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Journal of Traditional Chinese Medicine ›› 2026, Vol. 46 ›› Issue (4): 961-971.DOI: 10.19852/j.cnki.jtcm.2026.04.016

• Original Articles • Previous Articles     Next Articles

Efficacy and safety of Heshu Xiaoji pills (和枢消积丸) combined with standard treatment strategy in hepatitis B virus-related hepatocellular carcinoma: a single-center, open-label, prospective controlled, real-world cohort study

ZHU Xiaoning1, YIN Yue1, KONG Yuan2, PENG Mengyun1, PENG Zhaoxuan1, ZHENG Ding1, WANG Xiaodong1, HAN Yunwei3, LI Bo4, LIU Jurong1, WANG Encheng1, TIAN Zhen1, PENG Qinghua1, JIANG Yuanyuan1, MI Shaoping1, LIU Yong5, PU Qingrong6, GUO Yongcan7, HE Qizhou5, CHENG Chunxia8, LI Linghua9, JIA Hong2(), WANG Jing1()   

  1. 1 Department of Hepatobiliary Medicine, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China; Sichuan Clinical Research Center for Traditional Chinese Medicine of Liver Diseases, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China
    2 School of Public Health, Center for Evidence-Based Medicine, Southwest Medical University, Luzhou 646000, China
    3 Sichuan Clinical Research Center for Traditional Chinese Medicine of Liver Diseases, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China; Department of Oncology, the Affiliated Hospital, Southwest Medical University, Luzhou 646000, China
    4 Department of Hepatobiliary Surgery, the Affiliated Hospital, Southwest Medical University, Luzhou 646000, China
    5 Department of Medical Imaging, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China
    6 Institute of Pharmacy, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China
    7 Department of Laboratory Medicine, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China
    8 Department of Ultrasound, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China
    9 Department of Electrocardiography, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China
  • Received:2025-06-18 Accepted:2025-11-18 Online:2026-08-15 Published:2026-08-08
  • Contact: WANG Jing, Department of Hepatobiliary Medicine, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China; Sichuan Clinical Research Center for Traditional Chinese Medicine of Liver Diseases, the Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University, Luzhou 646000, China. lywj68@126.com;JIA Hong, School of Public Health, Center for Evidence-Based Medicine, Southwest Medical University, Luzhou 646000, China. Jhong_lz@163.com, Telephone: +86 13882726162; +86 13088316133
  • About author:ZHU Xiaoning and YIN Yue are co-first authors and contributed equally to this work
  • Supported by:
    Sichuan Science and Technology Program-funded Project: Evidence-based Research on Precision Treatment Strategies Using Traditional Chinese Medicine for Primary Liver Cancer(2024YFFK0086);Program of Southwest Medical University-funded Project: Mechanistic Study of Heshu Xiaoji Pills Targeting MicroRNAs to Regulate Cancer Stem Cells and Reduce Hepatocellular Carcinoma Recurrence(2023ZYYJ08);Natural Science Foundation of Sichuan Province-funded Project: Basic and Clinical Research on the Prevention and Treatment of Primary Liver Cancer Based on the Academic Thought of Professor Sun Tongjiao, a Nationally Renowned Traditional Chinese Medicine Practitioner(2022YFS0619);National Traditional Chinese Medicine Clinical Research Base Construction Unit of the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou Science and Technology Innovation Team, and the Science and Technology Innovation Team of the Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

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Abstract:

OBJECTIVE: To evaluate the effectiveness and safety of Heshu Xiaoji pills (HSXJ, 和枢消积丸) 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.

Key words: carcinoma, hepatocellular, chemotherapy, adjuvant, real-world cohort study, Heshu Xiaoji pills

Cite this article

ZHU Xiaoning, YIN Yue, KONG Yuan, PENG Mengyun, PENG Zhaoxuan, ZHENG Ding, WANG Xiaodong, HAN Yunwei, LI Bo, LIU Jurong, WANG Encheng, TIAN Zhen, PENG Qinghua, JIANG Yuanyuan, MI Shaoping, LIU Yong, PU Qingrong, GUO Yongcan, HE Qizhou, CHENG Chunxia, LI Linghua, JIA Hong, WANG Jing. Efficacy and safety of Heshu Xiaoji pills (和枢消积丸) combined with standard treatment strategy in hepatitis B virus-related hepatocellular carcinoma: a single-center, open-label, prospective controlled, real-world cohort study[J]. Journal of Traditional Chinese Medicine, 2026, 46(4): 961-971.