摘要
目的基于系统评价的方法学和证据质量,对新型静脉铁剂临床应用安全性进行再评价,为其临床合理应用提供循证依据。方法系统检索PubMed、Embase、Cochrane Library及中文数据库(包括中国学术期刊网络出版总库、万方数据库、中国生物医学文献数据库)中静脉铁剂安全性系统评价,检索时限均为建库至2022年9月。采用AMSTAR 2评价纳入系统评价的方法学质量,对结局指标进行描述性分析与总结。结果本研究最终共纳入6篇系统评价与meta分析。AMSTAR 2评价结果表明,2篇为方法学高质量、3篇低质量,1篇网状meta分析不适用该评价工具。妊娠期患者中,羧基麦芽糖铁不良事件发生率显著低于使用蔗糖铁(RR=0.53,95%CI:0.35~0.80,I^(2)=0%,P=0.003);慢性肾病患者中,纳米氧化铁治疗相关不良事件发生率低于传统补铁制剂(Hedge’s g=-0.242,95%CI:-0.521~0.037,Z=-1.699,P=0.089),但差异无统计学意义。在缺铁性贫血患者中,与右旋糖酐铁(RR=6.60,95%CI:1.91~220.00)、异麦芽糖酐铁(RR=7.90,95%CI:2.1~28.0)、蔗糖铁(RR=9.40,95%CI:2.3~33.0)以及纳米氧化铁(RR=24.0,95%CI:2.5~220.0)相比,羧基麦芽糖铁低磷血症发生率显著增加;与羧基麦芽糖铁(RR=0.59,95%CI:0.39~0.90)和蔗糖铁(RR=1.12,95%CI:0.90~1.40)相比,异麦芽糖酐铁发生心血管不良事件风险显著降低。结论总体来看,新型静脉铁剂在总体不良事件、心血管不良事件、消化道反应等方面可能优于传统铁制剂。新型静脉铁剂中,异麦芽糖酐铁具有心血管不良事件风险较低,而羧基麦芽糖铁低磷血症风险较高。
Objective To re-evaluate the clinical safety of novel intravenous iron formulations,the study was designed to perform an evidence-based research on current systematic reviews,and provide evidence-based references for its rational clinical application.Methods PubMed、Embase、Cochrane Library、CNKI、Wangfang Data、CBM were systematically searched for systematic reviews of the safety of novel intravenous iron formulations from inception to September,2022.The methodology quality of included systematic reviews was evaluated by Assessing The Methodological Quality Of Systematic Reviews 2(AMSTAR 2).Outcomes were comprehensively and qualitatively analyzed.Results Totally,6 systematic reviews were included.The assessment results using AMSTAR 2 tool showed that 2 systematic reviews were considered of high quality,3 were of low quality,and 1 network meta-analysis was not applicable.In pregnant women,the incidence of adverse events of ferric carboxymaltose(FCM)was significantly lower than that of sucrose iron(RR=0.53,95%CI:0.35-0.80,I2=0%,P=0.003).In patients with chronic kidney disease,the incidence of adverse events related to ferumoxytol treatment was lower than that of traditional iron supplement(Hedge’s g=-0.242,95%CI:-0.521-0.037,Z=-1.699,P=0.089),but there was no statistical difference.In patients with iron deficiency anemia,FCM was associated with significantly higher incidence of hypophosphatemia compared to iron dextran(RR:6.60,95%CI:1.91-220.0),iron isomaltoside(RR:7.90,95%CI:2.10-28.0),iron sucrose(IS)(RR:9.40,95%CI:2.30-33.0),and ferumoxytol(RR:24.0,95%CI:2.50-220.0);Iron isomaltoside(IIM)was associated with significantly lower incidence of cardiovascular adverse events compared to both FCM(RR=0.59,95%CI:0.39~0.90)and IS(RR=1.12,95%CI:0.90-1.40).Conclusion Generally speaking,the new intravenous iron preparation may be superior to the traditional iron preparation in terms of overall adverse events,cardiovascular adverse events and gastrointestinal reactions.Among the new intravenous iron preparations,iron isomaltose anhydride has a lower risk of cardiovascular adverse events,while iron carboxy maltose has a higher risk of hypophosphatemia.
作者
高伟祺
徐娜
宋再伟
姜丹
门鹏
赵荣生
GAO Wei-qi;XU Na;SONG Zai-wei;JIANG Dan;MEN Peng;ZHAO Rongsheng(Department of Pharmacy,Peking University Third Hospital,Bejing 100191,China;Department of Pharmacy,Shanxi Bethune Hospital,Shanxi Academy of Medical Sciences,Tongji Shanxi Hospital,Third Hospital Medical University,Shanxi Taiyuan 030032,China;Department of Pharmacy,Hebei Provincial Mental Health Center,The Sixth Clinical Medical College of Hebei University,Hebei Baoding 071000,China;Institute for Drug Evaluation,Peking University Health Science Center,Bejing 100191,China;Department of Pharmacy Administration and Clinical Pharmacy,School of Pharmaceutical Sciences,PekingUniversity,Beijing100191,China)
出处
《临床药物治疗杂志》
2022年第12期7-12,共6页
Clinical Medication Journal
基金
北京药学会专项课题(静脉用药配置安全性及配伍系统研究)。
关键词
新型静脉铁剂
缺铁性贫血
安全性
系统评价再评价
novel intravenous iron
intravenous iron formulations drug
iron deficiency anemia
safety
overview of systematic review
