| Objective:With the increasing stress of life and work,the incidence of insomnia is increasing gradually,which has had a great impact on people’s physical and mental health.In this study,a randomized controlled trial was conducted to observe the clinical efficacy of Anshen No.1 in the treatment of liver-fire and phlegm-heat insomnia,and to explore its mechanism and characteristics of drug use in order to provide more ideas and methods for the clinical treatment of insomnia.Methods:According to the principle of randomization,the selected cases were divided into two groups: the treatment group and the control group,with 30 cases in each group.The patients were divided into two groups: the treatment group(n=30)and the control group(n=30).Before the treatment,the basic data of the two groups,such as sex,age,course of disease,the degree of TCM condition,the proportion of TCM symptoms,the integral of TCM syndrome,and the PSQI score,were compared and the results showed that there was no statistical difference between the two groups.Comparable.In the treatment aspect,the Chinese medicine group was treated with Anshen 1 prescription,3 times a day,each time 200 ml,and the patent medicine group was treated with Patrinia tablets 3 times a day.Each time 3 tablets,the course of treatment in both groups was 4 weeks.After treatment,SPSS23.0 software was used to analyze the data of related therapeutic efficacy indexes,and the corresponding conclusions were drawn by observing the degree of improvement of clinical symptoms before and after treatment and the statistical analysis results.Results:In this study,there were no adverse reactions in the traditional Chinese medicine group,one case of epigastric discomfort and one case of mild diarrhea occurred in the patent medicine group,and all of them were able to continue to participate in the experimental study after related symptomatic treatment.Blood and urine routine,liver and kidney function and ECG were monitored before and after treatment.The body temperature,heart rate,blood pressure and pulse of the two groups were measured many times during the treatment,and no significant fluctuations were observed.The following results were obtained after statistical treatment of the related clinical efficacy indicators:(1)The comparability analysis of the two groups before treatment showed that there was no statistical difference in sex,age,course of disease,severity of illness,TCM syndrome score and PSQI score between the two groups(P>0.05).(2)By comparing the changes of TCM syndrome integral before and after treatment,it was concluded that the TCM syndrome integral of both the Chinese medicine group and the patent medicine group could be effectively reduced,and the difference between the two groups after treatment was statistically significant(P<0.05).It shows that Anshen No.1 prescription can obviously reduce the integral of TCM syndrome and improve the symptoms of TCM,and the curative effect is better than that of patent medicine group.(3)By comparing the changes of PSQI scores before and after treatment,it was concluded that both the traditional Chinese medicine group and the adult medicine group could effectively reduce the PSQI score,and there was a significant difference between the two groups after treatment(P<0.05).The results showed that Anshen No.1 could significantly reduce the PSQI score,and the curative effect was better than that of the patent medicine group.(4)By comparing the curative effect of TCM syndrome after treatment,the effective rate of Chinese medicine group and patent medicine group were 86.67% and 70.00%,respectively.There was statistical difference between the two groups(P<0.05).It shows that Anshen1 prescription is superior to patent medicine group in the curative effect of TCM syndrome.(5)The effective rates of the two groups were 83.33% and 66.67%,respectively,and there was a statistical difference between the two groups(P<0.05).The effect of Anshen No.1 on the overall clinical effect was better than that of the control group.(6)The recurrence rate of the traditional Chinese medicine group was10.34% and 35.71%,respectively,and there was a statistical difference between the two groups(P <0.05).The results indicated that the curative effect of Anshen No.1 was more stable than that of the control group.(7)The results showed that there was no significant difference in curative effect among different age groups,different course stages and different severity of the disease(P>0.05),there was statistical difference in curative effect among different courses of treatment(P<0.05).The results showed that the curative effect of Anshen 1 prescription was not affected by age,course of disease and condition,but closely related to the course of treatment.Conclusion:Anshen No.1 prescription is effective and safe in the treatment of liver-fire and phlegm-heat insomnia without obvious adverse reactions.It is worthy of further clinical study. |
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