莉芙敏与帕罗西汀联用治疗围绝经期综合征伴抑郁的临床观察

Clinical Observation of Remifemin Combined with Paroxetine for Perimenopausal Syndrome Complicating with Depression

目的:观察莉芙敏与帕罗西汀联用治疗围绝经期综合征伴抑郁的临床效果。方法:采用随机、双盲、平行对照的研究方法,将120例围绝经期综合征伴抑郁的患者随机均分为莉芙敏+帕罗西汀组(试验组)和安慰剂+莉芙敏组(对照组),所有患者均口服莉芙敏片20 mg,早晚各1次;试验组患者每日晨服帕罗西汀片20 mg,对照组患者每日晨服安慰剂20 mg,连续用药12周。治疗前及治疗6、12周后记录Kupperman绝经指数(KMI)总评分和单项评分、子宫内膜厚度以及性激素水平的变化,并观察治疗期间的不良反应。结果:治疗6、12周后,两组患者KMI总评分和各单项评分均显著低于治疗前,差异有统计学意义(P<0.05或P<0.01)。其中,试验组治疗6、12周时的烦躁焦虑和抑郁评分均显著低于对照组,差异有统计学意义(P<0.05)。两组患者治疗前、后子宫内膜厚度比较,差异无统计学意义(P>0.05)。两组患者的卵泡刺激素和黄体生成素水平治疗前、后比较,差异无统计学意义(P>0.05),但试验组前列腺素水平治疗6、12周后较治疗前显著升高,且显著高于同期对照组,两组比较差异有统计学意义(P<0.05)。两组均未见不良反应发生。结论:莉芙敏联用帕罗西汀可改善患者围绝经期症状,患者烦躁焦虑和抑郁症状也明显改善,效果优于单用莉芙敏,且安全性较好。

OBJECTIVE：To observe the clinical efficacy of remifemin combined with paroxetine for perimenopausal syndrome complicating with depression.METHODS：By randomized,double-blind,parallel-controlled method,120 cases of perimenopausal syndrome complicating with depression were randomly divided into remifemin combined with paroxetine group（trial group）and placebo＋ remifemin group（control group）.All patients were orally given Remifemin tablets 20 mg,morning and night.Trial group was given Paroxetine tablet 20 mg in the morning;control group was given placebo 20 mg in the morning for consecutive 12 weeks.Kupperman menopausal index（KMI）total score,KMI individual score,endometrial thickness,and hormone levels were all recorded before treatment and 6 and 12 weeks after treatment.Adverse drug reactions were observed during treatment.RESULTS：6 and 12 weeks after treatment,KMI total score and the individual scores of 2 groups were significantly lower than before;there was statistical significance（P0.05 or P0.01）.The anxiety and depression scores of trial group were significantly lower than those of control group 6 and 12 weeks after treatment;there was statistical significance（P0.05）.The endometrial thickness of 2 groups before and after treatment had no statistical significance（P0.05）.FSH and LH levels of 2 groups before and after treatment had no statistical significance（P0.05）.E2 levels of trial group 6 and 12 weeks after treatment were increased significantly;there was statistical significance between 2 groups（P0.05）.No ADR was found in 2 groups.CONCLUSIONS： Remifemin combined with paroxetine can improve perimenopausal symptoms and promote anxiety and depression symptoms significantly and safety,and it is better than remifemin alone.