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Clinical observation on the treatment of anxiety insomnia by invigorating spleen and clearing stomach and resolving phlegm combined with ezopiclone and its effect on serum 5-hydroxytryptamine and 25-hydroxyvitamin D3 levels
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DOI   10.11656/j.issn.1672-1519.2021.11.06
Key Words   anxiety insomnia;invigorating spleen and clearing stomach and removing phlegm method;ezopiclone;efficacy;5-hydroxytryptamine;25-hydroxy vitamin D3
Author NameAffiliationE-mail
DONG Lu Insomnia Clinic, The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang 050000, China  
YOU Xiaoyan Insomnia Clinic, The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang 050000, China  
LI Ling Insomnia Clinic, The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang 050000, China  
GAO He Insomnia Clinic, The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang 050000, China  
ZHANG Xun Insomnia Clinic, The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang 050000, China  
CHENG Li Insomnia Clinic, The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine, Shijiazhuang 050000, China chengli36524@qq.com 
Abstract
    [Objective] To observe the clinical efficacy and safety of invigorating spleen and clearing stomach and removing phlegm method combined with ezopiclone tablets in treating anxiety insomnia and its effect on serum 5-hydroxytryptamine and 25-hydroxyvitamin D3 levels. [Methods] From October 2018 to May 2020,114 patients with anxiety insomnia in insomnia clinic of The First Affiliated Hospital of Hebei College of Traditional Chinese Medicine were randomly divided into 3 groups,38 cases in each group according to random digital table method. The western medicine group took ezopiclone tablets orally,2 milligram before bedtime;the traditional Chinese medicine group took the traditional Chinese medicine granule based on invigorating spleen and clearing stomach and removing phlegm method,1 dose per day;combined group took the traditional Chinese medicine free decoction granule based on invigorating spleen and clearing stomach and removing phlegm method and the ezopiclone tablets simultaneously. The course of treatment was 4 weeks. Before treatment,the PSQI scores,HAMA scores,sleep time,sleep maintenance time,serum 5-hydroxytryptamine and 25-hydroxyvitamin D3 levels,and adverse reactions were compared before and after 2 weeks and 4 weeks of treatment,and the sleep time and sleep maintenance time were observed 4 weeks after withdrawal. [Results] After 4 weeks all groups received good effect. After 4 weeks of treatment,the PSQI scores,HAMA scores and sleep time of the combined group were significantly lower than that of the traditional Chinese medicine group and the western medicine group (P<0.05),and the sleep maintenance time was significantly longer than that of the traditional Chinese medicine group and the western medicine group (P<0.05);the levels of serum 5-HT and 25(OH) D3 in the three groups were higher than those before treatment,and the levels in the combined group were higher than those in western medicine group and traditional Chinese medicine group (P<0.05);the incidence of adverse reactions in western medicine group and traditional Chinese medicine group was 21.05% and 7.89% respectively,which was significantly higher than 2.63% in the combined group,the difference was statistically significant (P<0.05). Four weeks after withdrawal,the sleep time and sleep maintenance time of the combined group were better than that of the western medicine group and the traditional Chinese medicine group (P<0.05). [Conclusion] Invigorating spleen and clearing stomach and removing phlegm methods combined with ezopiclone tablets can effectively improve insomnia and anxiety symptoms,and can further improve the serum levels of 5-HT and 25(OH)D3 in patients. The clinical effect is accurate,the adverse reaction is small,and the long-term effect is good.

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