标准化给药方案在曲妥珠单抗治疗乳腺癌中的应用  

Application of Standardized Dosing Regimen in the Treatment of Breast Cancer with Trastuzumab

作　　者：史雅雯 李爱玲 温砺 董锴 SHI Ya-wen;LI Ai-ling;WEN Li;DONG Kai(The First People’s Hospital of Baiyin,Gansu Province)

机构地区：[1]甘肃省白银市第一人民医院

出　　处：《中国标准化》2025年第8期238-241,共4页China Standardization

摘　　要：目的:评估标准化给药方案在曲妥珠单抗(Trastuzumab)治疗HER2阳性乳腺癌患者中的临床效果及安全性。方法:本研究为一项前瞻性、随机对照试验,在2021年1月至2023年10月期间招募了80名确诊为HER2阳性早期或转移性乳腺癌的新诊断患者。所有参与者根据随机分配原则分为两组:实验组(n=40)接受标准化给药方案治疗,包括固定剂量的曲妥珠单抗联合标准化治疗药物;对照组(n=40)则遵循传统的个体化给药方式。主要疗效指标为无病生存期(DFS),次要指标包括总生存期(OS)以及治疗相关不良事件(TRAEs)。结果:实验组的DFS优于对照组(P<0.05),实验组的中位DFS为30个月,而对照组为24个月。OS方面,实验组也表现出更好的趋势,尽管差异未达到统计学意义(P=0.07)。关于安全性,虽然实验组报告的心脏事件略高于对照组,但在统计上没有显著差异(P=0.32)。其他TRAEs发生率在两组间相似,主要为轻度至中度的胃肠不适、疲劳等症状。结论:标准化给药方案在HER2阳性乳腺癌的治疗中显示出良好的临床效益,尽管存在轻微增加心脏事件的风险,但总体安全性良好。Objective:To evaluate the clinical effi cacy and safety of a standardized dosing regimen in patients with HER2-positive breast cancer treated with Trastuzumab.Methods:This study was a prospective,randomized controlled trial that enrolled 80 newly diagnosed patients with HER2-positive early stage or metastatic breast cancer between January 2021 and October 2023.All participants were randomly assigned to two groups:the experimental group(n=40)received a standardized dosing regimen consisting of a fi xed dose of trastuzumab combined with a standardized treatment agent;The control group(n=40)followed the traditional individualized dosing method.The primary outcome measure was disease-free survival(DFS),and secondary measures included overall survival(OS)and treatment-related adverse events(TRAEs).Results:The DFS in the experimental group was better than that in the control group(P<0.05),and the median DFS in the experimental group was 30 months,compared with 24 months in the control group.For OS,the experimental group also showed a better trend,although the difference did not reach statistical signifi cance(P=0.07).Regarding safety,although the experimental group reported slightly more cardiac events than the control group,there was no statistically signifi cant difference(P=0.32).The incidence of other TRAEs was similar between the two groups,mainly mild to moderate gastrointestinal discomfort,fatigue and other symptoms.Conclusion:The standardized dosing regimen has shown good clinical benefi t in the treatment of HER2-positive breast cancer,with an overall good safety profi le despite a slight increased risk of cardiac events.

关 键 词：曲妥珠单抗 标准化给药方案 乳腺癌治疗 药物安全性 

分 类 号：R737.9[医药卫生—肿瘤]