantageous in improving depression severity,neurotransmitters and sleep quality,with better safety.关键词
阿戈美拉汀片/文拉法辛缓释片/围绝经期抑郁症/临床疗效/安全性Key words
agomelatine tablet/venlafaxine sustained-release tablet/perimenopausal depression/clinical efficacy/safety分类
医药卫生
