| Objective:Observation and study of Fufang Zaoren Anshen capsule in the treatment ofprimary insomnia(Xinshenbujiao Type)clinical curative effect,for clinicalapplication of Fufang Zaoren Anshen capsule treating primary insomnia(Xinshenbujiao Type),especially for the evidence-based medicine of TCM,andTCM combined disease through many link,in the role of multipath,multipletargets of primary insomnia(Xinshenbujiao Type)complex pathological link ofaffirmative curative effect and the unique advantage to provide certain basis.Method:60 patients eligible for inclusion were randomly divided into the treatment groupand the control group of 30 patients according to the computer.The treatmentgroup was given 5 granules of Fufang Zaoren Anshen capsule and 7.5mg ofzopicron,before bed.The control group was given 7.5mg before bed.Bothsessions lasted 30 days.The level changes of TCM syndromes,PSQI and 5-ht,il-1and PGD2 were observed before and after treatment.Results:Therapeutic effect evaluation:1.Clinical curative effect:The total effective rate of the treatment group was 70%,lower than that of thecontrol group.Comparing the differences between the two groups(P>0.05),theresults showed that the two groups of drugs were close to the clinical efficacy ofprimary insomnia(Xinshenbujiao Type).2.Curative effect of traditional Chinese medicine:In this study,the total effective rate of TCM syndromes in the treatment group(Fufang Zaoren Anshen capsule combined zopiclone group)was 70%,compared with the effective rate was 16.67% in the control group hassignificant advantages.According to the correlation analysis of medical statistics,the difference between the two groups is obvious(P< 0.05),which can bereflected in improving symptom curative effect of traditional Chinese medicineFufang Zaoren Anshen capsule is zopiclone have considerable performancebetter.Efficacy evaluation:1.Integral analysis of PSQI scale:There was no significant difference between PSQI points in the two groups beforeoral administration(P>0.05);As the experiment was carried out,the PSQI scoresof the treatment group and the control group were weightily different from thosebefore the treatment(P<0.05).But,in the treatment group and control groupcomparison between PSQI score,although on numerical reflect slightly betterthan the control group,treatment group were found by professional analysis,however,no obvious difference between the statistical significance(P>0.05).There was no effective difference between the two groups in improving PSQIevaluation.2.Analysis of TCM syndromes:There was no significant difference between the two groups of patients beforethe experiment(P>0.05);However,the treatment group was significantlyimproved compared with the control group(P<0.01 or 0.05)after the treatment.The treatment group improved most of the items in the evaluation,while thecontrol group was only able to build a tree(P<0.05)in insomnia.Compared withthe control group,the treatment group showed obvious superiority in theimprovement of TCM symptoms.(P< 0.05).Conclusion:This study shows that the efficacy of Fufang Zaoren Anshen capsule combinedzopiclone in the treatment of primary insomnia(Xinshenbujiao Type)is ideal,similar to that of the western medicine zopiclone.But at the same time in thetreatment of sleep disorders,improve sleep quality,Fufang Zaoren Anshencapsule can both improve TCM symptoms,the patients in the environment,the adjustment of the overall situation of the western medicine has more obviousadvantages.In addition,according to the laboratory data,the above two methodscan increase the value of 5-ht and PGD2 while promoting sleep,and decrease thecontent of il-1 protein.There is no significant difference in medical statisticsbetween them.The correlation between 5-HT,IL-1,PGD2 and sleep mechanismwas demonstrated. |
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