Sezer Rabia Gönül, Akoğlu Handan Ayhan, Bozaykut Abdulkadir, Özdemir Gül Nihal
a Zeynep Kamil Maternity and Children's Diseases Training and Research Hospital, Department of Pediatrics , University of Health Sciences , Istanbul.
b Kanuni Sultan Süleyman Training and Research Hospital, Department of Pediatric Hematology and Oncology , University of Health Sciences , Istanbul.
Hematology. 2018 Oct;23(9):653-657. doi: 10.1080/10245332.2018.1456023. Epub 2018 Mar 24.
Although, oral replacement for vitamin B12 deficiency has been proved to be effective in adults, it is mainly treated with parenteral therapy. There are only few studies on oral replacement therapy of vitamin B12 with children. Therefore, we aimed to compare the efficacy of oral treatment with intramuscular vitamin B12 injections in pediatric population.
Children with serum cobalamin concentrations less than 300 pg/mL, were treated either with the parenteral therapy or with oral vitamin B12. The primary and secondary outcomes of the study were the normalization of serum vitamin B12 and hemoglobin at first month, respectively.
Post-treatment vitamin B12 values were significantly higher than pre-treatment values (p-value <.001). Vitamin B12 increased from 183.5 ± 47 pg/mL to 482 ± 318.9 pg/mL in the oral and from 175.5 ± 42.5 pg/mL to 838 ± 547 pg/mL in the parenteral treatment arm (p-value <.001). Before treatment, 82 children had anemia according to age and gender. After treatment, 14/41 and 8/41 patients still had anemia at the first month of treatment in the parenteral and oral arms, respectively. The number of patients who still have anemia at the end of the 1st month of treatment did not significantly changed in the parenteral and oral treatment groups (p-value = .44).
In this study, both oral and parenteral formulations were shown to be effective in normalizing vitamin B12 levels. We suggest that oral formulations may be considered to be safe as a first line treatment for vitamin B12 deficiency in children.
尽管口服补充维生素B12对成人维生素B12缺乏症已被证明有效,但目前主要采用肠外治疗。关于儿童维生素B12口服替代疗法的研究较少。因此,我们旨在比较口服治疗与肌肉注射维生素B12在儿科人群中的疗效。
血清钴胺素浓度低于300 pg/mL的儿童,分别接受肠外治疗或口服维生素B12治疗。该研究的主要和次要结局分别是治疗第一个月时血清维生素B12和血红蛋白恢复正常。
治疗后维生素B12值显著高于治疗前值(p值<.001)。口服组维生素B12从183.5±47 pg/mL增至482±318.9 pg/mL,肠外治疗组从175.5±42.5 pg/mL增至838±547 pg/mL(p值<.001)。治疗前,根据年龄和性别,82名儿童患有贫血。治疗后,肠外治疗组和口服组分别有14/41和8/41的患者在治疗第一个月仍有贫血。治疗第1个月结束时仍有贫血的患者数量在肠外治疗组和口服治疗组中没有显著变化(p值 = .44)。
在本研究中,口服和肠外制剂在使维生素B12水平恢复正常方面均显示有效。我们建议口服制剂可被视为儿童维生素B12缺乏症一线治疗的安全选择。