中国标准化Issue(8)：238-241,4.DOI:10.3969/j.issn.1002-5944.2025.08.047
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
摘要
Abstract
Objective:To evaluate the clinical efficacy 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 fixed 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 significance(P=0.07).Regarding safety,although the experimental group reported slightly more cardiac events than the control group,there was no statistically significant 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 benefit in the treatment of HER2-positive breast cancer,with an overall good safety profile 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Key words
trastuzumab/standardized administration schedule/breast cancer treatment/drug safety引用本文复制引用
史雅雯,李爱玲,温砺,董锴..标准化给药方案在曲妥珠单抗治疗乳腺癌中的应用[J].中国标准化,2025,(8):238-241,4.
