Aims: To evaluate the prevalence of vitamin B12 deficiency in Chinese patients with type 2 diabetes mellitus receiving metformin treatment and to investigate the effects of metformin daily dose and treatment duration on the prevalence of vitamin B12 deficiency and peripheral neuropathy (PN).
Materials and methods: In this multicenter cross-sectional study, 1027 Chinese patients who had been taking ≥1000 mg/day metformin for ≥1 year were enrolled using proportionate stratified random sampling based on daily dose and treatment duration. Primary measures included the prevalence of vitamin B12 deficiency (<148 pmol/L), borderline B12 deficiency (148 pmol/L-211 pmol/L), and PN.
Results: The prevalence of vitamin B12 deficiency, borderline deficiency, and PN were 2.15%, 13.66%, and 11.59%, respectively. Patients receiving ≥1500 mg/day metformin had significantly higher prevalence of borderline vitamin B12 deficiency (16.76% vs. 9.91%, p = .0015) and serum B12 ≤221 pmol/L (19.25% vs. 11.64%, p < .001) than patients receiving <1500 mg/day metformin. No difference was found in prevalence of borderline vitamin B12 deficiency (12.58% vs. 15.49%, p = .1902) and serum B12 ≤221 pmol/L (14.91% vs. 17.32%, p = .3055) between patients receiving metformin for ≥3 and <3 years. Patients with vitamin B12 deficiency had numerically higher PN prevalence (18.18% vs. 11.27%, p = .3192) than patients without it. Multiple logistic analyses revealed that HbA1c and metformin daily dose were associated with the prevalence of borderline B12 deficiency and B12 ≤221 pmol/L.
Conclusions: High daily dosage (≥1500 mg/day) played an important role in metformin-associated vitamin B12 deficiency while not contributing to the risk of PN.
目的:了解中国接受二甲双胍治疗的2型糖尿病患者维生素B12缺乏症的患病率, 探讨二甲双胍日剂量和治疗时间对维生素B12缺乏症患病率和周围神经病变(PN)的影响。 方法:在这项多中心横断面研究中, 采用基于日剂量和治疗时间的比例分层随机抽样, 纳入了1027例服用二甲双胍≥1000 mg/d≥1年的中国患者。主要指标包括维生素B12缺乏症(<148 pmol/L), B12临界缺乏(148 pmol/L-211 pmol/L)和PN的患病率。 结果:维生素B12缺乏, 临界缺乏和PN的患病率分别为2.15%, 13.66%和11.59%。接受≥1500mg /d二甲双胍治疗的患者与接受<1500mg /d二甲双胍治疗的患者相比, 维生素B12临界缺乏(16.76%vs.9.91%, p = 0.0015)和血清B12≤221 pmol/L(19.25%vs.11.64%, p<0.001)的患病率显著较高。服用二甲双胍≥3年和<3年的患者之间, 维生素B12临界缺乏(12.58%vs.15.49%, p = 0.1902)和血清B12≤221 pmol/L(14.91%vs.17.32%, p =0.3055)的患病率没有差异。与无维生素B12缺乏的患者相比, 缺乏维生素B12的患者PN患病率较高(18.18%vs.11.27%, p = 0.3192)。多元logistic回归分析显示, HbA1c 和二甲双胍日剂量与B12临界缺乏和B12≤221 pmol/L的患病率相关。 结论:高日剂量(≥1500mg /天)在二甲双胍相关的维生素B12缺乏症中起重要作用, 但不会增加PN的风险。.
Keywords: 2型糖尿病; metformin; type 2 diabetes mellitus; vitamin B12 deficiency; 二甲双胍; 维生素B12缺乏.
© 2023 The Authors. Journal of Diabetes published by Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.