| Objective:To observe and evaluate the safety and efficacy of self-made Anshen granules in treatment of the insomnia patients with syndrome of liver depression and fire transforming type,that is based on the traditional decoction of Longdan Xiegan decoction,Suanzaoren decoction and Xiaoyaosan.And to explore its influence on PSC parameters,so as to better apply PSG in clinical practice.To give full play to the advantages of traditional Chinese medicine granules,in order to explore better treatment methods of insomnia,and provide a reliable theoretical and clinical basis for the development of self-made Anshen granules.Method:The 40 patients were randomly divided into treatment group and control group with 20 cases in each group.The patients in the treatment group were given self-made Anshen granules,Pre-decocted were first boiled in a small fire for 10 minutes,then other granules were added,boiled for 5 minutes,and take 100 ml each one hour after breakfast and one hour after lunch and half an hour before going to bed,one dose daily for 4 weeks.The control group was given eszopiclone3.0mg orally half an hour before sleep every day,one dose daily for 4 weeks.All patients were given psychological counseling at the same time of drug treatment,and healthy and reasonable sleep habits were formulated according to the patient's condition.During the period of medication,the adverse reactions of patients were closely observed and timely record and dealt with.The changes in the sleep structure of the subjects were analyzed by monitoring the changes of the parameters in PSC before and after treatment in the two groups.The Pittsburgh sleep quality index scale(PSQI),clinical efficacy and TCM syndrome efficacy before and after treatment in the two groups were compared and evaluated.Result:(1)Efficacy evaluation:(1)Clinical efficacy:After treatment,the total clinical effective rate of the Chinese medicine treatment group was 75%,and that of the control group was 80%,which was lower than that of the control group.However,there was no significant difference(p>0.05)after statistical analysis,indicating that the two groups of drugs in the treatment of insomnia patients with syndrome of liver depression and fire transforming type of clinical efficacy is equivalent.(2)TCM syndrome efficacy:The total effective rate of the TCM treatment group was 95%,which was significantly higher than that in control group 50%.Statistical analysis showed significant difference(p<0.01),which showed that the self-designed Anshen granules were better than eszopiclone in improving the efficacy of TCM syndromes.(2)Evaluation of efficacy indicators:(1)Total score of PSQI and integral each component:After treatment,the PSQI scores of the two groups were significantly different from those before treatment(P<0.01),while there was no obvious difference in improving the daytime function factors in the con-trol group.There was significant statistical difference in improving the daytime func-tion between the two groups(P<0.01).There was no significant statistical difference in the total PSQI scores and other factors between the two groups,indicating that the two groups had the same overall effect in improving PSQI scores,but the self-designed Anshen granules was superior to eszopiclone in improving daytime function(P<0.01).(2)TCM syndrome score:There was no significant difference in syndrome scores between the two groups before treatment(P>0.05).After 2 weeks of treatment,the TCM syndrome score of the treatment group improved in most parts,and after 4 weeks of treatment,the TCM syndrome score of the treatment group improved significantly(P<0.05 or P<0.01).After 2 weeks of treatment,the control group only improved the symptoms of sleep disturbance and chest tightness(P<0.05),and after 4 weeks of treatment,some symptoms such as sleep disturbance,irritability,chest tightness,dreaming and dizziness were improved(P<0.05 or P<0.01).After 2 weeks of treatment,the treatment group was better than the control group in the improvement of chest and hypochondriac pain,phlegm and mucus syndrome(P<0.05);after 4 weeks of treatment,compared with the control group,except for the improvement of sleep disturbance symptoms,the improvement of other symptoms scores in the treatment group was significantly higher than that of the control group(P<0.05 or P<0.01).(3)PSG parameters:There were significant differences in total sleep time,sleep efficiency,sleep latency,REM latency,awakening index and N2 between the control group after treatment and before treatment(P<0.01).Compared with before treatment,the treatment group could not only effectively prolong the total sleep time of patients,but also shorten the sleep latency and REM latency,and reduce the awakening index and raise sleep efficiency,but there were significantly different in N2 sleep time and N3 sleep time(P<0.05 or P<0.01).After treatment,the treatment group was better than the control group in reducing sleep latency time(P>0.01),and the im-provement of sleep time in R phase was better than the control group(P>0.05),however,the two groups had similar effects in improving total sleep time,sleep efficiency,REM latency and awakening index,N1,N2 and N3 sleep time(P>0.05).Suggesting that the two groups were similar in improving sleep process and awakening events,but better in improving sleep structure than the control group.(4)Safety observation indicators:After treatment,there were no significant changes in vital signs,laboratory tests,electrocardiogram and other safety indicators compared with those before treatment.Conclusion:This study shows that Anshen Granule is effective in treating insomnia patients with syndrome of liver depression and fire transforming type,which is similar to Eszopiclone.But at the same time of improving patients' sleep,Anshen Granule can significantly improve the symptoms of traditional Chinese medicine,and has an advantage over Eszopiclone in regulating the overall state of the body.It can optimize the sleep process and sleep structure of insomnia patients fundamentally,so as to significantly improve the quality of sleep. |
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