| Objective:In this study,Ning Xin An Shen Fang was used to treat chronic insomnia with anxiety(blood deficiency and liver fever),to observe the clinical efficacy of Ning Xin An Shen Fang,and to further explore Ning Xin Anshen Fang to treat chronic insomnia with anxiety(blood deficiency liver fever).The mechanism of action is expected to provide more ideas and methods for the clinical treatment of chronic insomnia with anxiety.Methods:A randomized,double-blind,placebo-controlled trial was used to randomly divide 62 patients with chronic insomnia with anxiety(blood deficiency and liver fever)into an observation group and a control group,each with 31 cases;the observation group was given Ningxin Anshenfang granules For treatment,the control group was given placebo granules and boiled with water before half an hour before going to bed every night.The treatment time was 4 weeks,followed up for 4 weeks;PSQI,HAMA,and ISI scores were performed before treatment,2 weeks,4 weeks,and 4 weeks of follow-up;22 cases were randomly selected from the observation group and the control group by random sampling Before and after treatment,enzyme-linked immunosorbent assay(ELISA)was used to determine inflammatory cytokines,and colorimetric method(TBA method)was used to determine the changes of free radicals and antioxidant enzyme levels;safety indicators were tested before and after treatment,and the treatment period was recorded in time Adverse reactions.Result:1.Clinical efficacy evaluation:The PSQI index reduction rate before and after treatment is the main clinical efficacy evaluation index.The total effective rate of the observation group is 86.67%,and the total effective rate of the control group is 33.33%.The difference is statistically significant;The score reduction rate is an index for evaluating the efficacy of anxiety improvement.The total effective rate of the observation group is 86.67%;the total effective rate of the control group is 36.67%,the difference is statistically significant.2.Improvement of sleep quality:PSQI and ISI scores of the two groups were significantly reduced during the 2nd and 4th weekends of treatment,and the difference was statistically significant;PSQI scores in the observation group during the 2nd weekend treatment and PSQI and ISI scores in the observation group during the 4th weekend treatment were significantly lower The difference was statistically significant in the group;the PSQI and ISI scores of the observation group were significantly lowered during the 4-week follow-up,and were significantly lower than the control group.The difference was statistically significant.3.Improvement of anxiety status:HAMA scores of the observation group during the treatment of 2 weekends,4 weekends and follow-up 4 weekends were significantly reduced,the difference was statistically significant;HAMA scores of the observation group during the 4 weeks treatment and 4 weeks follow-up were significantly lower than the control group,the difference It was statistically significant;after 4 weeks of treatment,the HAMA score of the control group decreased significantly,and the difference was statistically significant.4.Serological indicators4.1 Inflammatory cytokines:the levels of IL-1β,IL-6,and TNF-α in the observation group were significantly reduced;the levels of IL-1β,IL-6,and TNF-α in the observation group were significantly lower than those in the control group,and the difference was statistically significant significance.After control treatment,the levels of IL-1β,IL-6,and TNF-α increased,and the difference was not statistically significant.4.2 Free radicals and antioxidant enzymes:the MD A level of the observation group was significantly reduced after treatment,and the levels of CAT,SOD and GSH-PX were significantly increased,the difference was statistically significant;the MDA level of the observation group after treatment was significantly lower than that of the control group,CAT,SOD and GSH-PX levels were significantly higher than the control group,the difference was statistically significant.After treatment,the level of MDA in the control group increased,and the levels of CAT,SOD,and GSH-PX decreased.There was no statistically significant difference.Conclusion:Ningxin Anshen Recipe can effectively improve the sleep quality of chronic insomnia with anxiety(blood deficiency and liver heat type)and relieve anxiety,which is significantly better than placebo;Ningxin Anshen Recipe can regulate the level of inflammatory cytokines to a certain extent,Reduce the body’s inflammatory response,reduce the damage of oxidative stress in serum,and then explain that it may be the target of the mechanism of action of Ningxin Anshen Recipe to improve chronic insomnia with anxiety;no obvious adverse events occur during the treatment process,and the safety is high,and It is convenient to take clothes before going to bed,which is worthy of further clinical research. |