Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2026
Efficacy and safety of Heshu Xiaoji pills combined with standard treatment strategy in hepatitis B virus-related hepatocellular carcinoma: a single-center, open-label, prospective controlled, real-world cohort study.
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Xiaoning Zhu, Yue Yin, Yuan Kong, Mengyun Peng, Zhaoxuan Peng, Ding Zheng, Xiaodong Wang, Yunwei Han, Bo L I, Jurong Liu, Encheng Wang, Zhen Tian, Qinghua Peng, Yuanyuan Jiang, Shaoping M I, Yong Liu, Qingrong P U, Yongcan Guo, Qizhou H E, Chunxia Cheng, Linghua L I, Hong Jia, Jing Wang
Аннотация
OBJECTIVE: To evaluate the effectiveness and safety of Heshu Xiaoji pills (HSXJ, ) as an adjunct to standard treatment in patients with hepatitis B virus-related hepatocellular carcinoma.
METHODS: Overall, 201 patients enrolled between May 2020 and February 2022 received either HSXJ plus standard treatment (TCM group, n = 136) or standard treatment alone (Control group, n = 65). Follow-up continued until February 2023. Propensity score matching (PSM) (2∶1) was used to adjust for baseline differences, yielding 61 TCM and 39 control patients. Overall survival (OS), progression-free survival (PFS), and safety were compared using multivariate Cox proportional hazard regression.
RESULTS: Before PSM, OS and PFS were significantly longer in the TCM group than in the Control group (OS: 609 vs 500 d; PFS: 609 vs 507 d). After PSM, PFS remained significantly longer (551 vs 449.5 d), but OS differences were not statistically significant. Adverse events were comparable between groups. Subgroup analysis identified patients with cirrhosis, prior resection or local therapy, Child-Pugh A stage, HBV-DNA ≥ 2000 IU/mL, and alpha-fetoprotein ≤ 200 ng/mL as the most responsive to this TCM therapy.
CONCLUSIONS: HSXJ combined with standard treatment strategy significantly improved PFS in patients with HBV-related HCC without added safety risks.
METHODS: Overall, 201 patients enrolled between May 2020 and February 2022 received either HSXJ plus standard treatment (TCM group, n = 136) or standard treatment alone (Control group, n = 65). Follow-up continued until February 2023. Propensity score matching (PSM) (2∶1) was used to adjust for baseline differences, yielding 61 TCM and 39 control patients. Overall survival (OS), progression-free survival (PFS), and safety were compared using multivariate Cox proportional hazard regression.
RESULTS: Before PSM, OS and PFS were significantly longer in the TCM group than in the Control group (OS: 609 vs 500 d; PFS: 609 vs 507 d). After PSM, PFS remained significantly longer (551 vs 449.5 d), but OS differences were not statistically significant. Adverse events were comparable between groups. Subgroup analysis identified patients with cirrhosis, prior resection or local therapy, Child-Pugh A stage, HBV-DNA ≥ 2000 IU/mL, and alpha-fetoprotein ≤ 200 ng/mL as the most responsive to this TCM therapy.
CONCLUSIONS: HSXJ combined with standard treatment strategy significantly improved PFS in patients with HBV-related HCC without added safety risks.