养血当归胶囊联合米非司酮治疗围绝经期功能性子宫出血的疗效与安全性评价

Efficacy and safety of Yangxue-danggui capsule combined with mifepristone on the dysfunctional uterine bleeding in the perimenopausal patients

目的:观察养血当归胶囊联合米非司酮治疗围绝经期功能性子宫出血患者的有效性和安全性。方法:将72例围绝经期功能性子宫出血患者随机分为对照组和观察组,各36例。对照组患者服用米非司酮,观察组患者使用养血当归胶囊联合米非司酮治疗,对比两组治疗3个月后的临床疗效、血清激素水平、子宫内膜变化和对肝肾功能影响。结果:治疗组患者治疗总有效率为86.1%,对照组患者总有效率61.1%,有明显差异(P<0.05);两组患者血清激素水平FSH、E_2、LH水平较治疗前均显著降低,治疗组血清激素水平下降优于对照组,有明显差异(P<0.05)。两组患者子宫内膜均明显变薄,治疗组患者治疗后子宫内膜变化较对照组显著,有明显差异(P<0.05)。两组患者治疗前后肝肾功能均无明显变化,无明显差异(P>0.05)。结论:养血当归胶囊能够提高米非司酮治疗围绝经期功能性子宫出血患者的临床疗效,且未增加明显的无不良反应,值得临床研究推广。

OBJECTIVE To evaluatethe efficacy and safety of the Yangxue-danggui capsule （YXDG） combined with mifepristone on the treatment of the perimenopausalpatients with dysfunctional uterine bleeding.METHODS Seventy two patients were randomly divided into control group and observation group, 36 cases in each group.The patients in control group were treated with mifepristone and who in the observation group with YXDG combined therapy with mifepristone for 3 months. The clinical total effective rate, serum sex-hormone levels, density of endometriumand function of liver and kidney were used as indexesin our study.RESULTS The clinical total effective rate was 86.1% and 61.1% in observation group patients and control group respectively,and there was significant difference（P〈0.05）. In two groups,the serum sex hormone levels FSH, E2, LH levels were significantly reduced. The serum sex hormone levels in observation group were reduced more than that of control group, and there was significant difference（P〈0.05）. The density of endometrium was significantly changed in both groups. In the treatment group,the change of density of endometrium was more than that in the control group, and there was significant difference （P〈0.05）. The function of liver and kidney had no obviously changed in two groups after treatment, and there was no significant difference （P〉0.05）.CONCLUSION YXDG could improve the clinical total effective rate ofmifepristone on the treatment of dysfunctional uterine bleeding in perimenopausal patients, and none of them had significantly increased adverse reactions.