Randomized Double-Blind Controlled Study on the Impact of Fuzheng Xiaoliu Formula Combined with Cryoablation on Immune Response in Patients with Advanced NSCLC

KOU Na; BIAN Linjie; DENG KangLi; LI Longzhao; ZHAO Mengyuan; ZHANG Ruichen; WANG Hongwu

Abstract：Objective To evaluate the immunomodulatory effects and clinical outcomes of Fuzheng Xiaoliu formula combined with argon-helium cryoablation on patients with advanced non-small cell lung cancer(NSCLC).Methods A randomized,double-blind,controlled study was conducted on 90 patients with advanced NSCLC who underwent argon-helium cryotherapy surgery.They were randomly divided into the treatment group(cryoablation+Fuzheng Xiaoliu formula,n=45)and the control group(cryoablation+placebo,n=45).Peripheral blood immune parameters including T-cell subsets(CD4+,CD8+,CD4+/CD8+ratio),mature myeloid dendritic cells(mDCs),plasmacytoid dendritic cells(pDCs),and serum cytokine levels(IL-6,IL-10,IL-12,TNF-α,IFN-γ)were assessed at baseline,1 week,and 4 weeks post-treatment.traditional Chinese medicine(TCM)symptom scores were recorded concurrently.Safety outcomes included postoperative complications and adverse events within 4 weeks.Results A total of 38 patients in the control group and 36 patients in the treatment group completed the study and were included in the statistical analysis,the TCM syndrome scores of the patients in both groups decreased at 1 week and 4 weeks after treatment(P<0.05).At 1 week after treatment,the levels of IL-6,IL-10,IL-12,and TNF-α in both groups increased significantly(P<0.05).At 4 weeks after treatment,the levels of IL-6 and TNF-α in the control group increased(P<0.05).Compared with the control group,the levels of peripheral blood CD4+and mature mDCs in the treatment group increased at 1 week after treatment(P<0.05).At 4 weeks after treatment,the levels of peripheral blood CD4+,CD8+,CD4+/CD8+ratio,mature mDCs,and mature pDCs in the treatment group increased,while the levels of IL-6,TNF-α,and TCM syndrome scores decreased(P<0.05).There was no significant difference in postoperative complications and drug-related safety indicators between the two groups(P>0.05).Conclusion The combination of Fuzheng Xiaoliu formula prescription and argon-helium cryotherapy enhances the immune response in patients with advanced NSCLC and improves their clinical symptoms.