| Objective: To observe the clinical efficacy and safety of Qinghuo Yangxin Anshen prescription in the treatment of insomnia with liver-fire disturbing heart type.Methods: A total of 60 patients who were admitted to the 4 departments of encephalopathy of Shijiazhuang Hospital of Traditional Chinese Medicine from November 2019 to August 2020 were selected.All of these patients were diagnosed as insomnia of Iiver-fire disturbing heart type after screening.A total of 60 patients randomly fell into two group: treatment group and control group,in which 30 patients were given Qinghuo Yangxin Anshen prescription as the treatment group,and the other 30 patients were given estazolam tablet as the control group.The treatment period of both groups was 4 weeks and observed after the end of the treatment.The Pittsburgh Sleep Quality Index(PSQI),TCM syndrome score,polysomnography(PSG)and safety indexes were evaluated in the two groups.We use the SPSS25.0statistical software to assess the clinical efficacy and safety of Qinghuo Yangxin Anshen prescription.Results:(1)Comparison of factor scores and total scores of PSQI: After treatment,the scores of each factor and total score of two groups were decreased to a certain extent compared with those before,with statistical significance(P<0.05).After treatment,there was no statistical significance in the factor scores and total scores of PSQI between the two groups(P>0.05).(2)Fractions of TCM symptoms and total fractions of TCM syndromes make comparisons: After treatment,the fractions of TCM symptoms and total fractions of TCM syndromes in both groups were decreased to a certain extent compared with those before treatment,with statistical significance(P<0.05).After treatment,the two groups of Chinese medicine symptoms of each component integral and total integral of Chinese medicine syndrome by comparison between groups,in the irritability,dizziness,red tinnitus,dry mouth bitter mouth,do not think about diet,constipation bare and total integral of Chinese medicine syndrome difference between the two groups has statistical significance(P<0.05),Compared with the control group,therapeutic effect of the treatment group is better.In improvement of the main symptom,two groups were no significant difference(P>0.05).(3)Comparison of PSG: After intra group comparison,the two Groups have statistically significant difference before and after treatment(P<0.05).After treatment,there were no significant differences in total sleep time(TST),sleep latency(SL),sleep efficiency(SE)and wakefulness times(AT)between the two groups(P>0.05).(4)Comparison of curative effect of sleep quality: After treatment,the total effective rate of two groups were no significant difference(P > 0.05),80.00% in the treatment group and 76.67% in the control group.(5)Comparison of curative effect of TCM syndromes: After treatment,two groups were no significant difference of curative effect of TCM syndromes(P<0.05).The effective rate of the treatment group was 93.33% and the effective rate of control group was66.67%.Compared with the control group,The therapeutic effect of the treatment group was better.(6)The comparison of security: there was no adverse reactions occurred in the entire research process in two groups.Conclusion:(1)Qinghuo Yangxin Anshen prescription and estazolam have the same effect in treating sleep quality of insomnia patients.(2)In terms of improving TCM syndromes,the therapeutic effect of oral Qinghuo Yangxin Anshen prescription group was higher than that of oral estazolam group.(3)Qinghuo Yangxin Anshen prescription has the same advantages in improving total sleep time,sleep latency,sleep efficiency and wakefulness times compared with estazolam.(4)Qinghuo Yangxin Anshen prescription has no adverse reactions in the treatment of insomnia patients,with high safety,which is worthy of further promotion in clinical practice. |
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