Aronoff George R, Bennett William M, Blumenthal Samuel, Charytan Chaim, Pennell J Phillip, Reed John, Rothstein Marcos, Strom James, Wolfe Anthony, Van Wyck David, Yee Jerry
University of Louisville School of Medicine, Louisville, Kentucky, USA.
Kidney Int. 2004 Sep;66(3):1193-8. doi: 10.1111/j.1523-1755.2004.00872.x.
Parenteral iron replacement and maintenance are frequently required in hemodialysis patients. However, serious adverse events have been reported after single doses of some intravenous iron products. This multicenter phase IV clinical trial examined the safety of iron sucrose for the treatment of iron deficiency and for the maintenance of iron sufficiency in hemodialysis patients.
In this safety study, iron sucrose was given in two dosing regimens. Iron deficient patients were treated with intravenous iron sucrose, 100 mg, during 10 consecutive hemodialysis sessions (replacement regimen). Iron replete patients were given iron sucrose, 100 mg intravenous (iv) over 5 minutes, weekly for 10 weeks (maintenance regimen). At the end of each 10-dose cycle, iron status was reassessed, and dosing during the subsequent cycle was based on the adequacy of iron stores as per Dialysis Outcome Quality Initiative (K/DOQI) Guidelines. With each dosing regimen, adverse events, if any, were recorded and described.
Six hundred and sixty-five hemodialysis patients, including 80 who had experienced previous intolerance to other parenteral iron preparations, received a total of 8583 doses of iron sucrose. One hundred eighty-eight patients received more than one iv iron cycle (replacement, maintenance, or both). There were no serious or life-threatening drug-related adverse events.
Iron sucrose is safe when given as treatment for iron deficiency or for maintenance of iron stores.
血液透析患者经常需要胃肠外补充和维持铁剂。然而，据报道，某些静脉铁剂单次给药后会出现严重不良事件。这项多中心IV期临床试验研究了蔗糖铁治疗血液透析患者缺铁及维持铁充足状态的安全性。
在这项安全性研究中，蔗糖铁采用两种给药方案。缺铁患者在连续10次血液透析过程中静脉输注100 mg蔗糖铁（补充方案）。铁充足的患者每周静脉输注100 mg蔗糖铁5分钟，共10周（维持方案）。在每个10剂周期结束时，重新评估铁状态，并根据透析结果质量倡议（K/DOQI）指南，依据铁储备是否充足确定后续周期的给药剂量。每种给药方案下，记录并描述所有不良事件。
665例血液透析患者，包括80例曾对其他胃肠外铁剂不耐受的患者，共接受了8583剂蔗糖铁。188例患者接受了不止一个静脉铁剂周期（补充、维持或两者皆有）。未发生严重或危及生命的药物相关不良事件。
蔗糖铁用于治疗缺铁或维持铁储备时是安全的。
