小剂量地塞米松预防CD19 CAR-T细胞治疗后严重细胞因子释放综合征的临床研究

Clinicalstudy of low dose dexamethasone in preventing severe CRS after CD19 CAR-T therapy

目的观察小剂量地塞米松预防CD19 CAR-T细胞治疗后严重细胞因子释放综合征(CRS)的临床应用效果。方法选取2018年1月~2021年3月在西部战区总医院血液科接受自体CD19嵌合抗原受体T细胞(CAR-T)治疗的67名急性淋巴细胞白血病(ALL)患者,依据入组时间的先后顺序,将患者分为小剂量地塞米松(日累计剂量≤5 mg/人)预防组(n=36)与对照组(n=31),比较2组间重度CRS发生率及CAR-T治疗结局。结果地塞米松预防组、对照组的严重CRS发生率8.3%(3/36)vs 38.7%(12/31)(P<0.05);外周血CAR-T细胞扩增峰值数目分别为329(83~371)vs 372(76~965)个/μL(P>0.05);完全缓解率分别为91.7%(33/36)vs 87.1%(27/31)(P>0.05);感染发生率分别为33.3%(12/36)vs 35.4%(11/31)(P>0.05)。结论早期预防性使用小剂量地塞米松明显降低CD19 CAR-T细胞治疗后严重CRS反应的发生,而对CAR-T细胞扩增及治疗结局无明显影响。

Objective To investigate the clinical application value of low dose dexamethasone in CRS prevention after CD19 CAR-T therapy.Methods 67 cases of acute lymphoblastic leukemia(ALL)patients from January 2018 to March 2021 were selected as the research subjects.According to the admission time,patients were divided into dexamethasone prevention(DDD≤5 mg)group(n=36)and the control(n=31).The incidence of severe CRS and treatment outcome were compared.Results In the dexamethasone prevention group and the control,the incidence of severe CRS were 8.3%(3/36)vs 38.7%(12/31)(P<0.05),the number of CAR-T cells(cells/μL)was 329(83~371)vs 372(76~965)(P>0.05),the complete remission rate was 91.7%(33/36)vs 87.1%(27/31)(P>0.05),and the infection rate was 33.3%(12/36)vs 35.4%(11/31)(P>0.05).Conclusion The low dose dexamethasone as a prophylactic could significantly reduce the incidence of severe CRS,but had no influence on CAR-T cell proliferation and treatment outcome.