Polyclonal Anti-T-Cell Therapy for Type 1 Diabetes Mellitus of Recent Onset

摘要: The destruction of pancreatic β-cells in type 1 diabetes mellitus is mediated by autoreactive T-lymphocyte clones. We initiated a prospective randomized controlled trial polyclonal rabbit anti-T-cell globulin (ATG) patients with within 4 weeks diagnosis and residual post-glucagon C-peptide levels still over 0.3 nmol/l. ATG was administered as an initial bolus 9 mg/kg followed 3 consecutive doses mg/kg. An interim analysis performed to establish whether any significant changes production insulin requirement had occurred that would justify the continuation this pilot study. By May 2004, 11 subjects were assigned treatment along intensified therapy 6 placebo, for period at least months. During first 12 months difference dose trends found between groups (p = 0.010) lower dosage group. There also glucagon stimulated level marginal significance 0.068). Compared values screening, significantly improved group 0.012) but not placebo Complete remission 2 none Glycosylated hemoglobin tended be 0.088). Significant adverse effects treatment, mainly transient fever moderate symptoms serum sickness (7 subjects, respectively) observed during month only. ongoing study suggests short-term recent onset contributes preservation requirements year following diagnosis.