口服结晶型钴胺素1000μg/天治疗恶性贫血的效果：一项针对10例患者的开放标签前瞻性研究。
Effects of oral crystalline cyanocobalamin 1000 μg/d in the treatment of pernicious anemia: An open-label, prospective study in Ten Patients.
作者信息
Andrès Emmanuel, Henoun Loukili Noureddine, Noel Esther, Maloisel Frédéric, Vinzio Stéphane, Kaltenbach Georges, Caro-Sampara Florence, Blicklé Jean-Frédéric
机构信息
Department of Internal Medicine, Strasbourg University Hospital, Strasbourg, France ; Department of Diabetes and Metabolic Disorders,Strasbourg University Hospital, Strasbourg, France.
Department of Hematology,Strasbourg University Hospital, Strasbourg, France.
出版信息
Curr Ther Res Clin Exp. 2005 Jan;66(1):13-22. doi: 10.1016/j.curtheres.2005.02.001.
BACKGROUND
Standard treatment of cobalamin (vitamin B12) deficiency involvesregular (1000 μg/mo) IM cyanocobalamin administration. It has been suggested that high-dose (>2000 μg/d) oral cyanocobalamin may be effective in patients with pernicious anemia.
OBJECTIVE
The aim of this study was to assess the efficacy and tolerability of oral crystalline cyanocobalamin 1000 μg/d in patients with cobalamin deficiency related to established pernicious anemia.
METHODS
This open-label, prospective study was conducted at StrasbourgUniversity Hospital, Strasbourg, France. Patients aged ≥18 years with well-documented cobalamin deficiency related to pernicious anemia were enrolled. Patients received crystalline cyanocobalamin 1000 μg QD PO (capsule) for at least 3 months. Serum cobalamin, folate, iron, and homocysteine concentrations were measured, and a complete blood count was obtained, before (month 0; baseline) and after treatment.
RESULTS
Ten patients (7 women, 3 men; mean [SD] age, 72.1 [15.5] years) entered the study. After 3 months of treatment, serum cobalamin concentration increased in all 9 patients in whom it was measured (mean [SD] increase, 117.4 [30.8] pg/mL; P < 0.001 vs baseline). Serum cobalamin concentrations were normalized (>200 pg/mL) in 6 patients. The serum cobalamin concentration was unavailable in 1 patient because of technical problems. Eight patients had increased hemoglobin concentrations (mean [SD] increase, 2.5 [2.4] g/dL; P < 0.01 vs baseline). All 10 patients had decreased mean erythrocyte corpuscular volumes (mean [SD] decrease, 10.4 [6.2] fL; P < 0.003 vs baseline). Four patients received concomitant blood transfusions or folate and iron supplementation. Three patients experienced clinical improvement in paresthesia, reflex abolition, or combined medullary sclerosis (each, 1 patient).
CONCLUSION
The results of this small study in patients with cobalamin deficiencyrelated to pernicious anemia suggest that oral crystalline cyanocobalamin 1000 μg/d may be an effective treatment.
背景
钴胺素（维生素B12）缺乏的标准治疗方法是定期（每月1000μg）肌肉注射氰钴胺。有人提出，高剂量（>2000μg/d）口服氰钴胺可能对恶性贫血患者有效。
目的
本研究旨在评估每日口服1000μg结晶氰钴胺对与确诊恶性贫血相关的钴胺素缺乏患者的疗效和耐受性。
方法
本开放标签、前瞻性研究在法国斯特拉斯堡大学医院进行。纳入年龄≥18岁、有充分记录的与恶性贫血相关的钴胺素缺乏患者。患者口服结晶氰钴胺1000μg，每日一次（胶囊），至少服用3个月。在治疗前（第0个月；基线）和治疗后测量血清钴胺素、叶酸、铁和同型半胱氨酸浓度，并进行全血细胞计数。
结果
10名患者（7名女性，3名男性；平均[标准差]年龄，72.1[15.5]岁）进入研究。治疗3个月后，所有9名接受测量的患者血清钴胺素浓度均升高（平均[标准差]升高，117.4[30.8]pg/mL；与基线相比，P<0.001）。6名患者的血清钴胺素浓度恢复正常（>200pg/mL）。1名患者因技术问题未获得血清钴胺素浓度数据。8名患者的血红蛋白浓度升高（平均[标准差]升高，2.5[2.4]g/dL；与基线相比，P<0.01）。所有10名患者的平均红细胞体积均下降（平均[标准差]下降，10.4[6.2]fL；与基线相比，P<0.003）。4名患者同时接受了输血或叶酸及铁补充剂治疗。3名患者的感觉异常、反射消失或合并脊髓亚急性联合变性（各1名患者）出现临床改善。
结论
这项针对与恶性贫血相关的钴胺素缺乏患者的小型研究结果表明，每日口服1000μg结晶氰钴胺可能是一种有效的治疗方法。
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