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长效胰岛素类似物与糖尿病视网膜病变:一项回顾性队列研究。

Long-acting insulin analogues and diabetic retinopathy: a retrospective cohort study.

作者信息

Lin Jen-Chieh, Shau Wen-Yi, Lai Mei-Shu

机构信息

Department of Ophthalmology, Taipei City Hospital, Heping Fuyoy Branch, Taipei, Taiwan; Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.

Graduate Institute of Clinical Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

Clin Ther. 2014 Sep 1;36(9):1255-68. doi: 10.1016/j.clinthera.2014.06.031. Epub 2014 Jul 28.

Abstract

PURPOSE

Long-acting insulin analogues were developed to facilitate consistent glycemic control without excessive hypoglycemia. However, structural modifications of the insulin molecule can alter biological responses and binding characteristics with specific receptors. The aim of this study was to estimate the risk of sight-threatening diabetic retinopathy (STDR) associated with treatment using long-acting insulin analogues compared with intermediate-acting insulin in patients with type 2 diabetes mellitus (T2DM).

METHODS

A retrospective cohort consisting of patients with T2DM aged 20 years of age and older with newly initiated treatment with long-acting insulin analogues (glargine and detemir) and intermediate-acting human insulin was identified from the National Health Insurance database between January 2004 and December 2006 and was subdivided into different cohorts. The risk of the development of STDR was determined by Cox regression models and compared between different cohorts.

FINDINGS

Of the 46,739 eligible patients, initiators of insulin glargine, insulin detemir, and neutral protamine Hagedorn (NPH) insulin were identified for comparison using propensity-score matching methods. Long-acting insulin analogues were not associated with changed risk for STDR by intention-to-treat and time-varying use approaches between either matched or unmatched cohorts.

IMPLICATIONS

The strategies that aim at preventing diabetic retinopathy by treating T2DM patients with long-acting insulin analogues remain further prospective studies with longer follow-up period to validate our observations within an appropriate dosage range and to further evaluate the safety of long-acting insulin analogues on reducing the progression of diabetic retinopathy.

摘要

目的

长效胰岛素类似物的研发旨在促进血糖的持续控制,同时避免严重低血糖。然而,胰岛素分子的结构修饰可改变生物学反应及与特定受体的结合特性。本研究的目的是评估2型糖尿病(T2DM)患者使用长效胰岛素类似物与中效胰岛素治疗相比,发生威胁视力的糖尿病视网膜病变(STDR)的风险。

方法

从2004年1月至2006年12月的国民健康保险数据库中,确定一个回顾性队列,该队列由年龄在20岁及以上、新开始使用长效胰岛素类似物(甘精胰岛素和地特胰岛素)及中效人胰岛素治疗的T2DM患者组成,并将其细分为不同队列。通过Cox回归模型确定STDR发生的风险,并在不同队列之间进行比较。

结果

在46739例符合条件的患者中,使用倾向评分匹配法确定了甘精胰岛素、地特胰岛素和中性鱼精蛋白锌(NPH)胰岛素的起始使用者进行比较。在匹配或未匹配的队列中,通过意向性治疗和时间变化使用方法,长效胰岛素类似物与STDR风险改变无关。

启示

旨在通过使用长效胰岛素类似物治疗T2DM患者来预防糖尿病视网膜病变的策略仍需进一步的前瞻性研究,进行更长时间的随访,以在适当剂量范围内验证我们的观察结果,并进一步评估长效胰岛素类似物在降低糖尿病视网膜病变进展方面的安全性。

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