Clinical Research Of Zhenzao Capsule In The Treatment Of Senile Insomnia Of Yin Huo Wang Type And Its Effect On TNF-α,IL-6 And IL-1β

Objective:The purpose of this experiment was to observe the clinical efficacy,safety and mechanism of zhenzao capsule in elderly patients with insomnia(yin huo wang type)by observing the changes of TCM symptoms scores,PSQI scores and the changes of serum TNF-α,IL-6,IL-1β before and after the treatment.Methods:According to the method of random,single blind and parallel control,sixty cases of senile insomnia with Yin Huo Wang were divided into two groups,respectively,the treatment group(30 cases)and control group(30 cases).The treatment group was given zhenzao capsules(Once a day,1.9g each time,taken orally half an hour before bed),while the control group took shumian capsules(Once a day,2.0g each time,taken orally half an hour before bed).This study explored the mechanism of sleep improvement by comparing the changes in TCM syndromes scores,PSQI scores and the change of levels in serum TNF-α,IL-6,IL-1β.Results:1.General information:Comparing the sex and average age of the two groups of patients,P>0.05,there was no statistical difference,and they were comparable.2.Comparison of Clinical curative effect of TCM:The group of zhenzao capsule,including 7 cases cured(23.33%),obviously improved 13 cases(43.33%),efficacious in 6 cases(20.00%),noneffective in 4 cases(13.33%),total efficacious rate was 86.67%;The group of shumian capsule,including 5 cases cured(16.67%),obviously improved 11 cases(36.67%),efficacious in 8 cases(26.67%),noneffective in 6 cases(20.00%),total efficacious rate was 80.00%.After treatment,the comparison between the two groups had statistical difference(P<0.05).Zhenzao capsule was better than Shumian capsule in improving the Clinical curative effect of TCM.3.Comparison of TCM syndromes and PSQI:Zhenzao capsule group before treatment,TCM symptoms score was(24.77±2.65),PSQI Total score was(15.90±1.65);Shumian capsule group before treatment,TCM symptoms score was(24.60±3.10),PSQI Total score was(16.33±1.42).After treatment with Zhenzao capsule group,TCM symptoms score was(10.53±3.92),PSQI Total score was(6.50±3.13);Shumian capsule group before treatment,TCM symptoms score was(13.20±4.47),PSQI Total score was(8.37±3.45).Comparing the TCM symptoms and PSQI total score within the respective groups,the differences had significantly statistical difference(P<0.01),and between the two groups had statistical difference(P<0.05).The improvement of PSQI and TCM symptoms scores of Zhenzao capsule was better than Shumian capsule.4.Comparison of inflammatory factors:After treatment,the levels of serum IL-6 and IL-1βwas decreased in both groups,and Zhenzao capsule was better than Shumian capsule(P<0.05).After treatment,the level of serum TNF-α was also decreased compared to before treatment,and the Zhenzao capsule group was more obvious than the Shumian capsule group(P<0.01),and the discrepancy was statistically significant.5.Safety evaluation:During the treatment,no adverse reactions such as liver and kidney dysfunction occurred in the two groups of patients,and there were no abnormalities in safety inspection index such as blood routine,urine routine,fecal routine and electrocardiogram.Conclusions:1.Zhenzao Capsule can improve TCM symptoms and PSQI scores of senile patients with insomnia(yin huo wang type),and improve the sleep quality and daytime functional status of senile patients.it has significantly clinical efficacy.2.Zhenzao Capsules can reduce seruam IL-6,TNF-α nd IL-1β content in the body of senile patients with insomnia(yin huo wang type type).The effect of treating insomnia is related to the intervention of inflammatory factors.3.Zhenzao Capsule has no obvious adverse reaction in the treatment of senile patients with insomnia(yin huo wang type),which shows that it was safe and effective,and its clinical application is worth promoting.