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.
In a single-center prospective real-world cohort of 201 adults with hepatitis B virus-related hepatocellular carcinoma, adjunctive Heshu Xiaoji pills were associated with longer progression-free survival after propensity score matching, no statistically significant overall-survival improvement, and comparable adverse events versus standard treatment alone.
Open original publication →What the AI sees
In a single-center prospective real-world cohort of 201 adults with hepatitis B virus-related hepatocellular carcinoma, adjunctive Heshu Xiaoji pills were associated with longer progression-free survival after propensity score matching, no statistically significant overall-survival improvement, and comparable adverse events versus standard treatment alone.
Research significance
The reported human observational evidence supports testing whether Heshu Xiaoji pills can improve progression-free survival when added to standard treatment for HBV-related hepatocellular carcinoma; any causal benefit, active constituent, biological mechanism, responsive subgroup, or relevance to pediatric liver cancer remains inferential and requires controlled validation.
Source abstract
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.