| Objective: To observe the effect of Shugan Jianpi decoction on patients with liver stagnation and spleen deficiency type insomnia clinical curative effect and safety;index score and the safety of the test by comparing the subjects before treatment,after the scale,to analyze the degree of Shugan Jianpi decoction and its clinical safety and efficiency,study and discuss the theoretical basis of Shugan Jianpi insomnia Decoction for the treatment of liver stagnation and spleen deficiency type,in order to bring the gospel has long been afflicted with insomnia.Methods:1.Western medicine is based on the 2012 "Chinese adult insomnia diagnosis and treatment guidelines" to select the research targets;traditional Chinese medicine is a reference to the 2002 "Chinese medicine clinical research guiding principles(Trial)",combined with Shugan Jianpi decoction with body composition and the function of drug effect observation to syndromes of insomnia depression the study of spleen deficiency.The subjects were informed of their specific projects and their trust and consent.92 eligible subjects were selected.According to the random number table,these people were be segmented into two parts,one was the treatment group contained 46 people and the other one was the control group contained 46 people.2.The treatment group were taken Shugan Jianpi decoction,2 times / day,taken sooner or later;control group was treated with Alprazolam Tablets,1 times / day at bedtime.The two groups were all taken for 28 days.3.Observe and compare the treatment group and control group after the drug Pittsburgh sleep quality index questionnaire(PSQI)before treatment,and the related changes of scores of TCM symptom score,were recorded,and pay attention to the subjects during the patients have no unexpected adverse,fill in the CRF table.The score of the PSQI scale and the symptom score of Chinese medicine were the main observation items of this test.4.Give the two groups of subjects before and after treatment,the clinical routine safety indicators(blood routine,liver function,renal function)detection by a detection result as evaluation of Shugan Jianpi decoction on clinical safety.5.Statistical analysis: the independent samples t test was used to measure the data which was in accordance with the normal distribution.The rank sum test was not used for the normal distribution,and the chi square test was used to count data.2.Results:Between the two groups in the age and sex of the patients before treatment,PSQI score and TCM syndrome score comparison,after statistics processing,two groups showed comparable premise,results: 1.were selected into the group of 92 patients,including 90 cases of patients completed the trial,two groups of 1 cases lost the loss rate was 2.17%.2.before treatment,there was no significant difference in the score of sex,age,PSQI scale and TCM syndrome scores between the two groups(P > 0.05).3.after treatment,in the treatment group,the overall response rate was 86.67%,and the rate in control group was 77.78%.The two groups were statistically significant(P < 0.05).4.after treatment,the two groups can improve PSQI score,TCM syndrome score,and between the two groups before and after treatment PSQI scores had no significant difference(P > 0.05),but the TCM syndrome score changes in treatment group(from 26.04 ± 2.892 to 9.42 ± 6.236 than the control group from 25.80 ± 2.809 to 12.53 ± 6.577),the t test revealed significant differences(P < 0.01).5.no adverse reactions were found in the two groups during the period of medication.There was no obvious abnormality in the routine examinations before and after the treatment.It indicates that Shugan Jianpi decoction is safe and reliable in the treatment of insomnia with liver depression and spleen deficiency.Conclusion:1.The curative effect of Shugan Jianpi decoction in the treatment of insomnia with spleen deficiency liver depression is better than that of the control group.2.Shugan Jianpi decoction has no obvious adverse reaction and has good safety.The above analysis showed that Shugan Jianpi decoction had no significant difference in patients with liver stagnation and spleen deficiency type insomnia curative effect score in PSQI and Alprazolam Tablets,however,is superior in terms of efficacy of TCM points Alprazolam Tablets,not only can improve the clinical symptoms of insomnia,and treatment of any adverse events did not occur during the Shugan Jianpi decoction can be used as effective drugs for treatment of insomnia the liver and spleen deficiency. |
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