关黄母颗粒治疗围绝经期综合征患者的临床疗效及对其内分泌紊乱、睡眠质量的影响

Guanhuangmu Granules Ameliorate Endocrine Disorders and Improve Sleep Quality in Patients with Perimenopausal Syndrome

目的探讨关黄母颗粒治疗围绝经期综合征(Perimenopausal syndrome,PMS)患者的临床疗效及对其内分泌紊乱、睡眠质量的影响。方法选取2021年2月—2023年1月期间江苏省苏北人民医院收治的192例PMS患者,采用随机数字表法分为对照组和观察组,每组各96例。对照组给予小剂量激素替代疗法(Hormone replacement therapy,HRT),观察组给予关黄母颗粒治疗,连续治疗8周。观察比较两组患者治疗效果、不良反应,同时检测治疗前后外周血性激素雌二醇(Estradiol,E_(2))、黄体生成素(Luteinizing hormone,LH)与促卵泡激素(Follicle-stimulating hormone,FSH)水平变化,评价中医证候评分、女性更年期综合征自我诊断评定表(Kupperman)评分、匹兹堡睡眠质量指数(Pittsburgh sleep quality index,PSQI)和围绝经期综合征生存质量量表(Menopause-specific quality of life,MENQOL)评分,测量子宫内膜厚度及腰椎骨密度(Bone mineral density,BMD)。结果治疗后两组患者中医证候各症状及总分均较治疗前降低,差异有统计学意义(P<0.05);且观察组中医证候各症状及总分均明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者Kupperman、PSQI和MEN-QOL评分均较治疗前降低,差异有统计学意义(P<0.05);且观察组Kupperman、PSQI和MEN-QOL评分均明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者内分泌指标E_(2)水平较治疗前升高,LH和FSH水平较治疗前降低,差异有统计学意义(P<0.05);但两组间比较,差异无统计学意义(P>0.05)。治疗后两组患者子宫内膜厚度及BMD均较治疗前升高,差异有统计学意义(P<0.05);但两组间比较,差异无统计学意义(P>0.05)。治疗后观察组总有效率94.62%(88/93)明显高于对照组76.09%(70/92),差异有统计学意义(P<0.05)。治疗期间,观察组无明显不良反应,与对照组的不良反应率10.87%比较,差异有统计学意义(P<0.05)。结论关黄母颗粒治疗PMS疗效显著且副作用少,能够有效纠正内分泌紊乱、减轻临床症状,并可改善睡眠质量及生活质量。

Objective To investigate the therapeutic effect of Guanhuangmu Granules on perimenopausal syndrome(PMS)and the influences on endocrine disorders and sleep quality.Methods A total of 192 patients with PMS treated in the Northern Jiangsu People's Hospital from February 2021 to January 2023 were selected and assigned with the random number table method into observation and control groups(n=96).The control group received low-dose hormone replacement therapy(HRT),and the observation group was treated with Guanhuangmu Granules.Both groups were treated for 8 weeks.The therapeutic effects and adverse reactions were observed and compared between the two groups.The levels of estradiol(E_(2)),luteinizing hormone(LH),and follicle-stimulating hormone(FSH)in the peripheral blood were measured before and after treatment.The traditional Chinese medicine(TCM)symptom scores,Kupperman score,Pittsburgh Sleep Quality Index(PSQI),and Menopause-Specific Quality of Life(MENQOL)score were evaluated,and the endometrial thickness and bone mineral density(BMD)of lumbar vertebrae were measured before and after treatment.Results After treatment,the scores of each TCM symptom,total TCM symptoms,Kupperman,PSQI,and MENQOL declined in both groups,and the observation group had lower scores than the control group(all P<0.05).After treatment,the E_(2) level elevated,while the LH and FSH levels declined in both groups(P<0.05).However,the E2,LH,and FSH levels showed no statistically significant differences between the two groups(P>0.05).After treatment,the endometrial thickness and BMD of both groups increased(P<0.05),whereas they had no statistically significant differences between the two groups(P>0.05).The total response rate in the observation group was 94.62%(88/93),which was higher than that(76.09%,70/92)in the control group(P<0.05).There was no obvious adverse reaction in the observation group,which had a difference from the control group with the incidence of adverse reactions being 10.87%(P<0.05).Conclusion Guanhuangmu Granules can correct endocrine disorders,alleviate clinical symptoms,and improve the sleep quality and quality of life,demonstrating definite therapeutic effect on PMS while causing few side effects.