| Objective: Through clinical studies,we observed the clinical efficacy of Xiaoliu Pingyi recipe combined with SOX chemotherapy in the treatment of advanced gastric cancer with Qi deficiency and blood stasis syndrome,and evaluated its effectiveness and safety,providing clinical trial basis for further exploring the mechanism of action of Xiaoliu Pingyi recipe in the treatment of advanced gastric cancer with Qi deficiency and blood stasis syndrome.Methods: Using the prospective randomized controlled study method,80 patients who met the inclusion criteria were collected and randomly divided into control group and observation group,with 40 patients in each group.The control group received SOX chemotherapy,and the observation group received Xiaoliu Pingyi recipe combined with SOX chemotherapy.After 2cycles of treatment,we compared the solid tumor efficacy,TCM clinical symptoms,quality of life,tumor markers and safety of the two groups of patients.SPSS 21.0 was used for statistical processing of the research data.Results: After two cycles of treatment,the changes of each observation index were as follows.(1)In terms of short-term efficacy evaluation,the objective remission rate(28.57%)and the tumor control rate(80.00%)of the observation group were higher than those of the control group(25.00%)and the tumor control rate(71.88%),and there was no statistical difference between the two groups(P>0.05).(2)In terms of TCM clinical symptoms,TCM clinical symptoms of the two groups were improved to varying degrees after treatment,the total effective rate of the control group was59.38%,and the total effective rate of the observation group was 82.86%,with statistical significance(P < 0.05).And there were statistical differences in the scores of three single TCM clinical symptoms of epigastric pain,nausea and vomiting and general fatigue between the two groups(P<0.05).(3)In terms of quality of life evaluation,KPS score in the observation group was stable or increased in 31 cases,accounting for88.57%,while that in the control group was stable or increased in 21 cases,accounting for 65.63%,the difference was statistically significant(P<0.05).The weight improvement rate in the observation group was 91.43%,which was significantly higher than that in the control group(71.88%),with statistical difference between groups(P<0.05).(4)In terms of tumor markers,three tumor markers in control group and observation group were decreased to varying degrees compared with before treatment,but there was no significant difference in CEA,CA199 and CA724 levels between the two groups after treatment(P>0.05).(5)In terms of coagulation function,the D-dimer and fibrinogen in the observation group were decreased to a certain extent after treatment,the difference was statistically significant(P<0.05),and the D-dimer level was significantly different between the observation group and the control group after treatment(P<0.05).(6)In terms of safety,there was no statistical significance in myelotoxicity,hepatorenal toxicity between the two groups(P>0.05).And there were statistical differences in neurotoxicity and digestive tract reaction between the two groups(P<0.05).Conclusion: Xiaoliu Pingyi recipe combined with SOX chemotherapy can significantly improve the clinical symptoms of TCM in patients with advanced gastric cancer of Qi deficiency and blood stasis syndrome,improve the quality of life of patients,and to a certain extent alleviate the hypercoagulability of blood,peripheral neurotoxicity,gastrointestinal reactions and other toxic and side effects,which can be further promoted and applied in clinic. |