Dietzfelbinger H, Kaboth W
Med Klin. 1979 Nov 30;74(48):1818-24.
In addition to a clinical study which investigated the bio-availability of three oral iron preparations S, L and X by using postabsorption serum iron concentration curves, the same drugs were compared in order to study their antianaemic efficacy, tolerance and drug costs arising during and iron therapy. Moreover, these iron drugs were related to other current clinical reports. Within all three iron preparations a very good correlation was found between bio-availability and haematopoietic efficacy: The very good absorbability of the bivalent quick release stick capsule preparation S (= 100%) corresponded with a very good capacity of haemoglobin regeneration (2,6 +/- 0,4 g Hb/1/day) whereas due to a very low absorbability (10% to 16%) the antianaemic efficacy of both iron(III) preparations L and X had to be rated as moderate to predominantly poor. In normal therapeutic dosis all three iron preparations showed no differences in tolerance. The ratio of side effects was similar to that after ingestion of placebo. In comparing the drug costs during a therapy leading to a real absorption of 1 g of iron the most effective iron(II)sulfate preparation S is 3.6 to 12.6 times cheaper than the compared trivalent preparations L and X. Therefore, there is no justification for the further production or introduction on the market of trivalent iron preparations.
除了一项通过吸收后血清铁浓度曲线研究三种口服铁制剂S、L和X的生物利用度的临床研究外,还对相同药物进行了比较,以研究它们在铁治疗期间的抗贫血疗效、耐受性和药物成本。此外,这些铁剂还与其他当前的临床报告相关。在所有三种铁制剂中,生物利用度与造血功效之间都发现了非常好的相关性:二价速释胶囊制剂S的吸收性非常好(=100%),其血红蛋白再生能力也非常好(2.6±0.4g Hb/1/天),而由于铁(III)制剂L和X的吸收性非常低(10%至16%),它们的抗贫血疗效只能评为中等至主要较差。在正常治疗剂量下,所有三种铁制剂在耐受性方面均无差异。副作用发生率与服用安慰剂后相似。在比较导致实际吸收1g铁的治疗期间的药物成本时,最有效的硫酸亚铁制剂S比所比较的三价制剂L和X便宜3.6至12.6倍。因此,没有理由进一步生产三价铁制剂或将其投放市场。