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[胃肠外铁剂治疗:问题与可能的解决方案]

[Parenteral iron therapy: problems and possible solutions].

作者信息

Hoigné R, Breymann C, Künzi U P, Brunner F

机构信息

Ehemaliger ärztlicher Leiter, Schweizerische Stiftung, Comprehensive Hospital Drug Monitoring (CHDM), Bern/St. Gallen.

出版信息

Schweiz Med Wochenschr. 1998 Apr 4;128(14):528-35.

PMID:9592894
Abstract

To investigate whether there are differences in the frequency of ADRs (adverse drug reactions) to parenteral iron preparations, we compared the results of 4 different data collections which contain observations in particular on i.m. or i.v. iron dextran and i.v. iron hydroxide sucrose complex, primarily in relation to anaphylactic/anaphylactoid reactions and common exanthemas. 1. In 206 patients of the department of general internal medicine in a city/teaching hospital (in association with the Swiss Foundation for Comprehensive Hospital Drug Monitoring--CHDM), 4 probably allergic reactions to i.m. iron dextran were found, one with acute severe dyspnea, cyanosis and flush, 3 with slight generalized, probably allergic reactions. Data from the USA on i.v. iron dextran do not show marked differences in the frequency of ADRs as compared with our data with i.m. administration. 2. A group of 400 otherwise healthy patients of the obstetric department of Zurich University Hospital were treated with i.v. iron sucrose for anemia due to iron loss during pregnancy or following childbirth. Seven generalized skin reactions, 4 in the form of flush and 3 of common exanthema, occurred. 3. In a retrospective study on patients on maintenance hemodialysis with chronic renal insufficiency and anemia, a questionnaire was answered by the medical heads of 17 selected hemodialysis units in Switzerland. Response was 100%. During around 8100 patient-years with approximately 160,000 ampoules of iron sucrose (with 100 mg elementary iron), not a single life threatening reaction was observed; only 5-7 situations of rapidly reversible blood pressure fall occurred, some 10 with flush, and one each with urticaria and vomiting/diarrhea. 4. The relatively good tolerance of i.v. iron sucrose in patients with chronic renal failure may be due either to reduced immune competence in patients with chronic renal insufficiency and/or to the use of the preparation itself, or probably both. 5. In ADRs of allergic appearance to iron sucrose, the 7 generalized skin reactions occurred on the first day of the injections, as did those under iron dextran. Preexisting hypersensitivity must be taken into consideration. 6. If our experience is confirmed, preventive measures with i.v. iron sucrose, mainly in patients with chronic renal insufficiency, could be reduced.

摘要

为了研究肠外铁制剂的药物不良反应(ADR)发生频率是否存在差异,我们比较了4种不同数据收集的结果,这些数据收集特别包含了关于肌肉注射或静脉注射右旋糖酐铁以及静脉注射氢氧化铁蔗糖复合物的观察数据,主要涉及过敏/类过敏反应和常见皮疹。1. 在一家城市/教学医院的普通内科(与瑞士综合医院药物监测基金会——CHDM合作)的206例患者中,发现4例可能对肌肉注射右旋糖酐铁过敏的反应,1例伴有急性严重呼吸困难、发绀和潮红,3例伴有轻微全身性、可能是过敏的反应。来自美国的关于静脉注射右旋糖酐铁的数据与我们肌肉注射给药的数据相比,ADR发生频率没有显著差异。2. 苏黎世大学医院妇产科的400例其他方面健康的患者因妊娠或分娩期间铁流失导致贫血而接受静脉注射蔗糖铁治疗。发生了7例全身性皮肤反应,4例为潮红,3例为常见皮疹。3. 在一项对患有慢性肾功能不全和贫血的维持性血液透析患者的回顾性研究中,瑞士17个选定血液透析单位的医疗负责人回答了一份问卷。回复率为100%。在约8100患者年期间,使用了约160,000支蔗糖铁安瓿(每支含100毫克元素铁),未观察到一例危及生命的反应;仅发生了5 - 7次血压迅速可逆下降的情况,约10次潮红,各有1次荨麻疹和呕吐/腹泻。4. 慢性肾衰竭患者对静脉注射蔗糖铁相对较好的耐受性可能是由于慢性肾功能不全患者免疫能力降低和/或制剂本身的使用,或者可能两者皆有。5. 在对蔗糖铁出现过敏样的ADR中,7例全身性皮肤反应与注射第一天发生的右旋糖酐铁引起的反应一样。必须考虑预先存在的超敏反应。6. 如果我们的经验得到证实,主要针对慢性肾功能不全患者的静脉注射蔗糖铁的预防措施可以减少。

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