Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)-猫眼课题宝

DOI：

10.1016/s0140-6736(98)07019-6

发表时间：

1998-09-12

期刊：

LANCET

影响因子：

168.9

通讯作者：

中科院分区：

医学1区

文献类型：

作者：

Turner, RC;Holman, RR;Ward, JD

背景：改善血糖控制可降低糖尿病微血管病变的进展，但对大血管并发症的影响尚不清楚。人们担心磺脲类药物可能增加2型糖尿病患者的心血管死亡率，高胰岛素浓度可能促进动脉粥样硬化的形成。我们在一项随机对照试验中比较了磺脲类药物或胰岛素强化血糖控制与常规治疗对2型糖尿病患者微血管和大血管并发症风险的影响。方法3867例新诊断的2型糖尿病患者，中位年龄54岁（IQR 48-60岁），在3个月的饮食治疗后，平均两次空腹血糖（FPG）浓度为6.1-15.0 mmol/L，随机分配磺脲类药物（氯磺丙脲，格列本脲，或.格列吡嗪）或胰岛素，或饮食的常规策略。强化组的目标是FPG <6 mmol/L。常规组以饮食补偿下达到最佳FPG为目标，仅在出现高血糖症状或FPG> 15 mmol/L时加用药物。使用三个汇总终点来评估常规治疗和强化治疗之间的差异：任何糖尿病相关终点（猝死、高血糖或低血糖导致的死亡、致死性或非致死性心肌梗死、心绞痛、心力衰竭、卒中、肾衰竭、截肢[至少一个手指]、玻璃体出血、需要光凝的视网膜病变、单眼失明或白内障摘除）;糖尿病相关死亡（心肌梗死、卒中、外周血管疾病、肾脏疾病、高血糖或低血糖和猝死导致的死亡）;全因死亡。还评估了单个临床终点和替代亚临床终点。所有的分析都是通过意向治疗和低血糖的频率进行了分析，实际therapy.Findings超过10年，血红蛋白A（1c）（HbA（1c））是7.0%（6.2-8.2）在强化组相比，7.9%（6.9-8.8）在常规组-一个11%的减少。强化组中各药物之间的HbA（1c）无差异。与常规组相比，强化组的任何糖尿病相关终点的风险降低12%（95%CI 1-21，p=0.029）;任何糖尿病相关死亡的风险降低10%（-11至27，p=0.34）;全因死亡率降低6%（-10至20，p=0.44）。任何糖尿病相关综合终点的大部分风险降低是由于微血管终点的风险降低25%（7-40，p=0.0099），包括视网膜光凝的需要。三种强化治疗药物（氯磺丙脲、格列本脲或胰岛素）的三个综合终点中的任何一个都没有差异。在两种类型的分析中，强化治疗组的患者比常规治疗组的患者有更多的低血糖发作（均p

Background Improved blood-glucose control decreases the progression of diabetic microvascular disease, but the effect on macrovascular complications is unknown. There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation. We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a randomised controlled trial.Methods 3867 newly diagnosed patients with type 2 diabetes, median age 54 years (IQR 48-60 years), who after 3 months' diet treatment had a mean of two fasting plasma glucose (FPG) concentrations of 6.1-15.0 mmol/L were randomly assigned intensive policy with a sulphonylurea (chlorpropamide, glibenclamide, or. glipizide) or with insulin, or conventional policy with diet. The aim in the intensive group was FPG less than 6 mmol/L. in the conventional group, the aim was the best achievable FPG with diet atone; drugs were added only if there were hyperglycaemic symptoms or FPG greater than 15 mmol/L. Three aggregate endpoints were used to assess differences between conventional and intensive treatment: any diabetes-related endpoint (sudden death, death from hyperglycaemia or hypoglycaemia, fatal or non-fatal myocardial infarction, angina, heart failure, stroke, renal failure, amputation [of at least one digit], vitreous haemorrhage, retinopathy requiring photocoagulation, blindness in one eye,or cataract extraction); diabetes-related death (death from myocardial infarction, stroke, peripheral vascular disease, renal disease, hyperglycaemia or hypoglycaemia, and sudden death); all-cause mortality. Single clinical endpoints and surrogate subclinical endpoints were also assessed. All analyses were by intention to treat and frequency of hypoglycaemia was also analysed by actual therapy.Findings Over 10 years, haemoglobin A(1c) (HbA(1c)) was 7.0% (6.2-8.2) in the intensive group compared with 7.9% (6.9-8.8) in the conventional group-an 11% reduction. There was no difference in HbA(1c) among agents in the intensive group. Compared with the conventional group, the risk in the intensive group was 12% lower (95% CI 1-21, p=0.029) for any diabetes-related endpoint; 10% lower (-11 to 27, p=0.34) for any diabetes-related death; and 6% lower (-10 to 20, p=0.44) for all-cause mortality. Most of the risk reduction in the any diabetes-related aggregate endpoint was due to a 25% risk reduction (7-40, p=0.0099) in microvascular endpoints, including the need for retinal photocoagulation. There was no difference for any of the three aggregate endpoints the three intensive agents (chlorpropamide, glibenclamide, or insulin).Patients in the intensive group had more hypoglycaemic episodes than those in the conventional group on both types of analysis (both p

Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)

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