Effect of<italic style="font-style: italic"> Yishen Ningxin Formula </italic>（益神宁心方） on Melatonin and Cortisol Levels in Saliva of Primary Insomnia Patients with Heart-spleen Deficiency Pattern

Jianing SHI; Ruijia CHAI; Yao HUANG; Tianjun JIANG; Yanying ZHU; Zhenxian ZHANG

doi:10.13288/j.11-2166/r.2021.24.009

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Effect of Yishen Ningxin Formula （益神宁心方） on Melatonin and Cortisol Levels in Saliva of Primary Insomnia Patients with Heart-spleen Deficiency Pattern

更新时间：2021-12-17

- Effect of Yishen Ningxin Formula （益神宁心方） on Melatonin and Cortisol Levels in Saliva of Primary Insomnia Patients with Heart-spleen Deficiency Pattern
- Journal of Traditional Chinese Medicine Vol. 62, Issue 24, Pages: 2157-2163(2021)
- 作者机构：
  
  上海中医药大学附属岳阳中西医结合医院，上海市甘河路110号，200437
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2021.24.009
  CLC：
- Received：18 July 2021，
  
  Revised：2021-09-20，
  
  Published：17 December 2021
- 稿件说明：
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史佳宁,柴瑞佳,黄瑶等.益神宁心方对原发性失眠心脾两虚型患者唾液褪黑素、皮质醇水平的影响[J].中医杂志,2021,62(24):2157-2163.

SHI Jianing,CHAI Ruijia,HUANG Yao,et al.Effect of Yishen Ningxin Formula （益神宁心方） on Melatonin and Cortisol Levels in Saliva of Primary Insomnia Patients with Heart-spleen Deficiency Pattern[J].Journal of Traditional Chinese Medicine,2021,62(24):2157-2163.
史佳宁,柴瑞佳,黄瑶等.益神宁心方对原发性失眠心脾两虚型患者唾液褪黑素、皮质醇水平的影响[J].中医杂志,2021,62(24):2157-2163. DOI： 10.13288/j.11-2166/r.2021.24.009.

SHI Jianing,CHAI Ruijia,HUANG Yao,et al.Effect of Yishen Ningxin Formula （益神宁心方） on Melatonin and Cortisol Levels in Saliva of Primary Insomnia Patients with Heart-spleen Deficiency Pattern[J].Journal of Traditional Chinese Medicine,2021,62(24):2157-2163. DOI： 10.13288/j.11-2166/r.2021.24.009.

摘要

目的

评价益神宁心方治疗原发性失眠心脾两虚型患者的临床疗效并探讨可能作用机制。

方法

将130例原发性失眠心脾两虚型患者随机分为治疗组和对照组各65例。治疗组给予益神宁心方治疗，每晚餐后半小时以温水冲服。对照组予酒石酸唑吡坦片治疗，每晚1次，每次10 mg，睡前顿服。两组疗程均为4周。于治疗前及治疗2、4周后进行中医证候积分量表评分、匹兹堡睡眠质量指数（PSQI）评分，并判定治疗4周后临床疗效及中医证候疗效；分别在治疗前后3天内采集同一天中12：00、16：00、20：00、24：00的唾液样本，检测唾液褪黑素（MT）、皮质醇（CORT）浓度。

结果

治疗组脱落1例，完成观察64例，对照组脱落3例，完成观察62例。治疗组的失眠临床总有效率与中医证候总有效率分别为92.19%、85.94%，高于对照组的83.87%、64.52%（

＜0.05）。治疗组治疗2周、4周后中医证候总积分及各单项评分均显著低于本组治疗前（

＜0.05），且治疗2周、4周时心悸、健忘、神疲乏力、纳谷不香、面色少华、舌象、脉象评分及总积分均低于对照组同期（

＜0.05）。治疗组治疗2周、4周后PSQI总积分及各成分评分均较治疗前显著降低（

＜0.05），且睡眠效率、睡眠障碍、催眠药物、日间功能障碍评分低于同期对照组（

＜0.05）。治疗组治疗4周后PSQI总积分低于同期对照组（

＜0.05）。治疗组治疗后患者24：00时唾液中MT浓度较治疗前显著升高，且高于对照组治疗后同时间点（

＜0.05）。两组患者治疗后12：00、16：00、20：00、24：00时唾液中CORT浓度均较治疗前下降（

＜0.05）。

结论

益神宁心方能有效改善原发性失眠心脾两虚型患者的临床症状及中医证候，其作用机制可能与调节患者唾液褪黑素、皮质醇水平及昼夜节律有关。

Abstract

Objective

To evaluate the clinical effect of

Yishen Ningxin Formula

（益神宁心方） in the treatment of primary insomnia due to heart and spleen deficiency， and to explore the possible mechanism.

Methods

Totally 130 primary insomnia patients with heart-spleen deficiency pattern were randomly divided into treatment group and control group with 65 patients in each group. The treatment group was given

Yishen Ningxin Formula

，taken with warm water half an hour after dinner， while the control group was treated with zolpidem tartrate tablets， once daily in the evening， 10 mg each time before sleep； the treatment course of both groups lasted for four weeks. The traditional Chinese medicine （TCM） syndrome score and Pittsburgh Sleep Quality Index （PSQI） score were assessed before treatment and two as well as four weeks after treatment； the clinical effect and TCM syndrome efficacy were evaluated after 4 weeks of treatment. Saliva samples at 12：00， 16：00， 20：00， and 24：00 in the same day within 3 days before and after treatment were tested for the concentration of melatonin （MT） and cortisol （CORT）.

Results

There were 64 complete cases and one drop-out in the treatment group， and 62 complete cases and three drop-outs in the control group. The total effective rate of insomnia and that of TCM syndromes in the treatment group were 92.19% and 85.94%， respectively， while those in the control group were 83.87% and 64.52% （

＜0.05）. After two weeks and four weeks of treatment， the score of overall TCM symptoms and of single symptom in the treatment group were decreased （

＜0.05）， and the scores of palpitations， poor memory， mental fatigue， poor appetite， pale complexion， tongue manifestation， pulse manifestation， and the overall score in the treatment group were lower than those in the control group （

＜0.05）. After two weeks and 4 weeks of treatment， the PSQI overall score and the domain scores in the treatment group significantly decreased （

＜0.05）， and the scores of sleep efficiency， sleep disturbances， use of sleeping medication， and daytime dysfunction in the treatment group were lower than those in the control group measured at the same timepoint （

＜0.05）. The total score of PSQI in the treatment group was lower than that in the control group after 4 weeks of treatment （

＜0.05）. The salivary MT at 24：00 significantly increased after treatment， and more increase was seen in the treatment group than in the control group （

＜0.05）. The levels of salivary CORT at 12：00. 16：00， 20：00 and 24：00 were significantly reduced after treatment in both groups （

＜0.05）.

Conclusion

Yishen Ningxin Formula

can effectively improve the clinical symptoms and TCM syndromes of patients with primary insomnia due to heart-spleen deficiency， and the mechanism may be related to its regulating effect on the levels of salivary MT and CORT and circadian rhythms.

关键词

Keywords

references

中华医学会神经病学分会，中华医学会神经病学分会睡眠障碍学组 . 中国成人失眠诊断与治疗指南（2017版）［J］. 中华神经科杂志， 2018 ， 51 （ 5 ）： 324 - 335 .

SOLDATOS CR ， ALLAERT FA ， OHTA T ， et al . How do individuals sleep around the world？ Results from a single-day survey in ten countries ［J］. Sleep Med ， 2005 ， 6 （ 1 ）： 5 - 13 .

时萌萌，刘春芳，郭岳瀚，等 . 唑吡坦不良反应文献分析［J］. 现代药物与临床， 2019 ， 34 （ 4 ）： 1252 - 1256 .

金巧俏 . 益神宁心方对原发性失眠的临床疗效及机制研究［D］. 上海：上海中医药大学， 2019 .

中华医学会精神科分会 . CCMD-3中国精神障碍分类与诊断标准［M］. 3版 . 山东：山东科学技术出版社， 2001 ： 112 - 113 .

中国中医科学院失眠症中医临床实践指南课题组 . 失眠症中医临床实践指南（WHO/WPO）［J］. 世界睡眠医学杂志， 2016 ， 3 （ 1 ）： 8 - 25 .

BUYSSE DJ ， REYNOLDS CF ， MONK TH ， et al . The Pittsburgh sleep quality index： a new instrument for psychiatric practice and research ［J］. Psychiat Res ， 1989 ， 28 （ 2 ）： 193 - 213 .

许琦 . 酒石酸唑吡坦与阿普唑仑治疗失眠症的成本-效果比较［J］. 中国药业， 2018 ， 27 （ 5 ）： 90 - 92 .

邓伟，贺佳 . 临床试验设计与统计分析［M］. 北京：人民卫生出版社， 2012 ： 127 - 128 .

李清伟，陆峥 . 成人慢性失眠症药物治疗的临床实践指南解读［J］. 世界临床药物， 2018 ， 39 （ 5 ）： 289 - 292 .

郑筱萸 . 中药新药临床研究指导原则（试行）［M］. 北京：中国医药科技出版社， 2002 ： 30 .

中华人民共和国卫生部 . 中药新药临床研究指导原则（第一辑）［M］. 北京：中华人民共和国卫生部， 1993 ： 186 - 187 .

李安洪，赵琴 . 1063例失眠患者证型分布及诊治规律探讨［J］. 陕西中医， 2014 ， 35 （ 2 ）： 158 - 159 .

陈士铎 . 本草新编［M］. 北京：中国医药科技出版社， 2011 ： 56 .

MONTI JM ， SPENCE DW ， BUTTOO K ， et al . Zolpidem's use for insomnia ［J］. Asian J Psychiatr ， 2017 ， 25 ： 79 - 90 . doi： 10.1016/j.ajp.2016.10.006 http://dx.doi.org/10.1016/j.ajp.2016.10.006 .

MOORE TJ ， MATTISON DR . Assessment of patterns of potentially unsafe use of zolpidem ［J］. JAMA Intern Med ， 2018 ， 178 （ 9 ）： 1275 - 1277 .

ZISAPEL N . New perspectives on the role of melatonin in human sleep，circadian rhythms and their regulation ［J］. Brit J Pharmacol ， 2018 ， 175 （ 16 ）： 3190 - 3199 .

ZISAPEL N . Circadian rhythm sleep disorders： pathophysiology and potential approaches to management ［J］. CNS Drugs ， 2001 ， 15 （ 4 ）： 311 - 328 .

DAWSON D ， ENCEL N . Melatonin and sleep in humans ［J］. J Pineal Res ， 1993 ， 15 （ 1 ）： 1 - 12 .

AULD F ， MASCHAUER EL ， MORRISON I ， et al . Evidence for the efficacy of melatonin in the treatment of primary adult sleep disorders ［J］. Sleep Med Rev ， 2017 ， 34 ： 10 - 22 . doi： 10.1016/j.smrv.2016.06.005 http://dx.doi.org/10.1016/j.smrv.2016.06.005 .

SLETTEN TL ， VINCENZI S ， REDMAN JR ， et al . Timing of sleep and its relationship with the endogenous melatonin rhythm ［J］. Front Neurol ， 2010 ， 1 ： 137 . doi： 10.3389/fneur.2010.00137 http://dx.doi.org/10.3389/fneur.2010.00137 .

DICKERSON SS ， KEMENY ME . Acute stressors and cortisol responses： a theoretical integration and synthesis of laboratory research ［J］. Psychol Bull ， 2004 ， 130 （ 3 ）： 355 - 391 .

VARGAS I ， VGONTZAS AN ， ABELSON JL ， et al . Altered ultradian cortisol rhythmicity as a potential neurobiologic substrate for chronic insomnia ［J］. Sleep Med Rev ， 2018 ， 41 ： 234 - 243 . doi： 10.1016/j.smrv. 2018. 03.003 http://dx.doi.org/10.1016/j.smrv.2018.03.003 .

秦海波，吴斌，胡文东，等 . 72h睡眠剥夺对志愿者Stroop色词测验、唾液皮质醇及褪黑素的影响［J］. 航天医学与医学工程， 2018 ， 31 （ 4 ）： 420 - 424 .

WANG ZJ ， ZHANG XQ ， CUI XY ， et al . Glucocorticoid receptors in the locus coeruleus mediate sleep disorders caused by repeated corticosterone treatment ［J］. Sci Rep ， 2015 ， 5 ： 9442 . doi： 10.1038/srep09442 http://dx.doi.org/10.1038/srep09442 .

ROEHRS T ， ROTH T . Hyperarousal in insomnia： pre-sleep and diurnal cortisol levels in response to chronic zolpidem treatment ［J］. Sleep Med ， 2019 ， 61 ： 52 - 56 . doi： 10.1016/j.sleep.2019.04.010 http://dx.doi.org/10.1016/j.sleep.2019.04.010 .

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Effect of Yishen Ningxin Formula （益神宁心方） on Melatonin and Cortisol Levels in Saliva of Primary Insomnia Patients with Heart-spleen Deficiency Pattern

DOI：10.13288/j.11-2166/r.2021.24.009

摘要

Abstract

关键词

Keywords

references