个体化中医方案联合替雷利珠单抗治疗驱动基因阴性晚期非小细胞肺癌的疗效与安全性OA

Objective To analyze the efficacy and safety of individualized traditional Chinese medicine regimens combined with tislelizumab in the treatment of advanced non-small cell lung cancer(NSCLC)with negative driver genes.Methods A total of 80 patients with advanced NSCLC who were negative for mutations in sensitive gene targets such as epidermal growth factor receptor(EGFR)and anaplastic lymphoma kinase(ALK)were selected and randomly divided into control group(40 cases)and observation group(40 cases).The control group was treated with tislelizumab while the observation group was treated with an individualized traditional Chinese medicine syndrome differenti-ation regimen based on qi deficiency and phlegm-dampness,qi stagnation and blood stasis,and defi-ciency of both qi and yin,in addition to the treatment given to the control group.The clinical efficacy,pulmonary CT perfusion parameters,serum tumor marker levels,lymphocyte subset indicator levels,and the occurrence of adverse reactions were compared between the two groups.Results After treatment,the disease control rate in the observation group was higher than that in the control group,with a statistically significant difference(RR=1.28,95％CI,1.03 to 1.57,P=0.019).After treatment,the blood flow(BF),blood volume(BV),and permeability surface area(PS)in both groups decreased compared with those before treatment,while the mean transit time(MTT)was prolonged,with statistically significant differences(P＜0.05).After Benjamini Hochberg FDR cor-rection for inter-group comparison,the BF,BV,and PS in the observation group were lower than those in the control group,and the MTT was longer than that in the control group,with statistically significant differences(q＜0.05).After treatment,the levels of the tumor markers serum cytokera-tin 19 fragment 21-1(CYFRA21-1),carbohydrate antigen 125(CA125),squamous cell carcinoma antigen(SCCAg),and carcinoembryonic antigen(CEA)in both groups decreased compared with those before treatment,with statistically significant differences(P＜0.05).After Benjamini Hoch-berg FDR correction for inter-group comparison,the levels of CEA,SCCAg,CYFRA21-1,and CA125 in the observation group were lower than those in the control group,with statistically signifi-cant differences(q＜0.05).After treatment,the levels of CD3+,CD4+,and natural killer(NK)cells in both groups increased compared with those before treatment,with statistically significant differences(P＜0.05),while the difference in the CD8+level compared with that before treatment was not statistically significant(P＞0.05).After Benjamini Hochberg FDR correction for inter-group comparison,the levels of CD3+,CD4+,and NK cells in the observation group were higher than those in the control group,with statistically significant differences(q＜0.05),while the differ-ence in the CD8+level was not statistically significant(q＞0.05).The overall incidence of grade 3 adverse reactions in the observation group was lower than that in the control group,with a statistical-ly significant difference(P＜0.05).Conclusion This study evaluates the efficacy of individual-ized traditional Chinese medicine regimens in enhancing the efficacy of immunotherapy and explores the synergistic effect of traditional Chinese medicine syndrome differentiation in immunotherapy.The combination of individualized traditional Chinese medicine regimens and tislelizumab shows signifi-cant efficacy in the treatment of patients with advanced NSCLC with negative driver genes,which may be related to the regulation of tumor microvessels,synergistic enhancement of immune function,and improvement of serum tumor marker levels.Itprovides an integrated traditional Chinese and western medicine treatment option for such patients who lack targeted therapy opportunities,demon-strating better safety,helping to reduce the occurrence of serious adverse events,and not increasing the overall burden of adverse events.