Clinical Observation Of Jianpi Wengtong Formula In Treating Advanced Gastric Cancer With Apatinib-Associated Diarrhea(Syndrome Of Spleen And Kidney Yang Deficiency)

ObjectiveTo observe the clinical efficacy and safety of Jianpi Wentong Formula in intervening spleen and kidney Yang deficiency diarrhea caused by Apatinib-targeted treatment in gastric cancer patients,which can provide impartial and valuable clinical data for the treatment of Apatinib-associated diarrhea by traditional Chinese medicine.MethodsThis study was a prospective randomized controlled trial.In strict accordance with the inclusion and exclusion criteria,advanced gastric cancer patients with Apatinib-induced diarrhea were included,whose Traditional Chinese Medicine(TCM)syndrome differentiation was spleen and kidney Yang deficiency syndrome in Shanxi Provincial Hospital of Traditional Chinese Medicine from June 2021 to December 2022.According to the 1:1 randomized control principle,the experimental group used Jianpi Wentong Formula and the control group used montmorillonite powder were treated for two weeks and followed up for four weeks.Before and after treatment,the changes in diarrhea grades,TCM syndrome,physical condition,serum electrolytes,diarrhea recurrence rate,and adverse reactions of patients were observed in both groups.Relevant data were sorted out and statistically analyzed by the software SPSS 26.0.ResultsA total of 78 patients were included in this study,of which eight cases were shed(four in the experimental group and four in the control group).Finally,the experimental and control groups were 35 patients each.There were no statistical differences in case characteristics and all indicators before treatment between the two groups(P>0.05),which were comparable.1.Comparison of diarrhea grades:After treatment,the diarrhea grades of patients in both groups decreased significantly,with statistical significance within and between groups(P<0.05).In the grading efficacy of diarrhea,the effective rate of the experimental group was 94.3%and that of the control group was 77.1%,with a statistically significant difference in overall efficacy(P<0.05).2.Comparison of TCM syndromes:After treatment,the total scores of TCM syndromes in both groups decreased significantly,with statistical significance within and between groups(P<0.05).In single scores of TCM syndromes,the experimental groups compared with those before treatment had statistical significance(P<0.05);the control group compared with those before treatment had statistical significance in the three symptoms scores of diarrhea in stool,abdominal pain and distension,and inappetence(P<0.05),and had no statistical difference in the three symptoms scores of soreness and weakness of waist and knee,fatigue and coldness(P>0.05);in comparison between the two groups of patients,the five symptoms scores of diarrhea in stool,inappetence,soreness and weakness of waist and knee,fatigue and coldness had statistical significance(P<0.05),and the single symptom scores of abdominal pain and distension had no statistical difference(P>0.05).In terms of TCM syndrome efficacy,the effective rate of the experimental group was 91.4%and that of the control group was 68.6%,with a statistically significant difference in overall efficacy(P<0.05).3.Comparison of physical condition:After treatment,the overall Karnofsky(KPS)scores of the experimental group were greatly improved,and the difference was statistically significant compared with before treatment(P<0.05);the overall KPS scores of the control group did not change markedly,and the difference was no statistical significance compared with before treatment(P>0.05).The difference between the two groups was statistically significant(P<0.05).In terms of KPS scores efficacy,the effective rate of the experimental group was 91.4%and that of the control group was 74.3%,with a statistically significant difference in overall efficacy(P<0.05).4.Comparison of serum electrolytes:After treatment,serum K~+in two groups was increased,with statistical significance within and between groups(P<0.05).There was basically no change in serum Na~+and Cl~-,and the differences within and between groups were not statistically significant(P>0.05).5.Comparison of diarrhea recurrence rate:After four weeks of follow-up,the recurrence rate of diarrhea in the experimental group was 2.9%and that in the control group was 22.9%,with a statistically significant difference in overall efficacy(P<0.05).6.Safety comparison:After treatment,the proportions of decreased hemoglobin,neutropenia,hypertension,hand-foot syndrome,proteinuria and elevated aminotransferase in the experimental groups were lower than those in the control group.Only the proportion of thrombopenia was higher than those in the control group.But there was no statistical significance in all adverse reactions between groups(P>0.05).ConclusionFor advanced gastric cancer with Apatinib-induced spleen and kidney Yang deficiency diarrhea,Jianpi Wentong Formula can significantly reduce diarrhea grades,improve TCM syndromes,strengthen physical condition,regulate serum electrolytes,and decrease diarrhea recurrence rate.The clinical efficacy is superior to Montmorillonite powder with higher safety,which has clinical application value.