FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease
FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease
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DOI：
10.1053/j.gastro.2011.06.005
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发表时间：
2011-09-01
期刊：
影响因子：
29.4
通讯作者：
Gasche, Christoph
中科院分区：
文献类型：
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作者：
Evstatiev, Rayko;Marteau, Philippe;Gasche, Christoph
背景与目的：缺铁性贫血(IDA)是一种常见的慢性病，静脉补铁是一种有效的治疗方法。然而，剂量计算和不便的给药可能会影响依从性和疗效。我们比较了一种新的固定剂量的Carboxymaltose方案(FCM)和单独计算的蔗糖铁(IS)剂量在炎症性肠病(IBD)和IDA患者中的有效性和安全性。方法：这项随机、对照、开放的多中心研究包括来自14个国家的88家医院和诊所的485名缺铁性贫血(铁蛋白和铁蛋白；100mU/L，血红蛋白7-12g/dL[女性]或7-13g/dL[男性])以及轻、中度或静止期IBD患者。患者接受FCM，最多3次输注1000或500毫克铁，或者接受Ganzoni计算的剂量，最多11次输注200毫克铁。主要终点是Hb反应(Hb增加=2g/dL)；次要终点是12周时贫血消退和铁状态正常化。结果：240例接受FCM治疗的患者和235例接受IS治疗的患者的结果进行了分析。FCM患者达到Hb应答(150例[65.8%]vs 118例[53.6%]；差异12.2%，P=.004)或Hb正常者(166例[72.8%]vs 136[61.8%]；差异11.0%，P=.015)。两种治疗方法都在12周时提高了生活质量评分。研究中的药物耐受性良好，与药物相关的不良事件符合药物特有的临床经验。在IS组中，偏离计划的总铁量的频率更高。结论：与Ganzoni计算的剂量方案相比，基于FCM的更简单的剂量方案显示出更好的疗效和依从性，以及良好的安全性。
BACKGROUND & AIMS: Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA. METHODS: This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin < 100 mu g/L, hemoglobin [Hb] 7-12 g/dL [female] or 7-13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni- calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase >= 2 g/dL); secondary end points included anemia resolution and iron status normalization by week 12. RESULTS: The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P = .004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0% difference, P = .015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group. CONCLUSIONS: The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen.