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2型糖尿病筛查

Screening for type 2 diabetes mellitus.

作者信息

Peer Nasheeta, Balakrishna Yusentha, Durao Solange

机构信息

Non-communicable Diseases Research Unit, South African Medical Research Council, Durban, South Africa.

Biostatistics Unit, South African Medical Research Council, Durban, South Africa.

出版信息

Cochrane Database Syst Rev. 2020 May 29;5(5):CD005266. doi: 10.1002/14651858.CD005266.pub2.

Abstract

BACKGROUND

Diabetes mellitus, a metabolic disorder characterised by hyperglycaemia and associated with a heavy burden of microvascular and macrovascular complications, frequently remains undiagnosed. Screening of apparently healthy individuals may lead to early detection and treatment of type 2 diabetes mellitus and may prevent or delay the development of related complications.

OBJECTIVES

To assess the effects of screening for type 2 diabetes mellitus.

SEARCH METHODS

We searched CENTRAL, MEDLINE, LILACS, the WHO ICTRP, and ClinicalTrials.gov from inception. The date of the last search was May 2019 for all databases. We applied no language restrictions.

SELECTION CRITERIA

We included randomised controlled trials involving adults and children without known diabetes mellitus, conducted over at least three months, that assessed the effect of diabetes screening (mass, targeted, or opportunistic) compared to no diabetes screening.

DATA COLLECTION AND ANALYSIS

Two review authors independently screened titles and abstracts for potential relevance and reviewed the full-texts of potentially relevant studies, extracted data, and carried out 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool. We assessed the overall certainty of the evidence using the GRADE approach.

MAIN RESULTS

We screened 4651 titles and abstracts identified by the search and assessed 92 full-texts/records for inclusion. We included one cluster-randomised trial, the ADDITION-Cambridge study, which involved 20,184 participants from 33 general practices in Eastern England and assessed the effects of inviting versus not inviting high-risk individuals to screening for diabetes. The diabetes risk score was used to identify high-risk individuals; it comprised variables relating to age, sex, body mass index, and the use of prescribed steroid and anti-hypertensive medication. Twenty-seven practices were randomised to the screening group (11,737 participants actually attending screening) and 5 practices to the no-screening group (4137 participants). In both groups, 36% of participants were women; the average age of participants was 58.2 years in the screening group and 57.9 years in the no-screening group. Almost half of participants in both groups were on antihypertensive medication. The findings from the first phase of this study indicate that screening compared to no screening for type 2 diabetes did not show a clear difference in all-cause mortality (hazard ratio (HR) 1.06, 95% confidence interval (CI) 0.90 to 1.25, low-certainty evidence). Screening compared to no screening for type 2 diabetes mellitus showed an HR of 1.26, 95% CI 0.75 to 2.12 (low-certainty evidence) for diabetes-related mortality (based on whether diabetes was reported as a cause of death on the death certificate). Diabetes-related morbidity and health-related quality of life were only reported in a subsample and did not show a substantial difference between the screening intervention and control. The included study did not report on adverse events, incidence of type 2 diabetes, glycosylated haemoglobin A1c (HbA1c), and socioeconomic effects.

AUTHORS' CONCLUSIONS: We are uncertain about the effects of screening for type 2 diabetes on all-cause mortality and diabetes-related mortality. Evidence was available from one study only. We are therefore unable to draw any firm conclusions relating to the health outcomes of early type 2 diabetes mellitus screening. Furthermore, the included study did not assess all of the outcomes prespecified in the review (diabetes-related morbidity, incidence of type 2 diabetes, health-related quality of life, adverse events, socioeconomic effects).

摘要

背景

糖尿病是一种以高血糖为特征的代谢紊乱疾病,伴有微血管和大血管并发症的沉重负担,常常未被诊断出来。对看似健康的个体进行筛查可能会实现2型糖尿病的早期发现和治疗,并可能预防或延缓相关并发症的发生。

目的

评估2型糖尿病筛查的效果。

检索方法

我们从数据库建库起就开始检索Cochrane系统评价数据库、MEDLINE、拉丁美洲及加勒比地区卫生科学数据库、世界卫生组织国际临床试验注册平台和美国国立医学图书馆临床试验数据库。所有数据库的最后检索日期为2019年5月。我们没有设置语言限制。

入选标准

我们纳入了涉及成人和儿童且无已知糖尿病的随机对照试验,试验持续时间至少三个月,评估糖尿病筛查(群体、目标性或机会性筛查)与不进行糖尿病筛查相比的效果。

数据收集与分析

两位综述作者独立筛选标题和摘要以判断潜在相关性,并对潜在相关研究的全文进行评审,提取数据,并使用Cochrane偏倚风险工具进行“偏倚风险”评估。我们采用GRADE方法评估证据的总体确定性。

主要结果

我们筛选了检索到的4651篇标题和摘要,并评估了92篇全文/记录以确定是否纳入。我们纳入了一项整群随机试验,即剑桥糖尿病筛查研究(ADDITION-Cambridge study),该研究涉及来自英格兰东部33家全科诊所的20184名参与者,评估了邀请高危个体与不邀请高危个体进行糖尿病筛查的效果。糖尿病风险评分用于识别高危个体;它包括与年龄、性别、体重指数以及使用处方类固醇和抗高血压药物相关的变量。27家诊所被随机分配到筛查组(11737名参与者实际参加了筛查),5家诊所被分配到不筛查组(4137名参与者)。两组中,36%的参与者为女性;筛查组参与者的平均年龄为58.2岁,不筛查组为57.9岁。两组中几乎一半的参与者正在服用抗高血压药物。这项研究第一阶段的结果表明,与不进行2型糖尿病筛查相比,筛查在全因死亡率方面没有显示出明显差异(风险比(HR)为1.06,95%置信区间(CI)为0.90至1.25,低确定性证据)。与不进行2型糖尿病筛查相比,筛查在糖尿病相关死亡率方面的HR为1.26,95%CI为0.75至2.12(低确定性证据)(基于死亡证明上是否将糖尿病报告为死亡原因)。仅在一个子样本中报告了糖尿病相关发病率和健康相关生活质量,筛查干预组和对照组之间没有显示出实质性差异。纳入的研究未报告不良事件、2型糖尿病发病率、糖化血红蛋白(HbA1c)以及社会经济影响。

作者结论

我们不确定2型糖尿病筛查对全因死亡率和糖尿病相关死亡率的影响。仅有一项研究提供了证据。因此,我们无法就2型糖尿病早期筛查的健康结局得出任何确凿结论。此外,纳入的研究未评估综述中预先设定的所有结局(糖尿病相关发病率、2型糖尿病发病率、健康相关生活质量、不良事件、社会经济影响)。

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