Andrès E, Kaltenbach G, Noblet-Dick M, Noel E, Vinzio S, Perrin A E, Berthel M, Blicklé J F
Department of Internal Medicine, Hopitaux Universitaires de Strasbourg, 67 091 Strasbourg cedex, France.
J Nutr Health Aging. 2006 Jan-Feb;10(1):3-6.
The aim of this trial was to demonstrate the efficacy of one month of oral cobalamin (vitamin B12) therapy in elderly patients with cobalamin deficiency related to food-cobalamin malabsorption (FCM).
Twenty elderly patients (mean age: 78+/-17 years) with established cobalamin deficiency related to FCM were included in an open-label, non-randomized, non-placebo trial. They were treated with a maximum of 1,000 microgram per day of oral crystalline cyanocobalamin for at least 1 month. Serum cobalamin levels (primary endpoint), blood count abnormalities and reticulocytes count (secondary endpoints) were determined at baseline and during the first month of treatment.
85% of the patients normalized their serum cobalamin levels with a mean increase of+167 pg/ml (p<0.001 compared with baseline). 100% of the patients corrected their initial macrocytosis and 25% their anemia; 100% of the patients had medullar regeneration with a mean increase of reticulocytes count of 32+/-11.3 x 106/l (p=0.03 compared with baseline).
Our findings support the view that one month of oral crystalline cyanocobalamin is effective to correct serum vitamin B12 levels and to obtain hematological responses in elderly patients with cobalamin deficiency related to FCM.
本试验旨在证明口服钴胺素(维生素B12)治疗1个月对因食物性钴胺素吸收不良(FCM)导致钴胺素缺乏的老年患者的疗效。
20例确诊因FCM导致钴胺素缺乏的老年患者(平均年龄:78±17岁)纳入一项开放标签、非随机、非安慰剂试验。他们接受每日最大剂量1000微克的口服结晶氰钴胺治疗至少1个月。在基线期和治疗的第一个月测定血清钴胺素水平(主要终点)、血细胞计数异常和网织红细胞计数(次要终点)。
85%的患者血清钴胺素水平恢复正常,平均升高167 pg/ml(与基线相比,p<0.001)。100%的患者纠正了初始的大细胞性贫血,25%的患者纠正了贫血;100%的患者有骨髓再生,网织红细胞计数平均升高32±11.3×10⁶/l(与基线相比,p=0.03)。
我们的研究结果支持以下观点,即口服结晶氰钴胺1个月可有效纠正因FCM导致钴胺素缺乏的老年患者的血清维生素B12水平并获得血液学反应。