首页|卡瑞利珠单抗注射液联合TACE治疗原发性肝癌患者的临床研究

卡瑞利珠单抗注射液联合TACE治疗原发性肝癌患者的临床研究

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目的 探究卡瑞利珠单抗注射液联合经动脉化疗栓塞(TACE)治疗原发性肝癌患者的临床疗效.方法 将原发性肝癌患者分为对照组和试验组.对照组给予TACE治疗,试验组在对照组治疗的基础上,于首次TACE术后第3~7天开始予以卡瑞丽珠单抗注射液每次200 mg,静脉滴注,每3周1次.所有患者均治疗12周.比较2组患者的临床疗效[客观缓解率(ORR)、肿瘤控制率(DCR)]、肝功能[总胆红素(TBil)、谷草转氨酶(GOT)、谷丙转氨酶(GPT)]、血清肿瘤相关标志物[甲胎蛋白(AFP)、肝细胞生长因子(HGF)、细胞间黏附分子-1(ICAM-1)]、T淋巴细胞亚群指标(CD4+/CD8+比值),并进行安全性评价.结果 试验组最终纳入38例,对照组最终纳入42例.治疗后,试验组和对照组的ORR分别为65.79%(25例/38例)和42.86%(18例/42例),DCR分别为89.47%(34例/38例)和71.43%(30例/42例),在统计学上差异均有统计学意义(均P<0.05).治疗后,试验组和对照组血清TBil分别为(18.34±5.52)和(21.03±6.32)µmol·L-1,GOT 分别为(54.79±17.07)和(60.57±18.29)U·L-1,GPT 分别为(47.23±6.15)和(54.48±7.68)U·L-1,血清 AFP 分别为(96.94±28.17)和(152.49±41.22)ng·mL-1,HGF 分别为(75.08±8.26)和(90.17±9.03)ng·mL-1,ICAM-1 分别为(432.38±131.43)和(526.15±184.36)ng·mL-1,CD4+/CD8+比值分别为 1.31±0.23 和1.16±0.21,试验组上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05).试验组的药物不良反应主要有反应性皮肤毛细血管增生症、胃肠道反应和手足综合征,对照组的药物不良反应主要有手足综合征、胃肠道反应.试验组和对照组的反应性皮肤毛细血管增生症发生率为52.63%和0,在统计学上差异有统计学意义(P<0.05).结论 卡瑞利珠单抗注射液联合TACE治疗原发性肝癌患者的临床疗效显著,可有效降低患者血清AFP、HGF、ICAM-1水平,改善免疫功能.
Clinical trial of carrilizumab injection combined with TACE in the treatment of patients with primary liver cancer
Objective To explore the efficacy of camrelizumab injection combined with transcatheter arterial chemoembolization(TACE)in the treatment of patients with primary liver cancer.Methods Patients with primary liver cancer were retrospectively studied and divided into control group and treatment group according to different treatment regimens.The control group was treated with TACE,while the treatment group was intravenously injected with 200 mg of camrelizumab injection once every 3 weeks on the 3rd day-7th day after first TACE on the basis of treatment in control group.All patients were treated for 12 weeks.The efficacy[objective response rate(ORR),disease control rate(DCR)],liver function[total bilirubin(TBil),glutamic oxalacetic transaminase(GOT),glutamic pyruvic transaminase(GPT)],serum tumor-related markers[alpha fetoprotein(AFP),hepatocyte growth factor(HGF),intercellular adhesion moleclar-1(ICAM-1)],T lymphocyte subsets(CD4+/CD8+ratio)and the safety was evaluated.Results There were 38 cases in treatment group and 42 cases in control group.After treatment,the ORR in treatment group and control group were 65.79%(25 cases/38 cases)and 42.86%(18 cases/42 cases),the DCR were 89.47%(34 cases/38 cases)and 71.43%(30 cases/42 cases),the differences were statistically significant(all P<0.05).After treatment,serum TBil levels in treatment group and control group were(18.34±5.52)and(21.03±6.32)μmol·L-1;GOT levels were(54.79±17.07)and(60.57±18.29)U·L-1;GPT levels were(47.23±6.15)and(54.48±7.68)U·L-1;serum AFP levels were(96.94±28.17)and(152.49±41.22)ng·mL-1;HGF levels were(75.08±8.26)and(90.17±9.03)ng·mL-1;ICAM-1 levels were(432.38±131.43)and(526.15±184.36)ng·mL-1,respectively;CD4+/CD8+ratios were 1.31±0.23 and 1.16±0.21,respectively(all P<0.05).Compared with the control group,the above indexes in treatment group were statistically significant(all P<0.05).The adverse drug reactions in the treatment group were mainly reactive cutaneous capillary hyperplasia,gastrointestinal reaction and hand-foot syndrome,while the adverse drug reactions in the control group were mainly hand-foot syndrome and gastrointestinal reaction.The incidence of reactive cutaneous capillary hyperplasia in test group and control group was 52.63%and 0,the difference was statistically significant(P<0.05).Conclusion Camrelizumab injection combined with TACE has significant efficacy in the treatment of patients with primary liver cancer.It can effectively reduce the levels of serum AFP,HGF and ICAM-1,and improve the immune function.

camrelizumab injectionprimary liver cancertranscatheter arterial chemoembolizationalpha fetoproteinhepatocyte growth factorintercellular adhesion molecule-1

彭建平、陆星宇、杨晶、李盼

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湖南中医药大学第一附属医院肝病/感染性疾病科,湖南长沙 410007

卡瑞利珠单抗注射液 原发性肝癌 经动脉化疗栓塞 甲胎蛋白 肝细胞生长因子 细胞间黏附分子-1

2024

中国临床药理学杂志
中国药学会

中国临床药理学杂志

CSTPCD北大核心
影响因子:1.91
ISSN:1001-6821
年,卷(期):2024.40(18)
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