Clinical Observation Of Zhenzao Capsule In The Treatment Of Senile Insomnia Of Yin Deficiency And Fire Exuberance Type And Its Effect On TNF-?,IL-6,COR And ACTH

Objective:This clinical study was based on the basic theory of traditional Chinese medicine,and adopted a randomized,single-blind and controlled trial method.By observing the effect of Zhenzao Capsule on the syndromes of senile insomnia patients with Yin deficiency and fire prosperity,and the changes of serum TNF-a,IL-6,COR and ACTH levels,we evaluated the clinical efficacy of Zhenzao Capsule in treating senile insomnia patients with Yin deficiency and fire prosperity,and its effect on inflammatory factors and HPA axis-related stress indicators.Methods:Sixty elderly insomniacs who accorded with the inclusion criteria were randomly and single blindly divided into treatment group(Zhenzao capsule group)and control group(Shumian capsule group)with 30 cases in each group.The treatment group was given Zhenzao capsule orally,while the control group was given Shumian capsule orally.The treatment period was 4 weeks.The test cycle was a course of treatment.The changes of TCM syndrome scores before and after treatment were compared between the two groups.The levels of TNF-?,IL-6,COR and ACTH in patients after treatment were compared.To explore the effects of Zhenzao Capsule on inflammatory factors and HPA axis related stress indicators.Results:1.In the treatment group,6 cases were cured,15 cases were markedly effective,5 cases were effective and 4 cases were ineffective.The total effective rate was 86.67%.In the control group,5 case was cured,4 cases were markedly effective,15 cases were effective and 6 cases were ineffective.The total effective rate was 80.00%.There was significant difference in the curative effect of TCM syndromes between the treatment group and the control group(P<0.05).After treatment,the scores of TCM syndromes in the two groups were lower than before.There was significant difference between the two groups before and after treatment(P<0.01).After treatment,the scores of TCM syndromes in the two groups were significantly different(P<0.05).2.After treatment,the levels of TNF-?,IL-6,COR and ACTH in the two groups were significantly lower than those in the control group(P<0.01),and the levels of TNF-?,IL-6,COR and ACTH in the treatment group were significantly lower than those in the control group(P<0.05).Conclusions:1.Zhenzao capsule can significantly improve the syndromes and clinical symptoms of elderly insomnia patients,improve the sleep quality and daytime functional status of patients,with significant clinical efficacy.2.Zhenzao Capsule can reduce the levels of serum TNF-?,IL-6,COR and ACTH in patients,which may be related to the regulation of inflammatory factors secretion and stress state of HPA axis.3.There were no obvious adverse reactions and adverse events during the treatment of Zhenzao Capsule.It is safe and effective to treat senile insomnia patients with Yin deficiency and Fire excess.