Crinó A, Schiaffini R, Ciampalini P, Suraci M C, Manfrini S, Visalli N, Matteoli M C, Patera P, Buzzetti R, Guglielmi C, Spera S, Costanza F, Fioriti E, Pitocco D, Pozzilli P
Department of Endocrinology and Diabetes, Clinica Medica, Universitá Catholica Sacro Cuore and Ospedale Pediatrico Bambino Gesu, Rome, Italy.
J Pediatr Endocrinol Metab. 2005 Aug;18(8):749-54. doi: 10.1515/jpem.2005.18.8.749.
A number of trials have evaluated residual beta-cell function in patients with recent onset type 1 diabetes mellitus (DM1) treated with nicotinamide in addition to intensive insulin therapy (IIT). In most studies, only a slight decline of C-peptide secretion was observed 12 months after diagnosis; however, no data is available on C-peptide secretion and metabolic control in patients continuing nicotinamide and IIT for up to 2 years after diagnosis.
We retrospectively analysed data from 25 patients (mean age 14.7 years +/- 5 SD) with DM1 in whom nicotinamide at a dose of 25 mg/kg b. wt. was added from diagnosis (< 4 weeks) to IIT (three injections of regular insulin at meals + one NPH at bed time) and continued for up to 2 years after diagnosis. Data were also analysed from patients (n = 27) in whom IIT was introduced at diagnosis and who were similarly followed for 2 years. Baseline C-peptide as well as insulin dose and HbA1c levels were evaluated at 12 and 24 months after diagnosis.
In the course of the follow-up, patients on nicotinamide + IIT or IIT alone did not significantly differ in terms of C-peptide secretion (values at 24 months in the two groups were 0.19 +/- 0.24 nM vs 0.19 +/- 0.13 nM, respectively). Insulin requirement (0.6 +/- 0.3 U/kg/day vs 0.7 +/- 0.2 U/kg/day at 24 months, respectively) did not differ between the two groups. However, HbA1c was significantly lower 2 years after diagnosis in patients treated with nicotinamide + IIT (6.09 +/- 0.9% vs 6.98 +/- 0.9%, respectively, p < 0.01). No adverse effects were observed in patients receiving nicotinamide for 2 years.
Implementation of IIT with the addition of nicotinamide at diagnosis continued for 2 years improves metabolic control as assessed by HbA1c. In both nicotinamide and control patients, no decline in C-peptide was detected 2 years after diagnosis, indicating that IIT preserves C-peptide secretion. We conclude that nicotinamide + IIT at diagnosis of DM1 prolonged for up to 2 years can be recommended, but longer follow-up is required to determine whether nicotinamide should be continued beyond this period.
多项试验评估了近期发病的1型糖尿病（DM1）患者在强化胰岛素治疗（IIT）基础上加用烟酰胺后的残余β细胞功能。在大多数研究中，诊断后12个月仅观察到C肽分泌略有下降；然而，关于诊断后持续使用烟酰胺和IIT长达2年的患者的C肽分泌和代谢控制情况尚无数据。
我们回顾性分析了25例DM1患者（平均年龄14.7岁±5标准差）的数据，这些患者从诊断（<4周）开始即在IIT（三餐注射常规胰岛素+睡前注射一次中效胰岛素）基础上加用剂量为25mg/kg体重的烟酰胺，并在诊断后持续使用长达2年。我们还分析了27例患者的数据，这些患者在诊断时开始接受IIT，并同样随访2年。在诊断后12个月和24个月评估基线C肽以及胰岛素剂量和糖化血红蛋白（HbA1c）水平。
在随访过程中，接受烟酰胺+IIT或仅接受IIT的患者在C肽分泌方面无显著差异（两组24个月时的值分别为0.19±0.24nM和0.19±0.13nM）。两组之间的胰岛素需求量（24个月时分别为0.6±0.3U/kg/天和0.7±0.2U/kg/天）无差异。然而，诊断后2年，接受烟酰胺+IIT治疗的患者的HbA1c显著更低（分别为6.09±0.9%和6.98±0.9%，p<0.01）。接受烟酰胺治疗2年的患者未观察到不良反应。
诊断时开始IIT并加用烟酰胺持续2年可改善代谢控制，以HbA1c评估。在烟酰胺组和对照组患者中，诊断后2年均未检测到C肽下降，表明IIT可保留C肽分泌。我们得出结论，DM1诊断时使用烟酰胺+IIT持续长达2年是可以推荐的，但需要更长时间的随访来确定在此之后是否应继续使用烟酰胺。
