Parry-Strong Amber, Langdana Fali, Haeusler Sylvan, Weatherall Mark, Krebs Jeremy
Centre for Endocrine, Diabetes and Obesity Research, Capital and Coast Health, Private Bag 7902, Wellington, New Zealand.
Department of Obstetrics and Gynaecology, Christchurch Women's Hospital, Christchurch.
N Z Med J. 2016 Jun 10;129(1436):67-75.
MAIM: To compare a single 1mg intramuscular hydroxocobalamin injection with a 3-month course of 1mg/day sublingual methylcobalamin supplements on serum vitamin B12 concentrations in participants withtype 2 diabetes treated with metformin.
Participants on metformin treatment with vitamin B12 concentrations below 220pmol/L were recruited through hospital diabetes clinics and primary care practices. They were randomised to receive either the injection or sublingual treatment. The primary outcome was serum vitamin B12 level after 3 months adjusted for baseline assessed by analysis of covariance (ANCOVA). The trial was registered on the Australia New Zealand Clinical Trial registry (ACTRN12612001108808).
A total of 34 participants were randomised; 19 to the tablet, and 15 to the injection. The mean (SD) age, duration of diabetes, and duration of metformin use were, 64.2 (7.3) years, 13.7 (6.4) years, and 11.6 (5.0) years, respectively. After 3 months, the mean (SD) vitamin B12 was 372.1 (103.3) pmol/L in the tablet group (n=19) compared to 251.7 (106.8) pmol/L in the injection group (n=15), ANCOVA estimated difference -119.4 (95% CI -191.2 to -47.6), p=0.002. After 6 months, the mean (SD) serum B12 was 258.8 (58.7) pmol/L in the tablet group (n=17) and 241.9 (40.1) pmol/L in the injection group (n=15); ANCOVA estimated difference -15.2 (95% CI -50.3 to 19.8), p=0.38. Higher metformin dose was associated with lower serum B12 at 3 months, but not at baseline or 6 months.
Decreased serum vitamin B12 level in patients with type 2 diabetes who are treated with metformin can be corrected through treatment with either hydroxocobalamin injections or methylcobalamin sublingual supplements.
目的：比较单次肌肉注射1毫克羟钴胺素与为期3个月、每日1毫克舌下含服甲钴胺补充剂对接受二甲双胍治疗的2型糖尿病患者血清维生素B12浓度的影响。
通过医院糖尿病诊所和初级医疗保健机构招募接受二甲双胍治疗且维生素B12浓度低于220皮摩尔/升的参与者。他们被随机分为接受注射治疗或舌下含服治疗。主要结局是3个月后经协方差分析（ANCOVA）校正基线后的血清维生素B12水平。该试验已在澳大利亚新西兰临床试验注册中心注册（ACTRN12612001108808）。
共34名参与者被随机分组；19人服用片剂，15人接受注射。平均（标准差）年龄、糖尿病病程和二甲双胍使用时长分别为64.2（7.3）岁、13.7（6.4）年和11.6（5.0）年。3个月后，片剂组（n = 19）的平均（标准差）维生素B12为372.1（103.3）皮摩尔/升，而注射组（n = 15）为251.7（106.8）皮摩尔/升，ANCOVA估计差异为 -119.4（95%置信区间 -191.2至 -47.6），p = 0.002。6个月后，片剂组（n = 17）的平均（标准差）血清B12为258.8（58.7）皮摩尔/升，注射组（n = 15）为241.9（40.1）皮摩尔/升；ANCOVA估计差异为 -15.2（95%置信区间 -50.3至19.8），p = 0.38。较高的二甲双胍剂量在3个月时与较低的血清B12相关，但在基线或6个月时无此关联。
接受二甲双胍治疗的2型糖尿病患者血清维生素B12水平降低可通过注射羟钴胺素或舌下含服甲钴胺补充剂进行纠正。
