| Objective: Preliminary study on the clinical efficacy and safety of Weifufang combined with Tigio capsules in the maintenance of chemotherapy for advanced gastric cancer(Qi deficiency and blood stasis syndrome),provide clinical reference and basis for the application and promotion of the party.Methods: The study used a prospective cohort study to divide 50 subjects who met the criteria into 25 cases in the treatment group and 25 cases in the control group.The subjects in the control group were given Tigio capsules for maintenance chemotherapy,and the subjects in the treatment group were given maintenance therapy for gastric complex,6 weeks is a course of treatment,and the short-term efficacy is evaluated after 2 consecutive cycles of treatment.Those who do not progress continue to take medicine until the disease progresses and dies.Through long-term follow-up,observe its longterm efficacy.Observation of short-term curative effect Changes of single TCM syndrome score,TCM syndrome total score,TCM syndrome efficacy,hemoglobin index,white blood cell index,platelet index,CEA value,CA724 value,CA-199 value,KPS score changes in both groups before and after treatment.Observe the PFS situation through long-term follow-up and record the occurrence of adverse events.Results: 1.With regard to the score of a single TCM syndrome,the treatment group had less food deficits,belching,acid reflux,nausea and vomiting,and fatigue and fatigue syndrome were better than the control group,and the difference was statistically significant(P <0.05).2.In terms of the total score of TCM syndromes,the total score of the treatment group after treatment was improved compared with the control group,and the difference was statistically significant(P <0.05).3.In terms of evaluation of the efficacy of TCM syndromes: the effective rate of the treatment group was 76%,and the effective rate of the control group was 32%,the difference was statistically significant(P <0.05).4.In terms of quality of life efficacy analysis: the KPS score of the treatment group and the control group both increased compared with before(P <0.05),the KPS score of the treatment group increased more significantly,and the difference between the two groups before and after treatment was statistically significant(P <0.05).5.In terms of hemoglobin index analysis: after treatment,the hemoglobin index of the treatment group was lower than that of the control group,and the difference in hemoglobin index between the two groups was statistically significant(P <0.05).In the analysis of white blood cell division: after treatment,the white blood cell division of the treatment group was lower than that of the control group,and the difference in white blood cell division between the two groups was statistically significant(P <0.05).In terms of platelet indexing analysis: after treatment,the platelet indexing of the two groups did not improve compared with that before the treatment,and there was no statistically significant difference between the two groups(P > 0.05).6.Recent efficacy of tumor markers: In terms of changes in CEA,the difference in CEA levels in the three treatment groups was statistically significant(P <0.05),and the median value of CEA after the second course of treatment was higher than before treatment(P <0.05).There was no statistically significant difference in CEA level in the control group during the three periods(P > 0.05),and there was no difference between the two groups in different treatment courses(P > 0.05).In terms of changes in CA199,there was no statistically significant difference in the level of CA199 in the treatment group during the three periods(P > 0.05),and the difference in the level of CA199 in the control group during the three periods was statistically significant(P <0.05).The value was lower than before treatment(P <0.05),there was no difference between the two groups in different treatment courses(P > 0.05).Regarding the change of CA724: the difference of CA724 level in the three periods of the treatment group was statistically significant(P <0.05).The median value of CA724 after the first course of treatment was higher than that before the treatment(P <0.05).The difference of C724 level in the three periods of the control group No statistical significance(P > 0.05),the CA724 level of the control group was better than that of the treatment group at the end of the first course of treatment.7.PFS comparison: No significant difference in progression-free survival(PFS)between the two groups(P > 0.05).8.Analysis of adverse events: There were 3 cases of gastrointestinal reaction(nausea and vomiting)in the treatment group and 9 cases in the control group,and the difference was statistically significant(P <0.05);In 4 cases,the difference was statistically significant(P <0.05);the remaining adverse events were: liver and kidney function impairment,hand-foot syndrome,and skin toxicity.(P > 0.05).Conclusion: Stomach compound maintenance therapy compared with Tigio capsule maintenance chemotherapy in patients with advanced gastric cancer(qi deficiency and blood stasis syndrome)can improve the clinical syndrome of traditional Chinese medicine,reduce hemoglobin and white blood cell indexing,and further improve the patient's quality of life.There is no advantage in reducing the value of CEA,CA199,CA724 and prolonging PFS,and it can be popularized for patients with maintenance therapy after first-line chemotherapy for advanced gastric cancer. |
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