新发型1型糖尿病中的β细胞功能和用热冲击蛋白 (DiaPep277) 进行免疫调节:一项随机,双盲,II期试验
1Department of Internal Medicine, Hadassah-Hebrew University Medical School, Jerusalem, Israel.
Lancet (London, England)
|December 6, 2001
概括
用p277 (DiaPep277) 治疗有助于维持新诊断为1型糖尿病的患者的胰岛素产量. 这种免疫调节可能会改变自身免疫T细胞的反应,提供一种潜在的新疗法.
科学领域:
- 免疫学 免疫学 免疫学
- 内分泌学 在内分泌学.
- 自免疫性疾病 自免疫性疾病
背景情况:
- 1型糖尿病涉及胰腺β细胞的自身免疫破坏.
- 热冲击蛋白60 (hsp60) 是1型糖尿病的抗原.
- 从hsp60衍生出来的p277之前在临床前模型中显示出有前途的结果.
研究的目的:
- 评估DiaPep277在新诊断为1型糖尿病的患者内源性胰岛素生产的保护方面的疗效和安全性.
- 评估DiaPep277对代谢控制和T细胞自身免疫性的影响.
主要方法:
- 一个随机的,双盲的,安慰剂控制的II期研究.
- 35名近期出现的1型糖尿病患者在基线,1个月和6个月接受了DiaPep277 (n=18) 或安慰剂 (n=17) 通过皮下注射.
- 主要终点:葡萄糖刺激的C-产量;次要终点:代谢控制和T细胞对hsp60和p277.7的反应性.
主要成果:
- 在10个月后,DiaPep277治疗维持了C-的平均度 (0.93nmol/L),与安慰剂组 (0.26nmol/L;p=0.039) 的下降相比.
- 接受DiaPep277治疗的患者需要的外源胰岛素比安慰剂 (0.67 U/kg; p=0.042) 少 (0.43 U/kg).
- 在T细胞对hsp60和p277的反应中,DiaPep277诱导了T助手-2细胞因子,没有报告的不良影响.
结论:
- 在新发型1型糖尿病中,DiaPep277治疗似乎可以保持内源性胰岛素的产生.
- 该机制可能涉及诱导自免疫T细胞反应从T-辅助-1转变为T-辅助-2表型的转变.
- 尽管样本大小小,但研究结果表明DiaPep277是1型糖尿病的潜在治疗剂.
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