利妥昔单抗注射液相关性肺炎的Meta分析  

Meta-analysis of Rituximab Injection Associated Pneumonia

作　　者：白浩[1] 孙朴 陈霞 

机构地区：[1]重庆市肿瘤医院/重庆市肿瘤研究所,重庆400030

出　　处：《中国药房》2018年第4期547-552,共6页China Pharmacy

基　　金：重庆市科委基础与前沿研究计划项目(No.cstc2013jcyj A10125);重庆市沙坪坝区科委社会发展领域科技项目(No.沙科委发[2016]41号-SF201601)

摘　　要：目的:系统评价利妥昔单抗与肺炎发生的相关性,为临床提供循证参考。方法:计算机检索Pub Med、Embase、Cochrane图书馆、Web of Science、中国生物医学文献数据库、中国知网和万方等数据库,收集随机对照试验、半随机对照试验及临床对照试验等,检索时限均为建库起至2017年3月。筛选文献、提取资料并参照《Cochrane干预措施系统评价手册》(5.3版)进行文献质量评定和偏倚风险分析,采用Rev Man 5.3软件对两组患者的肺炎发生率进行Meta分析。结果:最终纳入16篇文献,共14个RCT,涉及1 386例患者。Meta分析结果示,观察组患者利妥昔单抗致肺炎的发生率略低于对照组,但差异无统计学意义[OR=1.19,95%CI(0.75,1.91),Z=0.74,P=0.46]。按样本量大小、是否多中心和干预剂量等进行亚组分析,结果均显示两组患者利妥昔单抗致肺炎的发生率比较,差异均无统计学意义(P>0.05)。结论:观察组与对照组患者肺炎发生率无显著性差异,利妥昔单抗与肺炎的发生并不相关。由于受纳入研究的方法学限制,许多高质量长期随访研究并未纳入,今后仍有待大样本、高质量的临床研究进一步验证。OBJECTIVE:To systematically evaluate the relationship between rituximab and the occurence of pneumonia,and to provide evidenle-based reference in clinic. METHODS:Retrieved from Pub Med,Embase,Cochrane Library,Web of Science,CBM,CNKI,Wanfang database and other database,RCTs,quasi-RCTs,controlled clinical trials were searched from inception to Mar. 2017.After literature screening,data extraction,literature quality evaluation and analysis of bias risk referring to Cochrane Intervention Measure System Evaluation Manual(5.3 edition),Meta-analysis was conducted by using Rev Man 5.3 software. RESULTS:A total of16 literatures were finally included,consisting of 14 RCTs and 1 386 patients. The results of Meta-analysis showed that the incidence of rituximab associated pneumonia in observation group was lower than control group,but without statistical significance [OR=1.19,95%CI(0.75,1.91),Z=0.74,P=0.46]. Subgroup analysis was conducted according to sample size,multiple-center, intervention dose, there was no statistical significance in the incidence of rituximab-associated pneumonia between 2 groups(P>0.05).CONCLUSIONS:There was no significant difference in the incidence of pneumonia between observation group and control group,rituximab is not associated with the occurrence of pneumonia. Due to methodology limit of included studies,most of high quality longterm follow-up studies have not been included. Large-scale and high quality clinical studies are required for further valuation.

关 键 词：利妥昔单抗 肺炎 META分析 随机对照试验 

分 类 号：R969.3[医药卫生—药理学] R563.1[医药卫生—药学]