补肾仙至方治疗围绝经期综合征的临床研究

Clinical study on Bushen Xianzhi Decoction in the treatment of perimenopausal syndrome

目的探究补肾仙至方治疗围绝经期综合征的临床价值。方法选择2017年1月—2018年9月在上海市黄浦区中西医结合医院就诊的围绝经期综合征患者120例,随机分为观察组和对照组各60例,最终观察组纳入53例,对照组纳入51例。观察组予补肾仙至方口服,对照组予雌孕激素口服,2组疗程均为12周。观察2组性激素水平、Kupperman症状积分(KMI评分)、中医症状评分变化,统计2组疗程结束后、疗程结束3个月后的临床疗效。结果疗程结束后及疗程结束3个月后,2组雌二醇(E2)水平均明显高于治疗前(P均<0.05),黄体成生素(LH)、卵泡刺激素(FSH)水平及KMI评分、中医症状评分均明显低于治疗前(P均<0.05);疗程结束后,对照组E2水平明显高于同期观察组(P均<0.05),LH、FSH及KMI评分、中医症状评分均明显低于同期观察组(P均<0.05);疗程结束后3个月,观察组E2、LH、FSH及KMI评分、中医症状评分与疗程结束后比较差异均无统计学意义(P均>0.05),对照组E2水平明显低于疗程结束后及同期观察组(P均<0.05),LH、FSH及KMI评分、中医症状评分均明显高于疗程结束后及同期观察组(P均<0.05)。疗程结束后,观察组总有效率为77.4%(41/53),对照组总有效率为96.1%(49/51),观察组疗效差于对照组(P<0.05);疗程结束后3个月,观察组总有效率为83.0%(44/53),对照组总有效率为45.1%(23/51),观察组疗效明显优于对照组(P<0.05)。结论补肾仙至方治疗PMS安全有效,远期应用效果优于西医激素替代治疗。

Objective It is to explore the clinical value of Bushen Xianzhi Decoction in the treatment of perimenopausal syndrome.Methods A total of 120 patients with perimenopausal syndrome who were treated at Shanghai Huangpu District Hospital of Integrated Traditional Chinese and Western Medicine from January 2017 to September 2018 were selected and randomly divided into observation group and control group,with 60 cases in each group,finally,53 cases were included in the observation group and 51 cases in the control group.The observation group was treated with Bushen Xianzhi Decoction orally,and the control group was treated with estrogen and progesterone.The course of treatment in both groups was 12 weeks.The changes in the level of sex hormones,Kupperman symptom score(KMI score),and TCM symptom score after treatment were observed in the 2 groups,and the clinical efficacy of the 2 groups at the end of treatment and 3 months after the end of the treatment was evaluated in the two groups.Results At the end of the treatment course and 3 months after the end of the treatment course,the levels of estradiol(E2)were significantly higher while the levels of luteinizing hormone(LH),follicle stimulating hormone(FSH)and KMI score and TCM symptom score were significantly lower than those before treatment in the two groups(all P<0.05);after the treatment,the E2 level of the control group was significantly higher while the levels of LH,FSH and KMI score,TCM symptom score were significantly lower than those of the observation group during the same period(all P<0.05).In 3 months after the end of the treatment,there was no significant difference in the E2,LH,FSH and KMI scores,TCM symptom scores in the observation group(all P>0.05),the E2 level of the control group was significantly lower while the scores of LH,FSH,KMI,and TCM symptom scores were significantly higher than those after the end of the treatment course and in the observation group at the same period(all P<0.05).After the course of treatment,the total effective rate of the observation group was 77.4%(41/53),and the effective rate of the control group was 96.1%(49/51),the efficacy in the observation group was worse than that in the control group(P<0.05);in 3 months after the end of the treatment,the effective rate of the observation group was 83.0%(44/53),and the effective rate of the control group was 45.1%(23/51),the efficacy in the observation group was significantly better than that in the control group(P<0.05).Conclusion Bushen Xianzhi Decoction is safe and effective in the treatment of perimenopausal syndrome,and its long-term curative effect is better than that of western hormone replacement therapy.