Kiss Joseph E, Brambilla Donald, Glynn Simone A, Mast Alan E, Spencer Bryan R, Stone Mars, Kleinman Steven H, Cable Ritchard G
Institute for Transfusion Medicine, Pittsburgh, Pennsylvania.
RTI, Rockville, Maryland.
JAMA. 2015 Feb 10;313(6):575-83. doi: 10.1001/jama.2015.119.
Although blood donation is allowed every 8 weeks in the United States, recovery of hemoglobin to the currently accepted standard (12.5 g/dL) is frequently delayed, and some donors become anemic.
To determine the effect of oral iron supplementation on hemoglobin recovery time (days to recovery of 80% of hemoglobin removed) and recovery of iron stores in iron-depleted ("low ferritin," ≤26 ng/mL) and iron-replete ("higher ferritin," >26 ng/mL) blood donors.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, nonblinded clinical trial of blood donors stratified by ferritin level, sex, and age conducted in 4 regional blood centers in the United States in 2012. Included were 215 eligible participants aged 18 to 79 years who had not donated whole blood or red blood cells within 4 months.
One tablet of ferrous gluconate (37.5 mg of elemental iron) daily or no iron for 24 weeks (168 days) after donating a unit of whole blood (500 mL).
Time to recovery of 80% of the postdonation decrease in hemoglobin and recovery of ferritin level to baseline as a measure of iron stores.
The mean baseline hemoglobin levels were comparable in the iron and no-iron groups and declined from a mean (SD) of 13.4 (1.1) g/dL to 12.0 (1.2) g/dL after donation in the low-ferritin group and from 14.2 (1.1) g/dL to 12.9 (1.2) g/dL in the higher-ferritin group. Compared with participants who did not receive iron supplementation, those who received iron supplementation had shortened time to 80% hemoglobin recovery in both the low-ferritin (mean, 32 days, interquartile range [IQR], 30-34, vs 158 days, IQR, 126->168) and higher-ferritin groups (31 days, IQR, 29-33, vs 78 days, IQR, 66-95). Median time to recovery to baseline ferritin levels in the low-ferritin group taking iron was 21 days (IQR, 12-84). For participants not taking iron, recovery to baseline was longer than 168 days (IQR, 128->168). Median time to recovery to baseline in the higher-ferritin group taking iron was 107 days (IQR, 75-141), and for participants not taking iron, recovery to baseline was longer than 168 days (IQR, >168->168). Recovery of iron stores in all participants who received supplements took a median of 76 days (IQR, 20-126); for participants not taking iron, median recovery time was longer than 168 days (IQR, 147->168 days; P < .001). Without iron supplements, 67% of participants did not recover iron stores by 168 days.
Among blood donors with normal hemoglobin levels, low-dose iron supplementation, compared with no supplementation, reduced time to 80% recovery of the postdonation decrease in hemoglobin concentration in donors with low ferritin (≤26 ng/mL) or higher ferritin (>26 ng/mL).
clinicaltrials.gov Identifier: NCT01555060.
在美国，虽然允许每8周献血一次，但血红蛋白恢复到当前公认标准（12.5 g/dL）的时间常常延迟，一些献血者会出现贫血。
确定口服补铁对血红蛋白恢复时间（血红蛋白下降量恢复80%所需天数）以及铁储备耗尽（“低铁蛋白”，≤26 ng/mL）和铁储备充足（“高铁蛋白”，>26 ng/mL）的献血者铁储备恢复情况的影响。
设计、地点和参与者：2012年在美国4个地区血液中心对按铁蛋白水平、性别和年龄分层的献血者进行的随机、非盲临床试验。纳入215名年龄在18至79岁之间、在4个月内未捐献全血或红细胞的合格参与者。
捐献一单位全血（500 mL）后，每天服用一片葡萄糖酸亚铁（37.5 mg元素铁）或24周（168天）不补铁。
血红蛋白下降量恢复80%的时间以及铁蛋白水平恢复至基线作为铁储备的指标。
补铁组和不补铁组的平均基线血红蛋白水平相当，低铁蛋白组捐献后平均（标准差）血红蛋白水平从13.4（1.1）g/dL降至12.0（1.2）g/dL，高铁蛋白组从14.2（1.1）g/dL降至12.9（1.2）g/dL。与未接受补铁的参与者相比，接受补铁的参与者在低铁蛋白组（平均32天，四分位间距[IQR]为30 - 34天，而未补铁组为158天，IQR为126天->168天）和高铁蛋白组（31天，IQR为29 - 33天，未补铁组为78天，IQR为66 - 95天）恢复至血红蛋白下降量80%的时间均缩短。服用铁剂的低铁蛋白组恢复至基线铁蛋白水平的中位时间为21天（IQR为12 - 84天）。未服用铁剂的参与者恢复至基线的时间超过168天（IQR为1'28天->168天）。服用铁剂的高铁蛋白组恢复至基线的中位时间为107天（IQR为75 - 141天），未服用铁剂的参与者恢复至基线的时间超过168天（IQR为>168天->168天）。所有接受补铁的参与者铁储备恢复的中位时间为76天（IQR为20 - 126天）；未服用铁剂的参与者，中位恢复时间超过168天（IQR为147天->68天；P < 0.001）。不补充铁剂的情况下，67%的参与者在168天内未恢复铁储备。
在血红蛋白水平正常的献血者中，与不补铁相比，低剂量补铁可缩短低铁蛋白（≤26 ng/mL）或高铁蛋白（>26 ng/mL）的献血者血红蛋白浓度捐献后下降量恢复80%的时间。
clinicaltrials.gov标识符：NCT01555060。
