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静脉注射蔗糖铁用于治疗月经过多患者术前贫血的安全性和有效性:一项IV期、开放标签、前瞻性、随机研究。

Safety and usefulness of intravenous iron sucrose in the management of preoperative anemia in patients with menorrhagia: a phase IV, open-label, prospective, randomized study.

作者信息

Kim Yun Hwan, Chung Hyun Hoon, Kang Soon-Beom, Kim Seung Cheol, Kim Young Tae

机构信息

Department of Obstetrics and Gynecology, College of Medicine, Seoul National University, Seoul, Korea.

出版信息

Acta Haematol. 2009;121(1):37-41. doi: 10.1159/000210062. Epub 2009 Mar 31.

Abstract

BACKGROUND

The aim of this study was to compare the efficacy, safety and achievement of the target hemoglobin level (Hb >or=10 g/dl) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management.

METHODS

Seventy-six patients with Hb levels <9.0 g/dl who were scheduled to undergo surgical treatment were randomized to receive either intravenous iron sucrose (based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week, beginning 3 weeks before surgery) or oral iron (80 mg/day of oral iron protein succinylate daily).

RESULTS

The intravenous iron group had higher increases in Hb (3.0 vs. 0.8 g/dl; p < 0.0001) and ferritin levels (170.1 vs. 4.1 microg/l; p < 0.0001) than the oral iron group. Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group (76.7 vs. 11.5%; p < 0.0001). There were tolerable adverse events in both groups.

CONCLUSION

Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia.

摘要

背景

本研究旨在比较静脉注射蔗糖铁与口服琥珀酸亚铁蛋白治疗因月经过多导致术前贫血患者的疗效、安全性及目标血红蛋白水平(Hb≥10 g/dl)的达成情况。

方法

76例计划接受手术治疗且Hb水平<9.0 g/dl的患者被随机分为两组,分别接受静脉注射蔗糖铁(根据计算出的总铁缺乏量,分2安瓿静脉注射,每周3次,术前3周开始)或口服铁剂(每日口服80 mg琥珀酸亚铁蛋白)。

结果

静脉注射铁剂组的Hb升高幅度(3.0 vs. 0.8 g/dl;p<0.0001)和铁蛋白水平升高幅度(170.1 vs. 4.1 μg/l;p<0.0001)均高于口服铁剂组。静脉注射铁剂组达到目标Hb的比例也高于口服铁剂组(76.7% vs. 11.5%;p<0.0001)。两组均有可耐受的不良事件。

结论

术前静脉注射蔗糖铁在纠正因月经过多导致的术前贫血方面比口服铁剂更有效,且与口服铁剂治疗一样安全。

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