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临床试验/NCT03317210
NCT03317210已完成4 期

Treatment of Anemia of Chronic Disease With True Iron Deficiency in Pregnancy

University of Zurich0 个研究点目标入组 50 人开始时间: 2002年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
主要终点
Efficacy of Treatment: hemoglobin increase after therapy

研究概览

简要总结

The investigators assess and compare the efficacy of anemia treatment in pregnant women with anemia of chronic disease with true iron deficiency and in women with iron deficiency anemia.

详细描述

Fifty anemic pregnant women with moderate anemia were prospectively observed and treated in the Anemia clinic at the Department of Obstetrics, University Hospital Zurich. All patients had singleton pregnancies. All pregnant women fulfilled criteria of moderate iron deficiency anemia defined as hemoglobin (Hb) between 8.0 and 9.9 g/dl and serum ferritin <15 μg/l. In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted. According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly. Patients with an Hb level between 9.0 and 9.9 g/dl (33 patients) received 200 mg iron sucrose (VENOFER®, Vifor Int., St. Gallen, Switzerland) intravenously twice weekly (group A). If response to therapy was poor (i.e. Hb increase <0.7 g/dl) after 2 weeks (13 patients), patients additionally received rhEPO (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland) (group B). This cut-off for adequate primary response the investigators choose on the basis of previous experience. Patients with an Hb between 8.0 and 8.9 g/dl (17 patients) received iron sucrose (Venofer) and rhEPO (Eprex) twice weekly from the start of therapy (group C).

Sufficient overall response to therapy (the difference of baseline hemoglobin and after therapy) was defined as Hb increase >1.0 g/dl. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb > 10.5 g/dL was achieved.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • pregnant women with hemoglobin between 8.0 and 9.9 g/dl and serum ferritin <15 μg/l

排除标准

  • vitamin B12 deficiency anemia
  • folic acid deficiency anemia
  • hemoglobinopathy
  • multiples
  • liver disease
  • kidney disease

研究组 & 干预措施

iron therapy with good response

Other

Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. The maximum total iron dose was 1,600 mg, therefore therapy was stopped if the maximal iron sucrose dose was administered, or target Hb > 10.5 g/dL was achieved.

干预措施: iron sucrose (200 mg VENOFER®) (Drug)

iron therapy with poor response

Other

Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy with iron sucrose was poor (i.e. Hb increase <0.7 g/dl after 2 weeks), patients additionally received recombinant human erythropoietin (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland).

干预措施: iron sucrose (200 mg VENOFER®) (Drug)

iron therapy with poor response

Other

Patients with an Hb level between 9.0 and 9.9 g/dl received 200 mg iron sucrose intravenously twice weekly. If response to therapy with iron sucrose was poor (i.e. Hb increase <0.7 g/dl after 2 weeks), patients additionally received recombinant human erythropoietin (10,000 U EPREX®, Janssen-Cilag, Baar, Switzerland).

干预措施: recombinant human erythropoietin (10,000 U EPREX®) (Drug)

iron therapy and erythropoietin

Other

Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.

干预措施: iron sucrose (200 mg VENOFER®) (Drug)

iron therapy and erythropoietin

Other

Patients with an Hb between 8.0 and 8.9 g/dl received 200mg iron sucrose and recombinant human erythropoietin intravenously twice weekly.

干预措施: recombinant human erythropoietin (10,000 U EPREX®) (Drug)

结局指标

主要结局

Efficacy of Treatment: hemoglobin increase after therapy

时间窗: 4 weeks

In all women, the analyses of a blood count, iron status, erythropoietin, cross reactive protein (CRP), folic acid and vitamin B12 were conducted.The hematological parameters were checked twice a week in the anemia clinic and iron status once a week.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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