【摘要】 目的 观察和分析恩美曲妥珠单抗(Trastuzumab Emtansine, T-DM1)不良反应的主要表现，为更加优化不良反应的处理，促进更加合理的用药和药品不良反应监测提供参考。方法 选取云南省肿瘤医院、昆明医科大学第一附属医院、云南省第一人民医院、大理州人民医院、玉溪市人民医院、曲靖市人民医院、楚雄州人民医院和普洱市人民医院等8家医院于2022年2月至2023年10月使用恩美曲妥珠单抗治疗的乳腺癌患者164例，其中符合纳入标准的有114例。观察患者经T-DM1治疗后的不良反应并统计分析。结果 114例患者经T-DM1治疗后共产生11种不良反应(adverse reaction, ADR),其中年龄<52岁、绝经状态、ER/PR阴性及Ki-67≤30%是特定不良反应的显著风险因素。数据进一步显示HP联合方案可降低呕吐和发热发生率，BMI<24 kg/m~2患者的发热风险倍增(26.32%vs 7.89%),且总体血小板减少发生率为37.72%(含14例≥3级)。结论 临床应加强对患者T-DM1不良反应的监测，根据患者的实际情况，对症处理，尤其是对晚期后线恩美曲妥珠单抗治疗的患者，TDM-1治疗前应对血小板降低采取预防措施。更多还原

【Abstract】 Objective To observe and analyze the main adverse reactions of Trastuzumab Emtansine(T-DM1)for breast cancer, so as to provide reference for optimizing the treatment of adverse reactions and promoting more rational drug use and adverse drug reaction monitoring.Methods A total of 164 breast cancer patients treated with trastuzumab enmei from 8 hospitals including Yunnan Cancer Hospital, the First Affiliated Hospital of Kunming Medical University, the First People’s Hospital of Yunnan Province, Dali Prefecture People’s Hospital, Yuxi People’s Hospital, Qujing People’s Hospital, Chuxiong Prefecture People’s Hospital and Pu ’er People’s Hospital from February 2022 to October 2023 were selected.Among them, 114 cases met the inclusion criteria.The adverse reactions of patients after T-DM1 treatment were observed and statistically analyzed.Results A total of 11 kinds of adverse reactions(ADR)occurred in 114 patients after T-DM1 treatment.Among them, younger than 52 years old, menopausal status, negative ER/PR,and Ki-67≤30% were significant risk factors for specific ADR.The data further showed that HP combined regimen reduced the incidence of vomiting and fever, and the risk of fever doubled in patients with BMI less than 24 kg/m~2(26.32% vs 7.89%).The overall incidence of thrombocytopenia was 37.72%(including 14 cases of grade ≥3).Conclusion Clinical monitoring of adverse reactions to T-DM1 should be enhanced.If adverse reactions occur, appropriate symptomatic treatment measures should be taken based on the patient’s actual condition, especially in patients treated with Trastuzumab Emtansine in later-stage settings.Prophylactic measures to prevent platelet reduction before T-DM1 treatment could be considered as a future research direction.更多还原