| Objective:To observe the clinical efficacy and safety of Pei Shi Shugan Yangwei Decoction combined with SOX chemotherapy in the treatment of advanced gastric cancer,and to provide a basis for clinical trial and research on the mechanism of Pei Shi Shugan Yangwei Decoction in the further study.Methods: The 60 patients meeting the inclusion criteria were randomly divided into a test group and a control group with 30 cases each.The control group was treated with SOX chemotherapy,while the experimental group received Peishi Shugan Yangwei Decoction on the basis of chemotherapy.21 days is a course of treatment,and 2 consecutive courses of treatment are observed.After completing two treatment cycles,the changes of various test indicators in the experimental group and the control group were recorded,among which the main indicators included: solid tumor size,tumor markers(CEA,CA199,CA724),TCM clinical syndrome score,KPS score,toxicity and side effects evaluation.Results:(1)Efficacy evaluation of solid tumor: there was no significant difference in the improvement of tumor lesions between the experimental group and the control group(P>0.05):(2)Tumor markers CEA,CA199 and CA724:After treatment,the levels of serum tumor markers in 2 groups were lower than before,and there were differences within groups(P < 0.05).After treatment,the level of serum tumor markers in experimental group was lower than that in control group,and there was a difference between groups(P<0.05);(3)TCM clinical symptoms:In terms of TCM clinical symptom score,the scores of TCM clinical symptom in 2 groups were lower after treatment than before treatment,and there were differences within groups(P<0.05);(4)QOL score and KPS score:After treatment,QOL score and KPS score in 2 groups were improved compared with before and after treatment(P<0.05),but the improvement in the experimental group was more significant after treatment,and the comparison was statistically significant(P<0.05).(5)Safety evaluation: After treatment,the incidence of thrombocytopenia,digestive tract reaction,liver function and skin toxic reactions in 2 groups were compared,and the incidence of the above indexes in the test group was lower than that in the control group,with statistical significance(P<0.05).However,after treatment,there was no significant difference in the incidence of renal function injury,leukopenia,decreased hemoglobin,neutropenia and peripheral neuritis between the two groups(P>0.05).Conclusion:Pei Shi Shugan Yangwei Decoction can reduce the level of serum tumor markers(CEA,CA199,CA724)in patients with middle and advanced gastric cancer of liver and stomach discordant type,improve the clinical symptoms of patients,improve the quality of life,reduce the toxic and side effects of chemotherapy to a certain extent,without obvious adverse reactions,and can be widely used. |