■嵌合抗原受体T(CAR-T)细胞免疫治疗正在成为血液系统恶性肿瘤最有前途的治疗方法之一,然而,细胞因子释放综合征(CRS)等并发症严重威胁患者生命。白细胞介素6(IL-6)单克隆抗体是常见且有用的CRS医治办法,然而,目前尚不清楚在CAR-T治疗前预防性使用IL-6单克隆抗体是否能降低CRS的发生率.
■本研究旨在系统地评估预防性使用IL-6单克隆抗体是否可以降低CRS的发生率。
■我们搜索了PubMed,Embase,科学网,和CochraneLibrary数据库,用于报道在2022年12月之前预防性使用IL-6单克隆抗体治疗CAR-T细胞免疫治疗的CRS相关并发症的研究。根据既定的纳入和排除标准对文献进行筛选,提取相关数据,并使用量表Cochrane偏差风险评估工具对文献质量进行评估,ReviewManager5.3用于绘制相关图表。由于两个实验数据仅提供中位数,数据的最大值和最小值,平均值和标准值(标准偏差,SD)由本文件Delai计算,最后使用ReviewManager进行数据处理,和STATA软件进行补充。
■本研究共纳入2项试验,共37名参与者。Meta分析结果显示,与未使用IL-6单克隆抗体预防CRS,在CAR-T细胞输注前1小时给予患者8mg/kg的IL-6单克隆抗体,降低了CRS的发生率[RR:0.4195%置信区间(0.20,0.86)I[2]=0.0%P=0.338z=-2.369(p=0.018)]。在亚组分析中,与那些没有使用IL-6单克隆抗体来预防CRS的人相比,在CAR-T细胞输注前1小时给予患者8mg/kg的IL-6单克隆抗体,其中降低了乳酸脱氢酶(LDH)[MD:-617.21,95%置信区间(-1104.41,-130.01)I[2]=0%P=0.88Z=2.48(P=0.01)],预防性使用IL-6单克隆抗体对CAR-T治疗后C反应蛋白(CRP)峰值降低有显著影响[MD:-11.58,95%置信区间(-15.28,-7.88)I[2]=0.0%P=0.73z=6.14(p<0.00001)].
■预防性使用IL-6单克隆抗体可以显着降低CAR-T治疗后CRS并发症的发生率,还可以降低CAR-T治疗后的LDH值和CRP峰值值。
■https://www.crd.约克。AC.uk/prospro/display_record.php?ID=CRD42023487662,标识符CRD42023487662。
UNASSIGNED: Chimeric antigen receptor T (CAR-T) cell immunotherapy is becoming one of the most promising treatments for hematological malignancies, however, complications such as cytokine release syndrome (CRS) seriously threaten the lives of patients. Interleukin 6(IL-6) monoclonal antibody is the common and useful treatment of CRS, however, it is not clear whether prophylactic use IL-6 monoclonal antibody before CAR-T therapy can reduce the incidence of CRS.
UNASSIGNED: This study aims to systematically evaluate whether the prophylactic use of IL-6 monoclonal antibody can reduce the incidence of CRS.
UNASSIGNED: We searched the PubMed, Embase, web of Science, and Cochrane Library databases for studies that reported the prophylactic use of IL-6 monoclonal antibody in the treatment of CRS-related complications of CAR-T cell immunotherapy before December 2022. The literature is screened according to the established inclusion and exclusion criteria, relevant data are extracted, and the quality of the literature is evaluated using the scale Cochrane bias risk assessment tool, and the Review Manager 5.3 is used to draw for related charts. Since the two experimental data only provide the median, the maximum and minimum values of the data, the mean and standard (Standard Deviation, SD) are calculated by this document Delai, and finally use Review Manager for data processing, and STATA software for supplementation.
UNASSIGNED: A total of 2 trials with a total of 37 participants were included in this study. Meta-analysis showed that compared with no use of IL-6 monoclonal antibody to prevent CRS, IL-6 monoclonal antibody was given to patients at 8 mg/kg one hour before CAR-T cell infusion, which reduced the incidence of CRS [RR: 0.41 95% confidence interval (0.20, 0.86) I[2] = 0.0% P = 0.338 z = -2.369 (p = 0.018)]. In subgroup analysis, compared with those who did not use IL-6 monoclonal antibody to prevent CRS, IL-6 monoclonal antibody was given to patients at 8 mg/kg one hour before CAR-T cell infusion, which reduced lactate dehydrogenase (LDH)[MD: -617.21, 95% confidence interval (-1104.41, -130.01) I[2] = 0% P = 0.88 Z = 2.48 (P = 0.01)], prophylactic use of IL-6 monoclonal antibody has a significant effect on reducing peak C-reactive protein (CRP) after CAR-T therapy [MD: -11.58, 95% confidence interval (-15.28, -7.88) I[2] = 0.0% P = 0.73 z = 6.14 (p < 0.00001)].
UNASSIGNED: The prophylactic use of IL-6 monoclonal antibody can significantly reduce the incidence of CRS complications after CAR-T therapy, can also reduce LDH vaule and peak CRP vaule after CAR-T therapy.
UNASSIGNED: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023487662, identifier CRD42023487662.