门诊应用维奈克拉联合阿扎胞苷持续治疗急性髓系白血病的疗效及安全性分析  

Efficacy and safety analysis of continuous treatment of acute myeloid leukemia with venetoclax combined with azacitidine in outpatient settings

作　　者：李梦瑶 聂子元[1] 张晓红 李金澳 湛颖 张晓蕾[1] 任金海[1] 郭晓玲[1] LI Mengyao;NIE Ziyuan;ZHANG Xiaohong;LI Jin'ao;ZHAN Ying;ZHANG Xiaolei;REN Jinhai;GUO Xiaoling(Department of Hematology,the Second Hospital of Hebei Medical University,Shijiazhuang,050000,China)

机构地区：[1]河北医科大学第二医院血液内科,石家庄050000

出　　处：《临床血液学杂志》2025年第3期225-231,共7页Journal of Clinical Hematology

基　　金：河北省医学适用技术跟踪项目(No:GZ2023057);白求恩公益基金会血液科研能力建设项目(No:BCF-IBW-XY-20220930-22)。

摘　　要：目的:评估急性髓系白血病(acute myeloid leukemia,AML)患者缓解后,于门诊接受维奈克拉(venetoclax,VEN)联合阿扎胞苷(azacitidine,AZA)方案(VEN+AZA)持续治疗的疗效、安全性及可行性,为临床实践提供一定的参考。方法:回顾性分析2021年7月—2024年9月于河北医科大学第二医院血液内科门诊接受VEN+AZA持续治疗的AML患者的临床资料。结果:共观察37例患者,中位随访时间为12.3(1.9~39.4)个月,中位疗程数为7(2~29)个疗程,截止随访结束,25例(67.6%)患者获得持续缓解,12例(32.4%)患者出现了复发;在获取微小残留病(minimal residual disease,MRD)结果的32例患者中,23例(71.9%)患者达到最佳MRD阴性,10例(31.3%)患者MRD转阴,且MRD转阴的中位治疗周期为3(2~5)个周期;所有患者的中位总生存期(overall survival,OS)尚未达到,中位无复发生存期(recurrence free survival,RFS)为29.8个月,1年OS率为78.0%,至随访截止为60.7%;1年RFS率为65.4%,至随访截止为40.5%。门诊持续治疗期间最常见的不良事件为血液学不良事件,最常见的非血液学不良事件为肺部感染,所有的不良事件通过积极治疗均得到了控制和耐受,未发生治疗相关性死亡。结论:本中心的真实世界数据表明,AML患者经住院VEN+AZA诱导缓解后,于门诊进行持续治疗具有良好的安全性和可行性,不仅能提升患者生活质量和治疗依从性,还可提高病房周转率。然而,本研究存在一定的局限性,未来仍需开展多中心前瞻性研究,以进一步探究该门诊治疗方案在中国医疗环境中的可行性。Objective:This study aimed to evaluate the efficacy,safety and feasibility of continuous treatment with the venetoclax(VEN)combined with azacitidine(AZA)regimen(VEN+AZA)in outpatients of our hospital after remission of acute myeloid leukemia(AML),providing certain references for clinical practice.Methods:A retrospective analysis was conducted on AML patients who received continuous VEN+AZA treatment in the outpatient department of the Hematology Department of the Second Hospital of Hebei Medical University from July 2021to September 2024.Results:A total of 37patients were observed.The median follow-up time was 12.3(1.9-39.4)months,and the median number of treatment courses was 7(2-29)courses.By the end of the follow-up,25 patients(67.6%)achieved continuous remission,and 12patients(32.4%)relapsed.Among the 32patients with available minimal residual disease(MRD)results,23patients(71.9%)achieved optimal MRD negativity,10patients(31.3%)experienced MRD conversion to negative,and the median treatment cycle for MRD conversion to negative was 3(2-5)cycles.The median overall survival(OS)of all patients had not been reached,the median recurrence free survival(RFS)was 29.8months,the 1-year OS rate was 78.0%,and the OS rate was 60.7%at the end of the follow-up;the 1-year RFS rate was 65.4%,and the RFS rate was 40.5%at the end of the follow-up.The most common adverse events during outpatient continuous treatment were hematological adverse events,and the most common non-hematological adverse event was pulmonary infection.All adverse events were controlled and tolerated through active treatment,and no treatment-related deaths occurred.Conclusion:The real-world data of our center indicate that continuous outpatient treatment after in-hospital VEN+AZA induction remission for AML patients has good safety and feasibility.It can not only improve the quality of life and treatment compliance of patients but also increase the ward turnover rate.However,this study has certain limitations,and future multicenter prospective studies are st

关 键 词：急性髓系白血病 维奈克拉 持续治疗 门诊分级诊疗 安全性 可行性 

分 类 号：R733.71[医药卫生—肿瘤]