阿戈美拉汀片与帕罗西汀片治疗抑郁症伴失眠症状的临床研究

Clinical trial of agomelatine tablets or paroxetine tablets in the treatment of depression complicated with insomnia

目的比较阿戈美拉汀片与帕罗西汀片治疗抑郁症伴失眠症状的临床疗效及安全性。方法将64例抑郁症伴有失眠症状患者随机分为对照组和试验组,每组32例。对照组予以帕罗西汀20 mg·d^-1,qd,早餐后顿服;试验组予以阿戈美拉汀初始剂量25 mg·d^-1,如有必要可增加至50 mg·d^-1,qd,睡前顿服。2组患者均治疗8周。比较2组患者的临床疗效、汉密尔顿抑郁量表(HAMD)和匹兹堡睡眠质量指数(PSQI)评分,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为90.32%(28例/31例)和93.33%(28例/30例),差异无统计学意义(P>0.05)。试验组和对照组的HAMD评分在治疗后1周时分别为(22.56±3.26)和(25.83±3.43)分,HAMD评分在治疗后2周时分别为(17.36±2.53)和(20.07±2.66)分,试验组均显著低于对照组,差异均有统计学意义(均P<0.05)。试验组和对照组的PSQI评分治疗后8周时分别为(6.13±2.44)和(6.58±1.65)分,差异有统计学意义(P<0.05)。试验组发生的药物不良反应主要有头昏、恶心和头痛,对照组发生的药物不良反应主要有恶心、头昏、头痛和激越。试验组和对照组的总药物不良反应发生率分别为25.81%和30.00%,差异无统计学意义(P>0.05)。结论阿戈美拉汀片治疗抑郁症伴失眠症状较帕罗西汀片起效更快,抗抑郁及改善睡眠质量效果更强,但两者的安全性相当。

Objective To compare the clinical efficacy and safety of agomelatine tablets and paroxetine tablets in the treatment of insomnia complicated with depression.Methods Totally 64 patients of insomnia complicated with depression were randomly divided into control and treatment groups with 32 cases per group.Control group was given paroxetine 20 mg·d^-1,qd,orally after breakfast.Treatment group received agomelatine with the initial dose of 25 mg·d^-1,orally,which could be increased to 50 mg·d^-1,qd and taken at bedtime.Two groups were treated for 8 weeks.The clinical efficacy,Hamilton depression scale(HAMD)and Pittsburgh sleep quality index(PSQI)scores and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 90.32%(28 cases/31 cases)and 93.33%(28 cases/30 cases)without significant difference(P>0.05).After treatment,the HAMD scores of treatment group and control group were(22.56±3.26)and(25.83±3.43)at 1 week,(17.36±2.53)and(20.07±2.66)at 2 weeks,there were significant differences between two groups(all P<0.05).The PSQI scores of treatment group and control group were(6.13±2.44)and(6.58±1.65)at 8 weeks after treatment with significant difference(P<0.05).The main adverse drug reactions in the treatment group were dizziness,nausea and headache,which in the control group were nausea,dizziness,headache and irritation.The total incidences of adverse drug reactions in treatment and control groups were 25.81%and 30.00%without significant difference(P>0.05).Conclusion Agomelatine tablets are more effective than paroxetine tablets in the treatment of depression with insomnia symptoms,and are more effective in anti-depression and improve sleep quality,but they are equally safe.