培美曲塞注射剂联合卡铂注射液治疗表皮生长因子受体-酪氨酸激酶抑制药耐药后晚期肺腺癌患者的临床研究  

Clinical trial of pemetrexed injection combined with carboplatin injection in the treatment of advanced lung adenocarcinoma with epidermal growth factor receptor-tyrosine kinase inhibitor resistance

作　　者：张伟萍[1] 应海峰 尤匡掌[2] 贺茹依 ZHANG Wei-ping;YING Hai-feng;YOU Kuang-zhang;HE Ru-yi(a.Department of Geriatrics;b,Department of Anesthesiology,Taizhou Hospital of Zhejiang Province,Enze Medical Center,Taizhou 317000,Zhefiang Province,China)

机构地区：[1]恩泽医疗中心集团浙江省台州医院老年医学科,浙江台州317000 [2]恩泽医疗中心集团浙江省台州医院麻醉科,浙江台州317000

出　　处：《中国临床药理学杂志》2018年第19期2262-2265,共4页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省医药卫生科技计划基金资助项目(2014KYB310)

摘　　要：目的观察培美曲塞注射剂联合卡铂注射液治疗表皮生长因子受体-酪氨酸激酶抑制药(EGFR-TKI)耐药后晚期肺腺癌患者的临床疗效及安全性。方法将84例对EGFR-TKI耐药后晚期肺腺癌患者随机分为对照组和试验组,每组42例。对照组予以培美曲塞每次500 mg·m^(-2),静脉滴注,第1天;试验组在对照组治疗的基础上,予以卡铂每次300 mg·m^(-2),静脉滴注,第1天。2组患者均治疗2个周期以上,每个周期21 d。比较2组患者的临床疗效,血清癌胚抗原(CEA)、神经元特异性烯酶(NSE)和细胞角蛋白抗原19片段(CYFRA21-1)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为52.38%(22例/42例)和42.86%(18例/42例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组血清CEA分别为(37.53±6.28)和(39.15±5.80)ng·mL^(-1),NSE分别为(22.12±2.62)和(21.61±4.00)ng·mL^(-1),CYFRA21-1分别为(6.31±0.97)和(5.66±1.00)ng·mL^(-1),差异均无统计学意义(均P>0.05)。2组患者的药物不良反应均以恶心呕吐、骨髓抑制、肝功能损伤、皮疹和发热为主,试验组和对照组的总药物不良反应发生率分别为69.05%和64.29%,差异无统计学意义(P>0.05)。结论培美曲塞注射剂联合卡铂注射液治疗EGFR-TKI耐药后晚期肺腺癌患者的临床疗效和安全性与单用培美曲塞注射剂相当,两者均能显著抑制CEA、NSE及CYFRA21-1表达。Objective To observe the clinical efficacy and safety of pemetrexed injection combined with carboplatin injection in the treatment of advanced lung adenocarcinoma with epidermal growth factor receptor-tyrosine kinase inhibitor（ EGFR-TKI） resistance. Methods Eighty-four patients of advanced lung adenocarcinoma after EGFR-TKI resistance were divided into control and treatment groups with 42 cases per group. Control group received 500 mg·m^-2 pemetrexed per time,intravenous drip,day 1. Treatment group was given 300 mg·m^-2 carboplatin per time,intravenous drip,day 1,on the basis of control group. Two groups were treated for more than 2 cycles with 21 days per cycle. The clinical efficacy,serum levels of carcino embryonic antigen（ CEA）,neuron-specific enolase（ NSE） and cytokeratin antigen 19（ CYFRA21-1）,and adverse drug reactions were compared between two groups. Results After treatment,total effective rates of treatment and control groups were 52. 38%（ 22 cases/42 cases） and 42. 86%（ 18 cases/42 cases） without significant difference（ P 0. 05）. After treatment,the main indexes of treatment and control groups were compared： CEA were（ 37. 53 ± 6. 28） and（ 39. 15 ± 5. 80）ng·mL^-1,NSE were（ 22. 12 ± 2. 62） and（ 21. 61 ± 4. 00） ng·mL^-1,CYFRA21-1 were（ 6. 31 ± 0. 97） and（ 5. 66 ± 1. 00） ng·mL^-1,the differences were not statistically significant（ all P〉0. 05）. The adverse drug reactions of two groups were nausea,vomiting,myelosuppression,liver function damage,rash and fever. The total incidences of adverse drug reactions in treatment and control groups were 69. 05% and 64. 29% without significant difference（ P〉0. 05）. Conclusion The clinical efficacy and safety of pemetrexed injection combined with carboplatin injection in the treatment of advanced lung adenocarcinoma with EGFR-TKI resistance were equal to pemetrexed injection alone,and both could significantly inhibit the expressions of CEA,NSE and CYFRA21-1.

关 键 词：培美曲塞注射剂 卡铂注射液 表皮生长因子受体-酪氨酸激酶抑制药 晚期肺腺癌 安全性 

分 类 号：R979.1[医药卫生—药品]