The safety of intravenous iron dextran in hemodialysis patients
The safety of intravenous iron dextran in hemodialysis patients
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DOI：
10.1016/s0272-6386(96)90463-1
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发表时间：
1996-10-01
影响因子：
13.2
通讯作者：
Wish, J
中科院分区：
文献类型：
--
作者：
Fishbane, S;Ungureanu, VD;Wish, J
血液透析患者贫血的治疗经常受到次优铁储备的阻碍。静脉内右旋糖酐铁是常用的，以维持铁储备在这一人群中，但很少有关于不良事件的发生率和类型的公开数据。本研究的目的是评估这种药物的安全性。对1993年7月1日至1995年6月30日期间接受静脉内右旋糖酐铁（INFeD; Schein Pharmaceutical，Inc，弗洛勒姆公园，NJ）治疗的所有573例患者的四个血液透析中心的图表进行了研究。27例患者（4.7%）发生了与右旋糖酐铁相关的不良反应。4例患者（0.7%）发生严重反应（1例心脏骤停;另外3例需要住院治疗）。10例患者（1.7%）发生归类为类速发过敏反应。没有患者因反应而死亡或发生永久性残疾。最常见的不良反应包括瘙痒（1.5%的患者）和呼吸困难或喘息（1.5%）;其他包括胸痛（1.0%），恶心（0.5%），低血压（0.5%）、肿胀（0.5%）、消化不良（0.5%）、腹泻（0.5%）、皮肤潮红（0.3%）、头痛（0.3%）、心脏骤停（0.2%）和肌痛（0.2%）。所有反应中有5例发生在试验剂量期间;其中4例为类速发过敏反应。研究了几个因素作为不良反应的可能预测因素。阳性药物过敏史（比值比，2.4; P = 0.03）和多种药物过敏史（比值比，5.5; P = 0.0004）是反应的重要预测因素。总之，我们发现严重的不良反应是罕见的血液透析患者静脉注射右旋糖酐铁治疗。未来的前瞻性研究将有助于证实这一发现。(C)1996年由国家肾脏基金会，公司。
The treatment of anemia in hemodialysis patients is frequently hindered by the presence of suboptimal iron stores. Intravenous iron dextran is in common use to maintain iron stores in this population, but there are little published data regarding the incidence and type of adverse events. The purpose of this study was to evaluate the safety of this medication. Charts from four hemodialysis centers of all 573 patients treated with intravenous iron dextran (INFeD; Schein Pharmaceutical, Inc, Florham Park, NJ) between July 1, 1993, and June 30, 1995, were studied, Twenty-seven patients (4.7%) had adverse reactions that were related to iron dextran. Four patients (0.7%) had reactions classified as serious (one cardiac arrest; three others required hospitalization). Ten patients (1.7%) had reactions classified as anaphylactoid. No patients died or developed permanent disability as a result of reactions. The most common adverse reactions included itching (1.5% of patients) and dyspnea or wheezing (1.5%); others included chest pain (1.0%), nausea (0.5%%), hypotension (0.5%), swelling (0.5%), dyspepsia (0.5%), diarrhea (0.5%), skin flushing (0.3%), headache (0.3%), cardiac arrest (0.2%), and myalgias (0.2%). Five of all the reactions occurred during a test dose; four of these were anaphylactoid. Several factors were studied as possible predictors of adverse reactions. A positive history of drug allergy (odds ratio, 2.4; P = 0.03) and history of multiple drug allergy (odds ratio, 5.5; P = 0.0004) were significant predictors of reactions. In summary, we found serious adverse reactions to be uncommon in hemodialysis patients treated with intravenous iron dextran. Future prospective studies will help confirm this finding. (C) 1996 by the National Kidney Foundation, Inc.