异麦芽糖酐铁治疗缺铁性贫血的快速卫生技术评估
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篇名: 异麦芽糖酐铁治疗缺铁性贫血的快速卫生技术评估
TITLE: Iron isomaltoside for the treatment of iron deficiency anemia:a rapid health technology assessment
摘要: 目的 采用快速卫生技术评估(HTA)的方法评价异麦芽糖酐铁治疗缺铁性贫血的有效性、安全性和经济性,为临床决策提供循证依据。方法系统检索PubMed、Embase、CochraneLibrary、中国知网、万方数据库和国外HTA官方网站,检索时限均为建库起至2022年5月25日。按照纳入排除标准对文献进行资料提取、质量评价后,对异麦芽糖酐铁治疗缺铁性贫血的有效性、安全性和经济性进行描述性分析。结果与结论共纳入1篇HTA报告、3篇系统评价/Meta分析和5篇经济学研究。在有效性方面,与羧基麦芽糖铁相比,使用异麦芽糖酐铁患者的血红蛋白水平提高更多,但二者的应答患者比例比较,差异无统计学意义;与蔗糖铁比较,异麦芽糖酐铁在增加和维持血红蛋白方面具有非劣效性,2组患者生活质量比较差异无统计学意义。在安全性方面,羧基麦芽糖铁、蔗糖铁和异麦芽糖酐铁的不良事件发生率分别为12.0%、15.3%、17.0%;异麦芽糖酐铁相比羧基麦芽糖铁的低磷血症发生率更低,相比蔗糖铁、右旋糖酐铁、纳米氧化铁的低磷血症发生率则差异无统计学意义;在治疗紧急不良事件发生率、严重不良事件发生率和患者因不良事件退出率方面,目前尚无确切结论。在经济性方面,异麦芽糖酐铁的经济性优于蔗糖铁,而对比羧基麦芽糖铁的经济性尚未有定论。
ABSTRACT: OBJECTIVE To evaluate the effectiveness, safety and economy of iron isomaltoside in the treatment of iron deficiency anemia using a rapid health technology assessment (HTA) method, and provide an evidence-based basis for clinical decision-making. METHODS PubMed, Embase, Cochrane Library, CNKI, Wanfang database and foreign HTA official websites were systematically searched, and the search time frame of the databases was from the establishment of the database to May 25th 2022. After data extraction and quality evaluation of the literature according to the inclusion and exclusion criteria, a descriptive analysis of the effectiveness, safety and economy of iron isomaltoside in the treatment of iron deficiency anemia was performed. RESULTS & CONCLUSIONS A total of 1 HTA report, 3 systematic reviews/meta-analysis and 5 economic studies were included. In terms of effectiveness, compared with ferric carboxymaltose, the hemoglobin level of patients using iron isomaltoside increased more, but there was no significant difference in the proportion of responding patients; compared with iron sucrose, it had non- inferiority in increasing and maintaining hemoglobin level, and there was no difference in the quality of life. In terms of safety, the incidence of adverse events of ferric carboxymaltose, iron sucrose and iron isomaltoside were 12.0%, 15.3% and 17.0%, respectively. Iron isomaltoside had a lower incidence of hypophosphatemia, compared with ferric carboxymaltose. There was no statistical difference in the incidence of hypophosphatemia among iron isomaltoside, iron sucrose, iron-dextrin and nanocrystalline iron oxide. The conclusion of the incidence of treatment-emergent adverse event, the incidence of serious adverse events and the withdrawal rate of patients due to adverse events was not clear. In terms of economy, the economy of iron isomaltoside is better than that of iron sucrose, and the economy of iron isomaltoside versus that of ferric carboxymaltose had not been finalized.
期刊: 2022年第33卷第24期
作者: 刘旭婷,高胜男,齐冉,杜桂平,刘国强
AUTHORS: LIU Xuting,GAO Shengnan,QI Ran,DU Guiping,LIU Guoqiang
关键字: 异麦芽糖酐铁;缺铁性贫血;快速卫生技术评估
KEYWORDS: iron isomaltoside; iron deficiency anemia; rapid health technology assessment
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