安罗替尼联合厄洛替尼治疗表皮生长因子受体突变阳性晚期非小细胞肺癌患者的临床研究  

Clinical trial of anlotinib combined with erlotinib in the treatment of advanced non-small cell lung cancer patients with epidermal growth factor receptor mutation positive

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 Respiratory and Critical Care Medicine,Emergency Cardiac Ward,Affiliated Hospital of Jining Medical University,Jining 272000,Shandong Province,China;Department of Cardiology,Emergency Cardiac Ward,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20期2905-2909,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 观察安罗替尼胶囊联合厄洛替尼片治疗表皮生长因子受体(EGFR)突变阳性晚期非小细胞肺癌(NSCLC)患者的临床疗效及安全性。方法 将EGFR突变阳性晚期NSCLC患者随机分为对照组和试验组。对照组给予厄洛替尼片每次150 mg,qd,口服;试验组在对照组治疗的基础上,联合安罗替尼胶囊每次10 mg,qd,口服,连续服药14 d后停药7 d。2组患者1个疗程均为21 d,持续用药至疾病进展或治疗不耐受。比较2组患者的临床疗效、血管生成调节因子水平、生存时间(OS),以及药物不良反应的发生情况。结果 试验组入组50例,脱落2例,最终48例纳入分析;对照组入组50例,脱落1例,最终49例纳入分析。治疗后,试验组和对照组的疾病控制率分别为100.00%(48例/48例)和71.43%(35例/49例),客观缓解率分别为87.50%(42例/48例)和42.86%(21例/49例),差异均有统计学意义(均P<0.01)。治疗后,试验组和对照组的血管内皮生长因子水平分别为(382.53±26.82)和(397.45±26.19)ng·L^(-1),基质金属蛋白酶-9水平分别为(153.25±18.61)和(162.40±18.82)ng·mL^(-1),内皮抑素水平分别为(18.57±3.46)和(16.89±3.32)ng·mL^(-1),总生存期分别为12.00和10.00个月,差异均有统计学意义(均P<0.05)。2组患者发生的药物不良反应均以高血压、口腔黏膜炎、皮疹及蛋白尿为主。试验组和对照组的总药物不良反应发生率分别为33.33%和16.33%,差异无统计学意义(P>0.05)。结论 安罗替尼胶囊联合厄洛替尼片治疗EGFR突变阳性晚期NSCLC患者的临床疗效确切,其能显著改善血管生成调节因子水平,延长生存时间,且不会明显增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of anlotinib capsules combined with erlotinib tablets in the treatment of advanced non-small cell lung cancer (NSCLC) patients with epiderma growth factor receptor mutation positive (EGFR).Methods EGFR mutation positive patients with advanced NSCLC were randomly divided into control group and treatment group.Control group was given erlotinib150 mg per time,qd,orally.On the basis of control group,treatment group received anlotinib 10 mg per time,qd,taken orally for 14 days continuous administration and stopped for 7 days.Two groups continued to take the medication until disease progression or treatment intolerance with 21 days per course.The clinical efficacy,angiogenesis regulatory factor levels,survival time (OS) and adverse drug reaction were compared between two groups.Results Fifty cases were enrolled in the treatment group,2 cases dropped out,and 48 cases were included in the analysis;50 cases were enrolled in the control group,1 case dropped out,and 49 cases were included in the analysis.After treatment,the disease control rates of the treatment and control groups were 100.00%(48 cases/48 cases) and 71.43%(35 cases/49 cases),the objective response rates were 87.50%(42 cases/48 cases) and 42.86%(21 cases/49 cases),and the differences were statistically significant (all P0.01).After treatment,the levels of vascular endothelial growth factor in the treatment and control groups were (382.53±26.82) and (397.45±26.19) ng·L^(-1),the levels of matrix metalloproteinase-9were (153.25±18.61) and (162.40±18.82) ng·m L^(-1),the levels of endostatin were (18.57±3.46) and(16.89±3.32) ng·m L^(-1),the total survival time were 12.00 and 10.00 months,with statistically significant differences(all P0.05).The adverse drug reactions of two groups were hypertension,oral mucositis,rash and proteinuria.The total incidences of adverse drug reaction in the treatment and control groups were 33.33%and 16.33%,without significant difference (P0.05).Conclusion Anlotinib capsul

关 键 词：安罗替尼胶囊 厄洛替尼片 非小细胞肺癌 表皮生长因子受体突变阳性 安全性评价 

分 类 号：R979.1[医药卫生—药品]