静脉用铁制剂致过敏反应的风险：一项回顾性队列研究。

Risks for Anaphylaxis With Intravenous Iron Formulations : A Retrospective Cohort Study.

机构信息

Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, Rutgers University, New Brunswick, Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, and Department of Veterans Affairs New Jersey Health Care System, East Orange, New Jersey (C.V.D.).

Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, New York (G.M.B.).

出版信息

Ann Intern Med. 2022 May;175(5):656-664. doi: 10.7326/M21-4009. Epub 2022 Mar 29.

DOI:10.7326/M21-4009

PMID:35344378

Abstract

BACKGROUND

The risks for anaphylaxis among intravenous (IV) iron products currently in use have not been assessed.

OBJECTIVE

To compare risks for anaphylaxis among 5 IV iron products that are used frequently.

DESIGN

Retrospective cohort study using a target trial emulation framework.

SETTING

Medicare fee-for-service data with Part D coverage between July 2013 and December 2018.

PARTICIPANTS

Older adults receiving their first administration of IV iron.

MEASUREMENTS

The primary outcome was the occurrence of anaphylaxis within 1 day of IV iron administration, ascertained using a validated case definition. Analysis was adjusted for 40 baseline covariates using inverse probability of treatment weighting. The adjusted incidence rates (IRs) for anaphylaxis per 10 000 first administrations and odds ratios (ORs) were computed.

RESULTS

The adjusted IRs for anaphylaxis per 10 000 first administrations were 9.8 cases (95% CI, 6.2 to 15.3 cases) for iron dextran, 4.0 cases (CI, 2.5 to 6.6 cases) for ferumoxytol, 1.5 cases (CI, 0.3 to 6.6 cases) for ferric gluconate, 1.2 cases (CI, 0.6 to 2.5 cases) for iron sucrose, and 0.8 cases (CI, 0.3 to 2.6 cases) for ferric carboxymaltose. Using iron sucrose as the referent category, the adjusted ORs for anaphylaxis were 8.3 (CI, 3.5 to 19.8) for iron dextran and 3.4 (CI, 1.4 to 8.3) for ferumoxytol. When cohort entry was restricted to the period after withdrawal of high-molecular-weight iron dextran from the U.S. market in 2014, the risk for anaphylaxis associated with low-molecular-weight iron dextran (OR, 8.4 [CI, 2.8 to 24.7]) did not change appreciably. Anaphylactic reactions requiring hospitalizations were observed only among patients using iron dextran or ferumoxytol.

LIMITATION

Generalizability to non-Medicare populations.

CONCLUSION

The rates of anaphylaxis were very low with all IV iron products but were 3- to 8-fold greater for iron dextran and ferumoxytol than for iron sucrose.

PRIMARY FUNDING SOURCE

None.

摘要

背景

目前尚未评估常用静脉（IV）铁产品发生过敏反应的风险。

目的

比较 5 种常用 IV 铁产品发生过敏反应的风险。

设计

使用目标试验模拟框架的回顾性队列研究。

设置

2013 年 7 月至 2018 年 12 月期间，使用医疗保险按服务付费数据和部分 D 覆盖范围。

参与者

首次接受 IV 铁治疗的老年人。

测量

主要结局是 IV 铁给药后 1 天内发生过敏反应，使用经过验证的病例定义确定。使用逆概率治疗加权法调整了 40 个基线协变量的分析。计算了每 10000 次首次给药的过敏反应发生率（IR）和比值比（OR）。

结果

每 10000 次首次给药的过敏反应发生率分别为铁右旋糖酐 9.8 例（95%CI，6.2 至 15.3 例）、ferumoxytol 4.0 例（CI，2.5 至 6.6 例）、ferric gluconate 1.5 例（CI，0.3 至 6.6 例）、iron sucrose 1.2 例（CI，0.6 至 2.5 例）和 ferric carboxymaltose 0.8 例（CI，0.3 至 2.6 例）。以 iron sucrose 为参照类别，过敏反应的调整 OR 分别为铁右旋糖酐 8.3（CI，3.5 至 19.8）和 ferumoxytol 3.4（CI，1.4 至 8.3）。当将队列纳入时间限制在 2014 年高相对分子质量铁右旋糖酐从美国市场撤出后，与低相对分子质量铁右旋糖酐相关的过敏反应风险（OR，8.4 [CI，2.8 至 24.7]）并未明显改变。仅在使用铁右旋糖酐或 ferumoxytol 的患者中观察到需要住院治疗的过敏反应。