The Clinical Research On Effect Of Jianpi Huayu Xiaozheng Prescription Combined With Apatinib On Treating Ⅳ Period Gastric Cancer With The Spleen Deficiency And Blood Stasis Syndrome

Objective:The purpose of this project is to clarify Jianpi Huayu Xiaozheng Prescription’s clinical safety and efficacy by observing patients’s common clinical symptoms,tumor size,laboratory indexes(tumor markers,detection of cellular immune function),karnofsky score and investigating adverse reactions caused by Apatinib after oral Jianpi Huayu Xiaozheng Prescription combined with Apatinib on treating IV period gastric cancer with the spleen deficiency and blood stasis syndrome.Hopefully,this research will contribute to the further studies within the prescription of anti-cancer TCM and providing a new idea for the treatment of IV period gastric cancer.Method:This research used the randomized controlled methods,the 50 patients with IV period gastric cancer with the spleen deficiency and blood stasis syndrome,in accordance with the random number table,were divided into treatment group(n=25)and control group(n=25).The control group patients were given Apatinib,and Jianpi Huayu Xiaozheng Prescription was added to the treatment group.One treatment cycle contained 28 days,the therapeutic effects of two groups were evaluated after continuous treatment for 4 treatment cycles.Common clinical symptoms grading quantization table of spleen deficiency and blood stasis syndrome in IV period gastric cancer and karnofsky score were taken as major tools,and analyzed tumor size,tumor marker,detection of cellular immune function,adverse reactions before and after treatment.Result:Total the completion be 45 clinical research cases(2 cases in the treatment group and 3 cases in the control group were dropped out),among them treatment group 23,control group 22.1.Comparison of the clinical curative effects:Results of the objective response rates(ORR)and disease control rate(DCR)were 34.78%,86.96%and 31.82%,81.82%respectively.However,there was no significant difference between treatment group and control group(P>0.05)2.Comparison of the improvement of TCM syndromes:The treatment group of patients with effective rate was 78.26%,the control group was 45.45%,the difference between both groups was statistically significant(P<0.05).3.Comparison of tumor markers:After treatment,the patients who were randomized to treatment group,serum CEA and CA724 levels were significantly decreased.Compared with the control group,the difference of serum CA724 level had statistical significance(P<0.05).4.Comparison of cellular immune function:After the end of treatment,the cellular immune function of treatment group patients showed marked improvement.There were obvious difference on the levels of CD3,CD8 and CD4/CD8 ratio,and revealed significant difference(P<0.01)compared to the control group.5.Comparison of Karnofsky score:The Karnofsky score of treatment group remarkably enhances(P<0.01)compared with pretreatment,and the difference between two groups had statistical significance(P<0.05).6.Comparison of the incidence of drug-related adverse reactions:The drug-related adverse reactions were lower in the treatment group than that of the control group by different degrees.The incidence of hypertension in the treatment group was obviously lower than in the control group,which was statistically significant(P<0.05).Conclusion:Compared with Apatinib monotherapy,the treatment of Jianpi Huayu Xiaozheng Prescription combined with Apatinib can decrease levels of tumor markers,improve immunity,improve patients ’s quality of life and alleviate side effects of Apatinib.As a result,Jianpi Huayu Xiaozheng Prescription is safety and practicality in the field of IV period gastric cancer therapy.