阿司匹林肠溶片联合曲妥珠单抗治疗Her-2阳性乳腺癌的临床研究  

Clinical trial of aspirin enteric-coated tablets combined with trastuzumab in the treatment of patients with Her-2 positive breast cancer

作　　者：单宏杰[1] 宇辉[2] 李红[3] 马骖[1] SHAN Hong-jie;YU Hui;LI Hong;MA Can(Department of Oncology Surgery,Suzhou Municipal Hospital Affiliated to Anhui Medical University,Suzhou 234000,Anhui Province,China;Department of Neurology,Suzhou Municipal Hospital Affiliated to Anhui Medical University,Suzhou 234000,Anhui Province,China;Department of Oncology Medical,Suzhou Municipal Hospital Affiliated to Anhui Medical University,Suzhou 234000,Anhui Province,China)

机构地区：[1]安徽医科大学附属宿州市立医院肿瘤外科,安徽宿州234000 [2]安徽医科大学附属宿州市立医院神经内科,安徽宿州234000 [3]安徽医科大学附属宿州市立医院肿瘤内科,安徽宿州234000

出　　处：《中国临床药理学杂志》2019年第23期2995-2998,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家自然科学基金资助项目(81070877);宿州市科技局科技攻关计划课题资助项目(2015-03-02)

摘　　要：目的观察阿司匹林肠溶片联合曲妥珠单抗治疗Her-2阳性乳腺癌的临床疗效及安全性。方法将150例Her-2阳性乳腺癌患者随机分为对照组69例和试验组81例。对照组给予曲妥珠单抗首剂8 mg·kg^-1,之后6 mg·kg^-1,每3周1次,静脉输注;试验组在对照组治疗的基础上,给予阿司匹林肠溶片每次100 mg,qd,口服。2组患者均治疗1年。比较2组患者的临床疗效,血清癌胚抗原(CEA)、糖类抗原153(CA153)和CA125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67.90%(55例/81例)和40.58%(28例/69例),疾病控制率分别为87.65%(71例/81例)和72.46%(50例/69例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的CEA分别为(5.14±3.35)和(8.32±7.63)ng·L^-1,CA153分别为(25.59±6.08)和(30.33±11.56)U·L^-1,CA125分别为(33.37±8.04)和(37.49±11.94)U·L^-1,差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以心功能异常、肝功能异常、中粒细胞减少、胃肠道反应和出血为主。试验组和对照组的心功能异常发生率分别为22.22%和43.48%,肝功能异常发生率分别为16.04%和31.88%,差异均有统计学意义(均P<0.05)。结论阿司匹林肠溶片联合曲妥珠单抗治疗Her-2阳性乳腺癌的临床疗效显著优于单用曲妥珠单抗,且安全性较高。Objective To observe the clinical efficacy and safety of aspirin enteric-coated tablets combined with trastuzumab in the treatment of patients with Her-2 positive breast cancer.Methods A total of 150 cases with Her-2 positive breast cancer were randomly divided into control group(n=69 cases)and treatment group(n=81 cases).Control group was given trastuzumab 8 mg·kg^-1,followed by 6 mg·kg^-1 once every three weeks.Treatment group was given aspirin enteric-coated tablets 100 mg per time,qd,orally,on the basis of control group.Two groups were treated for one year.The clinical efficacy,levels of carcinoembryonic antigen(CEA),carbohydrate antigen 153(CA153)and CA125,and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 67.90%(55 cases/81 cases)and 40.58%(28 cases/69 cases),the disease control rates were 87.65%(71 cases/81 cases)and 72.46%(50 cases/69 cases),the differences were statistically significant(all P<0.05).After treatment,the indexes of treatment and control were compared:CEA were(5.14±3.35)and(8.32±7.63)ng·L^-1,CA153 were(25.59±6.08)and(30.33±11.56)U·L^-1,CA125 were(33.37±8.04)and(37.49±11.94)U·L^-1,the differences were statistically significant(all P<0.05).The adverse drug reactions of two groups were abnormal cardiac function,abnormal liver function,neutropenia,gastrointestinal reaction and bleeding.The incidences of cardiac insufficiency in the treatment and control groups were 22.22%and 43.48%,the incidences of liver dysfunction were 16.04%and 31.88%,respectively(all P<0.05).Conclusion The clinical efficacy of aspirin combined with trastuzumab in the treatment of Her-2 positive breast cancer is significantly better than that of trastuzumab,and the safety is high.

关 键 词：阿司匹林肠溶片 曲妥珠单抗 Her-2阳性乳腺癌 安全性评价 

分 类 号：R73[医药卫生—肿瘤]