Iron Replacement in Blood Donors
献血者的铁替代
基本信息
- 批准号:7593051
- 负责人:
- 金额:$ 1.36万
- 依托单位:
- 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:
- 关键词:AcuteBe++ elementBerylliumBloodBlood Component RemovalBlood DonationsBlood PlateletsBlood donorChargeControl GroupsCost-Benefit AnalysisCountDailyData ReportingDiabetes MellitusDietDoseDrug FormulationsEatingEnrollmentEquilibriumExhibitsFatigueFemaleFerritinFerrous GluconateFerrous SulfateFutureGeneticGoalsHemochromatosisHemoglobinHemoglobin concentration resultHemorrhageHemorrhagic ThrombocythemiaIceIncidenceIndividualInterventionInvestigationIronIron deficiency anemiaLaboratoriesLong-Term EffectsLongitudinal StudiesMedicineMethodsMonitorNutritionalOralOutcomePersonal SatisfactionPharmaceutical PreparationsPharmacy facilityPica DiseasePopulationPopulation StudyPremenopausePrevalenceProtocols documentationRateRecurrenceReplacement TherapyReportingResolutionRestless Legs SyndromeSafetyScreening procedureStarchStomachStructure of posterior inferior cerebellar arterySymptomsTabletsThalassemiaThyrotoxicosisTimeTransferrinTransfusionTreatment ProtocolsUnited States Food and Drug AdministrationUnited States National Institutes of HealthUterine hemorrhageVascular blood supplyVisitWhole BloodWomanabsorptioncravingdaygastrointestinalgluconategratitudemalemenpreventprogramsprospectivesatisfactiontrait
项目摘要
In the first 16 months of the study, 473 donors who were deferred from blood donation due to a screening fingerstick hemoglobin of less than 12.5 g/dL ("low hemoglobin" donors) and 395 concurrent "control" donors whose screening fingerstick hemoglobin equalled or exceeded 12.5 g/dL were enrolled. The low hemoglobin group contained a greater proportion of female (84 vs 35%) and first time (26 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 9% in the "low hemoglobin" and 18% in the control men. The prevalence of iron depletion (ferritin less than 19) was 58% 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 25% and 10% of the low hemoglobin and control women, respectively. Overall, in the low hemoglobin group, 67% of males and 56% of females were either iron depleted or deficient, and in the control group, 40% of males and 41% of females were either 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, chaulk, and dirt, and restless legs syndrome. A high incidence of both pica and restless legs syndrome was found in our study, with 9% of all iron deficient or depleted donors exhibiting pagophagia and 14% having restless legs. In contrast, pica was seen in only 2% and restless legs in only 6% of the control group. Donors tolerated the once daily dose of ferrous sulfate very well, with only 12% having symptoms of mild gastrointestinal upset which resolved upon changing the oral tablet to ferrous gluconate. Only 4% 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 two cases of gastrointestinal blood loss, 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, and were generally pleased to know that the effect of donation on their blood counts was being closely monitored. 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16个月,入组了473名因筛选时手指针刺血红蛋白低于12.5 g/dL而推迟献血的献血者(“低血红蛋白”献血者)和395名筛选时手指针刺血红蛋白等于或超过12.5 g/dL的同期“对照”献血者。与对照组相比,低血红蛋白组包含更大比例的女性(84 vs 35%)和首次(26 vs 12%)供体。在男性捐献者中,铁缺乏的患病率(定义为铁蛋白在19-29 mcg/L之间)在“低血红蛋白”组为9%,在对照组为18%。低血红蛋白组中铁缺乏(铁蛋白低于19)的患病率为58%,对照组男性为22%。 相比之下,在低血红蛋白组和对照组中,31%的女性供体出现铁缺乏(铁蛋白9-19 mcg/L),而在低血红蛋白组和对照组中,分别有25%和10%的女性出现铁耗竭(铁蛋白低于9)。 总体而言,在低血红蛋白组中,67%的男性和56%的女性铁缺乏或缺乏,而在对照组中,40%的男性和41%的女性铁缺乏或缺乏。 缺铁通常会导致疲劳和难以集中注意力的症状,这两者都很难与这些投诉的高背景率区分开来。然而,几种独特的症状可能伴随着缺铁,包括异食癖,一种上瘾的渴望吃非营养物质,如冰,淀粉,chaulk和污垢,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,9%的缺铁或铁耗尽的献血者表现出贪食癖,14%的人有不宁腿。 相比之下,对照组中只有2%的人出现异食癖,6%的人出现不宁腿。供体对每日一次剂量的硫酸亚铁耐受性非常好,只有12%的患者出现轻度胃肠道不适症状,在将口服片剂改为葡萄糖酸亚铁后症状消失。 只有4%的献血者由于严重的急性胃不适而不能耐受任何口服铁制剂。 口服硫酸亚铁或葡萄糖酸亚铁60天,每日一次,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,尽管连续献血之间平均间隔94天。 口头筛查和实验室监测发现2例胃肠道失血,6例子宫出血,1例原发性血小板增多症,7例糖尿病,1例甲状腺毒症,26例地中海贫血。 未发现GI恶性肿瘤,无受试者患有遗传性血色病。 献血者对口服铁替代物改善症状和实验室检查值表示感谢和满意,并普遍高兴地得知,献血对其血细胞计数的影响正在受到密切监测。铁替代对因手指针刺血红蛋白水平低而推迟供者发生率的影响仍在研究中。
铁替代疗法是一种廉价、安全和有效的预防献血者缺铁的方法,并且具有减少供体缺铁和增强供体健康的附加优势,从而增加总体供体满意度和保留。 研究完成后,将进行成本效益分析和铁干预对成功献血结果的影响分析(以献血者访视百分比表示)。
项目成果
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SUSAN F LEITMAN-KLINMAN其他文献
SUSAN F LEITMAN-KLINMAN的其他文献
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