【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。更多还原

【Abstract】 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.更多还原