Paesano Rosalba, Pacifici Enrica, Benedetti Samanta, Berlutti Francesca, Frioni Alessandra, Polimeni Antonella, Valenti Piera
Department of Women's Health and Territorial Medicine, Sapienza University of Rome, Rome, Italy.
Biometals. 2014 Oct;27(5):999-1006. doi: 10.1007/s10534-014-9723-x. Epub 2014 Mar 4.
Objective Evaluate the safety and efficacy of bovine lactoferrin (bLf) versus the ferrous sulphate standard intervention in curing iron deficiency (ID) and ID anaemia (IDA) in pregnant women affected by hereditary thrombophilia (HT). Design Interventional study. Setting Secondary-level hospital for complicated pregnancies in Rome, Italy. Population 295 HT pregnant women (≥18 years) suffering from ID/IDA. Methods Women were enrolled in Arm A or B in accordance with their personal choice. In Arm A, 156 women received oral administration of 100 mg of bLf twice a day; in Arm B, 139 women received 520 mg of ferrous sulphate once a day. Therapies lasted until delivery. Main outcome measures Red blood cells, haemoglobin, total serum iron, serum ferritin (haematological parameters) were assayed before and every 30 days during therapy until delivery. Serum IL-6, key factor in inflammatory and iron homeostasis disorders, was detected at enrolment and after therapy at delivery. Possible maternal, foetal, and neonatal adverse effects were assessed. Results Haematological parameters were significantly higher in Arm A than in Arm B pregnant women (P ≤ 0.0001). Serum IL-6 significantly decreased in bLf-treated women and increased in ferrous sulphate-treated women. BLf did not exert any adverse effect. Adverse effects in 16.5 % of ferrous sulphate-treated women were recorded. Arm A women experienced no miscarriage compared to five miscarriages in Arm B women. Conclusions Differently from ferrous sulphate, bLf is safe and effective in curing ID/IDA associated with a consistent decrease of serum IL-6. The absence of miscarriage among bLf-treated women provided an unexpected benefit.
ClinicalTrials.gov Identifier NCT01221844.
目的 评估牛乳铁蛋白（bLf）与硫酸亚铁标准干预措施相比，在治疗遗传性血栓形成倾向（HT）孕妇的缺铁（ID）和缺铁性贫血（IDA）方面的安全性和有效性。设计 干预性研究。地点 意大利罗马的一家治疗复杂妊娠的二级医院。研究对象 295名患有ID/IDA的HT孕妇（≥18岁）。方法 妇女根据个人选择被纳入A组或B组。在A组，156名妇女每天口服100毫克bLf两次；在B组，139名妇女每天口服520毫克硫酸亚铁。治疗持续至分娩。主要观察指标 在治疗前及治疗期间每30天直至分娩时，检测红细胞、血红蛋白、血清总铁、血清铁蛋白（血液学参数）。在入组时及分娩治疗后，检测血清IL-6，其是炎症和铁稳态紊乱的关键因素。评估可能的母体、胎儿和新生儿不良反应。结果 A组孕妇的血液学参数显著高于B组孕妇（P≤0.0001）。bLf治疗的妇女血清IL-6显著降低，硫酸亚铁治疗的妇女血清IL-6升高。bLf未产生任何不良反应。记录到16.5%的硫酸亚铁治疗妇女出现不良反应。A组妇女未发生流产，而B组妇女有5例流产。结论 与硫酸亚铁不同，bLf在治疗与血清IL-6持续降低相关的ID/IDA方面安全有效。bLf治疗的妇女未发生流产带来了意外的益处。
ClinicalTrials.gov标识符NCT01221844。
