MRC Epidemiology Unit, Institute of Metabolic Science, Cambridge, UK.
Lancet. 2011 Jul 9;378(9786):156-67. doi: 10.1016/S0140-6736(11)60698-3. Epub 2011 Jun 24.
Intensive treatment of multiple cardiovascular risk factors can halve mortality among people with established type 2 diabetes. We investigated the effect of early multifactorial treatment after diagnosis by screening.
In a pragmatic, cluster-randomised, parallel-group trial done in Denmark, the Netherlands, and the UK, 343 general practices were randomly assigned screening of registered patients aged 40-69 years without known diabetes followed by routine care of diabetes or screening followed by intensive treatment of multiple risk factors. The primary endpoint was first cardiovascular event, including cardiovascular mortality and morbidity, revascularisation, and non-traumatic amputation within 5 years. Patients and staff assessing outcomes were unaware of the practice's study group assignment. Analysis was done by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00237549.
Primary endpoint data were available for 3055 (99·9%) of 3057 screen-detected patients. The mean age was 60·3 (SD 6·9) years and the mean duration of follow-up was 5·3 (SD 1·6) years. Improvements in cardiovascular risk factors (HbA(1c) and cholesterol concentrations and blood pressure) were slightly but significantly better in the intensive treatment group. The incidence of first cardiovascular event was 7·2% (13·5 per 1000 person-years) in the intensive treatment group and 8·5% (15·9 per 1000 person-years) in the routine care group (hazard ratio 0·83, 95% CI 0·65-1·05), and of all-cause mortality 6·2% (11·6 per 1000 person-years) and 6·7% (12·5 per 1000 person-years; 0·91, 0·69-1·21), respectively.
An intervention to promote early intensive management of patients with type 2 diabetes was associated with a small, non-significant reduction in the incidence of cardiovascular events and death.
National Health Service Denmark, Danish Council for Strategic Research, Danish Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, Danish National Board of Health, Danish Medical Research Council, Aarhus University Research Foundation, Wellcome Trust, UK Medical Research Council, UK NIHR Health Technology Assessment Programme, UK National Health Service R&D, UK National Institute for Health Research, Julius Center for Health Sciences and Primary Care, University Medical Center, Utrecht, Novo Nordisk, Astra, Pfizer, GlaxoSmithKline, Servier, HemoCue, Merck.
强化治疗多种心血管危险因素可使已确诊 2 型糖尿病患者的死亡率减半。我们通过筛查来研究诊断后早期进行多因素治疗的效果。
在丹麦、荷兰和英国进行的一项实用、集群随机、平行组试验中，343 家普通诊所通过筛查年龄在 40-69 岁、无已知糖尿病的登记患者，随后对糖尿病患者进行常规治疗或对筛查患者进行强化治疗多种危险因素。主要终点是 5 年内首次心血管事件，包括心血管死亡率和发病率、血运重建和非创伤性截肢。评估结果的患者和工作人员不知道诊所的研究组分配。分析按意向治疗进行。该研究在 ClinicalTrials.gov 注册，编号为 NCT00237549。
3057 名筛查出的患者中有 3055 名（99.9%）有主要终点数据。平均年龄为 60.3（6.9）岁，平均随访时间为 5.3（1.6）年。强化治疗组的心血管危险因素（HbA1c 和胆固醇浓度及血压）改善略但显著优于常规治疗组。强化治疗组的首次心血管事件发生率为 7.2%（13.5/1000人年），常规治疗组为 8.5%（15.9/1000 人年）（风险比 0.83，95%CI 0.65-1.05），全因死亡率分别为 6.2%（11.6/1000 人年）和 6.7%（12.5/1000 人年）（0.91，0.69-1.21）。
促进 2 型糖尿病患者早期强化管理的干预措施与心血管事件和死亡发生率的小幅、无统计学意义降低相关。
丹麦国民健康服务部、丹麦战略研究理事会、丹麦研究基金会全科医学、丹麦评估和卫生技术评估中心、丹麦国家卫生局、丹麦医学研究理事会、奥胡斯大学研究基金会、惠康信托基金会、英国医学研究理事会、英国国民健康保险制度研究与发展署、英国国家健康研究所、丹麦朱利叶斯中心健康科学和初级保健、乌得勒支大学医学中心、诺和诺德、阿斯利康、辉瑞、葛兰素史克、施维雅、海默科尤、默克。
Zotero 插件
