The Curative Effect And Safety Evaluation Of Treatment Of Anxiety Disorder Insomnia Classified As Pathogenic Fire Derived From Stagnation Of Liver-Qi By Using Xinnaojing Tablets And Danzhixiaoyao Powder

Objective:Through observe the clinical curative effect and give safety evaluation of the trearment of the Anxiety disorder insomnia which is classified as pathogenic fire derived from stagnation of liver-QI in TCM syndrome differentiation by using Xinnaojing tablets,Danzhi Xiaoyao powder,to provide safe and effective clinical guidance and methods for the combined treatment of traditional Chinese medicine with the Anxiety disorder insomnia.Moreover,this study also provided evidences for the safety of Xinnaojing tablets’ clinical application.Methods:According to the principle of randomized,controlled by the diagnostic criteria,inclusion criteria and exclusion,326 cases were chosen and 1 to 1 randomly divided into treatment group and control group(n=163).Both of the 2 group cases took traditional Chinese medicine formula Danzhi Xiaoyao powder with the dosage of 150 ml,3 times a day.In addition,the treatment were as well as given Xinnaojing tablets,1.6mg(4tablets)once,3 times a day.The treatment course of two groups was 4weeks.HAMA score and TCM syndrome score were observed and recorded before the treatment,after weeks 2 and 4 weeks,PSQI score was recorded before and after the treatment,safety index and of 2 groups were also recorded for safety evaluation of each method.Results:1.Basic data:In this study,326 patients were enrolled,both treatment group and control group included 163 patients.24 cases were exfoliated,occupying 7.4%.3 cases were eliminated,and there were 3 cases dropping out because of low efficacy.Finally,a total of 296 cases were completed in fact(treatment group 149 and control group 147).Before treatment,there was no statistical difference in gender,age,course of disease,heart rate,MMSE score and disease degree between 2 groups(P>0.05).There was no statistical difference in MMSE score,HAMA score,TCM syndrome score and PSQI score between 2 groups(P>0.05).Thus the result showed that the data of 2 groups were comparable.2.In group Comparation of Western clinical symptoms and TCM syndrome of2 groups:After the treatment,the HAMA score,PSQI score and TCM syndrome score were compared with which before treatment,the difference between them was statistically meaningful(P<0.05).3.The Comparation of each standard of sleep quality in PSQI in 2groups:After treatment,the scores of sleep quality,sleep latency,sleep time,sleep efficiency,sleep disorder and daytime dysfunction was remarkably reduced(P<0.05).The score of sleep latency,sleep time,sleep efficiency,sleep disorder and daytime dysfunction in treatment descended much more than that in control group(P<0.05).After treatments,the total scores of PSQI in treatment group reduced much more than that in control group(P<0.05).4.The Comparation of curative effect:The effective rate of Anxiety disorder in treatment group was 83.2% and 80.3% in control group.There was no statistical difference in the effect of remedy to Anxiety disorder between 2 groups(P>0.05).The effective rate of TCM syndrome was 92.6%in treatment group and 89.1% in control group,the difference of curative effect of remedy to TCM syndrome was significant(P<0.05).As for the curative effect of insomnia,treatment group effectiveness 87.9%,control group total effective rate was 63.3%.2 groups of effectiveness was significantly different(P<0.05).5.Safety index:Comparing the heart rate after treatment with which before treatment in the treatment group,the 2 results were obviously different(P<0.05),and the descended heart rate was in the normal range.Before and after treatment,There was no remarkable difference in Hepatorenal function and hemogram in treatment group(P>0.05).However,during the course of treatment of liver and kidney dysfunction occurred in 3cases,and anemia in 1 case.4 weeks after the treatment,reviewing these cases,the results of cases’ Hepatorenal function and hemogram were not obviously changed,so these liver and kidney dysfunction,anemia cases had less relationship with the application of medicine.After treatment,both of 2 groups’ MMSE scores had no statistical difference with which before treatment(P>0.05).Conclusion:During the 4 weeks’ course of treatment,The application of Xinnaojing tablets combining Danzhixiaoyao powder and the single use of Danzhixiaoyao powder for the treatment to the Anxiety disorder insomnia could both reduce the scores of HAMA、TCM Syndrome and PSQI.The application of Xinnaojing on the basis of Danzhixiaoyao powder could decrease the scores of HAMA more effectively as well as more obviously reduce the scores of TCM syndrome and strengthen the curative effect of TCM syndrome.The use of Xinnaojing tablets and Danzhixiaoyao powder could more remarkably reduce the scores of sleep latency,sleep time,sleep efficiency,sleep disorder and daytime dysfunction.Moreover,its curative effect of insomnia was better than the control group.In addition,in the 4 week range,the application of Xinnaojing tablets could slow patients’ heart rates,and this effect was gentle,after being slowed,patients’ heart rates were within normal range and it had no influence in cognitive function,hepatorenal function and hemogram after treatment,there was no toxic side effect after treatment,the safety of clinical use was high.