School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland.
Solvotrin Therapeutics, Little Island, Cork, Ireland.
Int J Clin Pharm. 2024 Apr;46(2):390-400. doi: 10.1007/s11096-023-01640-7. Epub 2023 Dec 26.
Nutritional deficit and oral iron gastrointestinal intolerance may be a common cause of iron deficiency, which can be managed by pharmacists.
To understand the prevalence of iron deficiency in women of childbearing age with a self-reported history of intolerance to oral iron and the tolerability of three doses of an iron-whey-protein formulation in the care of these women.
Ferritin and haemoglobin levels were documented in women of childbearing age with oral iron gastrointestinal intolerance. In those with iron deficiency (ferritin < 30 µg/L), adherence, gastrointestinal tolerability, ferritin, transferrin saturation and haemoglobin levels were compared between their prior oral iron product and iron-whey-protein microspheres randomised to three doses (14 mg daily, 25 mg daily and 50 mg daily) for 12 weeks.
Most screened women had low iron stores (128 (62.7%); ferritin < 30 µg/L), 65 (31.9%) had moderate to severe iron deficiency (ferritin < 12 µg/L) and 33 (16.2%) had iron deficiency anaemia (ferritin < 30 µg/L, haemoglobin < 12 g/dL). Amongst the 59 women who participated in the prospective clinical study of iron-whey-protein microspheres over 12 weeks, 48 (81.4%) were classified as adherent/persistent and fewer instances of gastrointestinal intolerance were reported (0.59 ± 0.91) when compared to 12 (20.3%) and (4.0 ± 2.2) respectively while taking the prior oral iron (Fisher's Exact and T-test respectively, both p < 0.001). There was no difference in adherence or tolerability of different iron-whey-protein formulation doses. Ferritin, haemoglobin and energy levels increased significantly over 12 weeks.
Undiagnosed iron deficiency is common in women of childbearing age with a history of intolerance to oral iron and iron-whey-protein microspheres can improve adherence, GI tolerability, iron stores, haemoglobin and energy levels in these women.
Clinicaltrials.gov identifier (registration includes full trial protocol): NCT04778072.
营养不足和口服铁胃肠道不耐受可能是缺铁的常见原因，药剂师可以对此进行治疗。
了解自述口服铁不耐受的育龄期妇女缺铁的流行情况，以及三种剂量铁-乳清蛋白配方在这些妇女中的耐受性。
记录有口服铁胃肠道不耐受史的育龄期妇女的铁蛋白和血红蛋白水平。在那些缺铁的妇女中（铁蛋白<30μg/L），比较她们之前的口服铁产品和随机分配至三种剂量（每天 14mg、每天 25mg 和每天 50mg）的铁-乳清蛋白微球 12 周的依从性、胃肠道耐受性、铁蛋白、转铁蛋白饱和度和血红蛋白水平。
大多数筛选的妇女铁储存量低（128 例[62.7%]；铁蛋白<30μg/L），65 例（31.9%）有中重度缺铁（铁蛋白<12μg/L），33 例（16.2%）有缺铁性贫血（铁蛋白<30μg/L，血红蛋白<12g/dL）。在 59 例参加为期 12 周的铁-乳清蛋白微球前瞻性临床研究的妇女中，48 例（81.4%）被归类为依从/持续，胃肠道不耐受的报告例数较少（0.59±0.91），而分别服用之前的口服铁时为 12 例（20.3%）和（4.0±2.2）（Fisher 精确检验和 T 检验，均 P<0.001）。不同剂量的铁-乳清蛋白配方的依从性或耐受性无差异。铁蛋白、血红蛋白和能量水平在 12 周内显著升高。
有口服铁不耐受史的育龄期妇女中未确诊的缺铁很常见，铁-乳清蛋白微球可提高这些妇女的依从性、胃肠道耐受性、铁储存量、血红蛋白和能量水平。
Clinicaltrials.gov 标识符（注册包括完整的试验方案）：NCT04778072。
