Objective  To explore the clinical efficacy of Chaiqi Ningshen Anmian Decoction (CNAD) combined with wrist ankle acupuncture (WAA) in treating chronic insomnia (CI) patients with heart and spleen deficiency.

Methods  CI patients diagnosed and treated at the Beijing Huairou Hospital of Traditional Chinese Medicine from April 2022 to April 2023 were selected, and patients were randomly divided into the Eszolam (ET) group and the combination group (CNAD combined with WAA) according to the random number table method, with 50 cases in each group. The primary outcome was clinical efficacy [evaluated by the Traditional Chinese Medicine Syndrome Integral (TCMSI)]. Secondary outcomes included changes in cognitive function [assessed by the Montreal Cognitive Assessment (MoCA)], anxiety level [assessed by the Hamilton Anxiety Scale (HAMA)], sleep quality [assessed by the Pittsburgh Sleep Quality Index (PSQI)], glycated serum albumin (GA), serotonin (5-HT), interleukin-1β (IL^-1β), and C-reactive protein (CRP) before and after treatment in both groups.

Results  Before treatment, there was no significant differences in total TCMSI between the two groups (P>0.05). After treatment, the total TCMSI of the combination group was significantly lower than that of the ET group (P<0.05), and the treatment effectiveness rate was significantly higher in the combination group (P<0.05). Before treatment, there were no significant differences in MoCA score, HAMA score, PSQI score, serum GA level, serum 5-HT level, serum IL^-1 level and serum CRP level between the groups (P>0.05). After treatment, the MoCA score, serum GA level, and serum 5-HT level in the combination group were significantly higher than those in the ET group (P<0.05), while the HAMA score, PSQI score, serum IL^-1β level, and serum CRP level were significantly lower in the combination group (P<0.05).

Conclusion  Compared with ET, CNAD combined with WAA significantly improves insomnia symptoms in CI patients with heart and spleen deficiency, enhances cognitive function and sleep quality, and reduces anxiety levels. This may be related to the upregulation of serum 5-HT, IL^-1β and the inhibition of the inflammatory response.

1.李振华, 徐应甲, 平莉, 等. “脐四边穴”配伍针刺联合理气宁心汤治疗气郁质失眠的临床疗效观察[J]. 辽宁中医药大学学报, 2024, 26(4): 84-87. [Li ZH, Xu YJ, Ping Li, et al. Clinical observation on the therapeutic effect of the combination of "navel four sided acupoints" and acupuncture combined with Liqi Ningxin decoction in the treatment of qi stagnation and insomnia[J]. Journal of Liaoning University of Traditional Chinese Medicine, 2024, 26(4): 84-87.] DOI: 10.13194/j. issn.1673-842x.2024. 04.015.

2.Huang BQ, Xu GX, Luo L. The effect of acupuncture on emotional disorders in patients with insomnia: a protocol for systemic review and meta-analysis[J]. Medicine, 2020, 99(51): e23754. DOI: 10.1097/MD.0000000000023754.

3.拜晓伟, 李彤彤, 唐李, 等. 睡眠障碍与糖尿病的研究进展[J]. 华西医学, 2024, 39(1): 140-146. [Bai XW, Li TT, Tang L, et al. Research progress on sleep disorder and diabetes[J]. West China Medicine, 2024, 39(1): 140-146.] DOI: 10.7507/1002-0179.202307163.

4.叶圆圆, 刘娟, 李文涛. 失眠与高血压相关性的Meta分析[J]. 中国循证医学杂志, 2022, 22(7): 822-828. [Ye YY, Liu J, Li WT. Meta analysis of the correlation between insomnia and hypertension[J]. Chinese Journal of Evidence Based Medicine, 2022, 22(7): 822-828.] DOI: 10.7507/ 1672-2531.202203033.

5.张璐, 张卫, 袁长红, 等. 经颅直流电刺激联合右佐匹克隆治疗慢性失眠患者的临床研究[J]. 天津医药, 2023, 51(11): 1227-1231. [Zhang L, Zhang W, Yuan CH, et al. Clinical study of transcranial direct current stimulation combined with right zopiclone in the treatment of chronic insomnia patients[J]. Tianjin Medical Journal, 2023, 51(11): 1227-1231.] DOI: 10.11958/20230429.

6.张喜, 袁霭凤, 党娇娇, 等. 慢性失眠中医证候特征初步研究[J]. 辽宁中医杂志, 2023, 50(7): 19-23. [Zhang X, Yuan AF, Dang JJ, et al. Preliminary study on the characteristics of traditional Chinese medicine syndromes in chronic insomnia[J]. Liaoning Journal of Traditional Chinese Medicine, 2023, 50(7): 19-23.] DOI: 10.13192/j. issn.1000-1719.2023.07.004.

7.阎加民, 史玉梅, 朱世丽, 等. 网络式失眠认知行为疗法联合艾司唑仑对慢性失眠患者的临床疗效[J]. 中华行为医学与脑科学杂志, 2021, 30(12): 1089-1094. [Yan JM, Shi YM, Zhu SL, et al. The clinical efficacy of network style insomnia cognitive-behavioral therapy combined with estazolam in patients with chronic insomnia[J]. Chinese Journal of Behavioral Medicine and Brain Science, 2021, 30(12): 1089-1094.] DOI: 10.3760/cma.j.cn371468-20210712-00392.

8.朱晓芸. 交通心肾安神贴外敷涌泉穴联合艾司唑仑对肿瘤患者心肾不交型失眠的临床研究[D]. 南京: 南京中医药大学, 2023. DOI: 10.27253/d.cnki.gnjzu.2022.000621.

9.魏艾贞. 自拟柴胡龙骨牡蛎汤联合艾司唑仑片治疗肝郁化火型慢性失眠患者的效果[J]. 中国民康医学, 2022, 34(12): 102-104, 108. [Wei AZ. The effect of self-made chaihu longgu oyster soup combined with estazolam tablet in treating chronic insomnia patients with liver qi stagnation and fire transforming type[J]. Medical Journal of Chinese People's Health, 2022, 34(12): 102-104, 108.] DOI: 10.3969/j. issn.1672-0369.2022.12.030.

10.陈妩荻, 金丹, 顾婷婷. 柴芪宁神安眠汤结合艾司唑仑片对心脾两虚证慢性失眠患者睡眠结构的调节作用及机制研究[J/OL]. 中华中医药学刊, 2024: 1-8. [Chen WD, Jin D, Gu TT. The regulatory effect and mechanism of chai qi ning shen an mian tang combined with eszolam tablets on the sleep structure of chronic insomnia patients with heart and spleen deficiency syndrome[J/OL]. Chinese Journal of Traditional Chinese Medicine, 2024: 1-8.] http://kns.cnki.net/kcms/detail/21.1546.R.20231101.1600.002.html.

11.薛彤瑶. 腕踝针结合调神通络针法治疗缺血性脑卒中后失眠（肝火扰心型）的临床疗效观察[D]. 天津: 天津中医药大学, 2023. DOI: 10.27368/d.cnki.gtzyy.2023.000372.

12.王雪. 隔药饼灸治疗寒湿凝滞型盆腔炎性疾病后遗症的疗效观察[D]. 济南: 山东中医药大学, 2022. DOI: 10.27282/d.cnki.gsdzu.2022.000830.

13.刘莉. 磁枣安神汤联合艾司唑仑片治疗心肾不交型不寐的临床疗效观察[D]. 湖北恩施: 湖北民族大学, 2024. DOI: 10.27764/d.cnki.ghbmz.2023.000141.

14.高思妍, 王丽彦, 黄慧芹, 等. 左归丸合交泰丸加减辨治老年原发性高血压病合并失眠(肝肾阴虚证)的效果及机制[J]. 辽宁中医杂志, 2021, 48(5): 109-112. [Gao SY, Wang LY, Huang HQ, et al. The effect and mechanism of modified Zuogui Pill combined with Jiaotai Pill in the treatment of elderly patients with primary hypertension complicated with insomnia(liver kidney yin deficiency syndrome)[J]. Liaoning Journal of Traditional Chinese Medicine, 2021, 48(5): 109-112.] DOI: 10.13192/j.issn.1000-1719.2021.05.029.

15.冯孝清, 田自菊, 黄巧莉. 渐进式康复护理对帕金森病患者认知功能及生活质量的影响[J]. 海南医学, 2020, 31(2): 267-270. [Feng XQ, Tian ZJ, Huang QL. The impact of progressive rehabilitation nursing on cognitive function and quality of life in patients with Parkinson's disease[J]. Hainan Medical Journal, 2020, 31(2): 267-270.] DOI: 10.3969/j. issn.1003-6350.2020.02.038.

16.赵兴蓉, 曹玉萍, 陈壮飞, 等. 团体现实疗法对轻中度广泛性焦虑障碍患者疗效的随机对照试验[J]. 中国心理卫生杂志, 2019, 33(4): 253-259. [Zhao XR, Cao YP, Chen ZF, et al. A randomized controlled trial of the efficacy of group reality therapy in patients with mild to moderate generalized anxiety disorder[J]. Chinese Mental Health Journa, 2019, 33(4): 253-259.] DOI: 10.3969/j. issn.1000-6729.2019.04.003.

17.张修红, 陈金雄, 郑关毅, 等. 甘麦芪仙磁石汤联合艾司唑仑片治疗老年慢性失眠心脾两虚证临床观察 [J]. 中国中西医结合杂志, 2020, 40(6): 666-671. [Zhang XH, Chen JX, Zheng GY, et al. Clinical observation on the combination of ganmai qixian cishi tang and eszolam tablets in the treatment of elderly chronic insomnia with heart and spleen deficiency syndrome[J]. Chinese Journal of Integrated Traditional Chinese and Western Medicine, 2020, 40(6): 666-671.] DOI: 10.7661/j.cjim. 20191104.190.

18.Freeman D, Sheaves B, Waite F, et al. Sleep disturbance and psychiatric disorders[J]. Lancet Psychiatry, 2020, 7(7):628-637. DOI: 10.1016/S2215-0366(20)30136-X.

19.Tsiptsios D, Leontidou E, Fountoulakis PN, et al. Association between sleep insufficiency and dyslipidemia：a cross-sec-tional study among Greek adults in the primary care setting[J]. Sleep Sci, 2022, 15 (Spec1): 49-58. DOI: 10.5935/1984-0063.20200124.

20.袁建平, 王江海. 褪黑激素新论—(2)老年人褪黑激素分泌与睡眠障碍[J]. 中国食品学报, 2002, (3): 54-62. [Yuan JP, Wang JH. A new theory on melatonin-(2) melatonin secretion and sleep disorders in elderly people[J]. Journal of Chinese Institute of Food Science and Technology, 2002, (3): 54-62.] DOI: 10.16429/j.1009-7848.2002.03.011.

21.林丽华. 中老年慢性失眠障碍与慢性病及全基因组DNA甲基化关联性研究[D]. 广州: 华南理工大学, 2022. DOI: 10.27151/d.cnki.ghnlu.2022.004089.

22.李莹雪, 葛义俊, 孔晓艺, 等. 慢性失眠患者血清神经营养因子改变及其与睡眠质量和认知功能的关系 [J]. 中华神经科杂志, 2020, 53(2): 85-90. [Li YG, Ge YJ, Kong XY, et al. Changes in serum neurotrophic factors and their relationship with sleep quality and cognitive function in patients with chronic insomnia[J]. Chinese Journal of Neurology, 2020, 53(2): 85-90.] DOI: 10.3760/cma.j.issn. 1006-7876.2020.02.002.

23.张玉梅, 喻娟, 余倩. 心神安胶囊联合佐匹克隆治疗阴虚火旺型失眠症的疗效及对患者多导睡眠图和5-HT、SIL-2R水平的影响[J]. 药物流行病学杂志, 2020, 29(6): 373-377. [Zhang YM, Yu J, Yu Q. The therapeutic effect of Xinshen'an capsules combined with zopiclone in the treatment of insomnia with yin deficiency and fire excess type, and its impact on polysomnography and levels of5-HT and SIL-2R in patients[J]. Chinese Journal of Pharmacoepidemiology, 2020, 29(6): 373-377.] DOI: 10.19960/j.cnki.issn1005-0698.2020.06.001.

24.李绍旦, 杨明会, 王振福, 等. 亚健康失眠人群脑内神经递质水平分析[J]. 中国全科医学, 2008, (1): 24-26. [Li SD, Yang MH, Wang ZF, et al. Analysis of neurotransmitter levels in the brain of sub healthy insomnia population[J]. Chinese General Practitioner, 2008, (1): 24-26.] DOI: 10.3969/j.issn.1007-9572.2008.01.009.

25.王岐鸣, 叶磊, 黄刚, 等. 米氮平对脑卒中后抑郁患者的效果及对其神经递质及下丘脑外侧区分泌素含量的影响[J]. 国际精神病学杂志, 2022, 49(6): 1045-1047, 1055. [Wang QM, Ye L, Huang G, et al. The effect of mirtazapine on post-stroke depression patients and its effects on neurotransmitters and secretion levels in the lateral hypothalamic region[J]. Journal of International Psychiatry, 2022, 49(6): 1045-1047, 1055.] DOI: 10.13479/j. cnki. jip.2022.06.033.

26.黄楷棋, 汤永红. 白细胞介素因子与慢性失眠的相互作用研究进展[J]. 中国神经免疫学和神经病学杂志, 2024, 31(1): 57-61. [Huang KQ, Tang YH. Research progress on the interaction between interleukin factors and chronic insomnia[J]. Chinese Journal of Neuroimmunology and Neurology, 2024, 31(1): 57-61.] DOI: 10.3969/j. issn.1006-2963.2024.01.010.

27.秦冰, 李莉, 刘芳翡, 等. 老年失眠患者血清miR-147表达与Treg/Th17水平的关系[J]. 中国老年学杂志, 2021, 41(19): 4290-4293. [Qin B, Li L, Liu FF, et al. The relationship between serum miR-147expression and Treg/Th17levels in elderly insomnia patients[J]. Chinese Journal of Gerontology, 2021, 41(19): 4290-4293.] DOI: 10.3969/j. issn.1005-9202.2021.19.041.

28.李莹雪, 陈贵海. 慢性失眠患者血液生物学标志物的研究进展[J]. 中国神经免疫学和神经病学杂志, 2018, 25(6): 399-402. [Li YX, Chen GH. Research progress on blood biological markers in patients with chronic insomnia[J]. Chinese Journal of Neuroimmunology and Neurology, 2018, 25(6): 399-402.] DOI: 10.3969/j. issn. 1006-2963.2018.06.003.

29.黄进学. 柴胡疏肝散加味对失眠伴高血压患者睡眠质量及焦虑抑郁情绪状态的影响[D]. 兰州: 甘肃中医药大学, 2023. DOI: 10.27026/d.cnki.ggszc.2022.000237.