Family Division, Maccabi Healthcare Services, Tel-Aviv, Israel.
Internal Medicine Department, Ward E, Rabin Medical Center, Beilinson Campus, Petach Tikva, Israel.
Drug Deliv Transl Res. 2019 Jun;9(3):625-630. doi: 10.1007/s13346-018-00613-y.
There are several methods to treat vitamin B12 deficiency (VB12d): intramuscular (IM), oral, sublingual (SL), and intranasal vitamin B12 (VB12) preparations. Large studies comparing the efficacy of SL vs. IM supplements are lacking. The aim of the present study was to compare the efficacy of SL versus the standard IM administration of VB12 in restoring B12 levels. This was a retrospective analysis of data from the computerized pharmacy records of Maccabi Health Service (MHS). Data were recorded for all patients older than 18 years of age who were prescribed VB12 during January 2014-December 2017. The main outcome was the change in levels of serum vitamin B12 (sVB12) after treatment. Overall, there were 4281 patients treated with VB12 supplements. Of them, 830 (19.3%) patients were treated with VB12 IM injections and 3451 (80.7%) with SL tablets. The mean ± SD difference between sVB12 levels before and after administration of VB12 supplements was significantly higher in the SL group vs. IM injection group (252 ± 223 vs. 218 ± 184 ng/L, p < 0.001). SL VB12 significantly increased the odds ratio (OR) for an increase of sVB12 levels, compared to the IM group, OR 1.85, CI 95% 1.5-2.3, p < 0.001. This is the largest study that documents therapy with SL preparations of VB12 sufficient and even superior to the IM route. The SL overcomes the challenges of IM injections and should be the first line option for patients with VB12d.
有几种方法可以治疗维生素 B12 缺乏症（VB12d）：肌肉内（IM）、口服、舌下（SL）和鼻内维生素 B12（VB12）制剂。缺乏比较 SL 与 IM 补充剂疗效的大型研究。本研究的目的是比较 SL 与 VB12 的标准 IM 给药在恢复 B12 水平方面的疗效。这是对 Maccabi 健康服务（MHS）计算机化药房记录中数据的回顾性分析。记录了所有在 2014 年 1 月至 2017 年 12 月期间开 VB12 处方的年龄大于 18 岁的患者的数据。主要结局是治疗后血清维生素 B12（sVB12）水平的变化。总体而言，有 4281 名患者接受 VB12 补充剂治疗。其中，830 名（19.3%）患者接受 VB12 IM 注射治疗，3451 名（80.7%）患者接受 SL 片剂治疗。与 IM 注射组相比，SL 组治疗前后 sVB12 水平的平均差异显著更高（252±223 与 218±184ng/L，p<0.001）。与 IM 组相比，SL VB12 显著增加了 sVB12 水平升高的优势比（OR），OR 1.85，95%CI 1.5-2.3，p<0.001。这是一项记录 SL 制剂治疗 VB12 充足甚至优于 IM 途径的最大研究。SL 克服了 IM 注射的挑战，应该是 VB12d 患者的首选。
