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一项关于在产后贫血治疗中添加叶酸至铁补充剂的随机对照试验。

A randomized controlled trial examining the addition of folic acid to iron supplementation in the treatment of postpartum anemia.

作者信息

Van Der Woude Daisy A A, De Vries Jolanda, Van Wijk Eduard M, Verzijl Jacques M, Pijnenborg Johanna M A

机构信息

CoRPS, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Department of Gynecology and Obstetrics, TweeSteden Hospital, Tilburg, The Netherlands.

CoRPS, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Department of Medical Psychology, St Elisabeth Hospital, Tilburg, The Netherlands.

出版信息

Int J Gynaecol Obstet. 2014 Aug;126(2):101-5. doi: 10.1016/j.ijgo.2014.02.013. Epub 2014 Apr 13.

Abstract

OBJECTIVE

To evaluate the efficacy of adding folic acid to oral iron supplementation in postpartum women with anemia.

METHODS

A randomized controlled trial was conducted in the Netherlands between April 8, 2008, and August 31, 2010. A total of 112 postpartum women with anemia (hemoglobin <10.5 g/dL) were randomly allocated to receive 600 mg/day ferrous fumarate plus 1mg/day folic acid (FFFA group) or 600/day ferrous fumarate alone (FF group) for 4 weeks. Primary outcome measures were hemoglobin and health status. Secondary outcome measures were fatigue, compliance, and adverse reactions.

RESULTS

No between-group differences were observed in hemoglobin and health status after treatment, and no differences were found in fatigue scores. Approximately 75% of all women reported having at least one symptom resulting from ferrous fumarate use. Constipation caused by ferrous fumarate was significantly associated with non-compliance (P=0.014).

CONCLUSION

The addition of folic acid to iron supplementation is not beneficial in women with postpartum anemia, as it has no effect on hematologic or health status parameters.

CLINICAL TRIAL REGISTRATION

CCMO website NL21797.028.08 and Netherlands Trial Register NTR2232.

摘要

目的

评估在产后贫血女性中口服铁剂补充时添加叶酸的疗效。

方法

2008年4月8日至2010年8月31日在荷兰进行了一项随机对照试验。总共112名产后贫血(血红蛋白<10.5 g/dL)的女性被随机分配接受600毫克/天富马酸亚铁加1毫克/天叶酸(FFFA组)或仅600毫克/天富马酸亚铁(FF组),为期4周。主要结局指标为血红蛋白和健康状况。次要结局指标为疲劳、依从性和不良反应。

结果

治疗后血红蛋白和健康状况在组间未观察到差异,疲劳评分也未发现差异。约75%的女性报告至少有一项因使用富马酸亚铁导致的症状。富马酸亚铁引起的便秘与不依从显著相关(P = 0.014)。

结论

在产后贫血女性中,铁剂补充时添加叶酸并无益处,因为它对血液学或健康状况参数没有影响。

临床试验注册

CCMO网站NL21797.028.08和荷兰试验注册中心NTR2232。

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