阿美替尼片联合贝伐珠单抗注射液治疗表皮生长因子受体突变的晚期非小细胞肺癌患者的临床研究  

Clinical trial of ametinib tablets combined with bevacizumab injection in the treatment of advanced non-small cell lung cancer patients with epidermal growth factor receptor mutation

作　　者：杨光霞[1] 程云涛[2] 刘琳琳[1] 陈雪英 张雪梅 YANG Guang-xia;CHENG Yun-tao;LIU Lin-lin;CHEN Xue-ying;ZHANG Xue-mei(Department of Pulmonary and Critical Care Medicine,Affiliated Hospital of Jining Medical University,Jining 272000,Shandong Province,China;Cardiac Emergency Ward of Cardiology Department,Affiliated Hospital of Jining Medical University,Jining 272000,Shandong Province,China)

机构地区：[1]济宁医学院附属医院,呼吸与危重症医学科,山东济宁272000 [2]济宁医学院附属医院,心内科心脏急诊病区,山东济宁272000

出　　处：《中国临床药理学杂志》2023年第11期1528-1532,共5页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然科学基金资助项目(81700230)。

摘　　要：目的观察阿美替尼片联合贝伐珠单抗注射液治疗表皮生长因子受体(EGFR)突变的晚期非小细胞肺癌(NSCLC)患者的临床疗效及安全性。方法将EGFR突变的晚期NSCLC患者随机分为对照组和试验组。对照组给予贝伐珠单抗400 mg,静脉滴注,第1天+口服阿法替尼每次40 mg,qd;试验组给予贝伐珠单抗400 mg,静脉滴注,第1天+口服甲磺酸阿美替尼片每次110 mg,qd。2组患者均治疗3个疗程,每个疗程21 d。比较2组患者的临床疗效、细胞免疫水平、炎症因子水平和肿瘤标志物水平,以及药物不良反应的发生情况。结果试验组入组49例,脱落3例,最终46例纳入分析;对照组入组48例,脱落2例,最终46例纳入分析。治疗后,试验组和对照组的总有效率分别为86.96%(40例/46例)和63.04%(29例/46例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的CD4^(+)T细胞比例分别为(43.81±4.77)%和(38.02±3.27)%,CD8^(+)T细胞比例分别为(22.36±3.28)%和(28.84±2.43)%,NK细胞比例分别为(19.73±1.54)%和(16.73±1.95)%,高敏C反应蛋白分别为(11.15±3.04)和(18.30±2.37)mg·L^(-1),白细胞介素6分别为(9.40±2.83)和(13.12±2.47)ng·L^(-1),糖类抗原50分别为(196.26±38.63)和(218.67±33.53)U·mL^(-1),细胞角蛋白19片段抗原21-1分别为(128.51±16.95)和(143.61±23.03)ng·mL^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有厌食、皮疹、发热、疲劳、头晕和呕吐,对照组发生的药物不良反应有恶心、呕吐、疲劳、皮疹、发热、头晕、腹泻、厌食和呼吸困难。试验组和对照组的总药物不良反应发生率分别为15.22%和30.43%,差异无统计学意义(P>0.05)。结论阿美替尼片联合贝伐珠单抗注射液治疗EGFR突变的晚期NSCLC患者的临床疗效确切,其能有效地降低患者的炎症因子和肿瘤标志物水平,提高患者的免疫功能,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of ametinib tablets combined with bevacizumab injection in the treatment of advanced non-small cell lung cancer(NSCLC)patients with epidermal growth factor receptor(EGFR)mutation.Methods The advanced NSCLC patients with EGFR mutation were randomly divided into control group and treatment group.Control group was treated with bevacizumab 400 mg,intravenous drip,on the first day+oral afatinib 40 mg each time,qd.Treatment group was given bevacizumab 400 mg,intravenous drip,on the first day+oral amitinib mesylate tablets 110 mg each time,qd.Two groups were treated for 3 courses with 21 days per course.The clinical efficacy,cellular immune level,inflammatory factors and tumor markers and adverse drug reactions were compared between the two groups.Results A total of 49 cases in the treatment group,3 cases fell off,46 cases were included in the analysis,while 48 cases in the control group,2 cases fell off,and finally 46 cases were included in the analysis.After treatment,the total effective rates of the treatment and control groups were 86.96%(40 cases/46 cases)and 63.04%(29 cases/46 cases)with significant difference(P<0.05).After treatment,the proportions of CD4^(+)T cells in the treatment and control groups were(43.81±4.77)%and(38.02±3.27)%,the proportions of CD8^(+)T cells were(22.36±3.28)%and(28.84±2.43)%,the proportion of NK cells were(19.73±1.54)%and(16.73±1.95)%,high sensitivity C-reactive protein levels were(11.15±3.04)and(18.30±2.37)mg·L^(-1),interleukin 6 levels were(9.40±2.83)and(13.12±2.47)ng·L^(-1),carbohydrate antigen 50 levels were(196.26±38.63)and(218.67±33.53)U·mL^(-1),cytokeratin 19 fragment antigen 21-1 levels were(128.51±16.95)and(143.61±23.03)ng·mL^(-1),respectively.The differences of above indexes were statistically significant(all P<0.05).The adverse drug reactions of the treatment group were rash,fever,fatigue,dizziness and vomiting,while those in the control group were rash,fever,fatigue,dizziness,diarrhea,nausea,vomiting,ano

关 键 词：阿美替尼片 贝伐珠单抗注射液 表皮生长因子受体突变 晚期非小细胞肺癌 炎症 

分 类 号：R979.1[医药卫生—药品]