雷莫芦单抗联合索拉非尼对HCC患者免疫功能、临床疗效及安全性评估

摘要/Abstract

摘要： 目的探讨雷莫卢单抗联合索拉非尼对肝细胞肝癌(HCC)患者免疫功能、生活质量及生存状况的影响,及其临床疗效及安全性。方法选择2019年1月至2022年12月就诊于东部战区总医院的102例HCC晚期患者,随机分为单药治疗组与双药治疗组,每组51例。单药治疗组应用索拉非尼口服治疗,双药治疗组联合应用雷莫芦单抗注射治疗,所有患者均持续治疗至病情进展或无法耐受。比较2组治疗前后肝功能指标、T细胞比例、肿瘤标志物水平及生活质量的变化。记录2组患者治疗期间不良事件发生率。结果治疗后双药治疗组患者血清Alb、ALT、AST、TBil均低于单药治疗组,分别为(41.87±8.96比46.00±6.52)g/L、(105.42±26.08比92.24±18.19)U/L、 (108.63±24.32比96.75±20.29)U/L和 (61.07±6.11比53.54±6.71) μmol/L,差异均有统计学意义(t=2.663、3.940、2.962、5.929,P<0.05)。CD4⁺T淋巴细胞(42.15±6.61比36.24±6.15)、CD4⁺/ CD8⁺(1.79±0.37比1.45±0.39)比例均显著高于单药治疗组,CD8⁺T淋巴细胞比例(21.56±4.97比26.58±4.59)显著低于单药治疗组(t=4.677、5.299、4.607,P<0.05);血清AFP (52.96±13.80比74.40±20.26)、糖类抗原242 (36.72±9.94比44.82±12.47)等肿瘤标志物均显著低于单药治疗组(t=6.245、3.627,P<0.05);生活质量量表(SF-36)评分(62.78±6.59比59.04±5.81)及客观缓解率(ORR) (80.39%比60.78%)均显著高于单药治疗组(t=3.043、χ²=4.722,P<0.05)。治疗期间,2组患者不良事件发生率为9.80%比15.69%,差异无统计学意义(P>0.05)。结论雷莫芦单抗联合索拉非尼可提高HCC患者免疫功能、降低肝功能损伤程度及血清肿瘤标志物,具有更优的临床疗效。

关键词: 雷莫芦单抗, 索拉非尼, 肝细胞肝癌, 免疫功能, 临床疗效

Abstract: Objective To observe the effects of ramucirumab combined with sorafenib on immune function, quality of life and survival status of patients with hepatocellular carcinoma (HCC), and evaluate the clinical efficacy and safety of the combined treatment regimen. Methods Eighty-six patients with HCC in our hospital from January 2017 to December 2018 were included as the study subjects. They were randomly divided into a monotherapy group (46 cases) and a combined treatment group (46 cases) by random number table method. Patients in the monotherapy group received oral administration of sorafenib, and patients in the combined treatment group received ramucirumab injection treatment. All patients were continually treated until disease progression or intolerance. The clinical efficacy, liver function index, T cell ratio, tumor marker level and quality of life were compared between the two groups before and after treatment. Results After treatment, the serum albumin (Alb) (41.87±8.96 vs 46.00±6.52), alanine aminotransferase (ALT) (105.42±26.08 vs 92.24±18.19), aspartate aminotransferase (AST) (108.63±24.32 vs 96.75±20.29) and total bilirubin (TBil) (61.07±6.11 vs 53.54±6.71) of combined treatment group patients were significantly lower than those of the monotherapy group patients (t=2.663, 3.940, 2.962, 5.929, all P<0.05). CD4⁺T (42.15±6.61 vs 36.24±6.15) and CD4⁺/CD8⁺ ratio (1.79±0.37 vs 1.45±0.39) were significantly higher than those in monotherapy group, while CD8⁺ T ratio (21.56±4.97 vs 26.58±4.59) was significantly lower (t=4.677, 5.299, 4.607, all P<0.05). The serum alpha fetoprotein (AFP) (52.96±13.80 vs 74.40±20.26) and carbohydrate antigen 242 (CA242) (36.72±9.94 vs 44.82±12.47) were significantly lower than those in the monotherapy group (t=6.245, 3.627, all P<0.05). Short-form 36 questionnaire (SF-36) score (62.78±6.59 vs 59.04±5.81) and objective response rate (ORR) (80.39% vs 60.78%) were significantly higher than those in the monotherapy group (t=3.043, χ²=4.722, all P<0.05). During the treatment, there was no significant difference in the incidence of adverse events between the two groups (9.80% vs 15.69%, P>0.05). Conclusion Ramucirumab combined with sorafenib can effectively improve immune function, reduce liver function injury degree and serum tumor markers in HCC patients, and has better clinical efficacy, which has important clinical application value for improving quality of life and prognosis of HCC patients.

Key words: ramucirumab, sorafenib, hepatocellular carcinoma, immune function, clinical efficacy

尹星, 许健, 杨涛, 董丽, 高丽丽. 雷莫芦单抗联合索拉非尼对HCC患者免疫功能、临床疗效及安全性评估[J]. 肝脏, 2024, 29(10): 1189-1193.

YIN Xing, XU Jian, YANG Tao, DONG Li, GAO Li-li. An evaluation of immune function, clinical efficacy and safety of ramucirumab combined with sorafenib treatment in patients with hepatocellular carcinoma[J]. Chinese Hepatolgy, 2024, 29(10): 1189-1193.

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