Zhang Yi, Shi Ke, Li Yong-Qi, Liu Yao, Feng Ying, Wang Xian-Bo
Center of Integrative Medicine, Beijing Ditan Hospital, Capital Medical University, Beijing, 100015, China.
Chin J Integr Med. 2025 Jun 23. doi: 10.1007/s11655-025-3835-8.
To evaluate whether adding Fuzheng Jiedu Xiaoji (FZJDXJ) therapy improves survival in advanced hepatitis B virus-related HCC (HBV-HCC) patients.
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.
The median OS was significantly prolonged in the FZJDXJ group at 8.9 months (95% CI: 6.0-11.9) vs. 4.4 months (95% CI: 3.2-7.3) in the control group (P<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 (P<0.05). Additionally, DCR was significantly elevated in the FZJDXJ group (20.6%) compared to the control group (10.6%, P<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 function (Child-Pugh A and B, P<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.
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).
评估加用扶正解毒消积（FZJDXJ）疗法是否能提高晚期乙型肝炎病毒相关肝癌（HBV-HCC）患者的生存率。
本前瞻性随机对照研究于2020年10月至2022年10月在中国北京的一家主要学术医疗中心进行。符合条件的晚期HBV-HCC患者被随机等分为两组（1:1），分别接受FZJDXJ与西医常规疗法联合治疗（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）作为主要结局，无进展生存期（PFS）、疾病控制率（DCR）和不良事件（AE）作为次要指标。
FZJDXJ组的中位OS显著延长，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）（P<0.05）。FZJDXJ组的死亡风险比为0.59（95%CI：0.40 - 0.89），表明与对照组相比死亡风险降低了41%。结果显示，接受FZJDXJ治疗的患者PFS为5.1个月（95%CI：4.1至7.2个月），而对照组仅为2.9个月（95%CI：2.0至4.6个月）（P<0.05）。此外，FZJDXJ组的DCR显著高于对照组（20.6%对10.6%，P<0.05）。亚组分析表明，FZJDXJ显著改善了甲胎蛋白水平<400 ng/mL、年龄<60岁、巴塞罗那临床肝癌（BCLC）分期为C期且肝功能代偿（Child-Pugh A和B级）患者的OS（P<0.05）。多因素分析显示，FZJDXJ疗法是预防1年内死亡的独立因素。胃肠道症状是罕见的副作用，未报告与治疗相关的死亡病例。
这项随机对照试验表明，FZJDXJ联合西医常规疗法显著改善了晚期HBV-HCC患者的OS和PFS。（注册号：ChiCTR2000033941）
