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更新于：2026-10-22
Iron hydroxyethyl starch
更新于：2026-10-22
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 奥地利 (2012-03-21), |
最高研发阶段(中国)临床申请 |
特殊审评- |
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关联
2
项与 Iron hydroxyethyl starch 相关的临床试验NCT07687784
A Multicentre, Prospective, Randomized, Active-Controlled, Open-Label, Phase III Study to Test the Non-Inferiority of Intravenous Injection of Ferric Bepectate IV Injection Compared to Ferric Carboxymaltose for Treatment of Patients With Iron Deficiency Anaemia (IDA)
NCT04465539
The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning: A Randamized Controlled Clinical Trial
100 项与 Iron hydroxyethyl starch 相关的临床结果
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100 项与 Iron hydroxyethyl starch 相关的转化医学
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100 项与 Iron hydroxyethyl starch 相关的专利（医药）
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1
项与 Iron hydroxyethyl starch 相关的文献（医药）2022-07-01Basic & clinical pharmacology & toxicology
Are there safety concerns for frequently repeated dosages of intravenous irons?
Letter
作者: Muñoz, Manuel ; Waldorff, Stig
The i.v. iron drugs should be formulated to avoid its release iron into plasma.Following administration, macrophages from thereticulo endothelial system clear the iron carbohydrate complex from plasma and break it down.Thus, a linear relation between the i.v. drug dose and the maximal after dosing drug concentration would be expected.In a follow-up publication where dose-related pharmacokinetics of ferric bepectate was evaluated, it was proved that a second compartment of distribution appeared at the highest administered dose.The fraction of labile iron released from the iron drug at the time of administration and the short-term stability of the iron drug in plasma, as labile iron has well-known direct toxic effects and may influence pharmacokinetics and body distribution.EMA does not recommend a simple methodol. to characterize early after dosing stability of i.v. iron drugs.Whether recommended dose regimens for all marketed i.v. irons are designed to avoid capillary leak episodes with extravasation of iron and other plasma constituents is unknown.As for ferumoxytol, an i.v. iron drug marketed outside EU, iron extravasation as a secondary volume of distribution has been demonstrated.We, therefore, urge the Marketing Authorisation Holders to perform the two-step procedure described above especially for i.v. irons dose regimens used repeatedly (e.g., in CKD).Our suspicion of a deleterious effect of frequently repeated doses of i.v. iron in CKD patients could be clarified in a pharmacoepidemiol. study.CKD patients exposed to frequently repeated doses of i.v. iron should be compared with a group of CKD patients receiving a few yearly injections with respect to cardiovascular events.
1
项与 Iron hydroxyethyl starch 相关的新闻（医药）2026-10-22
·信狐药迅
100 项与 Iron hydroxyethyl starch 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 缺铁性贫血 | 奥地利 | 2012-03-21 |
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