滋水清肝理冲饮治疗围绝经期综合征肝郁肾虚证的临床研究

Effects of Zishui Qinggan Lichong granule in the treatment of perimenopausal syndrome with the pattern of liver stagnation and kidney deficiency

目的观察滋水清肝理冲饮对围绝经期综合征(PMS)肝郁肾虚证患者的临床疗效。方法收集2019年7月—2022年1月就诊于北京中医药大学第三附属医院PMS肝郁肾虚证患者共60例,按照随机数字表法分为滋水清肝理冲饮组30例和对照组30例。滋水清肝理冲饮组给予滋水清肝理冲饮颗粒剂,对照组不加干预,滋水清肝理冲饮组共治疗3个月。3个月后评估比较两组患者的围绝经期症状评分(改良Kupperman评分)、血清性激素水平和世界卫生组织生存质量简表(QOL-BREF)及不良反应。结果滋水清肝理冲饮组的总有效率为90%,明显高于对照组(P<0.05)。两组均无明显不良反应事件。滋水清肝理冲饮组改良Kupperman评分、卵泡刺激素(FSH)、促黄体生成素(LH)较治疗前明显降低,雌二醇(E)和QOL-BREF生理、心理、环境及自评分数较治疗前均明显升高(P<0.05);对照组改良Kupperman评分、FSH明显升高,QOL-BREF心理、社会、环境评分均降低(P<0.05)。与对照组比较,滋水清肝理冲饮组治疗后改良Kupperman评分、血清性激素水平和生活质量指标均明显改善(P<0.05)。结论滋水清肝理冲饮能够改善围绝经期女性的潮热汗出、失眠、情绪激动、抑郁、疲乏等典型症状,同时能改善性激素水平与生活质量,具有治疗PMS肝郁肾虚证的作用,且安全性高。

Objective To observe the clinical effect of Zishui Qinggan Lichong granule(ZQLG)on perimenopausal syndrome(PMS)patients with the pattern of liver stagnation and kidney deficiency.Methods A total of 60 patients with PMS identified as liver stagnation and kidney deficiency pattern who were treated in Beijing University of Chinese Medicine Third Affiliated Hospital from July 2020 to January 2022 were collected and divided into the observation group(n=30)and control group(n=30)by using the random number table method.In the observation group,ZQLG was used,and the control group was set as a blank control.The trial lasted 3 months.After 3 months,the modified Kupperman score,levels of sex hormones in serum and quality of life scale(QOL-BREF)and adverse reactions were evaluated and compared between the two groups.Results After 3 months,indexes mentioned above in the control group were worsened to varying degrees.The modified Kupperman score and follicle-stimulating hormone(FSH)level were significantly increased(P<0.05).The indexes in the observation group were significantly improved.The total therapeutic effectiveness rate was 90%without adverse events.The modified Kupperman score,the levels of FSH and luteinizing hormone(LH)were significantly decreased,and estradiol(E)level was increased.The scores of physical,psychological,environment,and self-assessment area of the QOL-BREF were significantly increased(P<0.05).Compared with the control group,besides improvement of Kupperman score and serum sex hormones,the score of social area in the QOL-BREF was also significantly increased(P<0.05).Conclusion ZQLG can ameliorate the characteristic symptoms such as hot flashes,sweating,insomnia,emotional agitation,depression,and lassitude,but also improve the sex hormone levels and QOL in patients with PMS,which demonstrates its efficacy in treating PMS with the pattern of liver stagnation and kidney deficiency.