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比较硫酸亚铁和蔗糖铁治疗妊娠缺铁性贫血的随机对照试验

Randomized Controlled Trial Comparing Ferrous Sulfate and Iron Sucrose in Iron Deficiency Anemia in Pregnancy.

作者信息

Chauhan Neha, Dogra Poojan, Sharma Reena, Kant Shashi, Soni Mridul

机构信息

Obstetrics and Gynaecology, Shri Lal Bahadur Shastri Government Medical College & Hospital, Mandi, IND.

Obstetrics and Gynaecology, All India Institute of Medical Sciences, Bilaspur, IND.

出版信息

Cureus. 2023 Feb 11;15(2):e34858. doi: 10.7759/cureus.34858. eCollection 2023 Feb.

Abstract

INTRODUCTION

Anemia among pregnant women is one of the major health concerns for healthcare workers. The management becomes a concern in the pregnancy where the question arises of which is better the intravenous iron sucrose or the oral ferrous sulfate tablets. To answer this, a randomized control trial comparing both the treatment options in a tertiary care government hospital was set up in the hilly terrains of India. This study discusses the effectiveness and practical aspect of using both, which seems to be the better out of both, and why.

METHODS

The study was conducted as a parallel-group, open-label randomized controlled trial (RCT) in the Department of Obstetrics and Gynecology of a tertiary care government hospital in India, with approximately 4,000 delivery loads annually. Ethical clearance was obtained from the institute's ethics committee (IEC), and the trial was registered with the Clinical Trial Registry of India (REF/2022/06/055013). Two hundred sixty-eight pregnant women between 18 and 45 years of age with moderate iron deficiency anemia (IDA) (hemoglobin (Hb) 7-9g/dl, microcytic-hypochromic, and serum ferritin <30ng/ml) were included in the study. Patients were randomly divided into two groups: group 1 with 134 patients to receive intravenous iron sucrose and group 2 with 134 patients to receive oral ferrous sulfate tablets.

RESULTS

The intravenous iron sucrose is superior in terms of tolerability and correction of iron deficiency anemia during pregnancy.

CONCLUSION

It yields a quicker rise in Hb and serum ferritin with no major side effects. In the difficult terrain of Himachal Pradesh, this makes IV iron sucrose a better option for anemic pregnant women who do not have easy access to health facilities resulting in a large number of them reaching hospitals with moderate to severe anemia at a later gestation.

摘要

引言

孕妇贫血是医护人员主要关注的健康问题之一。在孕期管理中,出现了静脉注射蔗糖铁和口服硫酸亚铁片哪种更好的问题。为了回答这个问题,在印度山区的一家三级护理政府医院开展了一项比较这两种治疗方案的随机对照试验。本研究讨论了使用这两种方法的有效性和实际情况,哪种似乎更好,以及原因。

方法

该研究在印度一家每年约有4000例分娩量的三级护理政府医院的妇产科进行,采用平行组、开放标签随机对照试验(RCT)。获得了该机构伦理委员会(IEC)的伦理批准,该试验已在印度临床试验注册中心注册(注册号:REF/2022/06/055013)。本研究纳入了268名年龄在18至45岁之间、患有中度缺铁性贫血(IDA)(血红蛋白(Hb)7 - 9g/dl、小细胞低色素性贫血且血清铁蛋白<30ng/ml)的孕妇。患者被随机分为两组:第1组134例患者接受静脉注射蔗糖铁,第2组134例患者接受口服硫酸亚铁片。

结果

静脉注射蔗糖铁在耐受性和孕期缺铁性贫血的纠正方面更具优势。

结论

它能使血红蛋白和血清铁蛋白更快升高,且无重大副作用。在喜马偕尔邦地形复杂的地区,对于那些难以获得医疗设施,导致大量孕妇在妊娠后期因中度至重度贫血才到医院就诊的贫血孕妇来说,静脉注射蔗糖铁是更好的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac41/10010153/76ce06419a00/cureus-0015-00000034858-i01.jpg

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