CD19 CAR-T细胞疗法与标准治疗用于复发/难治性弥漫性大B细胞淋巴瘤的疗效与安全性Meta分析OA

Objective:To systematically evaluate the efficacy and safety of CD19 CAR-T cell immunotherapy compared with standard treatment in patients with relapsed/refractory diffuse large B-cell lymphoma(R/R DLBCL),and to explore the potential impact of different CAR-T cell products on efficacy through exploratory analysis,so as to provide evidence-based references for clinical treatment decision-making.Methods:Computerized searches were conducted in China National Knowledge Infrastructure(CNKI),Wanfang Database,VIP Journal Database,China Biology Medicine Database(SinoMed),PubMed,Embase,and Cochrane Library databases.Randomized controlled trials(RCTs)comparing CD19 CAR-T cell therapy with standard treatment for R/R DLBCL were collected.The search time limit was from the establishment of the databases to October 25,2025.Two researchers independently conducted literature screening,data extraction,and quality evaluation,and Meta-analysis was performed using R4.2.2 software.Results:A total of 2 phase Ⅲ RCT studies(ZUMA-7,TRANSFORM)were included.Fixed-effect models were selected to merge data for all outcome indicators according to the results of heterogeneity test.In terms of therapeutic effect:CD19 CAR-T cell therapy significantly improved event-free survival(HR=0.455,95%CI:0.363-0.570,P<0.001)and reduced the risk of death(HR=0.738,95%CI:0.575-0.947,P=0.017)in patients.At the same time,it could significantly improve the complete response rate(RR=1.879,95%CI:1.574-2.242,P<0.001).The exploratory analysis by product type showed that both liso-cel and axi-cel were superior to the standard treatment(liso-cel:HR=0.380,95%CI:0.260-0.540,P<0.001;axi-cel:HR=0.510,95%CI:0.380-0.680,P<0.001),but this analysis was a comparison between different trials and the evidence level was limited.Safety outcomes showed that the incidence of immune effector cell-related neurotoxicity syndrome(ICANS)with CAR-T cell therapy was significantly increased(RR=22.387,95%CI:4.353-115.132,P<0.001);the incidence of grade≥3 cytokine release syndrome(CRS)increased(RR=8.181,95%CI:0.935-71.574,P=0.058),but the difference was not statistically significant.The overall risk of bias in the included studies was low;sensitivity analysis confirmed the robustness of the results.Conclusion:Based on the results of two RCTs,CD19 CAR-T cells(liso-cel/axi-cel)can be considered as one of the options for the second-line treatment of R/R DLBCL.Their efficacy is superior to that of standard treatment,and the characteristic adverse reactions(CRS/ICANS)can be controlled after standardized management.CAR-T cell products can be selected individually based on the baseline status of patients.The evidence base of this study is weak,and the above conclusions need to be verified by more high-quality and large-sample RCTs.