Objective To evaluate the role and differences of Fuzheng Jiedu formula in preventing postoperative recurrence and metastasis in patients with lymph node metastatic colorectal cancer.Methods Patients were categorized into two cohorts based on whether they received systematic traditional Chinese medicine(TCM)treatment or not.The primary endpoint was re-lapse-free survival(RFS),while the secondary endpoint was the hazard ratio(HR).Results A total of 407 patients were includ-ed in the study.After propensity score matching,no significant difference was observed in baseline characteristics between the groups(P＞0.05).The Fuzheng Jiedu formula significantly reduced the risk of recurrence and metastasis[HR:0.46,P＜0.05,Full Analysis Set(FAS)analysis],which was consistent with Per-Protocol Set(PPS)analysis.In the FAS analysis,for patients with＜4 involved lymph nodes(N1),the risk of recurrence and metastasis in the TCM group was 0.548 times that of the non-TCM group(95％CI:0.365-0.823).For patients with ≥4 involved lymph nodes(N2),the risk of recurrence and metastasis in the TCM group was 0.260 times that of the non-TCM group(95％CI:0.138-0.490).The findings from the PPS analysis were consistent.Conclusion The Fuzheng Jiedu formula can effectively reduce the risk of recurrence and metastasis after surgery for lymph node metastatic colorectal cancer,particularly benefiting patients in stage N2.

Objective To evaluate the role and differences of Fuzheng Jiedu formula in preventing postoperative recurrence and metastasis in patients with lymph node metastatic colorectal cancer.Methods Patients were categorized into two cohorts based on whether they received systematic traditional Chinese medicine(TCM)treatment or not.The primary endpoint was re-lapse-free survival(RFS),while the secondary endpoint was the hazard ratio(HR).Results A total of 407 patients were includ-ed in the study.After propensity score matching,no significant difference was observed in baseline characteristics between the groups(P＞0.05).The Fuzheng Jiedu formula significantly reduced the risk of recurrence and metastasis[HR:0.46,P＜0.05,Full Analysis Set(FAS)analysis],which was consistent with Per-Protocol Set(PPS)analysis.In the FAS analysis,for patients with＜4 involved lymph nodes(N1),the risk of recurrence and metastasis in the TCM group was 0.548 times that of the non-TCM group(95％CI:0.365-0.823).For patients with ≥4 involved lymph nodes(N2),the risk of recurrence and metastasis in the TCM group was 0.260 times that of the non-TCM group(95％CI:0.138-0.490).The findings from the PPS analysis were consistent.Conclusion The Fuzheng Jiedu formula can effectively reduce the risk of recurrence and metastasis after surgery for lymph node metastatic colorectal cancer,particularly benefiting patients in stage N2.