Clinical efficacy of Huaier granule on postoperative prevention of recurrence in HCC patients with high risk factors of recurrence

JIANG Kun-yuan; LIU Zi-hao; LI Jing-fei; YIN Da-long

doi:10.19538/j.cjps.issn1005-2208.2025.02.10

Abstract：Objective To investigate the clinical efficacy of Huaier granule in preventing postoperative recurrence in HCC patients associated with high-risk factors of recurrence.Methods Between January 2019 and January 2022,118 patients who were confirmed with high-risk factors of recurrence by pathological results(combined with microvascular invasion,tumor size ≥ 5 cm,or poor differentiation)in the First Affiliated Hospital of the University of Science and Technology of China(Anhui Provincial Hospital)were retrospectively analyzed.Based on whether they received Huaier granule or no further treatment after HCC resection,patients were divided into the Huaier group(38 cases)and the control group(80 cases).The primary endpoint was 1-year recurrence-free survival(RFS).Propensity score matching(PSM)was used to avoid possible selection bias.Results The median follow-up time was 13(2-40)months.Before PSM,there were significant differences in the proportion of males,positive for Hepatitis B surface antigen(HBsAg),alpha-fetoprotein(AFP)≥400 μg/L,and poor differentiation between the two groups(All P＜0.05).The 1-year RFS rates were 86.8％versus 51.2％(P＜0.001)for the Huaier and control groups,respectively.The Cox proportional hazards model identified the Huaier granule as an independent predictor for recurrence-free survival(RFS)(HR=0.333,95％CI 0.162-0.686,P=0.003).In the propensity model,the baseline variables were well-balanced between the two groups(both P＞0.05).The 1-year RFS rates were 84.6％versus 57.7％(P=0.042)for the Huaier and control groups,respectively.The difference was still statistically significant.Compared with the Huaier group,the control group had a higher incidence of intrahepatic multiple metastases(before PSM:0 vs.15.0％,P=0.028;after PSM:0 vs.23.1％,P=0.023).Conclusion For HCC patients at a high risk of recurrence after radical resection,Huaier granules can significantly improve the 1-year RFS and reduce the incidence of intrahepatic multiple metastases.It is an effective adjuvant therapy to prevent recurrence after HCC resection.