中国临床药理学杂志2025，Vol.41Issue(10)：1351-1356,6.DOI:10.13699/j.cnki.1001-6821.2025.10.001
恩沃利单抗治疗经PD-1抗体治疗后进展的晚期肺腺癌患者的临床研究
Clinical trial of envafolimab in the treatment of patients with advanced lung adenocarcinoma that progressed after PD-1 antibody therapy
摘要
Abstract
Objective To observe the clinical efficacy and safety of envafolimab injection in the treatment of advanced lung adenocarcinoma after programmed cell death protein 1(PD-1)antibody treatment.Methods Patients with advanced lung adenocarcinoma who progressed after PD-1 antibody treatment were divided into control group and treatment group according to cohort method.The control group was given pemetrexed injection 500 mg·m-2,carboplatin injection area under the concentration time curve(AUC)=5-6 or cisplatin injection 75 mg·m-2 on the first day,divided into 3 to 4 days.Every 21 days constitutes a treatment cycle,and 3 cycles of treatment were continued.On the basis of control group,patients in treatment group were treated subcutaneously with envafolimab injection,150 mg each time,once a week for 2 months.The clinical therapeutic effect,tumor marker level,immune function were compared between the two groups,and the safety was evaluated.Results There were 44 cases in the control group and 40 cases in the treatment group.After treatment,the disease control rates of treatment group and control group were 60.00％(24 cases/40 cases)and 36.36％(16 cases/44 cases),respectively,and the difference was statistically significant(P＜0.05).After treatment,carcinoembryonic antigen levels of treatment group and control group were(12.97±2.66)and(14.62±2.74)μg·L-1;cytokeratin-19 fragment antigen 21-1 levels were(12.33±2.28)and(13.62±2.58)μg·L-1;squamous cell carcinoma antigen levels were(4.98±1.02)and(5.59±1.15)μg·L-1;carbohydrate antigen 125 levels were(58.79±7.57)and 62.65±8.86)U·mL-1;cluster of differentiation 3 were(58.49±6.45)％and(55.15±6.04)％;cluster of differentiation 4/cluster of differentiation 8 were 1.37±0.31 and 1.18±0.22;the survival rates were 58.33％(21 cases/36 cases)and 31.71％(13 cases/41 cases),respectively.Comparison to the control group,the aforementioned indexes in the treatment group exhibited statistical significance(all P＜0.05).Adverse drug reactions in the treatment group included gastrointestinal reactions,bone marrow suppression,renal dysfunction,liver dysfunction and hypothyroidism.The adverse drug reactions in the control group included gastrointestinal reactions,bone marrow suppression and abnormal renal function.The total incidences of adverse drug reactions in treatment group and control group were 62.50％(25 cases/40 cases)and 72.50％(29 cases/44 cases),respectively,with no statistical significance(P＞0.05).Conclusion Envafolimab injection in the treatment of advanced lung adenocarcinoma patients who progressed after PD-1 antibody treatment has shown obvious clinical effects,which can effectively enhance the immune function of patients,reduce the level of tumor markers,improve the survival rate of patients,and has a certain safety.关键词
恩沃利单抗注射液/程序性死亡受体1/肺腺癌/肿瘤标志物/免疫功能Key words
envafolimab/programmed cell death protein 1/lung adenocarcinoma/tumor markers/immune function分类
医药卫生引用本文复制引用
尤冬山,夏晓阳,陈爱民,黄景慧,曹静,徐轶..恩沃利单抗治疗经PD-1抗体治疗后进展的晚期肺腺癌患者的临床研究[J].中国临床药理学杂志,2025,41(10):1351-1356,6.基金项目
北京白求恩公益基金会资助项目(STLKY2-058) （STLKY2-058）
