| Objective:To observe the clinical efficacy and safety of Shuanghe Zaoren Granule in the treatment of primary insomnia of yin deficiency and huowang type,the aim is to provide safer and more effective drugs for patients with primary insomnia.Methods: Observed subjects were from outpatients and inpatients in our hospital's Department of Neurology from September 2018 to August 2019.Using a randomized control design,the 80 cases collected were randomly divided into a treatment group and a control group with 40 cases each.The treatment group was given Shuanghe Zaoren Granule(provided by the preparation room of our hospital,4.5g per bag),1 bag / time,orally,once in the morning and evening,take it with boiling water.The control group was given 1 mg of estazolam(batch number: word H11020891,Beijing Yimin Pharmaceutical Co.,Ltd.),taking 1 capsule every night before going to sleep.The two groups were treated for 2 weeks as a course of treatment.After the end of a course of treatment,the main parameters of sleep EEG before and after medication,Pittsburgh Sleep Quality Index Scale(PSQI)and TCM syndrome score were analyzed and compared.Results:1.Before medication,the gender,age,duration of illness,main parameters of sleep EEG,Pittsburgh Sleep Quality Index Scale,and TCM symptom score were compared between the two groups.Statistical analysis showed that the difference was not statistically significant(P> 0.05).2.After medication:(1)Comparison of sleep electroencephalogram: first compare the two groups,the results suggest that the sleep process,sleep structure and other parameters of the two groups are improved compared with before treatment,the difference is statistically significant(P <0.05);comparison between groups,treatment group SL,AT,and ASA were significantly higher than the control group,suggesting that there was a statistical difference,suggesting that Shuanghe Zaoren Granules improved sleep progress indicators better than estazolam;the S3 and S4 of the treatment group were significantly higher than the control group,suggesting that there was a statistical difference,indicating that Shuanghe Zaoren Granule can improve the sleep structure more.(2)Comparison of PSQI scores between the two groups: The two groups were first compared within the group,and the results showed that the PSQI scores of the two groups had decreased,and the difference was statistically significant(P <0.05).Then compare between groups.SL,AT,and ASA in the treatment group were significantly higher than those in the control group.After testing,P = 0.003,P = 0.028,P = 0.000,(P<0.05),suggesting statistical differences.The treatment group was superior to the control group in improving SL,AT,and ASA in sleep progress.The S3 and S4 in the treatment group were significantly higher than those in the control group.After testing,P = 0.030 and P = 0.029(P <0.05),suggesting that Statistical difference,the treatment group is better than the control group in improving sleep structure S3,S4.(3)Comparison of TCM symptom scores between the two groups: First the two groups were compared within the group,and the results showed that the TCM symptom scores of the two groups had decreased,and the difference was statistically significant compared with before treatment(P <0.05).The comparison between the two groups showed that the difference was statistically significant(P <0.05),and the results in the treatment group were better than those in the control group.(4)Comparison of clinical efficacy between the two groups.The total effective rate in the treatment group was 92.5% and the total effective rate in the control group was87.5%.There was no difference between the two groups(P>0.05),The clinical efficacy of Shuanghe Zaoren Granule is better than that of the control group.Conclusion: Shuanghe Zaoren Granule has a significant effect on the treatment of primary insomnia of yin deficiency and fire-wang type,and no obvious adverse reactions have been found,It is an effective drug for the treatment of primary insomnia of Yin deficiency and Huowang type... |
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