4种静脉铁剂治疗缺铁性贫血的快速卫生技术评估  

Four intravenous iron formulations in the treatment of iron deficiencyanemia:a rapid health technology assessment

作　　者：邢质聪 孙福东[2] 薛青霞 张蓓 慕升君 赵泉[2] XING Zhicong;SUN Fudong;XUE Qingxia;ZHANG Bei;MU Shengjun;ZHAO Quan(School of Pharmacy,Binzhou Medical University,Yantai 264003,Shandong Province,China;Department of Pharmacy,Yantai Yuhuangding Hospital,Yantai 264000,Shandong Province,China)

机构地区：[1]滨州医学院药学院,山东烟台264003 [2]烟台毓璜顶医院药学部,山东烟台264000

出　　处：《药物流行病学杂志》2024年第9期1030-1043,共14页Chinese Journal of Pharmacoepidemiology

基　　金：山东省药学会共享天晴、“药”有所为学术课题项目(Kjyw2024-7)。

摘　　要：目的采用快速卫生技术评估方法评价4种静脉铁剂治疗缺铁性贫血(IDA)的有效性、安全性和经济性,为临床决策提供依据。方法计算机检索PubMed、Embase、Cochrane Library、CNKI、WanFang Data、SinoMed数据库和国外卫生技术评估机构官方网站,搜集蔗糖铁(IS)、右旋糖酐铁(ID)、羧基麦芽糖铁(FCM)和异麦芽糖酐铁(IIM)4种静脉铁剂治疗IDA的卫生技术评估报告、系统评价/Meta分析和药物经济学研究,检索时限均从建库至2024年8月15日。2名研究者独立筛选文献、提取资料并评价纳入研究的质量,对结果进行定性描述与分析。结果共纳入文献32篇,包括卫生技术评估报告1篇,系统评价/Meta分析16篇,药物经济学研究15篇。有效性方面,FCM的应答患者比例高于IS(P<0.05),FCM和IIM的应答患者比例差异无统计学意义(P>0.05);接受FCM补铁的患者比接受IS的患者具有更高的血红蛋白水平(P<0.05),IIM和FCM在血红蛋白水平改善方面尚无统一结论;对于铁蛋白变化值,FCM可能优于其他3种静脉铁剂。安全性方面,FCM、IS、ID和IIM的不良事件发生率分别为12.0%、15.3%、12.0%、17.0%;与FCM和IS相比,IIM导致的心血管不良事件发生率较低(P<0.05);在4种静脉铁剂中,FCM低磷血症发生率最高(P<0.05),且IIM、IS和ID之间低磷血症发生率差异无统计学意义(P>0.05);相对于FCM和IS,IIM发生严重或重度超敏反应的风险较低。经济性方面,相较于IS,FCM和IIM具有经济学优势;IS、ID和FCM按经济性优劣排序依次为FCM、ID、IS,FCM和IIM的经济性对比尚无定论。结论FCM和IIM在治疗IDA方面具有较好的有效性、安全性和经济性,但纳入的经济学研究多基于国外人群,国内经济学研究有待进一步论证。Objective To evaluate the efficacy,safety,and economy of 4 intravenous iron formulations in the treatment of iron deficiency anemia(IDA)by rapid health technology assessment,and to provide evidence for clinical decision-making.Methods PubMed,Embase,the Cochrane Library,CNKI,WanFang,SinoMed,and official websites of international health technology assessment agencies were electronically searched to collect health technology assessment reports,systematic reviews/Meta-analysis,and pharmacoeconomic studies concerning the treatment of IDA with iron sucrose(IS),iron dextran(ID),ferric carboxymaltose(FCM),and iron isomaltoside(IIM)from the inception to August 15,2024.Two researchers independently screened the studies,extracted data and assessed the quality of included studies.The results were then qualitatively described and analyzed.Results A total of 32 studies were included,including one health technology assessment report,16 systematic reviews/Meta-analysis,and 15 pharmacoeconomic evaluations.In terms of effectiveness,FCM had a higher response rate than that of IS(P﹤0.05),FCM and IIM had no statistical difference(P>0.05).Regarding hemoglobin level change,patients treated with FCM had higher hemoglobin levels than those treated with IS(P﹤0.05);the improvement in hemoglobin levels between IIM and FCM was inconclusive.In terms of ferritin level change,FCM might be superior to the other three intravenous iron formulations.In terms of safety,the adverse event rates for FCM,IS,ID and IIM were 12.0%,15.3%,12.0%and 17.0%,respectively;IIM was significantly associated with a lower rate of cardiovascular adverse events compared to FCM and IS(P﹤0.05);FCM had the highest rate of hypophosphatemia among the four formulations(P﹤0.05),and there was no significant difference among IIM,IS and ID(P>0.05);IIM had a lower risk of severe or serious hypersensitivity reactions compared to FCM and IS.In terms of economy,FCM and IIM had an economic advantage compared to IS.The economic efficiency ranking among IS,ID,and FCM was in the

关 键 词：蔗糖铁 右旋糖酐铁 羧基麦芽糖铁 异麦芽糖酐铁 缺铁性贫血 快速卫生技术评估 

分 类 号：R977[医药卫生—药品]