Efficacy of Jiedu formula (解毒方) as adjuvant therapy for early recurrence of hepatocellular carcinoma after radical surgery: a propensity score matching study

doi:10.19852/j.cnki.jtcm.2025.02.019

Abstract

Abstract:

OBJECTIVE: To investigate the clinical efficacy of using a Jiedu formula (解毒方) as an adjunctive therapy in patients with hepatocellular carcinoma (HCC) after hepatectomy.

METHODS: In total, 354 patients were included in this study. All patients were categorized into the traditional herbal medicine (THM) group (n =115) or the non-THM treatment (nTHM) group (n =239), with the Jiedu formula administered twice a day to the patients in the THM group. The primary outcome was recurrence-free survival (RFS). Univariate and multivariate Cox regression analyses were performed to identify the prognostic factors associated with RFS. Then, the high risk of recurrence among patients was identified, and propensity score matching (PSM) and RFS analysis were performed to analyze the prognostic factors for the outcomes of patients at a high risk of recurrence in different groups.

RESULTS: The one, two, three, and five-year RFS rates of the THM and nTHM groups were 76.4% vs66.1%, 65.5% vs48.8%, 57.9% vs39.9%, and 43.9% vs29.2%, respectively. The results of the Multivariate Cox analysis showed that giant tumors [hazard ratio (HR), 1.54, P = 0.04], poor degree of differentiation, microsatellite, or microvascular invasion (HR, 1.29, P= 0.09) increased the risk of recurrence. In the population with a high risk of recurrence, after PSM, the one, two, three, and five-year survival rates were 70.6% vs68.0%, 63.0% vs43.1%, 59.6% vs33.3%, and 41.9% vs26.4%, respectively.

CONCLUSION: In this study, THM was found to be an effective agent for adjuvant therapy for HCC to prevent early recurrence of HCC after hepatic resection.

Key words: carcinoma, hepatocellular, chemotherapy, adjuvant, propensity score, liver resection, Jiedu formula

FENG Qiuting, HU Jiajia, YU Song, ZHU Huirong, CHENG Simo, ZHAI Xiaofeng. Efficacy of Jiedu formula (解毒方) as adjuvant therapy for early recurrence of hepatocellular carcinoma after radical surgery: a propensity score matching study[J]. Journal of Traditional Chinese Medicine, 2025, 45(2): 443-449.

Figures/Tables 6

Figure 1 A flowchart of 354 eligible patients, including 115 patients in the THM group and 239 patients in the nTHM group THM: traditional herbal medicine; nTHM: non-THM treatment. THM group: Jiedu formula twice a day, 30 min after meals, within three months, and for more than six months after hepatic resection. nTHM group: no treatment with JDF.

Table 1 The demographic and clinicopathological characteristics of all patients [n (%)]

Variable		THM group (n = 115)	nTHM group (n = 239)	P value
Age	≤50 years	99 (86.1)	205 (85.8)	0.937^a
	>50 years	16 (13.9)	34 (14.2)
Male	Yes	92 (80.0)	206 (86.2)	0.135^a
	No	23 (20.0)	33 (13.8)
Viral hepatitis status	HBV	108 (93.9)	225 (94.1)	0.932^a
	Other hepatitis	7 (6.1)	14 (5.9)
Liver cirrhosis	Yes	48 (41.7)	78 (32.6)	0.094^a
	No	67 (58.3)	161 (67.4)
BCLC stage	A	104 (90.4)	189 (79.1)	0.008^b
	B	11 (9.6)	50 (20.9)
Child-Pugh	A	109 (94.8)	211 (88.3)	0.052^a
	B	6 (5.2)	28 (11.7)
Ascites	Yes	6 (5.2)	6 (2.5)	0.188^a
	No	109 (94.8)	233 (97.5)
Tumor Size	<5 cm	80 (69.6)	162 (67.8)	0.856^a
	≥10 cm	28 (24.3)	68 (28.5)
	≥5 cm and < 10 cm	7 (6.1)	9 (3.8)

Figure 2 The OS and RFS of the patients in the THM and nTHM groups A: the OS of the THM and nTHM groups; B: the median RFS of the THM group. THM group: Jiedu formula twice a day, 30 min after meals, within three months, and for more than six months after hepatic resection. nTHM group: no treatment with JDF. OS: overall survival; RFS: recurrence-free survival; THM: traditional herbal medicine; nTHM: non-THM treatment; HR: hazard ratio; RR: relative risk; CI: confidence interval. Comparisons between the THM group and the nTHM group. A comparison of survival was performed by the log-rank test. Univariate and multivariate Cox regression analyses were performed to assess the HR or RR and 90% CI for prognostic variables. The results with two-sided P values less than 0.05 were considered to be statistically significant.

Table 2 The demographic and clinicopathological characteristics of patients at high risk of recurrence [n (%)]

Variable		THM group (n = 79)	nTHM group (n = 161)	P value
Age	≤50 years	66 (84.6)	139 (86.3)	0.566^a
	>50 years	12 (15.4)	22 (13.7)
Gender	Male	61 (77.2)	137 (85.1)	0.132^a
	Female	18 (22.8)	24 (14.9)
Viral hepatitis status	HBV	75 (94.9)	150 (93.2)	0.595^a
	Unknown	4 (5.1)	11 (6.8)
Liver cirrhosis	Yes	33 (41.8)	58 (36)	0.389^a
	No	46 (58.2)	103 (64)
BCLC stage	A	68 (86.1)	112 (69.6)	0.006^b
	B	11 (13.9)	49 (30.4)
Child-Pugh	A	73 (92.4)	138 (85.7)	0.136^a
	B	6 (7.6)	23 (14.3)
Ascites	Yes	5 (6.3)	3 (1.9)	0.071^a
	No	74 (93.7)	158 (98.1)
Tumor Size	<5 cm	44 (55.7)	84 (52.2)	0.802^a
	≥10 cm	28 (35.4)	68 (42.2)
	≥5 cm and <10 cm	7 (8.9)	9 (5.6)

Figure 3 The OS and RFS of high-risk patients in the THM and nTHM groups A: the OS of the THM and nTHM groups; B: the median RFS of the THM group. THM group: Jiedu formula twice a day, 30 min after meals, within three months, and for more than six months after hepatic resection. nTHM group: no treatment with JDF. OS: overall survival; RFS: recurrence-free survival; THM: traditional herbal medicine; nTHM: non-THM treatment; HR: hazard ratio; RR: relative risk; CI: confidence interval. Comparisons between the THM group and the nTHM group. A comparison of survival was performed by the log-rank test. Univariate and multivariate Cox regression analyses were performed to assess the HR or RR and 90% CI for prognostic variables. The results with two-sided P values less than 0.05 were considered to be statistically significant.

Figure 4 The RFS of patients at high risk after PSM in the THM and nTHM groups THM group: Jiedu formula twice a day, 30 min after meals, within three months, and for more than six months after hepatic resection. nTHM group: no treatment with JDF. RFS: recurrence-free survival; PSM: propensity score matching; THM: traditional herbal medicine; nTHM: non-THM treatment; HR: hazard ratio; RR: relative risk; CI: confidence interval. Comparisons between the THM group and the nTHM group. A comparison of survival was performed by the log-rank test. Univariate and multivariate Cox regression analyses were performed to assess the HR or RR and 90% CI for prognostic variables. The results with two-sided P values less than 0.05 were considered to be statistically significant.

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