60min利妥昔单抗快速输注治疗成人B细胞淋巴瘤的安全性:一项单中心、单臂临床试验  

Safety of A 60-minute Rituximab Rapid Infusion Protocol for Adult B-cell Lymphoma Patients: A Single-center Single Arm Clinical Trail

作　　者：刘双娇 孟伟[1] 张艳彬[1] LIU Shuangjiao;MENG Wei;ZHANG Yanbin(Department of Hematology,PUMC Hospital,CAMS and PUMC,Beijing 100730,China)

机构地区：[1]中国医学科学院,北京协和医学院,北京协和医院血液科,北京100730

出　　处：《中国医学科学院学报》2018年第2期264-267,共4页Acta Academiae Medicinae Sinicae

摘　　要：目的探索60 min利妥昔单抗快速输注方案对非第1次用药的中国患者(包括老年患者)进行维持治疗的安全性,为快速输注方案在中国各中心化疗和日间病房应用的可行性提供支持。方法前瞻性纳入2015年2月至2016年7月北京协和医院血液科接诊的820例接受利妥昔单抗治疗的B细胞淋巴瘤患者,从第2程及以后化疗开始使用60 min快速利妥昔单抗输注方案(初始15 min输注速度为100 mg/h,余下的剂量在45 min内完成,没有最大输注速度,可达700 mg/h以上),记录不良反应发生情况,并针对65岁以下人群和老年人群(65岁及以上)的不良反应发生情况进行比较分析。结果总体不良反应发生率为4.20%,未出现4~5级不良反应。老年患者的不良反应发生率并未提高。结论对于包括老年人在内的中国B细胞淋巴瘤患者,在非首次用药时,采用60 min快速利妥昔单抗输注方案的不良反应率较低,是一种比较安全的治疗选择。Objective To investigate the safety of a 60-minute rituximab rapid infusion protocol in the maintenance therapy for Chinese B-cell lymphoma patients(including the elderly)and to discuss the feasibility of rituximab treatment in outpatient departments or daily wards.Methods This prospective study enrolled 820 patients diagnosed with B cell lymphoma in the Department of Hematology of Peking Union Medical College Hospital from February 2015 to July 2016.From the second chemotherapy cycle,rituximab was infused within 60 minutes(100 mg/h over the first 15 minutes and the remaining dose given over 45 minutes,there was no maximum infusion rate,and 700 mg/h was acceptable),and the adverse reactions were recorded.Comparison was done between patients<65 years and≥65 years.Results The overall adverse reaction rate was 4.20%and no grade 4 or higher adverse reactions were recorded.The adverse reaction rate in the elderly patients was not significantly elevated.Conclusion For Chinese patients(including the elderly)with B cell lymphoma,the 60-minute rapid infusion of rituximab(beyond the first cycle)is a safe treatment option with low adverse reaction rate.

关 键 词：淋巴瘤 利妥昔单抗 60 min快速输注 

分 类 号：R551.2[医药卫生—血液循环系统疾病]