Farrar Diane, Duley Lelia, Medley Nancy, Lawlor Debbie A
Maternal and Child Health, Bradford Institute for Health Research, Bradford Royal Infirmary, Duckworth Lane, Bradford, UK, BD9 6RJ.
Cochrane Database Syst Rev. 2015 Jan 21;1:CD007122. doi: 10.1002/14651858.CD007122.pub3.
BACKGROUND: Gestational diabetes mellitus (GDM) is carbohydrate intolerance resulting in hyperglycaemia with onset or first recognition during pregnancy. If untreated, perinatal morbidity and mortality may be increased. Accurate diagnosis allows appropriate treatment. Use of different tests and different criteria will influence which women are diagnosed with GDM. OBJECTIVES: To evaluate and compare different testing strategies for diagnosis of gestational diabetes mellitus to improve maternal and infant health while assessing their impact on healthcare service costs. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2014) and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised trials if they evaluated tests carried out to diagnose GDM. We excluded studies that used a quasi-random model. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: We identified six small trials, including 694 women. These trials were assessed as having varying risk of bias, with few outcomes reported. We prespecified six outcomes to be assessed for quality using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach; data for only one outcome (diagnosis of gestational diabetes) were available for assessment. One trial compared three different methods of delivering glucose: a candy bar (39 women), a 50-gram glucose polymer drink (40 women) and a 50-gram glucose monomer drink (43 women). We have reported results reported by this trial as separate comparisons. 75-gram oral glucose tolerance test (OGTT) versus 100-gram OGTT (one trial, 248 women): Women given the 75-gram OGTT had a higher relative risk of being diagnosed with GDM (risk ratio (RR) 2.55, 95% confidence interval (CI) 0.96 to 6.75). This difference was borderline in terms of statistical significance, and evidence was considered to be of very low quality when assessed by GRADE. No data were reported for the following additional outcomes prespecified for assessment in GRADE: caesarean section, macrosomia > 4.5 kg or however defined in the trial, long-term type 2 diabetes maternal, long-term type 2 diabetes infant and economic costs. Candy bar versus 50-gram glucose monomer drink (one trial, 60 women): More women receiving the candy bar, rather than glucose monomer, preferred the taste of the candy bar (RR 0.60, 95% CI 0.42 to 0.86). Infant outcomes were not reported. 50-gram glucose polymer drink versus 50-gram glucose monomer drink (three trials, 239 women): Mean difference (MD) in gestation at birth was -0.80 weeks (one trial, 100 women; 95% CI -1.69 to 0.09). Total side effects were less common with the glucose polymer drink (one trial, 63 women; RR 0.21, 95% CI 0.07 to 0.59), and no clear difference in taste acceptability was reported (one trial, 63 women; RR 0.99, 95% CI 0.76 to 1.29). Significantly fewer women reported nausea following the 50-gram glucose polymer drink compared with the 50-gram glucose monomer drink (one trial, 66 women; RR 0.29, 95% CI 0.11 to 0.78). No other measures of maternal morbidity or outcomes for the infant were reported. 50-gram glucose food versus 50-gram glucose drink (one trial, 30 women): Women receiving glucose in their food, rather than as a drink, reported fewer side effects (RR 0.08, 95% CI 0.01 to 0.56). No clear difference was noted in the number of women requiring further testing (RR 0.14, 95% CI 0.01 to 2.55). No other measures of maternal morbidity or outcome were reported for the infant. 75-gram oral glucose tolerance test (OGTT) World Health Organization (WHO) criteria versus 75-gram OGTT American Diabetes Association (ADA) criteria (one trial, 116 women): No clear differences in included outcomes were observed between women who received the 75-gram OGTT and were diagnosed using criteria based on WHO (1999) recommendations and women who received the 75-gram OGTT and were diagnosed using criteria recommended by the ADA (1979). Outcomes measured included diagnosis of gestational diabetes (RR 1.47, 95% CI 0.66 to 3.25), caesarean birth (RR 1.07, 95% CI 0.85 to 1.35), macrosomia defined as > 90th percentile by ultrasound or birthweight equal to or exceeding 4000 g (RR 0.73, 95% CI 0.19 to 2.79), stillbirth (RR 0.49, 95% CI 0.02 to 11.68) and instrumental birth (RR 0.21, 95% CI 0.01 to 3.94). AUTHORS' CONCLUSIONS: Evidence is insufficient to permit assessment of which strategy is best for diagnosing GDM.
背景:妊娠期糖尿病(GDM)是指妊娠期间首次发生或首次被识别的、由碳水化合物不耐受导致的高血糖症。若不进行治疗,围产期发病率和死亡率可能会增加。准确的诊断有助于进行适当的治疗。使用不同的检测方法和不同的诊断标准会影响哪些女性被诊断为GDM。 目的:评估和比较诊断妊娠期糖尿病的不同检测策略,以改善母婴健康,并评估其对医疗服务成本的影响。 检索方法:我们检索了Cochrane妊娠与分娩组试验注册库(2014年10月31日)以及检索到的研究的参考文献列表。 选择标准:如果随机试验评估了用于诊断GDM的检测,则纳入研究。我们排除了使用半随机模型的研究。 数据收集与分析:两位综述作者独立评估试验是否纳入及偏倚风险,提取数据并检查其准确性。 主要结果:我们确定了6项小型试验,共694名女性。这些试验被评估为具有不同程度的偏倚风险,报告的结果较少。我们预先设定了6项结局,使用GRADE(推荐分级、评估、制定与评价)方法评估其质量;仅可获得一项结局(妊娠期糖尿病的诊断)的数据进行评估。一项试验比较了三种不同的葡萄糖给药方法:一块糖果(39名女性)、一杯50克葡萄糖聚合物饮料(40名女性)和一杯50克葡萄糖单体饮料(43名女性)。我们将该试验报告的结果作为单独的比较进行了汇报。75克口服葡萄糖耐量试验(OGTT)与100克OGTT(一项试验,248名女性):接受75克OGTT的女性被诊断为GDM的相对风险更高(风险比(RR)2.55,95%置信区间(CI)0.96至6.75)。就统计学意义而言,这种差异处于临界状态,根据GRADE评估,证据质量被认为非常低。GRADE预先设定的用于评估的以下额外结局未报告数据:剖宫产、巨大儿(>4.5千克或试验中定义的其他标准)、母亲长期患2型糖尿病、婴儿长期患2型糖尿病以及经济成本。糖果与50克葡萄糖单体饮料(一项试验,60名女性):更多接受糖果而非葡萄糖单体的女性更喜欢糖果的味道(RR 0.60,95% CI 0.42至0.86)。未报告婴儿结局。50克葡萄糖聚合物饮料与50克葡萄糖单体饮料(三项试验,239名女性):出生时孕周的平均差(MD)为-0.80周(一项试验,100名女性;95% CI -1.69至0.09)。葡萄糖聚合物饮料的总副作用较少见(一项试验,63名女性;RR 0.21,95% CI 0.07至0.59),且在味道可接受性方面未报告明显差异(一项试验,63名女性;RR 0.99,95% CI 0.76至1.29)。与50克葡萄糖单体饮料相比,接受50克葡萄糖聚合物饮料后报告恶心的女性明显更少(一项试验,66名女性;RR 0.29,95% CI 0.11至0.78)。未报告其他母亲发病率指标或婴儿结局。50克葡萄糖食物与50克葡萄糖饮料(一项试验,30名女性):通过食物而非饮料接受葡萄糖的女性报告的副作用较少(RR 0.08,95% CI 0.01至0.56)。在需要进一步检测的女性数量上未发现明显差异(RR 0.14,95% CI 0.01至2.55)。未报告其他母亲发病率指标或婴儿结局。75克口服葡萄糖耐量试验(OGTT)采用世界卫生组织(WHO)标准与采用美国糖尿病协会(ADA)标准(一项试验,116名女性):接受75克OGTT并根据WHO(1999年)建议标准诊断的女性与接受75克OGTT并根据ADA(1979年)推荐标准诊断的女性之间,在纳入的结局方面未观察到明显差异。测量的结局包括妊娠期糖尿病的诊断(RR 1.47,95% CI 0.66至3.25)、剖宫产(RR 1.07,95% CI 0.85至1.35)、超声测量大于第90百分位数或出生体重等于或超过4000克定义的巨大儿(RR 0.73,95% CI 0.19至2.79)、死产(RR 0.49,95% CI 0.02至11.68)和器械助产(RR 0.21,95% CI 0.01至3.94)。 作者结论:证据不足,无法评估哪种策略最适合诊断GDM。
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