Real-world Study On The Population That Benefits From Guben Xiaoji Prescription Combined With Systemic Treatment For Metastatic Colorectal Cance

Objective:To preliminarily evaluate the clinical efficacy and safety of the combination of solid root and elimination formula with chemotherapy and targeted therapy for metastatic colorectal cancer.Methods:(1)Meta-analysis of clinical literature:The literature on the treatment of advanced metastatic colorectal cancer with TCM included in CNKI,Wanfang database and Vipshop database in the past 20 years was retrieved and screened according to the inclusion and exclusion criteria,and finally 50 articles were included,involving a total of 3175 cases.Statistical analysis was performed using RevMan 5.3 software,and the disease control rate,TCM evidence score,KPS score,blood routine,liver and kidney function,and common adverse reactions were used as observation indexes,and literature Meta-analysis was performed to evaluate the efficacy and safety of TCM combined with chemotherapy in the treatment of advanced metastatic colorectal cancer.(2)Beneficiary population real-world study:patients with metastatic colorectal cancer who were hospitalized in the inpatient department of the Cancer Treatment Center of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine and Hunan Cancer Hospital in the past 5 years were selected and screened according to the inclusion and exclusion criteria,and 64 cases were finally included.PFS,disease control rate,TCM evidence score,quality of life,KPS score,and weight change were used as observation indexes.The patients were divided into "benefit group" and "non-benefit group" at the baseline of "PFS≥10 months",and SPSS26.0 statistical software was used to analyze the survival benefit and prognosis.Results:(1)Studies in the literature:(ⅰ)the disease control rate,survival rate,improvement of TCM symptoms,and KPS score were improved in the herbal combination chemother apy group compared with the chemotherapy alone group(P<0.00001);(ⅱ)the leukopenia r ate,neurotoxicity incidence,liver and kidney function damage incidence,nausea and vom iting incidence,and diarrhea incidence were reduced in the herbal combination chemother apy group compared with the chemotherapy alone group(P<0.00001).(2)Clinical real-wor Id study:(ⅰ)Outcome indicators:64 patients included in the study,1 case of complete remis sion,12 cases of partial remission,16 cases of stability,OR of 36.11%,DCR of 80.56%in the test group,0 cases of complete remission,6 cases of partial remission,13 cases of sta bility,9 cases of progression,objective remission rate(OR)of 21.43%,disease control rat e(DCR)67.86%,comparing the DCR of patients in both groups,P=0.046<0.05,the differe nce was statistically significant.The improvement rate of TCM symptoms in the test gro up was 77.8%,and the improvement rate of TCM symptoms in the control group was 46.4%,and the difference was statistically significant when comparing the two groups,P=0.033<0.05.The improvement rate of KPS in the test group was 88.9%,and the improvement rate of KPS in the control group was 78.6%,and the difference was not statistically sig nificant when comparing the physical condition of the two groups,P=0.536>0.05.The wei ght stabilization rate in the test group accounted for 86.1%,and the weight stabilization r ate in the control group accounted for 60.7%,and the weight stabilization rate in the tw o groups was P=0.038<0.05,and the difference was statistically significant.(ⅱ)Safety evalu ation:According to the literature study,the incidence of toxic side effects of chemothera py alone was as follows in order:leukopenia 59.0%,neurotoxicity 46.5%,liver and kidney damage 28.9%,diarrhea 31.6%,nausea and vomiting 57.9%.The incidence of toxic side ef fects in the control group was 71.4%,42.9%,32.1%,25.0%,64.3%in order,and 59.0%,30.6%,27.8%,19.4%,52.8%in the test group,respectively,and the comparison of the three g roups revealed that the incidence of adverse reaction reactions in the test group was low er.(ⅲ)PFS:The mean PFS in the control group was 9.393±1.059 months,and the mean PFS in the test group was 12.924±1.302 months,and the difference was statistically si gnificant when compared with the two groups.(χ2=3.943,P=0.047<0.05).cox regression a nalysis:It can be seen that the degree of differentiation,treatment modality and enrollme nt KPS score were all independent influencing factors of PFS.(iv)Logistic regression an alysis:All other factors being equal,patients with advanced colorectal cancer with eviden ce of spleen deficiency and blood deficiency,internal stasis and toxicity,and duration of herbal intervention ≥6 months were the superior group of patients with survival benefit of solid root and elimination formula treatment(P<0.05).Conclusion:(1)Chinese medicine combined with chemotherapy and targeted therapy can significantly improve the disease control rate,prolong the PFS of patients with metastatic colorectal cancer,improve their quality of life and reduce the related side effects.(2)Independent factors affecting PFS include the degree of differentiation,treatment modality and enrollment KPS score.(3)Patients with metastatic colorectal cancer with spleen deficiency and blood deficiency,evidence of internal stasis and toxicity,and duration of herbal intervention>6 months were the superior group for survival benefit of solid root and elimination formula treatment.