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1.濮阳医学高等专科学校,河南 濮阳 457000;
2.濮阳市人民医院,河南 濮阳 457000;
3.河南中医药大学 第二附属医院,郑州 450002
赵杰荣,教授级高级讲师,从事中医教学、临床与科研工作,E-mail:pywsxx2659@163.com
收稿日期:2019-04-10,
网络出版日期:2019-05-30,
纸质出版日期:2019-10-20
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赵杰荣, 赵书豪, 郑伟峰. 六味地黄丸合黄连阿胶汤加减治疗老年原发性失眠肝肾阴虚证的临床观察[J]. 中国实验方剂学杂志, 2019,25(20):94-99.
Jie-rong ZHAO, Shu-hao ZHAO, Wei-feng ZHENG. Observation of Addition and Subtraction Therapy of Liuwei Dihuangwan Combined with Huanglian Ejiaotang to Primary Insomnia in Elderly Liver and Kidney Yin Deficiency Syndrome[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(20): 94-99.
赵杰荣, 赵书豪, 郑伟峰. 六味地黄丸合黄连阿胶汤加减治疗老年原发性失眠肝肾阴虚证的临床观察[J]. 中国实验方剂学杂志, 2019,25(20):94-99. DOI: 10.13422/j.cnki.syfjx.20191833.
Jie-rong ZHAO, Shu-hao ZHAO, Wei-feng ZHENG. Observation of Addition and Subtraction Therapy of Liuwei Dihuangwan Combined with Huanglian Ejiaotang to Primary Insomnia in Elderly Liver and Kidney Yin Deficiency Syndrome[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(20): 94-99. DOI: 10.13422/j.cnki.syfjx.20191833.
目的:
2
观察六味地黄丸合黄连阿胶汤加减治疗老年原发性失眠(肝肾阴虚证)的临床疗效及对神经递质的调节作用。
方法:
2
将136例患者随机分为对照组和观察组各68例。对照组睡前口服艾司唑仑片,1~2 mg/次,1次/d。观察组内服六味地黄丸合黄连阿胶汤加减,1剂/d。两组均给予睡眠及认知行为指导,均连续治疗8周,观察期间均禁用物理疗法、针灸等措施。进行治疗前后匹兹堡睡眠质量指数(PSQI)和整夜多导睡眠监测,记录睡眠潜伏期(SL),觉醒次数(AT),睡眠效率(SE),快速动眼(REM),潜伏期(RL),实际睡眠总时间(TST),睡眠阶段N1,N2,N3和REM占整个睡眠时间的百分比等指标;进行治疗前后抑郁自评量表(SDS),焦虑自评量表(SAS)和肝肾阴虚证评分;检测治疗前后5-羟色胺(5-HT),5-羟吲哚乙酸(5-HIAA),
γ
-氨基丁酸(GABA),去甲肾上腺素(NE)和多巴胺(DA)水平;进行副反应量表(TESS)评分。
结果:
2
经秩和检验,观察组PSQI疗效优于对照组(
Z
=2.115,
P
<
0.05);观察组PSQI各因子评分和PSQI总分均低于对照组(
P
<
0.01);观察组SL,RL,N2均少于对照组(
P
<
0.01),AT次数少于对照组(
P
<
0.01),TST,Nl,N3均长于对照组(
P
<
0.01),SE,REM比例均高于对照组(
P
<
0.01);观察组SDS,SAS和肝肾阴虚证评分均低于对照组(
P
<
0.01);观察组5-HT,GABA,5-HIAA水平均高于对照组(
P
<
0.01),NE,DA水平均低于对照组(
P
<
0.01);观察组不良反应累积发生率为8.2%,低于对照组的31.03%(
χ
2
=9.945,
P
<
0.01);观察组TESS评分低于对照组(
P
<
0.01)。
结论:
2
六味地黄丸合黄连阿胶汤治疗老年慢性失眠(肝肾阴虚证)可提高睡眠质量,延长睡眠时间,并可减轻抑郁、焦虑程度、还可调节神经递质,起到改善睡眠效果,PSQI疗效优于艾司唑仑片,且安全性更好。
Objective:
2
To observe the clinical efficacy of addition and subtraction therapy of Liuwei Dihuangwan combined with Huanglian Ejiaotang to primary insomnia in the elderly (liver and kidney Yin deficiency syndrome)
and to investigate its regulation effect on neurotransmitter.
Method:
2
Randomly 136 patients were divided into control group (68 cases) and observation group (68 cases) by number table. Patients in control group got Estazolam tablets by oral administration before going to bed
1-2 mg/time
1 time/day. Patients in observation group got addition and subtraction therapy of Liuwei Dihuangwan combined with Huanglian Ejiao tang
1 dose/day. Both groups of patients received sleep guidance and cognitive behavior guidance
with treatment course of 8 weeks. During the observation period
physical therapy and acupuncture could not been used. Before and after treatment
pittsburgh sleep quality index (PSQI)
whole night polysomnography
sleep latency (SL)
awakening times (AT)
sleep efficiency (SE)
rapid eye movement (REM)
latency (RL)
total actual sleep time (TST) and proportion of N1
N2
N3 and REM in the whole sleep stage were recorded. Scores of self-rating depression scale (SDS)
self-rating anxiety scale (SAS)
kidney Yin deficiency syndrome score and treatment emergent symptom scale (TESS) were graded
and levels of 5-hydroxytryptamine (5-HT)
5-hydroxyindole acetic acid(5-HIAA)
gamma-aminobutyric acid (GABA)
norepinephrine (NE) and dopamine (DA) were detected.
Result:
2
In rank sum test
clinical efficacy in observation group was better than that in control group (
Z
=2.115
P
<
0.05). Scores of various PSQI factors and total scores of PSQI in observation group were significantly lower than those in control group (
P
<
0.01). SL
RL
N2
AT were less than those in control group (
P
<
0.01). TST
Nl and N3 were longer than those in control group (
P
<
0.01). SE and REM proportions were higher than those in control group (
P
<
0.01). Scores of SDS
SAS
liver and kidney Yin deficiency syndrome and TESS were lower than those in control group (
P
<
0.01). Levels of 5-HT
GABA and 5-HIAA in observation group were higher than those in control group (
P
<
0.01)
while levels of NE and DA were lower than those in control group (
P
<
0.01). Cumulative incidence of adverse reactions in observation group was 8.2%
lower than 31.03%in control group (
χ
2
=9.945
P
<
0.01).
Conclusion:
2
Addition and subtraction therapy of Liuwei Dihuangwan combined with Huanglian Ejiaotang can improve sleep quality
prolong sleep time
alleviate depression
anxiety
and can also regulate neurotransmitters to improve sleep effect. The efficacy of PSQI is better than that of Estazolam tablets.
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