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妊娠期糖尿病女性的治疗:Cochrane系统评价概述

Treatments for women with gestational diabetes mellitus: an overview of Cochrane systematic reviews.

作者信息

Martis Ruth, Crowther Caroline A, Shepherd Emily, Alsweiler Jane, Downie Michelle R, Brown Julie

机构信息

Liggins Institute, The University of Auckland, Park Road, Grafton, Auckland, New Zealand, 1142.

出版信息

Cochrane Database Syst Rev. 2018 Aug 14;8(8):CD012327. doi: 10.1002/14651858.CD012327.pub2.

DOI:10.1002/14651858.CD012327.pub2
PMID:30103263
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6513179/
Abstract

BACKGROUND

Successful treatments for gestational diabetes mellitus (GDM) have the potential to improve health outcomes for women with GDM and their babies.

OBJECTIVES

To provide a comprehensive synthesis of evidence from Cochrane systematic reviews of the benefits and harms associated with interventions for treating GDM on women and their babies.

METHODS

We searched the Cochrane Database of Systematic Reviews (5 January 2018) for reviews of treatment/management for women with GDM. Reviews of pregnant women with pre-existing diabetes were excluded.Two overview authors independently assessed reviews for inclusion, quality (AMSTAR; ROBIS), quality of evidence (GRADE), and extracted data.

MAIN RESULTS

We included 14 reviews. Of these, 10 provided relevant high-quality and low-risk of bias data (AMSTAR and ROBIS) from 128 randomised controlled trials (RCTs), 27 comparisons, 17,984 women, 16,305 babies, and 1441 children. Evidence ranged from high- to very low-quality (GRADE). Only one effective intervention was found for treating women with GDM.EffectiveLifestyle versus usual careLifestyle intervention versus usual care probably reduces large-for-gestational age (risk ratio (RR) 0.60, 95% confidence interval (CI) 0.50 to 0.71; 6 RCTs, N = 2994; GRADE moderate-quality).PromisingNo evidence for any outcome for any comparison could be classified to this category.Ineffective or possibly harmful Lifestyle versus usual careLifestyle intervention versus usual care probably increases the risk of induction of labour (IOL) suggesting possible harm (average RR 1.20, 95% CI 0.99 to 1.46; 4 RCTs, N = 2699; GRADE moderate-quality).Exercise versus controlExercise intervention versus control for return to pre-pregnancy weight suggested ineffectiveness (body mass index, BMI) MD 0.11 kg/m², 95% CI -1.04 to 1.26; 3 RCTs, N = 254; GRADE moderate-quality).Insulin versus oral therapyInsulin intervention versus oral therapy probably increases the risk of IOL suggesting possible harm (RR 1.3, 95% CI 0.96 to 1.75; 3 RCTs, N = 348; GRADE moderate-quality).Probably ineffective or harmful interventionsInsulin versus oral therapyFor insulin compared to oral therapy there is probably an increased risk of the hypertensive disorders of pregnancy (RR 1.89, 95% CI 1.14 to 3.12; 4 RCTs, N = 1214; GRADE moderate-quality).InconclusiveLifestyle versus usual careThe evidence for childhood adiposity kg/m² (RR 0.91, 95% CI 0.75 to 1.11; 3 RCTs, N = 767; GRADE moderate-quality) and hypoglycaemia was inconclusive (average RR 0.99, 95% CI 0.65 to 1.52; 6 RCTs, N = 3000; GRADE moderate-quality).Exercise versus controlThe evidence for caesarean section (RR 0.86, 95% CI 0.63 to 1.16; 5 RCTs, N = 316; GRADE moderate quality) and perinatal death or serious morbidity composite was inconclusive (RR 0.56, 95% CI 0.12 to 2.61; 2 RCTs, N = 169; GRADE moderate-quality).Insulin versus oral therapyThe evidence for the following outcomes was inconclusive: pre-eclampsia (RR 1.14, 95% CI 0.86 to 1.52; 10 RCTs, N = 2060), caesarean section (RR 1.03, 95% CI 0.93 to 1.14; 17 RCTs, N = 1988), large-for-gestational age (average RR 1.01, 95% CI 0.76 to 1.35; 13 RCTs, N = 2352), and perinatal death or serious morbidity composite (RR 1.03; 95% CI 0.84 to 1.26; 2 RCTs, N = 760). GRADE assessment was moderate-quality for these outcomes.Insulin versus dietThe evidence for perinatal mortality was inconclusive (RR 0.74, 95% CI 0.41 to 1.33; 4 RCTs, N = 1137; GRADE moderate-quality).Insulin versus insulinThe evidence for insulin aspart versus lispro for risk of caesarean section was inconclusive (RR 1.00, 95% CI 0.91 to 1.09; 3 RCTs, N = 410; GRADE moderate quality).No conclusions possibleNo conclusions were possible for: lifestyle versus usual care (perineal trauma, postnatal depression, neonatal adiposity, number of antenatal visits/admissions); diet versus control (pre-eclampsia, caesarean section); myo-inositol versus placebo (hypoglycaemia); metformin versus glibenclamide (hypertensive disorders of pregnancy, pregnancy-induced hypertension, death or serious morbidity composite, insulin versus oral therapy (development of type 2 diabetes); intensive management versus routine care (IOL, large-for-gestational age); post- versus pre-prandial glucose monitoring (large-for-gestational age). The evidence ranged from moderate-, low- and very low-quality.

AUTHORS' CONCLUSIONS: Currently there is insufficient high-quality evidence about the effects on health outcomes of relevance for women with GDM and their babies for many of the comparisons in this overview comparing treatment interventions for women with GDM. Lifestyle changes (including as a minimum healthy eating, physical activity and self-monitoring of blood sugar levels) was the only intervention that showed possible health improvements for women and their babies. Lifestyle interventions may result in fewer babies being large. Conversely, in terms of harms, lifestyle interventions may also increase the number of inductions. Taking insulin was also associated with an increase in hypertensive disorders, when compared to oral therapy. There was very limited information on long-term health and health services costs. Further high-quality research is needed.

摘要

背景

妊娠期糖尿病(GDM)的成功治疗有可能改善患有GDM的女性及其婴儿的健康结局。

目的

全面综合Cochrane系统评价中有关治疗GDM的干预措施对女性及其婴儿的益处和危害的证据。

方法

我们检索了Cochrane系统评价数据库(2018年1月5日),以查找关于GDM女性治疗/管理的评价。排除对已患糖尿病孕妇的评价。两位综述作者独立评估评价是否纳入、质量(AMSTAR;ROBIS)、证据质量(GRADE),并提取数据。

主要结果

我们纳入了14项评价。其中,10项从128项随机对照试验(RCT)、27项比较、17984名女性、16305名婴儿和1441名儿童中提供了相关的高质量且偏倚风险低的数据(AMSTAR和ROBIS)。证据质量从高到极低(GRADE)。仅发现一种治疗GDM女性的有效干预措施。

有效

生活方式干预与常规护理相比

生活方式干预与常规护理相比可能会降低大于胎龄儿的风险(风险比(RR)0.60,95%置信区间(CI)0.50至0.71;6项RCT,N = 2994;GRADE中等质量)。

有前景

未发现任何比较的任何结局有可归为此类别的证据。

无效或可能有害

生活方式干预与常规护理相比

生活方式干预与常规护理相比可能会增加引产风险(IOL),提示可能有害(平均RR 1.20,95%CI 0.99至1.46;4项RCT,N = 2699;GRADE中等质量)。

运动干预与对照相比

运动干预与对照相比对于恢复孕前体重无效(体重指数,BMI)平均差0.11kg/m²,95%CI -1.04至1.26;3项RCT,N = 254;GRADE中等质量)。

胰岛素干预与口服治疗相比

胰岛素干预与口服治疗相比可能会增加引产风险,提示可能有害(RR 1.3,95%CI 0.96至1.75;3项RCT,N = 348;GRADE中等质量)。

可能无效或有害的干预措施

胰岛素干预与口服治疗相比

胰岛素与口服治疗相比,妊娠高血压疾病的风险可能增加(RR 1.89,95%CI 1.14至3.12;4项RCT,N = 1214;GRADE中等质量)。

不确定

生活方式干预与常规护理相比

关于儿童肥胖kg/m²(RR 0.91,95%CI 0.75至1.11;3项RCT,N = 767;GRADE中等质量)和低血糖的证据不确定(平均RR 0.99,95%CI 0.65至1.52;6项RCT,N = 3000;GRADE中等质量)。

运动干预与对照相比

关于剖宫产(RR 0.86,95%CI 0.63至1.16;5项RCT,N = 316;GRADE中等质量)和围产期死亡或严重发病综合结局的证据不确定(RR 0.56,95%CI 0.12至2.61;2项RCT,N = 169;GRADE中等质量)。

胰岛素干预与口服治疗相比

关于以下结局的证据不确定

子痫前期(RR 1.14,95%CI 0.86至1.52;10项RCT,N = 2060)、剖宫产(RR 1.03,95%CI 0.93至1.14;17项RCT,N = 1988)、大于胎龄儿(平均RR 1.01,95%CI 0.76至1.35;13项RCT,N = 2352)以及围产期死亡或严重发病综合结局(RR 1.03;95%CI 0.84至1.26;2项RCT,N = 760)。这些结局的GRADE评估为中等质量。

胰岛素干预与饮食干预相比

关于围产期死亡率的证据不确定(RR 0.74,95%CI 0.41至1.33;4项RCT,N = 1137;GRADE中等质量)。

胰岛素类似物与胰岛素相比

关于门冬胰岛素与赖脯胰岛素剖宫产风险的证据不确定(RR 1.00,95%CI 0.91至1.09;3项RCT,N = 410;GRADE中等质量)。

无法得出结论

对于以下情况无法得出结论

生活方式干预与常规护理相比(会阴创伤、产后抑郁、新生儿肥胖、产前检查/入院次数);饮食干预与对照相比(子痫前期、剖宫产);肌醇与安慰剂相比(低血糖);二甲双胍与格列本脲相比(妊娠高血压疾病、妊娠诱发高血压症、死亡或严重发病综合结局);胰岛素干预与口服治疗相比(2型糖尿病的发生);强化管理与常规护理相比(引产、大于胎龄儿);餐后与餐前血糖监测相比(大于胎龄儿)。证据质量从中等、低到极低。

作者结论

目前,对于本综述中比较GDM女性治疗干预措施的许多比较,关于对GDM女性及其婴儿健康结局影响的高质量证据不足。生活方式改变(至少包括健康饮食、体育活动和血糖自我监测)是唯一显示可能改善女性及其婴儿健康的干预措施。生活方式干预可能会减少巨大儿的数量。相反,在危害方面,生活方式干预也可能会增加引产的次数。与口服治疗相比,使用胰岛素还与妊娠高血压疾病的增加有关。关于长期健康和卫生服务成本的信息非常有限。需要进一步开展高质量的研究。

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本文引用的文献

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Cochrane Database Syst Rev. 2019 Sep 3;9(9):CD012544. doi: 10.1002/14651858.CD012544.pub2.
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Planned birth at or near term for improving health outcomes for pregnant women with gestational diabetes and their infants.在足月或接近足月时计划分娩,以改善患有妊娠期糖尿病的孕妇及其婴儿的健康结局。
Cochrane Database Syst Rev. 2018 Jan 5;1(1):CD012910. doi: 10.1002/14651858.CD012910.
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Insulin for the treatment of women with gestational diabetes.用于治疗妊娠期糖尿病女性的胰岛素。
Cochrane Database Syst Rev. 2017 Nov 5;11(11):CD012037. doi: 10.1002/14651858.CD012037.pub2.
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Cochrane Database Syst Rev. 2017 Oct 29;10(10):CD011069. doi: 10.1002/14651858.CD011069.pub2.
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BMJ Open. 2017 Jun 24;7(6):e015557. doi: 10.1136/bmjopen-2016-015557.
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Dietary supplementation with myo-inositol in women during pregnancy for treating gestational diabetes.孕期女性补充肌醇治疗妊娠期糖尿病。
Cochrane Database Syst Rev. 2016 Sep 7;9(9):CD012048. doi: 10.1002/14651858.CD012048.pub2.