| Objective:The study is based on the clinical observation on the treatment and classification of insomnia after stroke(sequela period)by "nourish the lower jiao and clear the upper jiao".In order to provide theoretical basis for improving the treatment of insomnia after stroke(sequelae period),we need to evaluate the efficacy and safety of modified prescription of Wutu Decoction and modified Huanglian Ejiao Decoction combined with alprazolam.Methods:Sixty-six patients with liver-kidney yin deficiency type and Sixty-six patients with heart-kidney disharmony type were randomly divided into two groups,respectively.There are thirty-three patients in each group.The control group was given alprazolam while the treatment group was given traditional Chinese medicine prescription plus alprazolam for 4 weeks.The patients with different syndrome types were treated with PSQI,TCM syndrome score scale and the scale of activities of daily living(ADL),before and after treatment and follow-up studies after 3 months.PSQI and TCM syndrome score scale were compared separately after two weeks of treatment.Results:A total of 132 patients were included in this study.During the study period,5 patients were lost to follow-up,including 1 patient in the treatment group with heart-kidney disharmony type,2 in the control group,and 1 patient in treatment group and 1 in control group with liver-kidney yin deficiency type.1.Heart-kidney disharmony type(1)Effective rate:The effective rate of treatment group and control group were 81.25%and 67.74%respectively after 4 weeks of treatment;The effective rate of the follow-up treatment group and control group were 75.00%and 58.06%respectively,and the differences were statistically significant(P<0.05).Compared with the treatment,the two groups decreased by 6.25%and 9.68%respectively.(2)PSQI score:The treatment group was significantly different from the control group in subjective sleep quality,sleep duration,habitual sleep efficiency and daytime dysfunction after 4 weeks of treatment and follow-up(P<0.05).(3)TCM symptom score:The treatment group was significantly different from the control group in terms of insomnia,palpitations,dry mouth and throat,hot flushes and night sweats after 4 weeks of treatment and follow-up(P<0.05).(4)ADL score:After 4 weeks of treatment,the changes of score in both groups were statistically significant(P<0.05),and there was no statistical significant between two groups(P>0.05).(5)Safety evaluation:There were no adverse reactions in the treatment group and control group during the study.2.Liver-kidney yin deficiency type(1)Effective rate:The effective rate of treatment group and control group were 78.13%and 65.63%respectively after 4 weeks of treatment;The effective rate of the follow-up treatment group and control group were 71.88%and 53.13%,respectively,and the differences were statistically significant(P<0.05).Compared with the treatment,the two groups decreased by 6.25%and 12.5%respectively.(2)PSQI score:The treatment group was significantly different from the control group in subjective sleep quality,sleep disturbance,and daytime dysfunction after 4 weeks of treatment and follow-up(P<0.05).(3)TCM symptom score:The treatment group was significantly different from the control group in terms of Insomnia,bitter mouth,emotional disturbance,hypochondriac pain after 4 weeks of treatment and follow-up(P<0.05).(4)ADL score:After 4 weeks of treatment,the changes of score in both groups were statistically significant(P<0.05),and there was no statistical significant between two groups(P>0.05).(5)Safety evaluation:Only one case in the control group had a slight sense of asthenia,which relieved itself 3 days later.No adverse reactions occurred in the treatment group.Conclusions:Randomized clinical studies have found that the treatment group can significantly improve the sleep quality and TCM symptoms of patients,and has a smaller decrease in the total effective rate at the follow-up,compared with the use of alprazolam alone.The curative effect of modified prescription of Wutu Decoction and modified Huanglian Ejiao Decoction combined with alprazolam on insomnia after stroke(sequelae period)is better than using alprazolam alone.The long-term effect is considerable and it is worthy of further promotion and application in clinical. |