Sallusto A, Eandi M, De Bartolo G, Curiale C, Massobrio M
Ospedale di Cremona, Divisione di Ostetricia e Ginecologia.
Minerva Ginecol. 1990 May;42(5):191-5.
Aim of this multicentric clinical trial was to evaluate the efficacy and tolerability of a new iron compound: iron proteinsuccinylate. 3,200 patients affected with iron deficiency due to obstetric or gynecologic etiology were treated with iron proteinsuccinylate, at a daily dose of 80 mg Fe3+, for at least 30 days. Iron proteinsuccinylate induced a statistically significant improvement (p less than 0.01) in mean values of hemoglobin and serum iron. The compound also caused a disappearance or improvement of subjective symptomatology (asthenia, anorexia) and of clinical conditions deriving from iron deficiency state (polypnea, cutaneous and mucous pallor). The treatment was well tolerated and caused a few slight side effects (diarrhea, epigastralgia, nausea) in 2.4% of patients.
这项多中心临床试验的目的是评估一种新型铁化合物——琥珀酸铁蛋白的疗效和耐受性。3200名因产科或妇科病因导致缺铁的患者接受了琥珀酸铁蛋白治疗,每日剂量为80毫克三价铁,治疗时间至少为30天。琥珀酸铁蛋白使血红蛋白和血清铁的平均值有统计学意义的显著改善(p小于0.01)。该化合物还使主观症状(乏力、厌食)以及缺铁状态引起的临床状况(呼吸急促、皮肤和黏膜苍白)消失或改善。治疗耐受性良好,2.4%的患者出现了一些轻微副作用(腹泻、上腹痛、恶心)。