| Objective:to observe the clinical efficacy and safety of modified Zhenzhu granules in the treatment of senile insomnia(liver-kidney Yin deficiency syndrome),and to compare it with wuling capsule in the control group,so as to provide a new therapeutic idea and drug selection for the treatment of senile insomnia.Methods:100 patients were divided into treatment group(add or subtract zhenzhu granule group)and control group(wuling capsule group)by random number method.modified Zhenzhu granules to take:80ml warm water,one dose every two days,take it three times after breakfast,lunch and dinner.The control group was given wuling capsule,which was taken three times after breakfast,lunch and dinner.The changes of PSQI evaluation,HAMA scale evaluation,TCM syndrome score and sf-36quality of life scale were analyzed before and after treatment for 2 weeks and after drug withdrawal for 2 weeks.Results:1.During the clinical observation and study,there were 5 cases of abscission of modified Zhenzhu granules group(treatment group)due to drug withdrawal without authorization,and the remaining 45 cases,with the abscission rate of 10%;In the wuling capsule group(control group),3 cases could not be contacted due to follow-up,and 4 cases were stopped without permission.A total of 7 cases fell off,and the remaining 43 cases were 14%.The total shedding rate was 12%,and a total of 88cases were counted.2.The clinical data of the two groups of patients before treatment were analyzed and compared,and the difference was not statistically significant(p>0.05),which was comparable.3.Analysis of clinical research results.3.1 statistical analysis results.3.1.Comparison of efficacy of PSQI score and sleep improvement.The effect and score of modified Zhenzhu granules on improving sleep quality were better than wuling capsule(statistical comparison:P<0.05),and its effect duration was better than wuling capsule(statistical comparison:P<0.05).There was no difference between the effect of modified Zhenzhu granules on PSQI scale score and wuling capsule two weeks after treatment and two weeks after drug withdrawal(statistical comparison:P>0.05).3.2 TCM syndrome score and syndrome improvement efficacy evaluation The efficacy and score of modified Zhenzhu granules in improving sleep quality were better than wuling capsule(statistical comparison:P<0.05),and its efficacy was longer than wuling capsule(statistical comparison:P>0.05).3.3 comparison of sf-36 quality of life score and quality of life improvement rate The efficacy and score of modified Zhenzhu granules in improving the quality of life were better than wuling capsule(statistical comparison:P<0.05),and there was no difference between the efficacy and the sf-36 quality of life score in improving the durability and wuling capsule(statistical comparison:P>0.05).3.4 comparison of HAMA scale score and anti-anxiety efficacy modified Zhenzhu granules has better anti-anxiety efficacy than wuling capsule(statistical comparison:P<0.05),and its efficacy is longer than wuling capsule.However,there was no difference between the improvement of HAMA scale score and wuling capsule after 2 weeks of treatment and 2 weeks after drug withdrawal(statistical comparison:P>0.05).(?)To sum up,the total effective rate of adding or subtracting modified Zhenzhu granules in improving sleep,TCM syndrome,anti-anxiety and quality of life is better than wuling capsule.Conclusion:according to the preliminary study,addition or subtraction of modified Zhenzhu granules has the effect of improving the elderly insomnia(liver and kidney Yin deficiency syndrome),safe and effective in the treatment of insomnia,no adverse reactions and side effects,good patient compliance;And its curative effect is better than wuling capsule group.In addition,it is better than wuling capsule in improving TCM syndrome,sleep quality and anti-anxiety.Therefore,it is recommended to add or subtract modified Zhenzhu granules for elderly patients with insomnia(liver,kidney and Yin deficiency),and for patients with abnormal anxiety and conscious decline in quality of life.In addition,for some anxious patients with liver and kidney Yin deficiency,we can try to use modified Zhenzhu granules. |
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