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ADDITION研究:关于通过筛查发现的2型糖尿病患者强化多因素干预对发病率和死亡率的成本效益的拟议试验。

The ADDITION study: proposed trial of the cost-effectiveness of an intensive multifactorial intervention on morbidity and mortality among people with Type 2 diabetes detected by screening.

作者信息

Lauritzen T, Griffin S, Borch-Johnsen K, Wareham N J, Wolffenbuttel B H, Rutten G

机构信息

Department of General Practice, University of Aarhus, Denmark.

出版信息

Int J Obes Relat Metab Disord. 2000 Sep;24 Suppl 3:S6-11. doi: 10.1038/sj.ijo.0801420.

DOI:10.1038/sj.ijo.0801420
PMID:11063279
Abstract

OBJECTIVE

The overall aims of the ADDITION study are to evaluate whether screening for prevalent undiagnosed Type 2 diabetes is feasible, and whether subsequent optimised intensive treatment of diabetes, and associated risk factors, is feasible and beneficial.

DESIGN

Population-based screening in three European countries followed by an open, randomised controlled trial.

SUBJECTS AND METHODS

People aged 40-69 y in the community, without known diabetes, will be offered a random capillary blood glucose screening test by their primary care physicians, followed, if equal to or greater than 5.5 mmol/l, by fasting and 2-h post-glucose-challenge blood glucose measurements. Three thousand newly diagnosed patients will subsequently receive conventional treatment (according to current national guidelines) or intensive multifactorial treatment (lifestyle advice, prescription of aspirin and ACE-inhibitors, in addition to protocol-driven tight control of blood glucose, blood pressure and cholesterol). Patients allocated to intensive treatment will be further randomised to centre-specific interventions to motivate adherence to lifestyle changes and medication. Duration of follow-up is planned for 5 y. Endpoints will include mortality, macrovascular and microvascular complications, patient health status and satisfaction, process-of-care indicators and costs.

摘要

目的

ADDITION研究的总体目标是评估对未确诊的2型糖尿病进行筛查是否可行,以及随后对糖尿病及相关危险因素进行优化强化治疗是否可行且有益。

设计

在三个欧洲国家进行基于人群的筛查,随后进行开放、随机对照试验。

研究对象与方法

社区中年龄在40 - 69岁、无已知糖尿病的人群将由其初级保健医生提供随机毛细血管血糖筛查检测,若血糖等于或高于5.5 mmol/l,则进一步进行空腹及葡萄糖耐量试验后2小时血糖测量。随后,3000名新确诊的患者将接受常规治疗(根据当前国家指南)或强化多因素治疗(生活方式建议、阿司匹林和血管紧张素转换酶抑制剂处方,以及按照方案严格控制血糖、血压和胆固醇)。分配到强化治疗组的患者将进一步随机接受特定中心的干预措施,以促使其坚持生活方式改变和药物治疗。计划随访期为5年。终点指标将包括死亡率、大血管和微血管并发症、患者健康状况和满意度、医疗过程指标及成本。

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The ADDITION study: proposed trial of the cost-effectiveness of an intensive multifactorial intervention on morbidity and mortality among people with Type 2 diabetes detected by screening.ADDITION研究:关于通过筛查发现的2型糖尿病患者强化多因素干预对发病率和死亡率的成本效益的拟议试验。
Int J Obes Relat Metab Disord. 2000 Sep;24 Suppl 3:S6-11. doi: 10.1038/sj.ijo.0801420.
2
The ADDITION-Cambridge trial protocol: a cluster -- randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients.ADDITION-剑桥试验方案:一项关于2型糖尿病筛查及对筛查出患者进行强化治疗的整群随机对照试验。
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Rationale and design of the ADDITION-Leicester study, a systematic screening programme and randomised controlled trial of multi-factorial cardiovascular risk intervention in people with type 2 diabetes mellitus detected by screening.ADDITION-Leicester 研究的原理和设计,这是一项针对通过筛查发现的 2 型糖尿病患者进行多因素心血管风险干预的系统筛查计划和随机对照试验。
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Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial.10 年期间筛查 2 型糖尿病和人群死亡率(ADDITION-Cambridge):一项集群随机对照试验。
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Does training of general practitioners for intensive treatment of people with screen-detected diabetes have a spillover effect on mortality and cardiovascular morbidity in 'at risk' individuals with normoglycaemia? Results from the ADDITION-Denmark cluster-randomised controlled trial.对全科医生进行培训以强化治疗筛查发现的糖尿病患者,这对血糖正常的“高危”个体的死亡率和心血管疾病发病率是否有溢出效应?来自丹麦ADDITION集群随机对照试验的结果。
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Repaglinide : a pharmacoeconomic review of its use in type 2 diabetes mellitus.瑞格列奈:对其在2型糖尿病治疗中应用的药物经济学综述
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Stepwise screening for diabetes identifies people with high but modifiable coronary heart disease risk. The ADDITION study.逐步筛查糖尿病可识别出冠心病风险高但可改变的人群。ADDITION研究。
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Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial.早期强化多因素治疗对筛查出的 2 型糖尿病患者 5 年心血管结局的影响(ADDITION-Europe):一项集群随机试验。
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Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy.药房糖尿病筛查试验:一项实用的整群随机对照试验方案,用于比较澳大利亚社区药房中三种未诊断2型糖尿病的筛查方法。
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