与近期出现的1型糖尿病患者的阿巴塞普特联合刺激调节:一个随机,双盲,安慰剂对照的随机试验
Tihamer Orban1, Brian Bundy, Dorothy J Becker
1Joslin Diabetes Center, Boston, MA, USA.
Lancet (London, England)
|July 2, 2011
概括
阿巴塞普特是一种协同刺激调节剂,通过在两年内减缓C减缓,在最近出现的1型糖尿病中保留了β细胞功能. 这表明T细胞激活是诊断的关键.
科学领域:
- 免疫学 免疫学 免疫学
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 1型糖尿病 (T1DM) 的发病包括T细胞自身免疫.
- T细胞激活需要超出抗原识别的共同刺激信号.
- 阿巴是一种免疫调节剂,其向共同刺激,以限制T细胞激活.
研究的目的:
- 评估阿巴切在维护近期T1DM患者的β细胞功能方面的疗效.
- 评估同刺激调节对T1DM两年进展的影响.
主要方法:
- 这是一项多中心,双盲,随机对照试验,涉及6至45岁的近期T1DM患者.
- 患者在2年内静脉输注27次,接受阿巴塔塞普特 (10毫克/千克) 或安慰剂.
- 主要结局是2年后混合食耐受性测试后,曲线下2小时血清C面积 (AUC) 的变化.
主要成果:
- 与安慰剂相比,Abatacept治疗导致在2年内调整后的C-AUC增加了59% (p=0.0029).
- 阿巴切显示,C-降低估计延迟了9.6个月.
- 在阿巴cept和安慰剂组之间,不良事件,感染和中性的发生率相似.
结论:
- 与阿巴塞普特一起的同时刺激调节有效地减缓了近2年来T1DM新发病的β细胞功能的下降.
- 这些发现表明,在临床T1DM诊断时发生了显著的T细胞激活.
- 需要进行进一步的研究,以确定在停用阿巴塔塞普特后,有益影响是否还存在.
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