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1.重庆市中医院,重庆 400021
2.福建省漳州市中医院,福建 漳州 363099
米秀娟,博士,副主任医师,从事神经内科临床工作,E-mail:457992994@qq.com
陈静,副主任医师,从事失眠的中医药研究,E-mail:chenjing_czy@163.com
收稿日期:2022-04-04,
网络出版日期:2022-06-22,
纸质出版日期:2022-08-20
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米秀娟,方俊南,余鑫源等.滋水补肝汤治疗围绝经期肝肾亏虚型失眠的临床疗效[J].中国实验方剂学杂志,2022,28(16):116-122.
MI Xiujuan,FANG Junnan,YU Xinyuan,et al.Clinical Efficacy of Zishui Bugan Decoction on Perimenopausal Insomnia Patients with Liver-kidney Deficiency[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(16):116-122.
米秀娟,方俊南,余鑫源等.滋水补肝汤治疗围绝经期肝肾亏虚型失眠的临床疗效[J].中国实验方剂学杂志,2022,28(16):116-122. DOI: 10.13422/j.cnki.syfjx.20221696.
MI Xiujuan,FANG Junnan,YU Xinyuan,et al.Clinical Efficacy of Zishui Bugan Decoction on Perimenopausal Insomnia Patients with Liver-kidney Deficiency[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(16):116-122. DOI: 10.13422/j.cnki.syfjx.20221696.
目的
2
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
2
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
2
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
2
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
2
To evaluate the efficacy of Zishui Bugan decoction
on perimenopausal insomnia of liver-kidney deficiency type and the safety.
Method
2
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
2
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
2
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.
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