Lancet：人工胰腺可改善1型糖尿病治疗

　　

生物通报道：最近，IRCM和蒙特利尔大学的研究人员，开展了第一项对比1型糖尿病三种治疗方法的临床试验，该试验由内分泌学家Rémi Rabasa-Lhoret博士带领。研究证实，与常规糖尿病治疗方法相比，体外人工胰腺可改善血糖控制和减少低血糖风险。相关研究结果，发表在2014年11月27日的《柳叶刀糖尿病和内分泌学》杂志（Lancet Diabetes & Endocrinology），可能对1型糖尿的治疗有着显著的影响，1型糖尿病是一种慢性疾病，可导致视力丧失和心血管疾病。

体外人工胰腺是治疗1型糖尿病的一种新兴技术，它是一种自动系统，通过根据血糖水平变化持续地调整胰岛素给药，来模拟正常胰腺。存在两种配置：仅传递胰岛素的单激素人工胰腺，和传递胰岛素及胰高血糖素的双激素人工胰腺。胰岛素可降低血糖水平，但胰高血糖素具有相反的效果，会提高血糖水平。

IRCM肥胖、代谢和糖尿病研究诊所主任、蒙特利尔大学营养系的Rabasa-Lhoret博士称：“我们的临床试验首次将人工胰腺的这两种配置，与常规利用胰岛素泵的胰岛素治疗相比较。我们想要确定胰高血糖素在人工胰腺中的作用，特别是防止低血糖，这仍然是达到血糖目标的主要障碍。”

1型糖尿病患者必须认真管理自己的血糖水平，确保他们保持在目标范围内，以防止严重的、长期的高血糖水平相关并发症（例如失明、肾衰竭），并减少低血糖风险（危险的低血糖可能会导致混乱、迷失方向，严重的会导致意识丧失、抽搐和昏迷）。

本研究第一作者、Rabasa-Lhoret博士研究组的博士后Ahmad Haidar解释说：“我们的研究证实，相比较传统的泵治疗，人造胰腺系统可改善血糖控制，并减少低血糖的风险。此外，我们发现，相比较单激素系统来说，双激素人工胰腺更加能够减少低血糖。”

蒙特利尔儿童医院儿科内分泌学家、本文共同作者Laurent Legault博士补充说：“鉴于低血糖在夜间仍然非常频繁，对严重夜间低血糖的恐惧，是压力和焦虑的一个主要来源，特别是家有糖尿病儿童的父母。人工胰腺有潜力大幅改善糖尿病的管理，以及患者和家庭的生活质量。”

IRCM研究人员正在进行人工胰腺的临床试验，以更长的时间和更大的患者群体，测试该系统。在未来五到七年内，该技术有望投入市场，早期世代专注于夜间血糖控制。

根据加拿大糖尿病协会介绍，全球估计有2.85亿人患有糖尿病，大约有10%为1型糖尿病。每年都有100万人患上糖尿病，到2030年这个数字可达438万，使其成为一种全球性的流行病。今天，超过900万的加拿大人正患糖尿病或前驱糖尿病。

随机对照试验在患有1型糖尿病的30名成年人和青少年中，比较了双激素人工胰腺、单激素人工胰腺和常规胰岛素泵治疗，这些人在过去至少三个月内接受了胰岛素泵治疗。患者三次被送往IRCM的临床研究结构。每次就诊包括调查三餐、选择的社会活动、夜间锻炼、睡前点心和过夜，在这些过程中监测血糖水平。

（生物通：王英）

延伸阅读：科学家开发出人工胰腺设备可帮助患者调节血糖

生物通推荐原文摘要：
Each visit included three meals, chosen social activities, an evening exercise, a bedtime snack and an overnight stay, throughout which blood glucose levels were monitored.
Summary
Background
The artificial pancreas is an emerging technology for the treatment of type 1 diabetes and two configurations have been proposed: single-hormone (insulin alone) and dual-hormone (insulin and glucagon). We aimed to delineate the usefulness of glucagon in the artificial pancreas system.
Methods
We did a randomised crossover trial of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy (continuous subcutaneous insulin infusion) in participants aged 12 years or older with type 1 diabetes. Participants were assigned in a 1:1:1:1:1:1 ratio with blocked randomisation to the three interventions and attended a research facility for three 24-h study visits. During visits when the patient used the single-hormone artificial pancreas, insulin was delivered based on glucose sensor readings and a predictive dosing algorithm. During dual-hormone artificial pancreas visits, glucagon was also delivered during low or falling glucose. During conventional insulin pump therapy visits, patients received continuous subcutaneous insulin infusion. The study was not masked. The primary outcome was the time for which plasma glucose concentrations were in the target range (4•0—10•0 mmol/L for 2 h postprandially and 4•0—8•0 mmol/L otherwise). Hypoglycaemic events were defined as plasma glucose concentration of less than 3•3 mmol/L with symptoms or less than 3•0 mmol/L irrespective of symptoms. Analysis was by modified intention to treat, in which we included data for all patients who completed at least two visits. A p value of less than 0•0167 (0•05/3) was regarded as significant. This trial is registered with ClinicalTrials.gov, number NCT01754337.
Findings
The mean proportion of time spent in the plasma glucose target range over 24 h was 62% (SD 18), 63% (18), and 51% (19) with single-hormone artificial pancreas, dual-hormone artificial pancreas, and conventional insulin pump therapy, respectively. The mean difference in time spent in the target range between single-hormone artificial pancreas and conventional insulin pump therapy was 11% (17; p=0•002) and between dual-hormone artificial pancreas and conventional insulin pump therapy was 12% (21; p=0•00011). There was no difference (15; p=0•75) in the proportion of time spent in the target range between the single-hormone and dual-hormone artificial pancreas systems. There were 52 hypoglycaemic events with conventional insulin pump therapy (12 of which were symptomatic), 13 with the single-hormone artificial pancreas (five of which were symptomatic), and nine with the dual-hormone artificial pancreas (0 of which were symptomatic); the number of nocturnal hypoglycaemic events was 13 (0 symptomatic), 0, and 0, respectively.
Interpretation
Single-hormone and dual-hormone artificial pancreas systems both provided better glycaemic control than did conventional insulin pump therapy. The single-hormone artificial pancreas might be sufficient for hypoglycaemia-free overnight glycaemic control.