Stratton I M, Adler A I, Neil H A, Matthews D R, Manley S E, Cull C A, Hadden D, Turner R C, Holman R R
Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Radcliffe Infirmary, Oxford OX2 6HE.
BMJ. 2000 Aug 12;321(7258):405-12. doi: 10.1136/bmj.321.7258.405.
To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes.
Prospective observational study.
23 hospital based clinics in England, Scotland, and Northern Ireland.
4585 white, Asian Indian, and Afro-Caribbean UKPDS patients, whether randomised or not to treatment, were included in analyses of incidence; of these, 3642 were included in analyses of relative risk.
Primary predefined aggregate clinical outcomes: any end point or deaths related to diabetes and all cause mortality. Secondary aggregate outcomes: myocardial infarction, stroke, amputation (including death from peripheral vascular disease), and microvascular disease (predominantly retinal photo-coagulation). Single end points: non-fatal heart failure and cataract extraction. Risk reduction associated with a 1% reduction in updated mean HbA(1c) adjusted for possible confounders at diagnosis of diabetes.
The incidence of clinical complications was significantly associated with glycaemia. Each 1% reduction in updated mean HbA(1c) was associated with reductions in risk of 21% for any end point related to diabetes (95% confidence interval 17% to 24%, P<0.0001), 21% for deaths related to diabetes (15% to 27%, P<0.0001), 14% for myocardial infarction (8% to 21%, P<0.0001), and 37% for microvascular complications (33% to 41%, P<0.0001). No threshold of risk was observed for any end point.
In patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia. Any reduction in HbA(1c) is likely to reduce the risk of complications, with the lowest risk being in those with HbA(1c) values in the normal range (<6.0%).
确定2型糖尿病患者随时间血糖暴露情况与大血管或微血管并发症风险之间的关系。
前瞻性观察性研究。
英格兰、苏格兰和北爱尔兰的23家医院门诊。
4585名英国糖尿病前瞻性研究(UKPDS)的白人、亚洲印度人和非洲加勒比人患者,无论是否随机接受治疗,均纳入发病率分析;其中3642名纳入相对风险分析。
预先设定的主要总体临床结局:任何与糖尿病相关的终点或死亡以及全因死亡率。次要总体结局:心肌梗死、中风、截肢(包括因外周血管疾病死亡)和微血管疾病(主要是视网膜光凝)。单一终点:非致命性心力衰竭和白内障摘除术。校正糖尿病诊断时可能的混杂因素后,糖化血红蛋白(HbA1c)每降低1%所带来的风险降低情况。
临床并发症的发生率与血糖水平显著相关。糖化血红蛋白(HbA1c)每降低1%,与糖尿病相关的任何终点风险降低21%(95%置信区间17%至24%,P<0.0001),糖尿病相关死亡风险降低21%(15%至27%,P<0.0001),心肌梗死风险降低14%(8%至21%,P<0.0001),微血管并发症风险降低37%(33%至41%,P<0.0001)。未观察到任何终点的风险阈值。
在2型糖尿病患者中,糖尿病并发症的风险与既往高血糖密切相关。糖化血红蛋白(HbA1c)的任何降低都可能降低并发症风险,HbA1c值在正常范围(<6.0%)的患者风险最低。