Efficacy and Safety of Fuzheng Jiedu Xiaoji Formula Combined with Conventional Western Therapy in Advanced HBV-HCC: A Single-Center, Randomized Controlled Trial

ZHANG Yi; SHI Ke; LI Yong-qi; LIU Yao; FENG Ying; WANG Xian-bo

doi:10.1007/s11655-025-3835-8

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Efficacy and Safety of Fuzheng Jiedu Xiaoji Formula Combined with Conventional Western Therapy in Advanced HBV-HCC: A Single-Center, Randomized Controlled Trial

Original Article | Updated：2025-09-23

- Efficacy and Safety of Fuzheng Jiedu Xiaoji Formula Combined with Conventional Western Therapy in Advanced HBV-HCC: A Single-Center, Randomized Controlled Trial
- Chinese Journal of Integrative Medicine Vol. 31, Issue 10, Pages: 867-876(2025)
- Affiliations：
  
  Center of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing (100015), China
- Author bio：
  
  Prof. WANG Xian-bo, E-mail: wangxb@ccmu.edu.cn
- Funds：
- DOI：10.1007/s11655-025-3835-8
  CLC：
- Accepted：05 March 2025，
  
  Published Online：23 June 2025，
  
  Published：2025-10
- Accepted：
Scan QR Code
ZHANG Yi, SHI Ke, LI Yong-qi, et al. Efficacy and Safety of Fuzheng Jiedu Xiaoji Formula Combined with Conventional Western Therapy in Advanced HBV-HCC: A Single-Center, Randomized Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(10): 867-876.
DOI：

ZHANG Yi, SHI Ke, LI Yong-qi, et al. Efficacy and Safety of Fuzheng Jiedu Xiaoji Formula Combined with Conventional Western Therapy in Advanced HBV-HCC: A Single-Center, Randomized Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(10): 867-876. DOI： 10.1007/s11655-025-3835-8.

摘要

目的:

评估扶正解毒消积方 (FZJDXJ) 联合治疗能否改善晚期乙型肝炎病毒相关肝细胞癌 (HBV-HCC) 患者的生存状况.

方法:

本前瞻性随机对照研究于2020年10月至2022年10月在中国北京一家医疗中心开展. 将符合条件的晚期HBV-HCC患者按1:1随机分组

分别接受FZJDXJ联合常规西医治疗 (63例

FZJDXJ组) 或单纯西医治疗 (66例

对照组) . 研究终点包括总生存期 (OS) 作为主要指标

无进展生存期 (PFS) 、疾病控制率 (DCR) 和不良事件 (AEs) 作为次要指标.

结果:

FZJDXJ组患者中位OS明显延长

为8.9个月 (95% CI: 6.0-11.9)

而对照组为4.4个月 (95% CI: 3.2-7.3;

0.05) . FZJDXJ组死亡风险比为0.59 (95% CI: 0.40-0.89)

提示与对照组相比死亡风险降低41%. 接受FZJDXJ治疗的患者PFS为5.1个月 (95% CI: 4.1-7.2个月)

而对照组仅为2.9个月 (95% CI: 2.0-4.6个月;

0.05) . 此外

FZJDXJ组DCR明显高于对照组 (20.6% vs 10.6%

0.05) . 亚组分析显示

FZJDXJ在甲胎蛋白水平

400 ng/mL、年龄

60岁、巴塞罗那临床肝癌分期 (BCLC) C期及代偿性肝功能 (Child-Pugh A级和B级) 患者中OS改善更为显著 (

0.05) . 多因素分析显示

FZJDXJ治疗是1年内死亡率的独立保护因素. 胃肠道症状为罕见不良反应

未报告与治疗相关的死亡病例.

结论:

本研究表明FZJDXJ联合西医常规治疗可显著改善晚期HBV-HCC患者的OS和PFS. (注册号: ChiCTR2000033941)

Abstract

Objective:

To evaluate whether adding Fuzheng Jiedu Xiaoji (FZJDXJ) therapy improves survival in advanced hepatitis B virus-related hepatocellular carcinoma (HBV-HCC) patients.

Methods:

This prospective

randomized controlled study was performed at a major academic medical center in Beijing

China from October 2020 to October 2022. Eligible patients with advanced HBV-HCC were randomly divided equally (1:1) to receive either the combination of FZJDXJ and conventional Western medical therapy (63 cases

FZJDXJ group) or solely Western medicine (66 cases

control group). The study endpoints consisted of overall survival (OS) as the primary outcome

with progression-free survival (PFS)

disease control rate (DCR)

and adverse events (AEs) as secondary measures.

Results:

The median OS was significantly prolonged in the FZJDXJ group at 8.9 months (95% CI: 6.0–11.9)

. 4.4 months (95% CI: 3.2–7.3) in the control group (

0.05). The hazard ratio for mortality in the FZJDXJ group was 0.59 (95% CI: 0.40–0.89)

suggesting a 41% lower risk of death compared to the control group. The results revealed that patients receiving FZJDXJ therapy achieved a PFS of 5.1 months (95% CI: 4.1 to 7.2 months)

compared to only 2.9 months (95% CI: 2.0 to 4.6 months) in the control group (

0.05). Additionally

DCR was significantly elevated in the FZJDXJ group (20.6%) compared to the control group (10.6%

0.05). Subgroup analysis demonstrated that FZJDXJ significantly improved OS in patients with alpha-fetoprotein levels

400 ng/mL

age

60 years

Barcelona Clinic Liver Cancer (BCLC) stage C

and compensated liver f

unction (Child-Pugh A and B

0.05). Multivariate analysis revealed that FZJDXJ therapy acted as an independent factor protecting against mortality within 1 year. Gastrointestinal symptoms are rare side effects

and no fatalities associated with the treatment were reported.

Conclusion:

This randomized controlled trial demonstrated that FZJDXJ combined Western conventional therapy significantly improves OS and PFS in patients with advanced HBV-HCC. (registration No. ChiCTR2000033941)

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