Clinical Effect Observation Of Ningshenanzang Capsule In The Treatment Of Refractory Insomnia With Liver Fire Disturbing Heart Syndrome

Objective To observe the curative effect of Ning Shen An Zang Capsule on patients with intractable insomnia,and explore the mechanism of action on patients with liver-fire disturbing heart.Methods A total of 128 patients with intractable insomnia of liver fire disturbing heart syndrome admitted to the outpatient department and inpatient department of TCM of the First People’s Hospital of Ningxia Autonomous Region and encephalopathy clinic of TCM Hospital of Ningxia Autonomous Region from December 2019 to December 2020 were selected.After clinical inclusion and exclusion criteria and baseline data investigation and screening,90 patients with intractable insomnia of liver fire disturbance type were finally selected.(Due to poor compliance and the influence of COVID-19 during the experiment,5 cases of separation in the treatment group and 6 cases in the control group were separated,and 79 cases were actually completed).The treatment group was Ning Shen An Zang Capsules group,which was given Ning Shen An Zang Capsules during the test period,and was asked to take 10 capsules in the morning,at noon and after supper.The control group was the western medicine treatment group,which was given Estezolam tablets during the test period,and one tablet was taken orally before going to bed.The treatment cycle for both groups was 28 days.In this study,sleep rating scale(PSQI),TCM syndrome scoring scale,anxiety rating scale(HAMA)and depression rating scale(HAMD)were observed and recorded respectively.Before and after treatment,electrocardiogram was examined,fasting venous blood was collected,and changes in blood routine,liver and kidney function indexes were observed.SPSS22.0 was used for data analysis.Results 1.Before treatment,the baseline data of demographic(age,gender,course of disease,basic disease)and clinical(PSQI,TCM syndrome scoring scale,HAMA scale and HAMD scale)of the two groups showed no statistical significance(P(29)0.05).2.Analysis of clinical efficacy after 1 course of treatment:(1)Analysis of efficacy of PSQI: 35 people in the treatment group were effective except those who were ineffective,and the total effective rate was 87.5%;In the control group,the remaining 36 persons were effective except those who were ineffective,and the total effective rate was 92.3%.There was no statistical difference between groups(P(29)0.05).After treatment,the total score of PSQI and the scores of each component in the two groups decreased to a certain extent,and there was significant difference between the two groups(P(27)0.01).There was no statistical difference in PSQI total score between the two groups(P(29)0.05).Among the 6 components,There was no statistical difference in the other 5 analyses except for the sleep efficiency comparison(P(27)0.05).(2)TCM syndrome integral efficacy analysis: the treatment group except invalid patients remaining 39 per capita effective,the total effective rate of 97.5%,In the control group,9 patients were ineffective and 30 patients were effective,the total effective rate was76.9%.There was statistical difference between groups(P(27)0.05).After treatment,the TCM syndrome scores of the two groups decreased significantly,and there was statistical difference between the treatment group and the control group(P(27)0.01).There were significant differences in total scores and some shapes such as difficult to sleep after waking,more dreams after sleeping,irritability and dizziness,head distension,bitter mouth and dry throat,yellow urine/constipation between the two groups(P(27)0.01).There were statistically significant differences in wakefulness and sleep,chest tightness and hypocholic pain(P(27)0.05),while there were no statistically significant differences in difficulty in falling asleep and waking up early at night(P(29)0.05).(3)Curative effect analysis of HAMD scale and HAMA scale: after treatment,there were significant differences in HAMD scale and HAMA scale within the group(P(27)0.01),and the difference between the groups was statistically significant(P(29)0.05).Analysis showed that both drugs could improve anxiety symptoms,but Ning Shen An Zang capsule had a more significant effect.3.After treatment,no obvious abnormality was found by safety routine examination.During the treatment,1 patient in the estazolam tablet group experienced mild head dizziness on the next day after drug application,which was tolerable;1 patient had obvious dry mouth after drug application,and the incidence of adverse reactions was 5.13%.No obvious adverse reactions occurred in the Ning Shen An Zang capsule group,,and there was no significant difference in the rate of adverse reactions between the two groups(P(29)0.05).Conclusion 1.Ning Shen An Zang capsule and Estezolam tablet can both improve sleep conditions and reduce TCM syndromes in the treatment of intractable insomnia of liver fire and disturbed heart type,but.Ning Shen An Zang capsule has more obvious improvement on syndrome of liver fire and disturbed heart type.2..Ning Shen An Zang capsule can relieve anxiety and depression in different degrees while treating intractable insomnia.