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使用肠促胰岛素类药物会增加 2 型糖尿病患者的癌症风险吗?

Does the use of incretin-based medications increase the risk of cancer in patients with type-2 diabetes mellitus?

机构信息

Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada.

Département de médecine sociale et préventive, Université de Montréal, Montréal, Québec, Canada.

出版信息

Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):489-499. doi: 10.1002/pds.4746. Epub 2019 Feb 18.

Abstract

PURPOSE

Incretin-based medications are a novel class of agents for the treatment of type-2 diabetes mellitus (DM2). The safety profile of these medications is not firmly established, and concerns have been raised about their potential carcinogenicity. The objective of our study was to produce new evidence on the effect of incretin-based medications on cancer risk in patients with DM2.

METHODS

We conducted a "retrospective cohort" study with data from the Clinical Practice Research Datalink and the Hospital Episodes Statistics in the UK. New users of either an incretin-based medication (n = 18 885) or a sulfonylurea medication (n = 36 929) between 2007 and 2013 were identified and followed for up to 8 years. Cox proportional-hazards models were used to estimate the quasi-intention-to-treat and quasi-per-protocol hazard-ratios for the association between incretin-based medications with cancer while adjusting for potential confounders.

RESULTS

The adjusted hazard ratio (95% confidence interval) for use of incretin-based medications versus use of sulfonylurea medications for the overall-cancer outcome was 0.97 (0.90, 1.05) in the quasi-intention-to-treat analysis and 0.90 (0.81, 1.00) in the quasi-per-protocol analysis. In both analyses, the hazard-ratio functions over the 8-year follow-up seemed fairly constant, and the 8-year cumulative-risk functions in the two subcohorts were similar.

CONCLUSIONS

Our study suggests that the use of incretin-based medications in patients with DM2 does not increase the risk of cancer relative to the use of sulfonylurea medications, at least in the first several years of the use. Further research is needed to assess long-term effects of the use of incretin-based medications on cancer risk.

摘要

目的

基于肠降血糖素的药物是治疗 2 型糖尿病(DM2)的一类新型药物。这些药物的安全性尚未得到充分确立,人们对其潜在致癌性表示担忧。我们的研究目的是提供关于 DM2 患者使用肠促胰岛素类药物对癌症风险影响的新证据。

方法

我们在英国的临床实践研究数据库和医院事件统计数据中进行了一项“回顾性队列”研究。在 2007 年至 2013 年期间,确定了新使用肠促胰岛素类药物(n=18885)或磺酰脲类药物(n=36929)的患者,并对其进行了长达 8 年的随访。使用 Cox 比例风险模型来估计在调整潜在混杂因素后,肠促胰岛素类药物与癌症之间的关联的准意向治疗和准方案风险比。

结果

在准意向治疗分析中,与使用磺酰脲类药物相比,使用肠促胰岛素类药物治疗总体癌症结局的调整后危险比(95%置信区间)为 0.97(0.90,1.05),在准方案分析中为 0.90(0.81,1.00)。在这两种分析中,8 年随访期间的风险比函数似乎相当稳定,两个亚队列的 8 年累积风险函数相似。

结论

我们的研究表明,与使用磺酰脲类药物相比,在 DM2 患者中使用肠促胰岛素类药物不会增加癌症风险,至少在使用的最初几年内是这样。需要进一步研究来评估使用肠促胰岛素类药物对癌症风险的长期影响。

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