摘要
目的:观察滋水补肝汤治疗围绝经期肝肾亏虚型失眠的有效性及安全性。方法:采用随机、双盲、安慰剂对照试验方法,将重庆市中医院脑病科门诊收治的72例围绝经期肝肾亏虚型失眠患者按1∶1比例随机分为观察组及对照组,分别给予滋水补肝汤和安慰剂治疗,疗程3周。观察治疗前后两组患者的主观睡眠情况,采用匹茨堡睡眠质量指数(PSQI)减分率进行失眠疗效评价,并观察两组患者治疗前后的围绝经期症状改良Kupperman评分、中医证候评分、焦虑自评量表(SAS)评分、抑郁自评量表(SDS)评分变化情况,以及安全性和不良反应发生情况。结果:观察组失眠总有效率为85.3%(29/34),对照组为17.6%(6/34),观察组总有效率显著高于对照组,差异具有统计学意义(Z=-5.582,P<0.01);与本组治疗前比较,两组患者PSQI评分、改良Kupperman评分、中医证候积分、SAS评分较治疗前均有所改善(P<0.05,P<0.01),且观察组明显优于对照组(P<0.05,P<0.01)。两组治疗前后安全性指标差异无统计学意义,均未见明显不良反应。结论:滋水补肝汤可提高患者主观睡眠质量,减轻围绝经期症状,改善焦虑及抑郁情绪,对围绝经期肝肾亏虚型失眠具有较好的临床疗效,且安全性良好。
Objective:To evaluate the efficacy of Zishui Bugan decoction on perimenopausal insomnia of liver-kidney deficiency type and the safety.Method:A randomized,double-blind,placebo-controlled trial was designed.To be specific,72 patients of perimenopausal insomnia with Liver-kidney deficiency were randomized into the treatment group and the control group at the ratio of 1∶1 and they were respectively treated with Zishui Bugan decoction and placebo for 3 weeks.The Pittsburgh sleep quality index(PSQI),modified Kupperman index,traditional Chinese medicine(TCM)syndrome score,self-rating anxiety scale(SAS)score,and self-rating depression scale(SDS)score,were compared before and after treatment to determine the clinical efficacy,with adverse effects recorded.Result:The total effective rate for insomnia was 85.3%(29/34)in treatment group and 17.6%(6/34)in control group(Z=-5.582,P<0.01).After treatment,PSQI score,modified Kupperman index,TCM syndrome score,and SAS score were improved in both groups(P<0.05,P<0.01),particularly the treatment group which showed significant difference from the control group(P<0.05,P<0.01).The safety indicators were insignificantly different between two groups before and after treatment.No related adverse effects were reported in both groups during the treatment.Conclusion:Zishui Bugan decoction can improve the sleep quality and alleviate the menopausal symptoms,such as depression and anxiety,which shows ideal efficacy and safety for the perimenopausal insomnia with liver-kidney deficiency type.
作者
米秀娟
方俊南
余鑫源
罗招亮
唐军
陈静
MI Xiujuan;FANG Junnan;YU Xinyuan;LUO Zhaoliang;TANG Jun;CHEN Jing(Chongqing Traditional Chinese Medicine(TCM)Hospital,Chongqing 400021,China;Zhangzhou TCM Hospital,Zhangzhou 363099,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2022年第16期116-122,共7页
Chinese Journal of Experimental Traditional Medical Formulae
基金
重庆市科技局科研机构绩效激励引导专项(cstc2019jxjl130016)
重庆市中医院名老中医药专家传承工作室建设项目(cqzyymzygzs-017)。
关键词
滋水补肝汤
失眠
围绝经期
随机对照临床试验
补肝汤
六味地黄丸
Zishui Bugan decoction
insomnia
perimenopause
randomized controlled clinical trial
Bugantang
Liuwei Dihuangwan
