| ObjectiveIn this study,we used randomly and controlledly clinical trial method to study the efficacy of Guben Anshen Decoction.Through the standardization of clinical research to verify the effective treatment of Guben Anshen Decoction in treating insomnia with malignant tumor patients ofthe adversity of heart and nephrotic,and further explore its mechanism of action to guide clinical practice.MethodsSixty patients with malignant tumors of heart and kidney incision who were treated in the Department of the Second Central Hospital of Guangdong Province from October 2015 to November 2016 were randomly and evenly divided into observation group and control group.The rats in the observation group were treated with Guben Anshen decoction and the control group was treated with estazolam tablets.The patients were assessed by the Pittsburgh Sleep Quality Index(PSQI),the Functional State(KPS)Scale and the TCM Symptom Scale.Respectively,before admission,at the same time point as the 7th,14th,21st and 28th day.Using EXCEL to establish the database for data management and maintenance and use SPSS21.0 software package for statistical analysis of the data.Results1.PSQI total score:The overall curative effect was 70.00%in the observation group,among them,0 cases were cured,2 cases were excelent,19 cases were effective,9 cases were ineffective;The effective rate of the control group was 100,among them,0 cases were cured,13 cases were excelent,17 cases were effective,0 cases were ineffective.The curative effect of the two groups have significant difference after inspection(P<0.05);and the effective rate was statistically significant(P<0.05).To marginal average and comparison test between 95%and 95%confidence interval for group:compared with control group,the observation group into the group,the group of 28 days before the PSQI overall mean there was no significant difference(P>0.05),the group of 21 days of PSQI overall mean significant difference(P<0.05),the group of 7 days,14 days PSQI overall mean significant difference(P<0.01).Indicating that the recent effect of estazolam is better than that of Guben Anshen Decoction.With the increase of the course of treatment,the superiority of Guben Anshen Decoction is gradually emerging and gradually converges with estazolam.2.TCM syndrome efficacy:The overall efficacy was 93.33%in the observation group,among them,0 cases were cured,8 cases were markedly effective,20 cases were effective,2 cases were ineffective.The overall efficacy was 53.33%in the control group,among them,0 cases were cured,2 cases were markedly effective,14 cases were effective,14 cases were ineffective.Upon examination,the curative effect of the two groups have significant difference(P<0.05).The results showed that there were significant differences between the two groups(P<0.05);the results showed that the total effective rate of the two groups was significantly different(P<0.05).With marginal average and 95%and 95%confidence interval between groups and groups within the mean comparison test,compared with control group,observation group into the TCM syndrome integral overall average before there was no significant difference(P>0.05),the group of PSQI overall average 7 days have significantly lower(P<0.05),the group of 14 days,21 days,28 days of TCM syndrome integral value of the overall average have significantly lower(P<0.01).Note With the increase in treatment,Guben Anshen decoction is better than estazolam.3.(KPS):The improvement rate of the two groups was 23 cases,stabilized in 4 cases and decreased in 3 cases,The improvement rate was 76.67%.In the control group,19 cases were improved,stabilized in 4 cases and decreased in 7 cases,the improvement rate was 63.33%,there is a no significant difference between the two groups of efficacy(P>0.05).4.Adverse reactions:The observation group patients with vomiting in 2 cases,1 case of diarrhea,constipation in 2 cases,the incidence of adverse reactions was 16.67%;In the control group,there were 2 cases of dizziness,3 cases of dry mouth,3 cases of fatigue,7 cases of lethargy,the incidence of adverse reactions was 50.00%.There was a significant difference between the two groups(P<0.05).5.Safety observation:There were no significant differences in the safety indexes(white blood cells,hemoglobin,platelet,alanine aminotransferase,aspartate aminotransferase,creatinine and urea nitrogen)in the observation group before and after treatment(P>0.05).Similarly,in the control group,there were no significant differences in the safety indexes(white blood cells,hemoglobin,platelet,alanine aminotransferase,aspartate aminotransferase,creatinine and urea nitrogen)before and after treatment(P>0.05).Conclusion1.Reduction of the PQSI index Guben Anshen soup and estazolam all have a role,and with the changes in time,but the effect of Guben Anshen decoction less than estazolam,especially in the recent medication,with the time the difference in the extension is reduced.2.In the traditional Chinese medicine symptoms of the two drugs have improved their role,and with the time of the change,but in general the effect of Guben Anshen soup was significantly better than estazolam.3.Guben Anshen decoction and estazolam both drugs have improved the role of KPS,and with the treatment time to change,but the role of the two drugs there is no statistical difference,that is,the effect is quite.4.The incidence of adverse reactions of Guben Anshen Decoction was less than that of estazolam.5.Two drugs have high clinical safety.In short,Guben Anshen Decoction can significantly improve the functional status of patients with malignancies with insomnia,good sleep and TCM symptoms,although the effect of reducing PSQI is less than estazolam,but in improving TCM syndrome is better than estazolam,high safety and low adverse reactions,,it has a clinical value. |
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