Cheng Yang, Wang Hao-Yi, Wan Cheng-Yi, Shi Jie-Wen, Jin Yuan-Yuan, He Sheng-Li, Yin Bao-Bing, Chen Jian-Jie
Institute of Liver Diseases, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Key Laboratory of Liver and Kidney Diseases of Ministry of Education, Shanghai, 201203, China.
Chin J Integr Med. 2025 May;31(5):394-401. doi: 10.1007/s11655-024-3818-1. Epub 2024 Dec 5.
To assess the efficacy and safety of Erzhu Jiedu Decoction (EZJDD) Granules in treating mid-advanced hepatitis B virus-associated primary liver cancer (HBV-PLC) patients with Pi (Spleen)-deficiency and dampness-heat syndrome.
From January 2021 to June 2023, a cohort of 132 patients were enrolled and randomly assigned to a control group or a EZJDD group according to the random numbers, with 66 patients in each group. The patients in the control group received conventional treatment for 3 months, followed by a 3-month follow-up. In addition to the conventional treatment, patients in the EZJDD group were administered EZJDD Granules (10.9 g/pack, 2 packs twice per day) orally for same duration. Progression-free survival (PFS) as primary outcome was evaluated by Kaplan Meier method. Karnofsky performance status (KPS) scores were used to assess the quality of life in two groups before and after treatment, and survival rates were determined as well. The efficacy of Chinese medicine syndrome was calculated with Nimodipine method. Liver function, tumor indicators and T lymphocyte subsets were measured, respectively. Safety indicators were recorded and assessed.
Of the 116 patients who completed the study, 57 were in the control group and 59 in the EZJDD group. The median PFS was 3.53 months (106 days) in the EZJDD group compared to 2.33 months (70 days) in the control group (P=0.005). Six-month survival rate was 52.63% (30/57) in the control group and 69.49% (41/59) in the EZJDD group (P=0.039). The median KPS score in the EZJDD group [70(63, 90)] was higher than that in the control group [70(60, 80)] (P=0.013). The total effective rate of CM syndrome was 52.63% (30/57) in the control group and 77.97% (46/59) in the EZJDD group (P=0.005). The levels of alpha fetoprotein, alpha fetoprotein-L3, alpha-L-fucosidase and protein induced by Vitamin K absence or antagonist- II in the EZJDD group increased less than the control group (P>0.05). CD8 levels were decreased, while CD3 and CD4 levels, as well as CD4/CD8 ratio were significantly increased in the EZZJD group (P<0.05). No treatment-related adverse reactions were observed during the study.
EZJDD Granules significantly prolonged the median PFS and improved 6-month survival rate in patients with mid-advanced HBV-PLC (Registration No. ChiCTR2200056922).
评估二术解毒汤（EZJDD）颗粒治疗中晚期乙肝病毒相关性原发性肝癌（HBV-PLC）脾虚湿热证患者的疗效和安全性。
2021年1月至2023年6月，纳入132例患者，根据随机数字表法随机分为对照组和EZJDD组，每组66例。对照组患者接受3个月的常规治疗，随后进行3个月的随访。EZJDD组患者在常规治疗的基础上，口服EZJDD颗粒（10.9 g/包，每日2次，每次2包），疗程相同。采用Kaplan-Meier法评估无进展生存期（PFS）作为主要结局。采用卡氏功能状态（KPS）评分评估两组治疗前后的生活质量，并确定生存率。采用尼莫地平法计算中医证候疗效。分别检测肝功能、肿瘤指标和T淋巴细胞亚群。记录并评估安全指标。
116例完成研究的患者中，对照组57例，EZJDD组59例。EZJDD组的中位PFS为3.53个月（106天），对照组为2.33个月（70天）（P=0.005）。对照组6个月生存率为52.63%（30/57），EZJDD组为69.49%（41/59）（P=0.039）。EZJDD组的中位KPS评分[70(63, 90)]高于对照组[70(60, 80)]（P=0.013）。对照组中医证候总有效率为52.63%（30/57），EZJDD组为77.97%（46/59）（P=0.005）。EZJDD组甲胎蛋白、甲胎蛋白-L3、α-L-岩藻糖苷酶和维生素K缺乏或拮抗剂-II诱导蛋白的水平升高幅度小于对照组（P>0.05）。EZJDD组CD8水平降低，而CD3、CD4水平以及CD4/CD8比值显著升高（P<0.05）。研究期间未观察到与治疗相关的不良反应。
EZJDD颗粒显著延长了中晚期HBV-PLC患者的中位PFS，提高了6个月生存率（注册号：ChiCTR2200056922）。
