益坤宁颗粒联合替勃龙、帕罗西汀治疗更年期综合征75例

Yikunning Granules Combined with Tibolone and Paroxetine in the Treatment of 75 Cases of Menopausal Syndrome

目的:探讨益坤宁颗粒联合替勃龙、帕罗西汀治疗更年期综合征的临床疗效和安全性。方法:150例更年期综合征患者随机分为对照组和观察组各75例,对照组予替勃龙片2.5 mg,po,qd,帕罗西汀片20 mg,po,qd,观察组再对照组基础上加用益坤宁颗粒3 g,po,tid。3个月后采用改良Kupperman评分评价两组患者临床症状,比较两组血清雌二醇(E2)、促黄体生成素(LH)、促卵泡生成素(FSH)、泌乳素(PRL)、孕酮(P)水平变化,观察两组药品不良反应。结果:治疗后,两组患者改良Kupperman评分多数指标较治疗前有不同程度改善(P<0.05),且观察组潮热出汗、焦虑、忧郁、心悸及总分等指标改善优于对照组(P<0.05);两组患者E2增高,LH、FSH降低(P<0.05);PRL、P无明显改变(P>0.05),且观察组E2、LH、FSH水平均较对照组改善更明显(P<0.05)。两组药品不良反应发生率比较,差异无统计学意义(P>0.05)。结论:益坤宁颗粒联合替勃龙、帕罗西汀治疗更年期综合征能有效改善患者临床症状和性激素水平,效果优于西药治疗。

Objective： To explore the clinical effect and safety of Yikunning granules combined with tibolone and paroxetine in the treatment of female patients with menopausal syndrome. Methods： Totally 150 female patients with menopausal syndrome were randomly divided into the control group （75 cases） and the study group （75 cases）. The control group was orally given tibolone （2.5mg,po,qd） and paroxetine tablets （20mg ,po, qd）, and the study group was treated with Yikunning granules additionally （3g ,po, tid）. After 3-month treatment, the modified Kupperman score was used to evaluate the clinical symptoms, radioimmunoassay was used to detect the serum lev- els of estradiol （ E2）, luteinizing hormone （ LH）, follicle stimulating hormone （ FSH）, prolactin （PRL） and progesterone （P） , and the adverse reactions were recorded. Results： After the treatment, most of the indices in the modified Kupperman score were improved in the two groups （P 〈 0. 05）. In the study group, such symptoms as hot flashes and perspiration, anxiety, depression and palpitations, and the general score were improved more notable than those in the control group （P 〈 0.05 ）. After the treatment, serum levels of E2 was increased, while FSH and PRL were decreased（ P 〈 0. 05 ）, and PRL and P were unchanged （P 〉 0. 05 ）. The improvement of E2, LH and FSI-I in the study group was better than that in the control group （ P 〈 0.05 ）. There was no significant difference in the adverse reactions between the two groups （P 〈 0.05 ）. Conclusion： Yikunning granules combined with tibolone and paroxetine show good effectiveness in the treatment of menopausal syndrome with improved clinical symptom and sex hormone levels, which is worthy of promotion.