终结不可能!JAMA报道:口服胰岛素能延缓糖尿病发生
2017/11/28
对于每天注射胰岛素的糖尿病人来说,打胰岛素是一件痛苦的事。近期JAMA上发表一项新的研究表明,口服胰岛素药片可以延缓1型糖尿病的发生。


开发口服胰岛素片的想法从1930年就开始了,科学家对改变胰岛素剂型的研究也从来没有放弃,但非注射胰岛素一直是梦想,很多关键技术难题依然没有办法解决。如今,致力于1型糖尿病研究的国际小组——TrialNet发现口服胰岛素能够延缓1型糖尿病的发生。

口服胰岛素抑制自身免疫攻击

1型糖尿病是一种自身免疫性疾病,并没有与生活方式有关的2型糖尿病那么常见。1型糖尿病患者几乎没有胰岛素,因为他们的免疫系统错误地攻击胰腺中胰岛素产生的β细胞。治疗这类患者,必须通过注射或胰岛素泵来补充胰岛素。

研究的第一作者Carla Greenbaum博士说,胰岛素口服不同于注射胰岛素,并不能用来补充胰岛素,它对血糖没有影响,因为消化系统破坏胰岛素药片的成分。这一理论认为口服产生的肽可能被免疫系统认为是无害的。研究人员希望,这可能会至少有一段时间抑制自身免疫性攻击。因为预防或延缓糖尿病将产生重大临床效果。

第一次延缓1型糖尿病的进展

研究人员测试了胰岛素药片对560名亲属患有1型糖尿病的儿童和成人的疗效,来了解口服胰岛素是否能延缓或预防1型糖尿病。对大多数人来说,这种药物起不到预防1型糖尿病的作用。但研究人员称,对于那些具有最大的患1型糖尿病风险的人来说,口服胰岛素会使这种全面发展的疾病推迟大约2到2年半的时间。

Greenbaum说:“这是用口服胰岛素进行的最大规模的研究。” Jessica Dunne,JDRF(原青少年糖尿病研究基金会)的研究主任,将结果称之为“一个巨大的成功。”Dunne说:“我们终于能够第一次延缓1型糖尿病的进展。”。但她补充说这些发现需要在其他研究中验证。

延迟1型糖尿病发病31个月

研究对象来自欧美各个国家。研究人员根据糖尿病风险将这些人分成四组,然后被随机挑选进一个主动治疗组,每天服用7.5毫克的胰岛素或安慰剂。一半的人随访了2.7年半,另一半少于这个时间。

在一小部分研究参与者中,研究人员发现口服胰岛素药片确实起了作用。Greenbaum说在那些已经显示出早期的低量胰岛素分泌人群中,相比安慰剂组,口服胰岛素治疗能够将1型糖尿病发病延迟31个月。

对高危人群有效的原因

Dunne说出现1型糖尿病延迟发病的人是“1型糖尿病的高危人群,可能已经有1型糖尿病。他们是最容易产生胰岛素依赖的人。”Greenbaum和她的团队推测这些人有反应是因为自身免疫性攻击可能当时已经很活跃了。但是,她补充道这只是一个理论。Dunne说这项研究也增加了证据,表明1型糖尿病并不是那种在每个人中都是一样的单一疾病。

Greenbaum说,她的团队已经在一个新的试验里测试较高剂量的胰岛素药片,来看看是否能更长地延缓病情。他们还希望测试胰岛素药片和治疗免疫系统的药物结合的效果。Dunne和Greenbaum建议延迟发病的能力可能有助于预防并发症(如失明和因愈合受损导致截肢)的发生。

参考资料

1) Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes

2) Insulin pill may delay type 1 diabetes in some

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  • Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes

    Importance Type 1 diabetes requires major lifestyle changes and carries increased morbidity and mortality. Prevention or delay of diabetes would have major clinical effect. Objective To determine whether oral insulin delays onset of type 1 diabetes in autoantibody-positive relatives of patients with type 1 diabetes. Design, Setting, and Participants Between March 2, 2007, and December 21, 2015, relatives with at least 2 autoantibodies, including insulin autoantibodies and normal glucose tolerance, were enrolled in Canada, the United States, Australia, New Zealand, the United Kingdom, Italy, Sweden, Finland, and Germany. The main study group (n = 389) had first-phase insulin release on an intravenous glucose tolerance test that was higher than the threshold. The 55 patients in the secondary stratum 1 had an identical antibody profile as the main study group except they had first-phase insulin release that was lower than the threshold. Secondary strata 2 (n = 114) and strata 3 (n = 3) had different autoantibody profiles and first-phase insulin release threshold combinations. Follow-up continued through December 31, 2016. Interventions Randomization to receive 7.5 mg/d of oral insulin (n = 283) or placebo (n = 277), including participants in the main study group who received oral insulin (n = 203) or placebo (n = 186). Main Outcome and Measures The primary outcome was time to diabetes in the main study group. Significance was based on a 1-sided threshold of .05, and 1-sided 95% CIs are reported. Results Of a total of 560 randomized participants (median enrollment age, 8.2 years; interquartile range [IQR], 5.7-12.1 years; 170 boys [60%]; 90.7% white non-Hispanic; 57.6% with a sibling with type 1 diabetes), 550 completed the trial including 389 participants (median age, 8.4 years; 245 boys [63%]), 382 (96%) in the main study group. During a median follow-up of 2.7 years (IQR, 1.5-4.6 years) in the main study group, diabetes was diagnosed in 58 participants (28.5%) in the oral insulin group and 62 (33%) in the placebo group. Time to diabetes was not significantly different between the 2 groups (hazard ratio [HR], 0.87; 95% CI, 0-1.2; P = .21). In secondary stratum 1 (n = 55), diabetes was diagnosed in 13 participants (48.1%) in the oral insulin group and in 19 participants (70.3%) in the placebo group. The time to diabetes was significantly longer with oral insulin (HR, 0.45; 95% CI, 0-0.82; P = .006). The HR for time to diabetes for the between-group comparisons for the 116 participants in the other secondary stratum was 1.03 (95% CI, 0-2.11; P = .53) and for the entire cohort of 560 participants was 0.83 (95% CI, 0-1.07; P = .11), which were not significantly different. The most common adverse event was infection (n = 254), with 134 events in the oral insulin group and 120 events in the placebo group, but no significant study-related adverse events occurred. Conclusions and Relevance Among autoantibody-positive relatives of patients with type 1 diabetes, oral insulin at a dose of 7.5 mg/d, compared with placebo, did not delay or prevent the development of type 1 diabetes over 2.7 years. These findings do not support oral insulin as used in this study for diabetes prevention.

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