儿童2型糖尿病和糖调节异常筛查方案的研究

The study of screening for type 2 diabetes and impaired glucose regulation in children

目的评价及比较在不同特征人群中进行2型糖尿病(T2DM)和糖调节异常(IGR)筛查的效果及成本,优化和推荐儿童青少年T2DM筛查方案。方法采用分层整群随机抽样方法获取19593例北京市中小学生,用空腹指末梢血糖(FCBG)对其进行T2DM和IGR筛查,FCBG异常者(≥5.6mmol·L-1)采用1999年WHO口服葡萄糖耐量试验标准进行诊断。并参照美国糖尿病协会建议儿童青少年T2DM筛查的高危对象标准和Dean提出的诊断标准进行T2DM的分型诊断。将研究人群分为一般人群、超重/肥胖和肥胖组,分别计算回访率、血糖异常阳性率、直接医疗成本和确诊每例成本,根据成本-效果推荐儿童青少年T2DM筛查方案。结果一般人群组,FCBG异常者回访率为47.97%(225/469),超重/肥胖和肥胖组FCBG异常者回访率分别为59.29%(83/140)和68.00%(51/75),差异有统计学意义。一般人群组T2DM/IGR确诊率最低,为1.67/1000例;总花费11.21万元和确诊每例T2DM/IGR的花费0.35万元,最高。肥胖组T2DM/IGR确诊率最高,为8.09/1000例;总花费1.62万元和确诊每例T2DM/IGR的花费0.11万元,最低,较一般人群组分别下降85.55%和68.57%。超重/肥胖组介于两者之间。肥胖、超重/肥胖与一般人群组相比,肥胖组有2例T2DM(33.33%,2/6)漏诊,超重/肥胖组没有T2DM漏诊。建议在超重/肥胖组中进行T2DM和IGR筛查。进一步选择除超重/肥胖外,与T2DM相关的危险因素(黑棘皮病、T2DM家族史和青春期),随调查对象具有危险因素数量的增加,患病危险性增加,筛查依从性增高,T2DM/IGR确诊率升高,筛查总成本和每例成本降低,但是从调查对象具有3个或以上危险因素开始,对T2DM/IGR筛查敏感度下降,与在一般人群组筛查相比,在4个危险因素人群中进行筛查,将有83.33%的T2DM得不到确诊。结论本大样本研究以成本-效果分析说明:在儿童中符合健康经济学的T2DM筛查方案是在达到超重标准,同时具有1个以上危险因素(黑棘皮病、T2DM家族史和青春期)儿童青少年中进行目的性筛查。

Objective To compare and evaluate the cost-effectiveness of different screening protocol for type 2 diabetes （T2DM） or impaired glucose regulation （IGR）,and to suggest the protocol.Methods The population for survey was selected as a stratified cluster sample from 8 urban and 10 rural areas in Beijing. Fasting capillary blood glucose （FCBG） was determined in 19 593 children and adolescents aged 6 to 18 years in 4 urban and 3 rural areas using haemosaccharometer model Ⅱ（Roche Diagnostic, （Shanghai） Ltd ）. OGTT was performed in those with FCBG≥5.6 mmol·L^-1 following initial screening. The diagnosis of diabetes mellitus was reached according to the criteria of WHO, the diagnosis of type 2 diabetes mellitus was reached according to the high-risk criteria of screening for type 2 diabetes of ADA and the criteria raised by Dean. The whole study population was divided into different groups according to clinical features,general population, overweight/obese, obese group and those with other T2DM risk factors, including acanthosis nigricans, family history of T2DM and puberty, the response rate, final diagnosis rate, and cost-effectiveness of different screening protocol were calculated, then the best subgroup fit for screening was chosen and the screening protocol was suggested.Results The response rate of abnormal FCBG among general population（48%）, was significantly lower than those among overweight and obese group （59.29% and 68.00%, respectively）. General population had the lowest final diagnosis rate（1.67/1 000 cases）, highest total direct medical cost （112.1 thousands yuan） and highest cost per case （3.5 thousands yuan）. Obese group had the highest final diagnosis rate（8.09/1 000 cases）, lowest total direct medical cost （16.2 thousands yuan） and lowest cost per case （1.1 thousands yuan）. Compared with the general population, 2 cases of T2DM were misdiagnosed in obese group, 15 and 12 cases of IGR were misdiagnosed in obese and overweight group respectively. Screening T2DM and IGR should be performed in overweight children. Choosing risk factors correlated with T2DM including overweight, acanthosis nigricans, family history of T2DM and puberty, with the number of risk factors increased, the compliance rate and the prevalence of T2DM/IGR were increased, total cost and cost per case were declined. However, if a subject had 3 or more risk factors, the sensitivity of screening was declined, 83.3% of T2DM would be misdiagnosed when screening was performed in those who had 4 risk factors.Conclusions The study group recommended that screening for T2DM and IGR should be performed in high-risk children. Those with 2 or more risk factors aged 8-18 years should be recommended to be screened when considering cost and effectiveness simultaneously.