Iron supplements

铁补充剂
  • 文章类型: Journal Article
    引言妊娠引起各种生理变化,经常导致并发症。妊娠期生理性贫血,由于血浆体积和促红细胞生成素水平增加,构成重大健康风险。与妊娠期贫血相关的不良结局包括孕产妇和围产期死亡率,早产,低出生体重。药物利用研究旨在促进合理用药,以改善健康结果。美国食品和药物管理局(FDA)根据致畸风险对药物进行分类,为临床医生提供指导。这项研究旨在分析阿南德地区孕妇贫血的处方趋势和FDA风险类别。材料和方法该研究获得了机构伦理批准,并涉及从2021年12月至2023年3月在产前诊所就诊的816名孕妇。参与者提供知情同意书,数据收集包括每三个月的血红蛋白(Hb)水平,将参与者分为贫血组(Hb<11gm/dL)和非贫血组。记录了处方药物,并使用世卫组织基本药物清单(WHO-EML)和国家基本药物清单-2022(NLEM-2022)对其必要性进行了评估。FDA药物风险类别用于评估药物安全性。进行描述性和统计分析。结果妊娠期贫血患病率为62.50%~65.93%,总体平均值为64.42%。铁和叶酸的补充在三个月内是显著的,处方率不同。钙补充显示波动,在妊娠后期有100%的处方率。在整个怀孕期间,贫血孕妇服用抗坏血酸明显。多种维生素是一致的处方,强调其重要性。WHO-EML和NLEM-2022强调了必需的微量营养素,而FDA类别表明药物安全性。结论整个孕期贫血患病率居高不下,强调需要一致的补充。处方模式与循证指南一致,专注于铁和叶酸的补充。钙处方的变化表明了特定于三个月的考虑因素。处方趋势反映了在怀孕期间管理贫血的负责任的方法,强调预防性铁和叶酸治疗。缺乏高风险药物强调了谨慎的处方做法。这项研究为循证药物治疗和孕产妇保健提供了有价值的见解。
    Introduction Pregnancy induces various physiological changes, often leading to complications. Physiological anemia of pregnancy, resulting from increased plasma volume and erythropoietin levels, poses significant health risks. Adverse outcomes associated with anemia during pregnancy include maternal and perinatal mortality, premature delivery, and low birth weight. Drug utilization research aims to promote rational drug use for improving health outcomes. The Food and Drug Administration (FDA) categorizes drugs based on teratogenic risk, providing guidance for clinicians. This study aims to analyze prescription trends and FDA risk categories for anemia in pregnant women in the Anand district. Materials and methods The study received institutional ethics approval and involved 816 pregnant women attending antenatal clinics from December 2021 to March 2023. Participants provided informed consent, and data collection included hemoglobin (Hb) levels at each trimester, categorizing participants into anemic (Hb < 11 gm/dL) and non-anemic groups. Prescribed drugs were recorded, and their essentiality was assessed using the WHO Essential Medicines List (WHO-EML) and the National List of Essential Medicines-2022 (NLEM-2022). FDA drug risk categories were utilized for assessing drug safety. Descriptive and statistical analyses were performed. Results Anemia prevalence across trimesters ranged from 62.50% to 65.93%, with an overall average of 64.42%. Iron and folic acid supplementation were significant across trimesters, with varying rates of prescription. Calcium supplementation showed fluctuations, with 100% prescription rates in later trimesters. Ascorbic acid was significantly prescribed in anemic pregnant women throughout pregnancy. Multivitamins were consistently prescribed, emphasizing their importance. The WHO-EML and NLEM-2022 highlighted essential micronutrients, while FDA categories indicated drug safety. Conclusion Anemia prevalence remained high throughout pregnancy, emphasizing the need for consistent supplementation. Prescription patterns aligned with evidence-based guidelines, focusing on iron and folic acid supplementation. Variations in calcium prescription suggest trimester-specific considerations. Prescription trends reflect a responsible approach to managing anemia during pregnancy, emphasizing prophylactic iron and folic acid therapy. The absence of high-risk medications underscores cautious prescribing practices. This study contributes valuable insights into evidence-based pharmacotherapy and maternal health care.
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  • 文章类型: Clinical Trial Protocol
    背景:世界卫生组织建议在超过40%的人口出现贫血的国家,对6-23个月的儿童普遍补充铁。常规的亚铁盐由于患有炎症的儿童的低口服吸收而具有低功效。血红素铁更具有生物可利用性,它的吸收可能不会因炎症而减少。这项研究旨在比较补充12周后每天补充血红素铁和硫酸亚铁对血红蛋白浓度和血清铁蛋白浓度的影响。
    方法:这将是双臂,随机对照试验。6-12个月的冈比亚贫血儿童将在预定的地理区域内招募,并由训练有素的现场工作人员招募。符合条件的参与者将使用1:1的比例在置换块内进行每日补充,为期12周,使用10.0mg元素铁作为血红素或硫酸亚铁。临床团队将每天评估安全性结果,例如腹泻和感染相关的不良事件(参见Bah等人。附加文件4_不良事件eCRF)。线性回归将用于分析连续结果,使用对数变换来根据需要对残差进行归一化。二元结果将通过二项回归或逻辑回归进行分析,初步分析将通过修改后的意向治疗(即,那些被随机分组并摄入至少一个补充剂量的铁),使用多个估算来替换丢失的数据。将根据基线协变量调整效应估计值(C反应蛋白,α-1-酸糖蛋白,血红蛋白,铁蛋白,可溶性转铁蛋白受体)。
    结论:本研究将确定在6-12个月的贫血儿童中,治疗性补充血红素铁是否比常规硫酸亚铁更有效地提高血红蛋白和铁蛋白浓度。
    背景:泛非临床试验注册PACTR202210523178727。
    BACKGROUND: The World Health Organization recommends universal iron supplementation for children aged 6-23 months in countries where anaemia is seen in over 40% of the population. Conventional ferrous salts have low efficacy due to low oral absorption in children with inflammation. Haem iron is more bioavailable, and its absorption may not be decreased by inflammation. This study aims to compare daily supplementation with haem iron versus ferrous sulphate on haemoglobin concentration and serum ferritin concentration after 12 weeks of supplementation.
    METHODS: This will be a two-arm, randomised controlled trial. Gambian children aged 6-12 months with anaemia will be recruited within a predefined geographical area and recruited by trained field workers. Eligible participants will be individually randomised using a 1:1 ratio within permuted blocks to daily supplementation for 12 weeks with either 10.0 mg of elemental iron as haem or ferrous sulphate. Safety outcomes such as diarrhoea and infection-related adverse events will be assessed daily by the clinical team (see Bah et al. Additional file 4_Adverse event eCRF). Linear regression will be used to analyse continuous outcomes, with log transformation to normalise residuals as needed. Binary outcomes will be analysed by binomial regression or logistic regression, Primary analysis will be by modified intention-to-treat (i.e., those randomised and who ingested at least one supplement dose of iron), with multiple imputations to replace missing data. Effect estimates will be adjusted for baseline covariates (C-reactive protein, alpha-1-acid glycoprotein, haemoglobin, ferritin, soluble transferrin receptor).
    CONCLUSIONS: This study will determine if therapeutic supplementation with haem iron is more efficacious than with conventional ferrous sulphate in enhancing haemoglobin and ferritin concentrations in anaemic children aged 6-12 months.
    BACKGROUND: Pan African Clinical Trial Registry PACTR202210523178727.
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  • 文章类型: Journal Article
    缺铁性贫血(IDA)和糖尿病(DM)是最常见的疾病,糖尿病患者更容易患IDA。因此,这项研究的主要目的是调查糖尿病患者与IDA之间的关系,即每天和每隔一天服用铁丸以减少与之相关的影响。91名参与者被招募并随机分为两组,与72例患者的最终分析队列。主要关注血清Hb和铁蛋白水平的变化。筛查阶段持续了24周,导致72名符合条件的参与者符合进入研究的标准。此外,该研究检测了缺铁患者治疗后Hb和HbA1C水平的变化.各组间Hb和铁蛋白水平差异无统计学意义(分别为P=0.096和P=0.500)。治疗前后HbA1C与Hb水平呈正相关(r2=0.187)。本研究的结果表明,尽管使用口服铁补充剂的有效性在增加血红蛋白和铁蛋白方面没有显着差异,每隔一天使用一次口服铁,比每天使用口服铁更有效,在这项研究中,像其他研究一样,此结果得出结论,HbA1C与Hb呈负相关,并检查糖尿病患者的HbA1C状况,首先应考虑Hb水平。
    Iron deficiency anaemia (IDA) and diabetes mellitus (DM) are most prevalent disease, that diabetic patients are more prone to IDA. Therefore, the main aim of this study was to investigate the relationship between patients with diabetes and IDA in relation to taking iron pills daily and every other day to reduce the effects related to it. Ninety-one participants were enroled and randomly divided into two groups, with a final analysis cohort of 72 patients. The primary focus was on changes in serum Hb and Ferritin levels. The screening phase lasted 24 weeks, leading to 72 eligible participants meeting the criteria for entry into the study. Additionally, the study examined alternations in Hb and Hb A1C levels after treating patients with iron deficiency. The Hb and ferritin level contrasts between groups were not significant (P = 0.096 and P = 0.500, respectively). The relationship between Hb A1C and Hb levels before and after treatment was positive and significant (r 2 = 0.187). The results of the present study show that although the effectiveness of using oral iron supplements did not have a significant difference in terms of increasing haemoglobin and ferritin, the use of oral iron once every other day was more effective than the use of oral iron every day, and also in this study Like other studies, this result concluded that there is a negative correlation between Hb A1C and Hb, and to check the status of Hb A1C in diabetics, the level of Hb should be considered first.
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  • 文章类型: Journal Article
    The objective of this study was to investigate the potential associations between serum iron levels, dietary iron intake, and iron supplementation, and the prevalence of metabolic syndrome (MetS) in adolescents A cross-sectional analysis was conducted, utilizing data from adolescents participating in the 2003-2018 cycle of the National Health and Nutrition Examination Survey (NHANES). Odds ratios (ORs) and their corresponding 95% confidence intervals (CIs) pertaining to serum iron, dietary iron, and iron supplementation were derived through multivariate logistic regression models. Additionally, a restricted cubic spline (RCS) regression model was applied to explore the nonlinear relationship between dietary iron and serum iron concerning MetS. The study encompassed 4858 American adolescents aged 12 to 19, among whom 413 (8.5%) manifested MetS. The study cohort exhibited an average age of 15.52 years, comprising 2551 males (52.51%) and 2307 females (47.49%). Relative to individuals in the lowest serum iron quartile, those in the highest quartile for serum iron (OR = 0.33, 95% CI 0.21-0.50), the highest quartile for dietary iron (OR = 0.53, 95% CI 0.32-0.89), and those utilizing iron supplements (OR = 0.61, 95% CI 0.37-0.99) evinced a diminished prevalence of MetS, even post adjustment for potential confounding variables. A non-linear relationship was discerned between serum iron and MetS, exhibiting a statistically significant negative correlation when serum iron concentrations exceeded the inflection point (serum iron = 8.66 µmol/L, P for nonlinear < 0.001). This investigation reveals that higher levels of serum iron, increased dietary iron intake, and the use of iron supplements are linked to a lower prevalence of MetS in US adolescents. These findings suggest that dietary modifications could play a role in promoting the health of adolescents.
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  • 文章类型: Journal Article
    为贫血儿童开具的铁补充剂可能会导致牙齿染色。在接触铁补充剂后,预防乳牙染色的可能方法需要一个小时。
    进行该研究的目的是评估牙釉质表面涂层对乳牙中含铁补充剂的染色能力的影响。
    这是一项体外实验研究。
    将完整牙冠的一百四十四个初级门牙依次编号,并随机分为四个主要组,每组36个样品,接受不同的釉质表面涂层,例如没有表面涂层,MI氟化物清漆™,GCG-coatPlus™和GC-Equia®-forte-coat。每组又分为两组,即A(健全的牙齿)和B(人工脱矿的牙齿)。将所有样品浸入含有10ml铁补充剂的250ml人工唾液中,使铁浓度为100mg。在基线和90天测量牙齿的阴影,使用VITAEasyshade®V数字分光光度计。使用Kruskal-Wallis检验和Mann-WhitneyU检验对数据进行统计分析。通过SPSS23进行描述性和推断性统计分析。
    当使用GC-Equia®-forte-coat作为具有0.017的pvalue的搪瓷表面涂层时,发现在第90天结束时,声音样品中的总体颜色变化显著较小。在脱矿质样品中,当MIVarnish™用作釉质表面涂层时,总颜色变化在第90天结束时最小,P=0.042。
    GC-Equia®-forte-coat,MIVarnish™和GC-G-coat-plus™可用作预防或预防措施,以最大程度地减少牙齿的污染。90天结束时GC-Equia®-forte-coat的颜色变化量最少,然后是MIvarnish™,GCGcoatPlus™和对照组。
    UNASSIGNED: Iron supplements prescribed to anemic children may results in teeth staining. Possible methods for preventing staining of primary teeth following exposure to iron supplements are need of an hour.
    UNASSIGNED: This study was conducted with the aim to assess effect of enamel surface coating on staining capability of iron containing supplements in primary teeth.
    UNASSIGNED: This is an in vitro Experimental study.
    UNASSIGNED: Hundred and forty-four primary incisors with intact crowns were sequentially numbered and randomly divided into four main groups of 36 samples receiving different enamel surface coating such as no surface coating, MI fluoride varnish™, GC G-coat Plus™ and GC-Equia®-forte-coat. Each group was subdivided into two groups, namely A (sound teeth) and B (artificially demineralized teeth). All the samples were immersed in 250 ml artificial saliva containing 10 ml of iron supplement to make the iron concentration 100 mg. The shade of the teeth was measured at baseline and at 90 days, using VITA Easy shade® V digital spectrophotometer. The data was statistically analyzed using the Kruskal-Wallis test and Mann-Whitney U test. Descriptive and inferential statistical analyses was made via SPSS 23.
    UNASSIGNED: Overall color change was found to be significantly less at the end of 90th day in sound samples when GC-Equia®-forte-coat was used as an enamel surface coating with pvalue of 0.017. In demineralized samples the overall color change was least at the end of 90th day when MI Varnish™ used as an enamel surface coating with P = 0.042.
    UNASSIGNED: GC-Equia®-forte-coat, MI Varnish™ and GC-G-coat-plus™ can be used as a preventive or a precautionary measure to minimizes the staining of teeth. The amount of color change at the end of 90 days with GC-Equia®-forte-coat was least followed by MI varnish™, GC G coat Plus™ and control group.
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  • 文章类型: Randomized Controlled Trial
    背景:在低收入和中等收入国家,普遍提供铁补充剂或含铁多种微量营养素粉(MNPs)被广泛用于预防幼儿贫血。BRISC(儿童铁干预的益处和风险)试验比较了孟加拉国农村地区2岁以下儿童的铁补充剂和MNPs与安慰剂。
    目的:我们旨在评估孟加拉国农村地区幼儿使用铁补充剂或含铁MNPs的成本效益。
    方法:我们使用BRISC试验结果和资源使用数据对MNPs和铁补充剂进行了成本效益分析,和来自文献的程序数据。从卫生系统的角度评估了医疗保健成本。我们计算了增量成本效益比(ICER),以避免每残疾调整生命年(DALY)美元为单位。为了探索不确定性,我们使用一系列成本效益阈值上的自举数据构建了成本效益可接受性曲线.单向和双向灵敏度分析测试了不同关键参数值对我们结果的影响。
    结果:提供MNPs估计可避免0.0031(95%CI:0.0022,0.0041)DALYs/child,而铁补充剂避免了0.0039(95%CI:0.0030,0.0048)DALYs/儿童,与没有干预相比,超过1年。与无干预相比,MNPs的增量平均成本为0.75美元(95%CI:0.73,0.77),与无干预相比,铁补充剂的增量平均成本为0.64美元(0.62美元,0.67美元)。铁补充剂主导了MNPs,因为它更便宜,避免了更多的DALY。与没有干预相比,铁补充剂的ICER为每DALY1645美元(1333美元,2153美元)。并且在成本效益阈值为200美元(反映孟加拉国的健康机会成本)和每DALY避免985美元[人均国内生产总值(GDP)的一半]时,成为最佳策略的可能性为0%。情景和敏感性分析支持基本案例调查结果。
    结论:这些研究结果并不支持在孟加拉国农村地区普及铁补充剂或微量营养素粉作为一种经济有效的干预措施。该试验已在anzctr.org注册。AU作为ACTRN1261700066038和试验搜索。谁。int为U1111-1196-1125。
    Universal provision of iron supplements or iron-containing multiple micronutrient powders (MNPs) is widely used to prevent anemia in young children in low- and middle-income countries. The BRISC (Benefits and Risks of Iron Interventions in Children) trial compared iron supplements and MNPs with placebo in children <2 y old in rural Bangladesh.
    We aimed to assess the cost-effectiveness of iron supplements or iron-containing MNPs among young children in rural Bangladesh.
    We did a cost-effectiveness analysis of MNPs and iron supplements using the BRISC trial outcomes and resource use data, and programmatic data from the literature. Health care costs were assessed from a health system perspective. We calculated incremental cost-effectiveness ratios (ICERs) in terms of US$ per disability-adjusted life-year (DALY) averted. To explore uncertainty, we constructed cost-effectiveness acceptability curves using bootstrapped data over a range of cost-effectiveness thresholds. One- and 2-way sensitivity analyses tested the impact of varying key parameter values on our results.
    Provision of MNPs was estimated to avert 0.0031 (95% CI: 0.0022, 0.0041) DALYs/child, whereas iron supplements averted 0.0039 (95% CI: 0.0030, 0.0048) DALYs/child, over 1 y compared with no intervention. Incremental mean costs were $0.75 (95% CI: 0.73, 0.77) for MNPs compared with no intervention and $0.64 ($0.62, $0.67) for iron supplements compared with no intervention. Iron supplementation dominated MNPs because it was cheaper and averted more DALYs. Iron supplementation had an ICER of $1645 ($1333, $2153) per DALY averted compared with no intervention, and had a 0% probability of being the optimal strategy at cost-effectiveness thresholds of $200 (reflecting health opportunity costs in Bangladesh) and $985 [half of gross domestic product (GDP) per capita] per DALY averted. Scenario and sensitivity analyses supported the base case findings.
    These findings do not support universal iron supplementation or micronutrient powders as a cost-effective intervention for young children in rural Bangladesh. This trial was registered at anzctr.org.au as ACTRN1261700066038 and trialsearch.who.int as U1111-1196-1125.
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  • 文章类型: Journal Article
    背景:2019年住院冠状病毒病(COVID-19)患者中多种病原体共同感染的诊断可能是共同的挑战,对于适当的治疗至关重要,缩短住院时间并防止抗菌素耐药性。这项研究旨在调查COVID-19患者细菌和真菌共感染结果的负担。这是一项针对巴勒斯坦Beit-Jala医院住院COVID-19患者的单中心横断面研究。方法:该研究包括2020年6月至2021年3月期间入住ICU的321例住院患者,年龄≥20岁。通过在鼻咽拭子上进行的逆转录酶-聚合酶链反应试验证实了COVID-19的诊断。患者的信息是使用电子医疗报告中的分级数据表格收集的。结果:通过患者的临床表现和血或痰培养阳性,明确诊断为细菌和真菌感染。所有病例在重症监护病房(ICU)入院前都接受了经验性抗菌治疗,和ICU住院期间的不同治疗方案。细菌合并感染率为51.1%,主要来自革兰氏阴性分离株(肠杆菌和肺炎克雷伯菌)。烟曲霉真菌共感染率为48.9%,死亡率为8.1%。然而,目前尚不清楚它是归因于SARS-CoV-2还是巧合。结论:在巴勒斯坦ICU的COVID-19患者中,细菌和真菌共同感染很常见,但目前尚不清楚这些病例是否归因于SARS-CoV-2或巧合,因为几乎没有数据可以将其与大流行前当地ICU部门的继发感染率进行比较。全面来说,这些结论提供的数据支持对COVID-19感染严重不适的患者进行保守抗生素治疗.我们对使用抗真菌药物治疗COVID-19患者的影响的研究可以作为未来COVID-19治疗的成功参考。
    Background: Diagnosis of co-infections with multiple pathogens among hospitalized coronavirus disease 2019 (COVID-19) patients can be jointly challenging and essential for appropriate treatment, shortening hospital stays and preventing antimicrobial resistance. This study proposes to investigate the burden of bacterial and fungal co-infections outcomes on COVID-19 patients. It is a single center cross-sectional study of hospitalized COVID-19 patients at Beit-Jala hospital in Palestine. Methods: The study included 321 hospitalized patients admitted to the ICU between June 2020 and March 2021 aged ≥20 years, with a confirmed diagnosis of COVID-19 via reverse transcriptase-polymerase chain reaction assay conducted on a nasopharyngeal swab. The patient\'s information was gathered using graded data forms from electronic medical reports. Results: The diagnosis of bacterial and fungal infection was proved through the patient\'s clinical presentation and positive blood or sputum culture results. All cases had received empirical antimicrobial therapy before the intensive care unit (ICU) admission, and different regimens during the ICU stay. The rate of bacterial co-infection was 51.1%, mainly from gram-negative isolates ( Enterobacter species and K.pneumoniae). The rate of fungal co-infection caused by A.fumigatus was 48.9%, and the mortality rate was 8.1%. However, it is unclear if it had been attributed to SARS-CoV-2 or coincidental. Conclusions: Bacterial and fungal co-infection is common among COVID-19 patients at the ICU in Palestine, but it is not obvious if these cases are attributed to SARS-CoV-2 or coincidental, because little data is available to compare it with the rates of secondary infection in local ICU departments before the pandemic. Comprehensively, those conclusions present data supporting a conservative antibiotic administration for severely unwell COVID-19 infected patients. Our examination regarding the impacts of employing antifungals to manage COVID-19 patients can work as a successful reference for future COVID-19 therapy.
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  • 文章类型: Journal Article
    铁营养状况与人类先天性心脏病(CHD)之间的关系尚不清楚。本研究旨在探讨妊娠期孕妇铁摄入量、孕妇和新生儿铁状态与冠心病的关系。
    这项基于医院的病例对照研究分析了陕西的474例病例和948例对照。在医院等待分娩的合格妇女接受了采访,以报告她们在怀孕期间的饮食和特征。我们方便地收集分娩前的母体血液和新生儿脐带血,以获得50例和100例对照的亚组。使用混合逻辑回归模型来估计与铁摄入相关的CHD的ORs(95CIs)。使用混合线性回归模型来评估CHD与铁状态之间的关系。
    胎儿患有冠心病的母亲在怀孕期间摄入总铁和血红素铁的可能性较小,线性趋势检验均具有显著性(均P<0.05)。胎儿患有冠心病的母亲在怀孕期间(OR=0.28,95CI:0.21,0.36)和孕早期(OR=0.32,95CI:0.12,0.84)服用铁补充剂的可能性较小。产妇分娩前SF和Hb浓度较低,产妇分娩前sTfR/SF高于对照组。
    与胎儿相比,胎儿患有冠心病的母亲不太可能摄入较高的总铁和血红素铁,并在怀孕期间服用铁补充剂。胎儿患有CHD的母亲分娩前的铁状况较低。
    The relationships between iron nutritional status and congenital heart defects (CHDs) among humans are still unclear. This study aimed to explore the associations of maternal iron intake during pregnancy and maternal and neonatal iron status with CHDs.
    This hospital-based case-control study analyzed 474 cases and 948 controls in Shaanxi China. Eligible women waiting for delivery in the hospital were interviewed to report their diets and characteristics during pregnancy. We conveniently collected maternal blood before delivery and neonatal cord blood to get a subgroup of 50 cases and 100 controls. Mixed logistic regression models were used to estimate ORs (95%CIs) for CHDs associated with iron intake. Mixed linear regression models were used to assess the relationships between CHDs and iron status.
    Mothers whose fetuses have CHDs were less likely to have higher intakes of total iron and heme iron during pregnancy, and the tests for linear trend were significant (all P < 0.05). Mothers whose fetuses have CHDs were less likely to take iron supplements during pregnancy (OR = 0.28, 95%CI: 0.21, 0.36) and during the first trimester (OR = 0.32, 95%CI: 0.12, 0.84). Maternal SF and Hb concentrations before delivery were lower and maternal sTfR/SF before delivery was higher among the cases than the controls.
    Mothers whose fetuses have CHDs are less likely to have higher intakes of total iron and heme iron and take iron supplements during pregnancy compared to their counterparts. Maternal iron status before delivery is low among mothers whose fetuses have CHDs.
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  • 文章类型: Journal Article
    背景:首次怀孕前补充铁可以通过减少母亲贫血来改善母亲和婴儿的未来健康。铁补充剂可以,然而,增加疟疾感染,特别是在最容易感染的primigravidae中。其他利用铁的病原体的致病性也可能增加,引起炎症,导致不良分娩结局的风险增加。本文报告了布基纳法索在疟疾高流行地区进行的一项安全性试验得出的预先指定的二次分娩结局。该试验的主要结果调查了长期每周补充铁对非孕妇和孕妇的疟疾和生殖道感染的影响。
    方法:双盲,随机对照试验。未产,主要是青春期女性,单独随机分组,每周接受60毫克元素铁和2.8毫克叶酸,或单独2.8毫克叶酸,继续为那些怀孕的人进行第一次产前检查。次要结果是超声测孕龄,胎儿生长,胎盘疟疾,绒毛膜羊膜炎和铁生物标志物。评估了季节性影响。分析是有意治疗。
    结果:1959年妇女发生了478次怀孕:258/980名妇女分配了铁和叶酸,220/979名妇女仅分配了叶酸。首次产前检查时的疟疾患病率为53%(铁)和55%(对照)。铁组的平均出生体重较低111g(95%CI9:213g,P=0.033)。平均胎龄分别为264天(铁)和269天(对照)(P=0.012),37周为27.5%,而对照组为13.9%(adjRR=2.22;95%CI1.39-3.61),P<0.001)。三分之一的婴儿受到生长限制,但不同试验组的发病率没有差异.一半的胎盘有过去疟疾感染的证据。C-反应蛋白>5mg/l在出生前<37周时更常见(adjRR=2.06,95%CI1.04-4.10,P=0.034)。雨季早产发生率在铁臂中为约50%,在对照组中为<20%(P=0.001)。绒毛膜羊膜炎患病率在旱季达到高峰(P=0.046),各试验组没有差异(P=0.14)。
    结论:在疟疾流行地区,对未产妇女长期每周补铁与首次妊娠早产风险较高相关。试用注册NCT01210040。2010年9月27日在Clinicaltrials.gov注册。
    BACKGROUND: Iron supplementation before a first pregnancy may improve the future health of mother and baby by reducing maternal anaemia. Iron supplementation could, however, increase malaria infections, notably in primigravidae who are most susceptible. The pathogenicity of other iron-utilizing pathogens could also increase, causing inflammation leading to increased risk of adverse birth outcomes. This paper reports pre-specified secondary birth outcomes from a safety trial in Burkina Faso in an area of high malaria endemicity. Primary outcomes from that trial had investigated effects of long-term weekly iron supplementation on malaria and genital tract infections in non-pregnant and pregnant women.
    METHODS: A double-blind, randomized controlled trial. Nulliparous, mainly adolescent women, were individually randomized periconceptionally to receive weekly either 60 mg elemental iron and 2.8 mg folic acid, or 2.8 mg folic acid alone, continuing up to the first antenatal visit for those becoming pregnant. Secondary outcomes were ultrasound-dated gestational age, fetal growth, placental malaria, chorioamnionitis and iron biomarkers. Seasonal effects were assessed. Analysis was by intention to treat.
    RESULTS: 478 pregnancies occurred to 1959 women: 258/980 women assigned iron and folic acid and 220/979 women assigned folic acid alone. Malaria prevalence at the first antenatal visit was 53% (iron) and 55% (controls). Mean birthweight was 111 g lower in the iron group (95% CI 9:213 g, P = 0.033). Mean gestational ages were 264 days (iron) and 269 days (controls) (P = 0.012), with 27.5% under 37 weeks compared to 13.9% in controls (adjRR = 2.22; 95% CI 1.39-3.61) P < 0.001). One-third of babies were growth restricted, but incidence did not differ by trial arm. Half of placentae had evidence of past malaria infection. C-reactive protein > 5 mg/l was more common prior to births < 37 weeks (adjRR = 2.06, 95% CI 1.04-4.10, P = 0.034). Preterm birth incidence during the rainy season was ~ 50% in the iron arm and < 20% in controls (P = 0.001). Chorioamnionitis prevalence peaked in the dry season (P = 0.046), with no difference by trial arm (P = 0.14).
    CONCLUSIONS: Long-term weekly iron supplementation given to nulliparous women in a malaria endemic area was associated with higher risk of preterm birth in their first pregnancy. Trial Registration NCT01210040. Registered with Clinicaltrials.gov on 27th September 2010.
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  • 文章类型: Clinical Trial
    Iron is an essential micronutrient while its excessive load has been related to the etiology of diabetes. We used data of 3289 pregnant women from the Ma\'anshan birth cohort (MABC) study in China to examine the associations of three iron-related factors (i.e., serum iron (SI) concentration, hemoglobin level, and use of iron supplements) with risk of gestational diabetes mellitus (GDM). Emphatically explore the potential non-linear relationship between SI concentration and risk of GDM. SI concentration was measured in fasting blood using inductively coupled plasma mass spectrometry (ICP-MS). GDM diagnosis was determined by 75 g oral glucose tolerance test at 24~28 weeks. Restricted cubic splines with three knots were used to examine potential non-linear relationship between SI concentration and GDM risk. We observed a U-shape relation between SI concentration in the first trimester and risk of GDM. In the multivariate-adjusted model, compared with the middle level (ln(SI), 7.1-7.7 μg/L), both the lowest level (ln(SI) ≤ 7.1 μg/L) (odds ratio (OR) = 1.35, 95% confidence interval (CI) = 1.04-1.76) and the highest level (ln(SI) > 7.7 μg/L) (OR = 1.63, 95%CI = 1.16-2.28) increased risk of GDM. Associations of hemoglobin level in the first trimester and risk of GDM attenuated to non-significance after adjustment for pre-pregnancy body mass index (BMI) and blood pressure. Pre-pregnancy iron supplement use was associated with an increased risk of GDM (OR = 1.57, 95%CI = 1.06-2.32). In conclusion, the three iron-related factors are all related to GDM risk on some level.
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