Observation on the clinical efficacy of compound kushen injection combined with targeted and immune therapy in the treatment of advanced hepatocellular carcinoma

doi:10.11958/20252381

Abstract

Abstract:

Objective To observe the clinical efficacy of compound kushen injection combined with targeted and immunotherapy in patients with advanced malignant liver tumors. Methods A total of 100 patients with advanced primary liver cancer were divided into two groups according to the treatment methods: the control group (camrelizumab + lenvatinib, n = 50) and the observation group (camrelizumab + lenvatinib + compound Sophora flavescens injection, n = 50). Both groups received three treatment cycles. The clinical efficacy, traditional Chinese medicine (TCM) syndrome scores, T lymphocyte subset levels, incidence of adverse reactions and survival time were compared before and after treatment between the two groups. Results The objective response rate (ORR), disease control rate (DCR) and total effective rate of TCM syndrome score were significantly higher in the observation group than those of the control group (P < 0.05). After treatment, TCM syndrome scores for hypochondriac pain, abdominal distension, poor appetite, jaundice and fatigue were lower in the observation group than those of the control group. Levels of CD4⁺ and the CD4⁺/CD8⁺ ratio were higher, while CD8⁺ levels were lower in the observation group than those in the control group (P < 0.05). The total incidence of adverse reactions was significantly lower in the observation group than that of the control group. Moreover, both progression-free survival (PFS) time and overall survival (OS) time were significantly longer in the observation group than that of the control group (P<0.05). Conclusion Compound Sophora flavescens injection combined with targeted and immunotherapy demonstrates good clinical efficacy in patients with advanced malignant liver tumors. It can effectively improve clinical symptoms, regulate immune function, prolong survival time and have good safety.

Key words: liver neoplasms, Fu Fang Ku Shen Zhu She Ye, immunotherapy, molecular targeted therapy, comparative effectiveness research

CLC Number:

R735.3，R273

Figures/Tables 8

References 22

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组别		年龄/岁		性别（男/女）		ECOG
组别		年龄/岁		性别（男/女）		1分		2分
对照组		64.40±11.57		41/9		24（48.0）		26（52.0）
观察组		65.64±10.63		39/11		22（44.0）		28（56.0）
t或χ²		0.558		0.250		0.161
组别	Child-Pugh分级				形态学
组别	A级		B级		弥漫型		结节型		巨块型
对照组	24（48.0）		26（52.0）		16（32.0）		14（28.0）		20（40.0）
观察组	22（44.0）		28（56.0）		16（32.0）		17（34.0）		17（34.0）
χ²	0.161				0.534

组别		年龄/岁		性别（男/女）		ECOG
组别		年龄/岁		性别（男/女）		1分		2分
对照组		64.40±11.57		41/9		24（48.0）		26（52.0）
观察组		65.64±10.63		39/11		22（44.0）		28（56.0）
t或χ²		0.558		0.250		0.161
组别	Child-Pugh分级				形态学
组别	A级		B级		弥漫型		结节型		巨块型
对照组	24（48.0）		26（52.0）		16（32.0）		14（28.0）		20（40.0）
观察组	22（44.0）		28（56.0）		16（32.0）		17（34.0）		17（34.0）
χ²	0.161				0.534

组别	n	CR	PR	SD	PD	ORR	DCR
对照组	50	0（0）	20（40.0）	17（34.0）	13（26.0）	20（40.0）	37（74.0）
观察组	50	1（2.0）	29（58.0）	16（28.0）	4（12.0）	30（60.0）	46（92.0）
χ²						4.000^＊	5.741^＊

组别	n	CR	PR	SD	PD	ORR	DCR
对照组	50	0（0）	20（40.0）	17（34.0）	13（26.0）	20（40.0）	37（74.0）
观察组	50	1（2.0）	29（58.0）	16（28.0）	4（12.0）	30（60.0）	46（92.0）
χ²						4.000^＊	5.741^＊

组别		胁痛						腹胀					纳差
组别		治疗前		治疗后	Z			治疗前		治疗后	Z		治疗前		治疗后		Z
对照组		6.0（3.0，6.0）		3.0（2.3，6.0）	3.597^＊＊			3.0（0.0，6.0）		3.0（0.0，6.0）	1.757		3.0（3.0，6.0）		3.0（0.0，3.0）		4.695^＊＊
观察组		6.0（0.0，6.0）		3.0（0.0，3.0）	4.185^＊＊			3.0（3.0，6.0）		0.0（0.0，3.0）	4.624^＊＊		6.0（3.0，6.0）		0.0（0.0，3.0）		6.059^＊＊
Z		0.732		2.825^＊＊				0.257		2.817^＊＊			0.937		3.152^＊＊
组别	黄疸						乏力							尿少
组别	治疗前		治疗后			Z	治疗前		治疗后			Z		治疗前		治疗后		Z
对照组	0.0（0.0，0.0）		0.0（0.0，0.0）			0.000	3.0（2.3，6.0）		3.0（0.0，6.0）			2.108^＊		0.0（0.0，0.0）		0.0（0.0，0.0）		1.000
观察组	0.0（0.0，0.0）		0.0（0.0，0.0）			3.000^＊＊	3.0（3.0，6.0）		1.5（0.0，3.0）			4.611^＊＊		0.0（0.0，0.0）		0.0（0.0，0.0）		0.000
Z	0.047		3.128^＊＊				0.369		2.175^＊					0.755		1.346