中医药辨证治疗绝经相关睡眠障碍的前瞻性队列研究  

Treatment with traditional Chinese medicine based on syndrome differentiation for menopause-related sleep disorders:A prospective cohort study

作　　者：翟子琦 李盛楠 徐莲薇[1] ZHAI Ziqi;LI Shengnan;XU Lianwei(Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200023,China)

机构地区：[1]上海中医药大学附属龙华医院,上海200023

出　　处：《现代中西医结合杂志》2023年第14期1951-1956,1962,共7页Modern Journal of Integrated Traditional Chinese and Western Medicine

基　　金：促进市级医院临床技能与临床创新能力三年行动计划(SHDC2020CR2050B);上海市老龄化和妇儿健康研究专项计划(2020YJZX0217)。

摘　　要：目的通过前瞻性队列研究方法观察中医药辨证治疗绝经相关睡眠障碍的有效性和安全性。方法收集2021年1月—2022年3月在上海市质控中心的22家医院诊治的200例绝经相关睡眠障碍患者资料,最终188例完成随访,其中中药队列组96例,激素队列组92例。中药队列组依据辨证论治采用中药口服治疗,激素队列组采用芬吗通及替勃龙治疗,2组治疗周期均为3个月。在治疗的第0,1,2,3个月和停药后的第6个月,观察并比较2组患者的匹兹堡睡眠质量指数量表(PSQI)评分、失眠严重程度指数(ISI)评分、改良Kupperman量表(KMI)评分、汉密尔顿焦虑量表(SAS)评分、汉密尔顿抑郁量表(SDS)评分。结果2组治疗1个月末、治疗2个月末、治疗3个月末、停药6个月末PSQI评分、改良KMI评分均明显均低于治疗前(P均<0.05),且中药队列组PSQI评分、改良KMI评分均明显低于同期激素队列组(P均<0.05)。2组治疗1个月末、治疗2个月末、治疗3个月末、停药6个月末ISI评分均明显低于治疗前(P均<0.05),且中药队列组治疗3个月末ISI评分明显低于同期激素队列组(P<0.05)。2组治疗1个月末、治疗2个月末、治疗3个月末、停药6个月末SAS评分、SDS评分均明显低于治疗前(P均<0.05),且中药队列组治疗1个月末、治疗2个月末SAS评分和停药6个月末SDS评分均明显低于同期激素队列组(P均<0.05)。结论中药和激素均能改善绝经相关睡眠障碍和绝经相关焦虑、抑郁状态;在改善睡眠质量方面,中药治疗2个月末、治疗3个月末、停药6个月末的疗效优于激素治疗;在改善绝经相关症状方面,中药在各个时间节点的疗效均优于激素治疗;在改善情绪状态方面,激素能够更迅速地改善绝经相关焦虑状态;在改善绝经相关抑郁状态方面,中药的疗效延续时间更长久。Objective It is to observe the efficacy and safety of therapy with Chinese medicine based on syndrome differentiation in the treatment of menopause-related sleep disorders through a prospective cohort study.Methods The data of 200 patients with menopause-related sleep disorders treated in 22 hospitals of Shanghai Quality Control Center from January 2021 to March 2022 were collected,and 188 cases finally completed the follow-up,including 96 cases in the traditional Chinese medicine cohort group and 92 cases in the hormone cohort group.The Chinese medicine cohort group was treated with Chinese medicine by oral administration based on syndrome differentiation,and the hormone cohort group was treated with fenmotepine and tibolone,both groups were treated for 3 months.The scores of Pittsburgh Sleep Quality Index(PSQI),Insomnia Severity Index(ISI),Modified Kupperman menopausal index(KMI),Hamilton Anxiety Scale(SAS),and Hamilton Depression Scale(SDS)at the 0th,1th,2th,and 3rd months of treatment and the 6th month after drug discontinuation of patients in the two groups were observed and compared.Results The PSQI scores and modified KMI scores at the end of 1 month,2 months and 3 months of treatment,and at the end of 6 months after drug discontinuation were significantly lower than those before treatment in the two groups(all P<0.05),and the PSQI scores and modified KMI scores in the herbal cohort group were significantly lower than those in the hormone cohort group during the same period(all P<0.05).The ISI scores at the end of 1 month,2 months and 3 months of treatment,and at the end of 6 months after drug discontinuation were significantly lower than those before treatment in the two groups(all P<0.05),and the ISI scores at the end of 3 months of treatment in the herbal cohort group were significantly lower than those in the hormone cohort group(all P<0.05).The SAS scores and SDS scores at the end of 1 month,2 months and 3 months of treatment,and at the end of 6 months after drug discontinuation were significantly low

关 键 词：绝经相关睡眠障碍 前瞻性队列研究 中医药 辨证论治 

分 类 号：R338.63[医药卫生—人体生理学]