| Objective: To observe the clinical effect of Huanglian and Ejiao combined with Suanzaoren decoction in the treatment insomnia of Yin deficiency and Fire-excess Syndromeand,provide more evidence for clinical application.Methods: According to the diagnostic criteria of insomnia in traditional Chinese medicine and western medicine,Sixty subjects with insomnia of TCM symptoms with Yin Deficiency and Fire-excess type were enrolled in this study,who went to the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine from January 2020 to January 2021 for diagnosis and treatment of encephalopathy area I outpatient.According to random number table,the sixty subjects were divided into treatment group(n= 30)and control group(n = 30).The control group was treated with Dexzopiclone tablet(Take 3mg once a day,half an hour before sleeping),while the treatment group was treated with Huanglian and Ejiao combined with Suanzaoren decoction(Take 200 ml twice a day,half an hour after lunch and supper).Each group was treated for 14 days as one course,and there were2 courses in total.Before and after treatment,The TCM syndrome score,Pittsburgh sleep quality index and overall clinical efficacy of the two groups of subjects were evaluated,and the safety was observed.Results:(1)The baseline to compare: Before treatment,there was no difference and no statistical significance in age,gender and course of disease between the two groups,(P>0.05),indicating comparability there was no statistical significance between the two groups in terms of age,gender and course of disease,(P>0.05).(2)Clinical effect: After 28-day intervention,The clinical efficacy is83.3% and 94.4% respectively between the control group and the treatment group.In comparison of clinical efficacy,the difference was not obvious and not statistically significant between the two groups(P>0.05),indicating that the treatment group and the control group had similar overall efficacy in the treatment of insomnia with Yin deficiency and Fire-excess syndrome.(3)TCM symptom grading quantitative score: Before and after treatment,in comparison of the total scores of the subjects of two groups,and it was found that the total scores of the treatment group and the control group were more decreased than before treatment,and there was a significant difference(P<0.05).Comparing the two groups after treatment,it was found that the total score of the treatment group decreased more significantly than that of the control group(P<0.05).Shows that the treatment group is better than the control group in treating TCM symptoms,(P<0.05).(4)The Efficacy of Sleep Quality:(1)The total effective rate of the treatment group and the control’s were 93.3% and 76.7% Respectively.In the treatment group,7 cases were full recovered,18 cases were markedly effective,3 cases were effective,and 2 cases were ineffective.In the treatment group,5 cases were full recovered,11 cases were markedly effective,7 cases were effective,and 7 cases were ineffective.After treatment,comparison of the efficacy of sleep quality between the two groups,there were difference significant and Statistical significance,(P<0.05).(2)After treatment,the Various factors and total scores of PSQI were obviously improved than before in the control groups and the treatment group.The difference is statistically significant.The difference is statistically significant before treating.Compared with the control group,the treatment group improved significantly in terms of sleep quality,time to fall asleep,sleep disturbance and daytime function,(P<0.05).The difference is statistically significant.The difference in sleep time and sleep efficiency were compared.No statistically significant,(P>0.05)(5)Safety: After treatment,no adverse reactions were observed in the two groups,and no obvious abnormalities were observed in blood routine and Electrocardiogram indicators..Conclusion:Huanglian and Ejiao combined with Suanzaoren decoction with the effect of Yin-Enriching and Fire-Downbearing and Nourishing Blood and Tranquilization can effectively improve the sleep quality index and TCM syndrome integral of Yin Deficiency and Fire-excess insomnia,and it improve sleep quality,speed up the time to fall asleep,reduce daytime dysfunction,improve the quality of daily life of patients,with definite clinical efficacy,good safety and non-toxic side effects. |