Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
Ann Surg Oncol. 2011 Dec;18(13):3711-7. doi: 10.1245/s10434-011-1764-6. Epub 2011 May 10.
Vitamin B12 deficiency is a common long-term sequelae after total gastrectomy. Intramuscular injection of vitamin B12 is the only known treatment. We investigated the efficacy and safety of oral vitamin B12 replacement for gastric cancer patients with vitamin B12 deficiency after total gastrectomy.
We performed a single-arm, open-label, fixed-drug dosage, prospective study (NCT00699478) involving gastric cancer patients who underwent total gastrectomy. Vitamin B12-deficient (<200 pg/ml) patients (n = 30) received daily oral vitamin B12 (dosage: 1500 μg mecobalamin) administration for 3 months. The primary outcome measurement was serum vitamin B12. The secondary outcome measurements were improvement of neurologic symptoms and hematologic findings (serum folate, homocysteine, ferritin, iron, total iron binding capacity, transferrin, and mean corpuscular volume). For comparison, another group of vitamin B12 deficient patients (n = 30) received intramuscular vitamin B12 injections (dosage: 1000 μg cyanocobalamin) weekly for 5 weeks and monthly thereafter for a total of 3 months in a separate study period.
In both groups, mean serum vitamin B12 increased after 30 days of treatment and was maintained up to 90 days. No adverse effects related to oral or intramuscular vitamin B12 replacements were noted. Both groups showed decreased homocysteine levels. Before treatment, 29 patients in the oral vitamin B12 group had neurologic symptoms related to vitamin B12 deficiency. After oral vitamin B12 treatment, 28 patients experienced symptom relief, and 16 patients were symptom free.
Oral vitamin B12 replacement is an effective and safe treatment for vitamin B12 deficiency in gastric cancer patients after total gastrectomy.
维生素 B12 缺乏是全胃切除术后的常见长期后遗症。肌内注射维生素 B12 是目前已知的唯一治疗方法。我们研究了口服维生素 B12 替代治疗全胃切除术后维生素 B12 缺乏的胃癌患者的疗效和安全性。
我们进行了一项单臂、开放标签、固定剂量、前瞻性研究(NCT00699478),纳入了接受全胃切除术的胃癌患者。维生素 B12 缺乏(<200 pg/ml)的患者(n=30)接受每日口服维生素 B12(剂量:1500 μg 甲钴胺)治疗 3 个月。主要结局测量指标为血清维生素 B12。次要结局测量指标为神经症状和血液学发现(血清叶酸、同型半胱氨酸、铁蛋白、铁、总铁结合力、转铁蛋白和平均红细胞体积)的改善。为了比较,另一组维生素 B12 缺乏患者(n=30)在另一个研究期间每周接受肌内注射维生素 B12(剂量:1000 μg 氰钴胺素)治疗 5 周,然后每月一次,共 3 个月。
两组患者在治疗 30 天后血清维生素 B12 均值均升高,并维持至 90 天。未观察到与口服或肌内注射维生素 B12 替代相关的不良反应。两组同型半胱氨酸水平均降低。在口服维生素 B12 治疗前,口服维生素 B12 组 29 例患者有与维生素 B12 缺乏相关的神经症状。口服维生素 B12 治疗后,28 例患者症状缓解,16 例患者无症状。
口服维生素 B12 替代治疗是全胃切除术后胃癌患者维生素 B12 缺乏的有效且安全的治疗方法。