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Iron Replacement in Blood Donors

献血者的铁替代

基本信息

批准号：
7733573
负责人：
SUSAN F LEITMAN-KLINMAN
金额：
$ 6.3万
依托单位：
CLINICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/7733573
关键词：
Acute Be++ element Beryllium Blood Blood Component Removal Blood Donations Blood Platelets Blood donor Charge Control Groups Cost-Benefit Analysis Daily Diabetes Mellitus Dose Drug Formulations Eating Enrollment Exhibits Fatigue Female Ferritin Ferrous Gluconate Ferrous Sulfate Future Genetic Goals Hemochromatosis Hemoglobin Hemoglobin concentration result Hemorrhage Hemorrhagic Thrombocythemia Ice Incidence Individual Intervention Investigation Iron Iron deficiency anemia Laboratories Long-Term Effects Medicine Methods Monitor Nutritional Oral Outcome Personal Satisfaction Pharmaceutical Preparations Pharmacy facility Pica Disease Population Population Study Premenopause Prevalence Protocols documentation Rate Recurrence Replacement Therapy Resolution Restless Legs Syndrome Safety Screening procedure Starch Stomach Structure of posterior inferior cerebellar artery Symptoms Tablets Thalassemia Thyrotoxicosis Time Transferrin Transfusion Treatment Protocols United States Food and Drug Administration United States National Institutes of Health Uterine hemorrhage Vascular blood supply Visit Whole Blood Woman craving day gastrointestinal gluconate gratitude male men prevent programs prospective satisfaction trait

项目摘要

In the first 30 months of the study, 891 donors who were deferred from blood donation due to a screening fingerstick hemoglobin of less than 12.5 g/dL ("low hemoglobin" donors) and 406 concurrent "control" donors whose screening fingerstick hemoglobin exceeded 12.5 g/dL were enrolled. The low hemoglobin group contained a greater proportion of female (86 vs 36%) and first time (31 vs 12%) donors compared to the control group. The prevalence of iron deficiency in male donors, defined as a ferritin between 19-29 mcg/L, was 10% in the "low hemoglobin" and 18% in the control men. The prevalence of iron depletion (ferritin less than 19) was 53% in the low hemoglobin and 22% in the control males. In contrast, iron deficiency in female donors (ferritin 9-19 mcg/L) was seen in 31% of both the low hemoglobin and the control groups, whereas iron depletion (ferritin less than 9) was found in 22% and 10% of the low hemoglobin and control women, respectively. Overall, in the low hemoglobin group, 63% of males and 54% of females were either iron depleted or deficient, and in the control group, 40% of both the males and females were iron depleted or deficient. Iron deficiency commonly causes symptoms of fatigue and difficulty concentrating, both of which are difficult to differentiate from high background rates of these complaints. However, several unique symptoms can accompany iron deficiency, including pica, an addictive-like craving to eat non-nutritional substances such as ice, starch, or dirt, and restless legs syndrome. A high incidence of both pica and restless legs syndrome was found in our study, with 8% of all iron deficient or depleted donors exhibiting pagophagia and 12% having restless legs. In contrast, pica was seen in only 3% and restless legs in 9% of the control group. Donors tolerated the once daily dose of ferrous sulfate very well, with 18% having symptoms of mild gastrointestinal upset which resolved upon changing the oral tablet to ferrous gluconate. Only 3% of donors were unable to tolerate any oral formulation of iron due to severe acute gastric discomfort. Sixty days of oral once-daily ferrous sulfate or gluconate resulted in signficant increases in mean hemoglobin, MCV, ferritin, and transferrin saturation, and decreases in mean RDW, despite continued blood donation at a mean of 94 days between successive donations. Verbal screening and laboratory monitoring detected three cases of gastrointestinal blood loss, two cases of B12 deficiency, six cases of uterine bleeding, one case of essential thrombocythemia, seven cases of diabetes, one case of thyrotoxicosis, and 26 cases of thalassemia trait. No GI malignances were found, and no subjects had genetic hemochromatosis. Donors expressed gratitude and satisfaction at the improvement in symptoms and laboratory values produced by oral iron replacement. The effect of iron replacement on the incidence of donor deferral for low fingerstick hemoglobin levels remains under investigation. Iron replacement therapy is a cheap, safe, and effective method of preventing iron deficiency in blood donors, and has added advantages of decreasing donor deferrals and enhancing donor well-being, thereby increasing overall donor satisafaction and retention. A cost-benefit analysis and analysis of the effect of iron intervention on successful donation outcomes as a percentage of donor visits will be performed when the study is completed.

在研究的前30个月，891名由于筛查手指血红蛋白低于12.5 g/dL而推迟献血的献血者（“低血红蛋白”献血者）和406名同时筛查手指血红蛋白超过12.5 g/dL的“对照”献血者被纳入研究。与对照组相比，低血红蛋白组的女性献血者（86比36%）和首次献血者（31比12%）的比例更高。在男性供体中，铁蛋白在19-29微克/升之间的缺铁率在“低血红蛋白”组中为10%，在对照组中为18%。低血红蛋白组中铁缺乏（铁蛋白小于19）的发生率为53%，对照组中为22%。相比之下，31%的低血红蛋白组和对照组女性供体缺铁（铁蛋白9-19微克/升），而22%和10%的低血红蛋白组和对照组女性供体缺铁（铁蛋白低于9微克/升）。总体而言，在低血红蛋白组中，63%的男性和54%的女性缺铁或缺铁，而在对照组中，40%的男性和女性缺铁或缺铁。缺铁通常会引起疲劳和注意力难以集中的症状，这两种症状很难与这些疾病的高背景发生率区分开来。然而，缺铁会伴随一些独特的症状，包括异食癖，一种像上瘾一样渴望吃非营养物质，如冰、淀粉或污垢，以及不宁腿综合征。在我们的研究中发现异食癖和不宁腿综合征的发病率很高，8%的缺铁或缺铁供者表现出食癖，12%的供者患有不宁腿。相比之下，异食癖只有3%，不宁腿在对照组中有9%。供体对每日一次硫酸亚铁的耐受性很好，18%的供体出现轻度胃肠道不适症状，将口服药片改为葡萄糖酸亚铁后症状消失。由于严重的急性胃部不适，只有3%的供体不能耐受任何口服铁制剂。每天口服一次硫酸亚铁或葡萄糖酸盐60天导致平均血红蛋白、MCV、铁蛋白和转铁蛋白饱和度显著增加，平均RDW降低，尽管连续献血的平均间隔为94天。口头筛查及实验室监测发现胃肠出血3例，B12缺乏症2例，子宫出血6例，原发性血小板增多症1例，糖尿病7例，甲状腺毒症1例，地中海贫血特征性26例。未发现胃肠道恶性肿瘤，未发现遗传性血色素沉着症。捐助者对口服补铁后症状和化验值的改善表示感谢和满意。铁替代对低血红蛋白水平供体延迟发生率的影响仍在调查中。