Middleton Philippa, Crowther Caroline A, Simmonds Lucy
ARCH: Australian Research Centre for Health of Women and Babies, Discipline of Obstetrics and Gynaecology, Robinson Institute,The University of Adelaide, Adelaide, Australia..
Cochrane Database Syst Rev. 2012 Aug 15;8(8):CD008540. doi: 10.1002/14651858.CD008540.pub3.
The optimal glycaemic control target in pregnant women with pre-existing diabetes is unclear, although there is a clear link between high glucose concentrations and adverse birth outcomes.
To assess the effects of different intensities of glycaemic control in pregnant women with pre-existing type 1 or type 2 diabetes.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2012).
We included randomised controlled trials comparing different glycaemic control targets in pregnant women with pre-existing diabetes.
Two review authors assessed trial eligibility and risk of bias, and extracted data.
We included three trials all in women with type 1 diabetes (223 women and babies), and all with a high risk of bias. Two trials compared very tight (3.33 to 5.0 mmol/L fasting blood glucose (FBG)) with tight-moderate (4.45 to 6.38) glycaemic control targets, with one trial of 22 babies reporting no perinatal deaths or serious perinatal morbidity. In the same trial, there were two birth defects in the very tight and none in the tight-moderate group with no significant differences in caesarean section between groups (risk ratio 0.92, 95% confidence interval (CI) 0.49 to 1.73). In these two trials glycaemic control was not significantly different between the very tight and tight-moderate groups by the third trimester, although one trial of 22 women found significantly less maternal hypoglycaemia in the tight-moderate group.In a trial of 60 women and babies comparing tight (≤ 5.6 mmol/L FBG); moderate (5.6 to 6.7); and loose (6.7 to 8.9) glycaemic control targets, there were two neonatal deaths in the loose and none in the tight or moderate groups. There were significantly fewer women with pre-eclampsia, fewer caesareans and fewer birthweights greater than 90th centile in the combined tight-moderate compared with the loose group.
AUTHORS' CONCLUSIONS: In a very limited body of evidence, few differences in outcomes were seen between very tight and tight-moderate glycaemic control targets in pregnant women with pre-existing type 1 diabetes, including actual glycaemic control achieved. There is evidence of harm (increased pre-eclampsia, caesareans and birthweights greater than 90th centile) for 'loose' control (FBG above 7 mmol/L). Future trials comparing interventions, rather than glycaemic control targets, may be more feasible particularly for pregnant women with type 2 diabetes.
尽管高血糖浓度与不良分娩结局之间存在明确联系,但孕前糖尿病孕妇的最佳血糖控制目标尚不清楚。
评估不同强度血糖控制对孕前1型或2型糖尿病孕妇的影响。
我们检索了Cochrane妊娠与分娩组试验注册库(2012年4月30日)。
我们纳入了比较孕前糖尿病孕妇不同血糖控制目标的随机对照试验。
两位综述作者评估了试验的合格性和偏倚风险,并提取了数据。
我们纳入了3项试验,均为1型糖尿病女性(223名女性和婴儿),且均具有较高的偏倚风险。两项试验比较了极严格(空腹血糖(FBG)3.33至5.0 mmol/L)与适度严格(4.45至6.38)的血糖控制目标,一项涉及22名婴儿的试验报告无围产期死亡或严重围产期发病情况。在同一试验中,极严格组有2例出生缺陷,适度严格组无出生缺陷,两组剖宫产率无显著差异(风险比0.92,95%置信区间(CI)0.49至1.73)。在这两项试验中,孕晚期极严格组与适度严格组的血糖控制无显著差异,尽管一项涉及22名女性的试验发现适度严格组的母体低血糖显著较少。在一项涉及60名女性和婴儿的试验中,比较了严格(FBG≤5.6 mmol/L)、适度(5.6至6.7)和宽松(6.7至8.9)的血糖控制目标,宽松组有2例新生儿死亡,严格组和适度组无新生儿死亡。与宽松组相比,严格-适度联合组的子痫前期女性更少、剖宫产更少且出生体重高于第90百分位数的情况更少。
在非常有限的证据中,孕前1型糖尿病孕妇在极严格与适度严格的血糖控制目标之间,包括实际实现的血糖控制方面,未观察到结局有明显差异。有证据表明“宽松”控制(FBG高于7 mmol/L)存在危害(子痫前期增加、剖宫产增加以及出生体重高于第90百分位数)。未来比较干预措施而非血糖控制目标的试验可能更可行,特别是对于2型糖尿病孕妇。