| Objective:To evaluate the efficacy and safety of Erteng-Sanjie capsule combined with Apatinib in the treatment of advanced gastric cancer,and to provide objective data support for ErtengSanjie capsule combined with Apatinib in the treatment of advanced gastric cancer.To explore the application of the concept of "supporting righteousness and expelling evil,reducing toxicity and increasing efficiency" in the clinical treatment of tumors,so as to provide a theoretical basis for the treatment of tumors with integrated traditional Chinese and Western medicine.Methods:The effect of Erteng-Sanjie capsule combined with Apatinib on advanced gastric cancer(spleen deficiency,phlegm,and blood stasis type)was observed and evaluated.The subject was treated with complete randomized control design.In strict accordance with the inclusion and exclusion criteria,82 patients with advanced gastric cancer treated in the outpatient and inpatient department of Shanxi Provincial Hospital of traditional Chinese medicine from December 2019 to December 2020 were collected.They were divided into experimental groups and control groups according to the principle of randomization.The ratio of the two groups was 1:1,with 41 cases in each group.Control group: oral Apatinib mesylate tablets(Jiangsu Hengrui Pharmaceutical Co.,Ltd.);Experimental group: based on the control group,Erteng-Sanjie capsule was taken orally at the same time.Four weeks contain 1 treatment cycle and 2 cycles of continuous treatment.Fill in the case data in detail,observe the progression-free survival time of patients before and after treatment,the curative effect of solid tumor,the curative effect of traditional Chinese medicine syndrome,the score of gastric cancer Pro scale,physical condition,immune function,tumor markers of gastric cancer,vascular endothelial growth factor and toxic and side effects.The data were statistically analyzed by statistical software SPSS 25.0.Results:A total of 74 patients completed the clinical study(8 cases fell off),38 cases in the experimental group,and 36 cases in the control group.1.Comparison of survival time: the median Progression-free survival(PFS)of the experimental group(4.43 months)was higher than that of the control group(3.83 months),but there was no significant difference between the two groups(P>0.05).2.Comparison of short-term efficacy: Objective response rate(ORR)(23.69%)and Disease control rate(DCR)(65.79%)in the experimental group was higher than ORR(19.44%)and DCR(61.11%)in the control group,but there was no significant difference between the two groups(P>0.05).3.Comparison of TCM syndrome efficacy: after treatment,the improvement of TCM syndrome scores of stomach pain,fullness,stupidity,belching,nausea and vomiting,and loose stool in the experimental group was better than that in the control group,and the difference was statistically significant(P<0.05);The effective rate of TCM syndrome in the experimental group was 73.68%,which was higher than 44.44% in the control group(P<0.05).4.Comparison of physical condition score: the Karnofsky score of the experimental group was significantly higher than that of the control group after treatment,and the difference was statistically significant(P<0.05).5.Comparison of cellular immune function: the cellular immune function(CD4+,CD8+,CD4+/CD8+)of the experimental group was significantly improved after treatment,which was better than that of the control group(P<0.05).6.Comparison of tumor marker levels of gastric cancer: the tumor marker related indexes(CEA,CA724,and CA199)of gastric cancer in the two groups decreased after treatment,and the difference was statistically significant(P<0.05).However,there was no significant difference between the two groups(P>0.05).7.Comparison of vascular endothelial growth factor level: serum VEGF was highly expressed in patients with advanced gastric cancer,and the serum VEGF level decreased after treatment,but there was no significant difference between the two groups before and after treatment(P>0.05).Subgroup analysis showed that the level of serum VEGF in patients with effective treatment(CR+PR)was significantly lower than before treatment;There was no significant difference between before and after treatment(SD+PD)(P>0.05).8.Comparison of adverse reactions: the incidence of proteinuria(42.11%),hypertension(28.95%),hand-foot syndrome(23.68%)and diarrhea(15.79%)in the experimental group was lower than that in the control group.The difference between the diarrhea groups was statistically significant(P<0.05),and the difference of other adverse reactions was not statistically significant(P>0.05).Conclusion:Erteng-Sanjie capsule combined with Apatinib can improve the clinical symptoms of patients with advanced gastric cancer,improve the quality of life and cellular immune function.Erteng-Sanjie capsule can reduce the related toxic and side effects of Apatinib,with high safety and clinical application value. |
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