曲妥珠单抗共轭复合物治疗人表皮生长因子受体阳性晚期乳腺癌安全性的Meta分析  

Meta-analysis of the Safety of Ado-trastuzumab Emtansine in the Treatment of Her-2 Positive Advanced Breast Cancer

作　　者：郭子寒 焦园园[1,2] 范丽萍[1,2,3] 张艳华[1,2] 

机构地区：[1]北京大学肿瘤医院 [2]北京市肿瘤防治研究所药剂科/恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [3]北京大学医学部临床药学与药事管理系,北京100191

出　　处：《中国药房》2015年第15期2100-2102,共3页China Pharmacy

摘　　要：目的:系统评价曲妥珠单抗共轭复合物(T-DM1)治疗人表皮生长因子受体(Her-2)阳性晚期乳腺癌的安全性,以为临床治疗提供循证参考。方法:计算机检索Pub Med、中国期刊全文数据库等,收集T-DM1发生不良事件的随机对照试验(RCT),提取资料并评价质量后,采用Stata 12.0统计软件进行Meta分析。结果:共纳入5项RCT,合计1 184例患者。Meta分析结果显示,使用T-DM1治疗后,患者的血小板减少发生率为24%[95%CI(16,31)]、低钾血症发生率为14%[95%CI(8,20)]、天冬氨酸氨基转移酶(AST)升高发生率为24%[95%CI(12,36)]、丙氨酸氨基转移酶(ALT)升高发生率为24%[95%CI(12,36)]、头痛发生率为29%[95%CI(23,36)]、发热发生率为24%[95%CI(17,31)]、鼻衄发生率为23%[95%CI(15,30)]、便秘发生率为23%[95%CI(21,26)]、周围神经病变发生率为14%[95%CI(10,19)]。结论:T-DM1治疗Her-2阳性晚期乳腺癌,可引起患者血小板减少、低钾血症、AST升高、ALT升高、头痛、发热、鼻衄、便秘、周围神经病变的发生,临床应重视对不良反应的防治。由于纳入研究数量较少,该结论有待大样本、高质量的RCT进一步验证。OBJECTIVE：To systematically evaluate the safety of ado-trastuzumab emtansine（T-DM1） and provide evidencebased reference for the clinical treatment.METHODS：Pub Med,and CJFD were retrieved to collect the RCT of the adverse events of T-DM1.After information collection and quality evaluation,Stata 12.0 was performed for Meta-analysis.RESULTS：There were totally 5 research,including 1 184 patients.The results of Meta-analysis showed,after T-DM1 treatment,the incidence of thrombocytopenia was 24%[95%CI（16,31）],hypokalemia was 14%[95%CI（8,20）],AST increasing was 24% [95%CI（12,36）],ALT increasing was 24%[95%CI（12,36）],headache was 29%[95%CI（23,36）],pyrexia was 24% [95%CI（17,31）],epistaxis was 23%[95% CI（15,30）],constipation was 23% [95% CI（21,26）] and the neuropathy peripheral was 14% [95% CI（10,19）].CONCLUSIONS：The incidences of thrombocytopenia,hypokalaemia,AST increasing,ALT increasing,headache,pyrexia,epistaxis,constipation and neuropathy peripheral of T-DM1 in the treatment（Trastuzumab）of Her-2 positive Advanced Breast cancer were high and the prevention of adverse events should be emphasized.Due to the less quantity of included studies,it remains to be further verified with large-sample and high-quality RCT.

关 键 词：曲妥珠单抗共轭复合物 人表皮生长因子受体 转移性乳腺癌 安全性 META分析 

分 类 号：R737.9[医药卫生—肿瘤] R979.19[医药卫生—临床医学]