目的 系统评价利妥昔单抗联合化疗治疗儿童成熟B 细胞淋巴瘤的有效性和安全性.方法 计算机检索PubMed、Embase、Cochrane Library、中国知网、万方等数据库,由2 名研究者分别进行资料提取、质量评价,并交叉核对,检索时限为从建库至2022年7 月.收集利妥昔单抗联合化疗对比单纯化疗的研究,以3年无事件生存率(EFS)、不良反应发生率作为结局指标.使用STATA11.0软件进行Meta分析、亚组分析、敏感性分析和发表偏倚分析.结果 共纳入9 项研究,包含908 例新诊断的儿童成熟B细胞淋巴瘤患者.Meta分析结果显示,与单纯化疗组相比,利妥昔单抗联合化疗组治疗新诊断的儿童成熟B细胞淋巴瘤的3年EFS明显增高(HR=0.37,95%CI:0.24~0.58,P<0.05).亚组分析显示,利妥昔单抗使用≥6 次时利妥昔单抗联合化疗组3年EFS 高于单纯化疗组,差异有统计学意义(HR=0.32,95%CI:0.17~0.57,P<0.05);利妥昔单抗使用4 次时利妥昔单抗联合化疗组3 年EFS与单纯化疗组相比,差异无统计学意义(HR=0.41,95%CI:0.17~1.01,P>0.05).利妥昔单抗联合化疗组与单纯化疗组≥4级不良反应发生率比较,差异无统计学意义(OR=1.24,95%CI:0.80~1.94,P>0.05),两组≥3 级中性粒细胞减少发生率比较,差异无统计学意义(OR=1.34,95%CI:0.62~2.91,P>0.05),两组≥3 级感染发生率比较,差异有统计学意义(OR=1.82,95%CI:1.23~2.71,P<0.05).结论 利妥昔单抗联合化疗可提高儿童成熟B细胞淋巴瘤患者的生存率,应用≥6 次利妥昔单抗临床效果更好,总体不良反应发生率较低.
Objective To systematically evaluate the efficacy and safety of rituximab combined chemother-apy in the treatment of childhood mature B-cell lymphoma.Methods The electronic databases such as PubMed,Embase,Cochrane Library,China National Knowledge Infrastructure,and Wanfang Database were retrieved by computer.The two researchers respectively conducted the data extraction,quality evaluationand cross checking.The retrievaltime limit was from the establishment of the database to July 2022.The compara-tive studies of the rituximab combined chemotherapy andsimple rituximab were collected and the 3-year event free survival(EFS)and incidence rate of adverse reactions served as the outcome indicators.The STATA11.0 software was used for conducting the Meta-analysis,subgroup analysis,sensitivity analysis,and publication bi-as analysis.Results A total of 9 studies were included,including 908 patients with newly diagnosed pediatric mature B-cell lymphoma.The Meta-analysis results showed that,compared to the simple chemotherapy group,the 3-year EFS of the patients with newly diagnosed mature B-cell lymphoma in the rituximab combi-nation chemotherapy group was significantly increased(HR=0.37,95%CI:0.24-0.58,P<0.05).Sub-group analysis showed 3-year EFS in after ≥≥ 6 times of rituximab use the rituximab combination chemothera-py group was higher than that in the simple chemotherapy group(HR=0.32,95%CI:0.17-0.57,P<0.05),and there was no statistically significant difference in 3-year EFS between the rituximab combined chemotherapy group and the simple chemotherapy group in the rituximab four times(HR=0.41,95%CI:0.17-1.01,P>0.05).There was no statistically significant difference in the incidence rate of≥4 grade ad-verse reactions between the rituximab combined chemotherapy group and the simple chemotherapy group(OR=1.24,95%CI:0.80-1.94,P>0.05),the incidence rate of ≥3 grade neutropenia between the two groups was not statistically significant(OR=1.34,95%CI:0.62-2.91,P>0.05),and the incidence rate of ≥3 grade infection between the two groups was statistically significant(OR=1.82,95%CI:1.23-2.71,P<0.05).Conclusion Rituximab combined chemotherapy can improve the survival rate in children patients with mature B-cell lymphoma,and the application of ≥6 times of rituximab has better clinical effect with low-er overall incidence rate of adverse events.