Clinical Research Of Zhenzao Capsule Treating Elderly Insom-Nia In Yin Deficiency With Fire Hyperactivity And The Role Of Improving Sleep Structure

Objective To evalution the clinical efficacy and syndromes efficacy of TCM by Zhenzao capsule in elderly yin deficiency with fire hyperactivity insomnia patients with the way of random grouping, single-blind, and parallel comparing.Moreover,observe the levels of5-HT and DA,and monitor the changes of sleep structure by PSG,in order to study the mechanism of Zhenzao capsule on curing insomnia.Methods According to diagnosis standard of insomnia,a total of60elderly patients in yin deficiency with fire hyperactivity were enrolled and evaluated.Using random, single-blind, placebo-controlled study methods included in the study to divided all the patients into treatment group and control group, each group were30patients. Treatment group were treated with zhenzao capsule (Agreement prescription of TCM Hospital of JiangSu province).In the control group, the patients were given shumian capsule.The continuous course of treatment was4weeks, observation time was one course of treatment.The change of clinical symptoms of insomnia were observed before and after treatment.And observed patients with total sleep time, sleep latency time, awakening times and NREM sleep staging time to analyze the changes in sleep structure by monitoring the transformation of PSG.Moreover,the level of5-serotonin and dopamine were measured in order to analyze the mechanism of improvement of sleep.Results Our research reaveals that:(1)30cases in treatment group,6cases were clinically cured,12cases had marked effective,8cases had effective, and4cases without effect, the total curitive rate was86.67%; in the control group, the total effective rate was76.67%, with5cases cured,7cases had marked effective,11cases had effective,7cases without effect,but the difference of the total effective rate between2group was not statically significant(P>0.05).(2)Treatment group total effective rate of the TCM syndromes efficacy was90.0%,73.33%in the control group, the difference of the total effective rate between2group was statically significant(P<0.05).(3)With the data of polysomnography,all the treatments can prolong total sleep time,but the difference was not statistically significant(P>0.05);all the treatments can shorten sleep latency time,and the curative effect of treatment group was superior to the control group(P<0.05);all he treatments can reduce awakening times,and the treatment group have an advantage compared to the control group, P<0.05.(3)A11the treatments can shorten the time of shallow sleep and light sleep in NREM,and the curative effect of treatment group was superior to the control group (P<0.05);sum time of moderate sleep and deep sleep were significantly increased,and the treatment group have an advantage compared to the control group,P<0.05.(5)A11the treatments can increase5-HT levels and reduce DA levels,and the curative effect of treatment group was superior to the control group (P <0.05).Conclusions1.Zhenzao capsule can improves the Clinical symptoms of traditional Chinese medicine and quality of life in the elderly insomnia patients in yin deficiency with fire hyperactivity,and clinical curative effect is distinct.2.Zhenzao capsule can improve the quality of sleep that it can efficiently regulate sleep structure.It can increase total sleep time and shorten the sleep latency time,it also can reduce the time of shallow sleep and light sleep.3.Zhenzao capsule can improve the Insomnia symptoms of the elderly insomnia patients in yin deficiency with fire hyperactivity by raising the level of serotonin and reduce dopamine levels,...