| Objectives To preliminary explore the characteristics of senile insomnia about TCM syndrome by observing TCM of patients with senile insomnia in order to provide theoretical basis about chinese medicine treatment senile insomnia. The patients with senile insomnia which is root in the first affiliated hospital of Anhui university. Through observe clinical effect of Yang-Yin-An-Shen-Tang in treating senile insomnia of Yin Xu Huo Wang to evaluation the curative effect of Yang-Yin-An-Shen-Tang for senile insomnia of Yin Xu Huo Wang.Methods1. This study enact a unified form and collect 200 cases of senile patients with insomnia of general acquisition、TCM four diagnostic information。And the research group assigned after strict training of professional investigators to measure and get the informations about 200 cases of senile patients with insomnia of “ TCM syndrome questionnaire of senile insomnia”, “SPIEGEL”.2. Our research use randomized parallel controlled clinical trial methods. Will meet the inclusion criteria of senile insomnia patients according to the principle of random digit assigned to treatment group and the control group, treatment with Yang-Yin-An-Shen-Tang treatment group( n=30) and Estazolam control group( n=30). Adopting TCM syndrome, the international PSQI, the SF-36 as observational indexes, we make comparisons of the self-control before and after therapy, and also between the two groups after therapy, then evaluate the improvements of sleeping ﹠quality of life for both groups.Results1. The patients’ ratio of male and female is 1:1.47. The top 10 symptoms of senile insomnia: night sleep uneasy and insomnia 72.50%,not easy to sleep 68.00%, Tinnitus and deafness 49.00%,forgetfulness 48.50%,irritability and susceptibility to rage47.00%,palpitation 45.50%, dizziness 38.50%, stringy pulse 37.50%, frequentsigh 37.00%,dysphyoria with feverish sensation in chest, palms and soles,tidal fever, night sweating35.50%. The syndromes of senile insomnia: Yin Xu Huo Wang 25.50%, Tang Re Nei Rao 21.00%, Gan Yu Hua Huo 17.00%, Xin Pi Liang Xu 15.00%, Xin xu Dan Qie12.00%,Wei Qi Bu He 0.90%. SPIEGEL scale:More common in patients with Yin Xu Huo Wang decreased frequency of night waking, depth of sleep,dreams while sleeping while other condition and on the night waking times than syndrome of Gan Yu Hua Huo more. Syndrome of Gan Yu Hua Huo more than other syndromes in using a long time for every night to sleep and feeling unwell after wake up. Senile insomnia with Tang Re Nei Rao can appear in the night wake up times. Senile insomnia with Xin Pi Liang Xu were not more common lack of sleep.2. After 4 weeks of treatment,the clinical assessment of two groups:(1) The analysis of clinical efficacy: The total effective rate of the therapy group is 81.89% and the control group is 88.47%.There was no statistically significant difference(P>0.05),comparing the two groups,which suggested that the efficacy of two drugs are almost the same;(2) The analysis of clinical efficacy of TCM syndrome: The total effective rate of the therapy group is 88.88% and the control group is 65.38%. Before and after therapy, the two groups had different degrees advance on the total score and symptom(P<0.05 or P<0.01). After therapy, there were significant differences between the two groups of therapeutic effect(P<0.05), the curative effect of the therapy group is higher than the control group.the control group had very obvious improvement on dry mouth,dysphoria,hectic cheek and tidal fever,feverish palms and soles(P<0.01);(3)Before and after therapy, the two groups had significant difference among the factors of PSQI score(P<0.05),After therapy, there were significant difference between the two groups of scores for factor of daytime function(P<0.05).there weren’t significant difference between the two groups of other scores for factors of PSQI score and total score(P>0.05). Before and after therapy, the therapy group had significant difference among SF-36 scale score(P<0.05). the control group don’t statistically significant among SF-36 scale score(P>0.05). After therapy, there were significant difference between the two groups of PSQI score(P<0.05).(4) After After therapy,the clinical sleep quality’s assessment of two groups: The analysis of clinical efficacy: The total effective rate of the therapy group is 81.89% and the control group is 84.62%.There was no statistically significant difference(P>0.05).(5) After the treatment finished, the adverse event’s incidence rate of the therapy group was 3.7%, and the control group they were 11.54% There were had significant difference in adverse event in two group patients.Conclusion1.The senile insomnia of Yin Xu Huo Wang is most common Prosperous symptom group.2.Yang-Yin-An-Shen-Tang can be improve patients’ sleeping situation﹠quality of life effectively and the clinical efficiency was almost equal with estazolam tablets. On improvement of TCM syndrome and sleep quality﹠quality of life, it was better than estazolam tablets. |
