| ObjectiveTo observe the clinical efficacy of Siweixiaoliuyin on TCM symptoms,quality of survival,immune function and the side-effects of chemotherapy in glioma chemotherapy patients.MethodsThis was a prospective clinical randomized controlled trial.On the basis of the inclusion criteria and exclusion criteria,66 patients which were chosen from July 2016 to January 2017 in Guangdong Province Hospital of TCM or sun yat-sen university cancer center for neurosurgery.By the random number table,66 patients were divided into two groups,33 cases received chemotherapy and Si.weixiaoliuyin treatment in control group and 33 cases received chemotherapy in experimental group,The treatment time was 2 months.TCM syndrome score,functional status score(KPS score)and immune function before and after treatment and the side-effects of chemotherapy in the process of treatment would be compared and analyzed to explore the clinical effect of Siweixiaoliuyin.ResultsThis study included 66 subjects,one case in treatment group and three cases in control group fell off according to the shedding standard,so 32 cases in treatment group and 30 cases in control group completed this study finally.During the test,there was no serious adverse event caused in two groups.Before the study,we compared patients' gender,age,course of the disease,chemotherapy treatment course,chemotherapy drugs,tumor grade,recurrent tumors or not,the degree of tumor resection and the TCM syndrome types of two groups,there was no statistically significant difference(P>0.05),which showed that it could be compared in observation indicators between two groups.TCM syndrome score:Before the treatment,there was no statistically significant difference on TCM syndrome score in the two groups(P>0.05).After the treatment,the TCM symptom score in both of two groups declined,the difference in experimental group was statistically significant(P<0.05);it was not statistically significant in the control group(P>0.05).Statistical difference was found between the two groups after the treatment(P<0.05);it was found in two groups before and after treatment too(P<0.05).Statistically significant difference was found between two groups through evaluation of TCM symptom score's change(P<0.05).Functional status score(KPS score):Statistically significant difference was not found between the two groups before study(P>0.05).After the treatment,the KPS score in experimental group rised,which in control group reduced,the difference in experimental group was not statistically significant(P>0.05),while it was statistically significant in the control group(P<0.05).Statistical difference was found between the two groups after the treatment(P<0.05),and the difference in two groups before and after treatment had statistically significant difference(P<0.05).Through evaluation of KPS score 's change,the statistically significant difference was found(P<0.05).Immune function:The immune indexes had no statistically significant difference between the two groups before treatment(P>0.05).Both of CD3+CD4+and CD3-CD16+CD56+ increased in the experimental group,while they reduced in control group,the difference in experimental group was statistically significant(P<0.05),while there was no statistically significant difference in the control group(P>0.05).The differences after treatment between two groups were statistically significant(P<0.05),and the difference in two groups before and after treatment had statistically significance(P<0.05).CD3+CD8+ reduced in experimental group,there was no statistically significant difference in this group(P>0.05),while it increased in control group,the difference was statistically significant(P<0.05).The difference between two groups after treatment was not statistically significant(P>0.05),but the difference before and after treatment in two groups was statistically significant(P<0.05).The CD3+CD4+/CD3+CD8+ ratio in experimental group increased,there was no statistically significant difference in this group(P>0.05),while it reduced in the control group,the difference was statistically significant(P<0.05).The difference between two groups after treatment were not statistically significant(P>0.05),but the difference in two groups before and after treatment was statistically significant(P<0.05).CD3-CD19+ decreased in both of experimental group and control group,there was statistically significant difference in experimental group(P<0.05),while the difference was not statistically significant in the control group(P>0.05).The difference between two groups after treatment were not statistically significant(P>0.05),but the difference in two groups before and after treatment had statistically significance(P<0.05).Adverse reaction of chemotherapy:During the treatment,the adverse reactions of chemotherapy were observed,but the difference between two groups was not statistically significant(P>0.05).ConclusionSiweixiaoliuyin can improve TCM symptoms and quality of survival of these patients.In addition to,it can change cellular immune and humorous immune and improve the immune function of glioma chemotherapy patients.It does not have the function of significantly reducinging the side-effects of chemotherapy,but it has no toxic side effect,and it is safe and feasible in human glioma therapy. |
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