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大连理工大学附属中心医院(大连市中心医院)药学部,辽宁 大连 116089
主管药师,硕士。研究方向:抗肿瘤药物。E-mail:xinkuo1994@hotmail.com
主任药师,博士研究生。研究方向:临床药学、循证医学。E-mail:yalinxi@163.com
纸质出版日期:2024-09-30,
收稿日期:2024-05-13,
修回日期:2024-08-21,
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郑新阔,席雅琳.卡瑞利珠单抗联合阿帕替尼一线治疗不可切除晚期肝细胞癌的疗效与安全性 Δ[J].中国药房,2024,35(18):2288-2292.
ZHENG Xinkuo,XI Yalin.Efficacy and safety of camrelizumab combined with apatinib in first-line treatment of unresectable advanced hepatocellular carcinoma[J].ZHONGGUO YAOFANG,2024,35(18):2288-2292.
郑新阔,席雅琳.卡瑞利珠单抗联合阿帕替尼一线治疗不可切除晚期肝细胞癌的疗效与安全性 Δ[J].中国药房,2024,35(18):2288-2292. DOI: 10.6039/j.issn.1001-0408.2024.18.17.
ZHENG Xinkuo,XI Yalin.Efficacy and safety of camrelizumab combined with apatinib in first-line treatment of unresectable advanced hepatocellular carcinoma[J].ZHONGGUO YAOFANG,2024,35(18):2288-2292. DOI: 10.6039/j.issn.1001-0408.2024.18.17.
目的
2
评价卡瑞利珠单抗联合阿帕替尼一线治疗不可切除晚期肝细胞癌的疗效与安全性。
方法
2
基于真实世界数据,回顾性选择2020年1月-2023年1月我院收治的67例不可切除晚期肝细胞癌患者为研究对象,根据其用药方案的不同分为卡瑞利珠单抗联合阿帕替尼组(32例)和卡瑞利珠单抗联合奥沙利铂组(35例)。两组患者均治疗12个月以上,随访期为开始治疗后的12个月。对比两组患者的疗效,治疗前后肿瘤标志物、肝肾功能指标、血常规指标水平;采用Kaplan-Meier法绘制生存曲线,通过Log-rank检验分析组间生存差异,并采用多因素COX回归分析影响患者生存的因素。
结果
2
治疗后,卡瑞利珠单抗联合阿帕替尼组患者的疾病控制率为68.8%,显著高于卡瑞利珠单抗联合奥沙利铂组的45.7%(
P
<0.05);两组患者治疗半年后的甲胎蛋白、糖类抗原19-9(卡瑞利珠单抗联合奥沙利铂组除外)、糖类抗原15-3水平均显著降低,且卡瑞利珠单抗联合阿帕替尼组甲胎蛋白、癌胚抗原、糖类抗原15-3的下降程度更明显(
P
<0.05);卡瑞利珠单抗联合阿帕替尼组患者的天冬氨酸转氨酶水平显著升高(
P
<0.05)。与卡瑞利珠单抗联合奥沙利铂组比较,卡瑞利珠单抗联合阿帕替尼组患者的总生存期显著延长(风险比为2.97,95%置信区间为1.305~6.749,Log-rank检验的
P
值为0.006);治疗方案和诊断时患者的肝细胞癌分期是影响其生存的重要因素(风险比分别为2.97、5.16,95%置信区间分别为1.305~6.749、2.261~11.780,
P
<0.05)。
结论
2
卡瑞利珠单抗联合阿帕替尼一线治疗不可切除晚期肝细胞癌具有较好的临床疗效,且安全性总体可控,但在用药时应注意监测患者的肝功能指标。
OBJECTIVE
2
To evaluate the efficacy and safety of camrelizumab combined with apatinib in first-line treatment of unresectable advanced hepatocellular carcinoma.
METHODS
2
Based on real-world data, 67 patients with unresectable advanced hepatocellular carcinoma admitted to our hospital from January 2020 to January 2023 were retrospectively selected as the subjects. According to their different medication regimens, they were divided into two groups: camrelizumab combined with apatinib group (32 cases) and camrelizumab combined with oxaliplatin group (35 cases). Both groups of patients were treated for more than 12 months, with a follow-up period of 12 months from the start of treatment. The therapeutic effects of two groups, as well as the levels of tumor markers, liver and kidney function indicators, and blood routine indicators before and after treatment were compared; Kaplan-Meier method was used to draw survival curves, and Log-rank test was used to analyze the differences in survival between two groups. Multivariate Cox regression analysis was used to identify factors that affect patient survival.
RESULTS
2
After treatment, the disease control rate of patients in camrelizumab combined with apatinib group was 68.8%, significantly higher than 45.7% in camrelizumab combined with oxaliplatin group (
P
<0.05); the levels of alpha-fetoprotein, carbohydrate antigen 19-9 (except for camrelizumab combined with oxaliplatin group) and carbohydrate antigen 15-3 in both groups were significantly reduced, and the decrease in alpha-fetoprotein, carcinoembryonic antigen and carbohydrate antigen 15-3 was more significant in camrelizumab combined with apatinib group (
P
<0.05); the levels of aspartate transaminase were significantly increased in camrelizumab combined with apatinib group (
P
<0.05). Compared with camrelizumab combined with oxaliplatin group, camrelizumab combined with apatinib group had significantly prolonged overall survival (hazard ratio of 2.97, 95% confidence interval of 1.305-6.749,
P
value of Log-rank test of 0.006); the treatment plan and stage of hepatocellular carcinoma at the time of diagnosis were important factors affecting patient survival (hazard ratios of 2.97 and 5.16, 95% confidence intervals of 1.305-6.749 and 2.261-11.780, respectively,
P
<0.05).
CONCLUSIONS
2
Camrelizumab combined with apatinib as first-line treatment for unresectable advanced hepatocellular carcinoma has good clinical efficacy and overall controllable safety, but attention should be paid to monitoring patients’ liver function indicators during medication.
卡瑞利珠单抗阿帕替尼奥沙利铂肝细胞癌疗效安全性真实世界研究
apatiniboxaliplatinhepato-cellular carcinomatherapeutic efficacysafetyreal-world study
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