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2015年英国国家卫生与临床优化研究所(NICE)妊娠期糖尿病标准的临床意义

Clinical Implications of the NICE 2015 Criteria for Gestational Diabetes Mellitus.

作者信息

Bhatia Meena, Mackillop Lucy H, Bartlett Katy, Loerup Lise, Kenworthy Yvonne, Levy Jonathan C, Farmer Andrew J, Velardo Carmelo, Tarassenko Lionel, Hirst Jane E

机构信息

Oxford University Hospitals NHS Foundation Trust, Headington OX3 9DU, UK.

Nuffield Department of Women's Reproductive Health, University of Oxford, Oxford OX3 9DU, UK.

出版信息

J Clin Med. 2018 Oct 22;7(10):376. doi: 10.3390/jcm7100376.

Abstract

BACKGROUND

In response to concerns that the International Association of Diabetes in Pregnancy Study Group (IADPSG) criteria labeled too many women with gestational diabetes mellitus (GDM) without evidence of clinical or economic benefit, NICE recommended a change in diagnostic criteria in 2015.

AIM

To compare diabetes associated maternal and neonatal complications in pregnancies complicated by GDM diagnosed using IADPSG criteria only, to those with GDM diagnosed using both IADPSG and NICE 2015 criteria. GDM screening was risk factor based.

METHODS

This was a secondary analysis of a trial of women with GDM diagnosed by the IADPSG criteria (fasting blood glucose (BG) ≥ 5.1 mmol/L, 1 h ≥ 10.0 mmol/L and 2 h ≥ 8.5 mmol/L). Outcomes were compared for two groups: NICE + IADPSG defined as those with GDM diagnosed by both the NICE 2015 and IADPSG criteria (fasting BG ≥ 5.6 mmol/L, 2 h ≥ 8.5 mmol/L); and IADPSG-ONLY (fasting BG 5.1 mmol/L to 5.5 mmol/L, and/or 1-hour ≥10.0 mmol/L, and 2 h ≥ 8.5 mmol/L). We were not able to obtain data for women with a 2-h value between BG 7.8⁻8.4 mmol/L (i.e., NICE-ONLY; NICE 2015 positive and IADPSG negative). All women were treated for GDM using targets of fasting BG < 5.3 mmol/L and 1-h post prandial BG < 7.8 mmol/L respectively.

RESULTS

Of 159 women, 65 (40.9%) were NICE + IADPSG and 94 (59.1%) IADPSG-ONLY. Hypoglycaemic medication use was similar in both groups: 52.3% NICE + IADPSG, 46.8% IADPSG-ONLY, OR 1.0 (0.5⁻1.9). The IADPSG-ONLY group delivered later than the NICE + IADPSG group; 39.0 weeks (sd 1.4) compared to 38.2 weeks (sd 2.5), value 0.02. Fewer caesarean sections occurred in IADPSG-ONLY group 30.9% vs. 52.3%, OR 0.4 (0.2⁻0.9). Birthweight, large for gestational age, and other neonatal complications were not significantly different between groups.

CONCLUSIONS

Gestational diabetes-associated perinatal complications were similar in both groups. The IADPSG criteria detect women with evidence of ongoing hyperglycaemia who may benefit from treatment during pregnancy.

摘要

背景

鉴于国际妊娠糖尿病研究组(IADPSG)的诊断标准将过多女性诊断为妊娠糖尿病(GDM),却无临床或经济效益方面的证据,英国国家卫生与临床优化研究所(NICE)于2015年建议更改诊断标准。

目的

比较仅采用IADPSG标准诊断为GDM的妊娠中与糖尿病相关的孕产妇及新生儿并发症,与采用IADPSG和NICE 2015标准联合诊断为GDM的妊娠中的并发症情况。GDM筛查基于风险因素。

方法

这是一项对采用IADPSG标准(空腹血糖(BG)≥5.1 mmol/L,1小时≥10.0 mmol/L,2小时≥8.5 mmol/L)诊断为GDM的女性进行的试验的二次分析。比较两组的结局:NICE + IADPSG组定义为采用NICE 2015和IADPSG标准联合诊断为GDM的女性(空腹BG≥5.6 mmol/L,2小时≥8.5 mmol/L);仅IADPSG组(空腹BG 5.1 mmol/L至5.5 mmol/L,和/或1小时≥10.0 mmol/L,2小时≥8.5 mmol/L)。我们无法获取2小时BG值在7.8⁻8.4 mmol/L之间的女性的数据(即仅NICE组;NICE 2015标准阳性而IADPSG标准阴性)。所有GDM女性的治疗目标分别为空腹BG < 5.3 mmol/L和餐后1小时BG < 7.8 mmol/L。

结果

159名女性中,65名(40.9%)为NICE + IADPSG组,94名(59.1%)为仅IADPSG组。两组使用降糖药物的情况相似:NICE + IADPSG组为52.3%,仅IADPSG组为46.8%,比值比为1.0(0.5⁻1.9)。仅IADPSG组的分娩时间晚于NICE + IADPSG组;分别为39.0周(标准差1.4)和38.2周(标准差2.5),P值为0.02。仅IADPSG组的剖宫产率较低,分别为30.9%和52.3%,比值比为0.4(0.2⁻0.9)。两组间出生体重、大于胎龄儿及其他新生儿并发症无显著差异。

结论

两组中与妊娠糖尿病相关的围产期并发症相似。IADPSG标准能检测出有持续高血糖证据且可能在孕期从治疗中获益的女性。

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