复方苦参注射液联合靶向和免疫治疗对晚期肝癌的疗效观察

doi:10.11958/20252381

摘要/Abstract

摘要：

目的观察复方苦参注射液联合靶向及免疫治疗对晚期肝癌患者的临床疗效。方法纳入100例晚期原发性肝癌患者并按治疗方式分为对照组（卡瑞利珠单抗+仑伐替尼治疗，50例）和观察组（卡瑞利珠单抗+仑伐替尼+复方苦参注射液治疗，50例），2组均进行3个周期治疗。比较2组患者的临床疗效、治疗前后中医证候积分、T淋巴细胞亚群水平、不良反应发生率及生存时间。结果观察组的客观缓解率、疾病控制率和中医证候积分总有效率高于对照组（P<0.05）。治疗后，观察组胁痛、腹胀、纳差、黄疸、乏力中医证候积分低于对照组；CD4⁺、CD4⁺/CD8⁺较对照组升高，CD8⁺较对照组降低（P<0.05）。观察组总不良反应发生率显著低于对照组，且无进展生存期和总生存期较对照组明显延长（P<0.05）。结论复方苦参注射液联合靶向及免疫治疗对晚期肝癌患者疗效明显，可有效改善其临床症状，调节免疫功能，延长生存时间，安全性较好。

关键词: 肝肿瘤, 复方苦参注射液, 免疫疗法, 分子靶向治疗, 疗效比较研究

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

中图分类号:

R735.3，R273

图/表 8

参考文献 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