静注人免疫球蛋白治疗重症和危重症COVID-19患者有效性和安全性的meta分析  

Meta-analysis of the Effectiveness and Safety of Intravenous Human Immunoglobulin in the Treatment of Severe and Critical COVID-19 Patients

作　　者：刘克锋[1,2] 卢晓静 杨勇杰 张旭锋 鲁春云 张晓坚 康建[1,2] LIU Kefeng;LU Xiaojing;YANG Yongjie;ZHANG Xufeng;LU Chunyun;ZHANG Xiaojian;KANG Jian(Department of Pharmacy,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Henan Drug Clinical Comprehensive Evaluation Center,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院药学部,郑州450052 [2]河南省药品临床综合评价中心,郑州450052

出　　处：《中国现代应用药学》2024年第22期3182-3191,共10页Chinese Journal of Modern Applied Pharmacy

基　　金：河南省医学科技攻关计划联合共建项目(LHGJ20220390);河南重点研发与推广项目(232102310245);中华医学会临床药学分会2022年度临床药学科研基金(Z-2021-46-2101)。

摘　　要：目的系统评价静注人免疫球蛋白(human immunoglobulin for intravenous injection,IVIG)治疗重症和危重症COVID-19患者有效性和安全性,以期为临床用药提供参考。方法计算机检索PubMed、Embase、Cochrane图书馆、中国知网和万方数据库,收集IVIG对比常规治疗用于重症和危重症COVID-19患者的随机对照试验(randomized controlled trial,RCT)或者观察性研究,检索时限从建库至2023年1月。由2名研究者独立筛选文献、提取资料后采用Cochrane 5.1.0偏倚风险评估工具和Newcastle-Ottawa Scale评价量表对纳入文献质量进行评价,并用GRADE方法对证据体进行质量分级,采用RevMan 5.3软件和Stata 14.0软件进行meta分析。结果共纳入5篇RCT和11篇队列研究,涉及3803例重症和危重症COVID-19患者。Meta分析结果显示,IVIG的治疗对于重症或危重症COVID-19患者总体死亡率略低于对照组[RR=0.90,95%CI(0.75,1.08),P=0.26],总体住院时间略高于对照组[MD=1.46,95%CI(−3.16,6.08),P=0.54],总体ICU停留时间略高于对照组[MD=0.11,95%CI(−1.32,1.54),P=0.88],差异均无统计学意义;2组不良反应发生率相当[RR=1.09,95%CI(0.89,1.34),P=0.40]。结论使用IVIG并不能降低重症或危重症COVID-19患者的死亡率、住院时间和ICU停留时间,因此并不推荐临床使用IVIG治疗重症或危重症COVID-19患者。OBJECTIVE To systematically evaluate the effectiveness and safety of intravenous human immunoglobulin(IVIG)for the treatment of severe and critical COVID-19 patients,to provide a reference for clinical use of the drug.METHODS PubMed,Embase,Cochrane Library,CNKI and Wanfang database were searched to collect randomized controlled trials(RCTs)or observational studies of IVIG versus conventional treatment for severe and critical COVID-19 patients,and the period of searching was from the establishment of the database to January 2023.The quality of the included literature was evaluated by two investigators who independently screened the literature and extracted information using the Cochrane 5.1.0 risk of bias assessment tool and the Newcastle-Ottawa Scale evaluation scale,and the body of evidence was graded for quality using the GRADE method.Meta-analysis was performed using RevMan 5.3 software and Stata 14.0 software.RESULTS A total of 5 RCTs and 11 cohort studies involving 3803 patients with severe and critical COVID-19 were included.Meta-analysis showed that IVIG treatment had a slightly lower overall mortality rate in patients with severe or critical COVID-19 than control subjects[RR=0.90,95%CI(0.75,1.08),P=0.26],the overall length of hospital stay was slightly higher than that of the control group[MD=1.46,95%CI(−3.16,6.08),P=0.54],the overall ICU stay was slightly higher than that of the control group[MD=0.11,95%CI(−1.32,1.54),P=0.88],but the differences were not statistically significant;the incidence of adverse effects in the two groups incidence was comparable[RR=1.09,95%CI(0.89,1.34),P=0.40].CONCLUSION The use of IVIG does not reduce the mortality rate,length of hospital stay,and ICU stay in patients with severe or critical COVID-19,and therefore the clinical use of IVIG is not recommended for the treatment of patients with severe or critical COVID-19.

关 键 词：静注人免疫球蛋白 重症 危重症 COVID-19 META分析 

分 类 号：R969.3[医药卫生—药理学]