Objective:To evaluate the clinical efficacy and safety of modified Guifu Lizhong decoction in the treatment of gastric cancer after operation and chemotherapy for the type of deficient cold of spleen and stomach,to provide new ideas and methods of TCM in the treatment of gastric cancer after operation and chemotherapy for the type of deficient cold of spleen and stomach.Methods : A randomized controlled clinical trial was conducted to establish a diagnostic criteria for the sample,inclusion criteria,exclusion criteria and clinical trial termination criteria.To observe the inpatients from Yunnan Provincial Hospital of TCM Dianchi district(December 2016 to December 2017)in 48 cases,24 cases in the treatment group,24 cases in the control group.treatment group:(1)Modified Guifu Lizhong Decoction;(2)Shenqi Fuzheng injection 250ml;(3)Routine treatment: basic support,symptomatic treatment,but can not accept other anti tumor treatment.The control group:(1)Shenqi Fuzheng Injection 250ml;(2)Routine treatment: basic support,symptomatic treatment,but can not accept other anti tumor treatment.Two groups were recorded before and after treatment,TCM syndromes(deficient cold of spleen and stomach),PS score [Zubrod-ECOG-WHO(ZPS,5 points method)],blood T lymphocyte subsets: CD3+,CD4+,CD8+ and CD4+/CD8+,to evaluate curative effect and do statistical analysis.Results:1.Clinical data analysis: two groups of patients before treatment,gender and age,TCM syndrome score,PS score,blood T lymphocyte subsets,the discrepancy are statistic meaningless(P>0.05)for counting but comparability.2.TCM syndrome score: two groups after treatment of TCM syndrome scores were lower than before,The comparison of treatment group before and after treatment(P<0.05)has statistical significance.Comparison between TCM syndrome groups.After treatment,the scores of TCM syndrome(P<0.05)was statistically significant.Comparison of clinical efficacy between the two groups after treatment shows: The total efficiency of the treatment group was better than that of the control group,and the inefficiency was lower than that of the control group(P<0.05).,The difference was statistically significant.It was suggested that the TCM syndromes and clinical efficacy were improved after the medicine involvement in the two groups,and the treatment group was better than the control group.3.PS score: After treatment,PS score was decreased in both groups(P<0.05).;the comparison between the two groups was better than the control group(P<0.05),with statistical significance.The results showed that the physical status of the two groups was improved after treatment,and the treatment group was better than the control group.4.Blood T lymphocyte subsets: CD3+,CD4+,CD8+,CD4+/CD8+ value changes after treatment in two groups,representing the whole T lymphocytes CD3+,helper/inducer T lymphocyte immune regulation CD4+,CD4+/CD8+ index values have increased,on behalf of suppressor/cytotoxic T lymphocyte CD8+numerical decline,compared between the two groups before and after treatment(P<0.05),there was statistical significance;The comparison between the two groups(P<0.05)was statistically significant.,.The results showed that the immune function of the two groups were improved after treatment,and the treatment group was better than the control group.5.Safety evaluation: safety indicators before and after treatment showed no significant difference(P> 0.05),show that modified Guifu Lizhong decoction has no effect on the safety indicators.Conclusion: The clinical curative effect of modified Guifu Lizhong decoction in the treatment of gastric cancer after operation and chemotherapy for the type of deficient cold of spleen and stomach can improve obviously,The treatment can improve the TCM syndromes,PS score and blood T lymphocyte subsets: CD3+,CD4+,CD8+ and CD4+/CD8+,improve the quality of patients life. |