UNASSIGNED:一些系统评价和荟萃分析研究了左甲状腺素(LT4)治疗对亚临床甲状腺功能减退症(SCH)孕妇的影响。然而,所有这些研究都存在临床或方法学问题(例如采用旧的2011年美国甲状腺协会[ATA]诊断标准,直接结合随机对照试验[RCTs]和队列研究进行荟萃分析,等等),并且不能提供准确和令人满意的结果。因此,我们进行了更新的系统审查,meta分析和试验序贯分析(TSA)评估LT4治疗对孕妇SCH的影响,目的是为临床实践提供更准确可靠的证据。
UNASSIGNED:从成立到2022年2月,我们搜索了9个数据库。搜索策略针对RCT和妊娠队列研究,根据新的2017年ATA诊断标准,SCH孕妇接受LT4治疗后的新生儿和儿童结局.我们分别对随机对照试验和队列研究进行了荟萃分析,并通过排除具有高偏倚风险的研究进一步进行荟萃分析.进行运输安全管理局是为了测试目前的证据是否充分,并采用GRADE法对证据质量进行评价。
UNASSIGNED:共纳入9项RCT和13项队列研究,包括11273名SCH孕妇。LT4组和对照组在所有主要和次要结局方面均无统计学差异。如早产(RR=0.46,95CI:0.19-1.09,P=0.08,I2=65%),流产(RR=0.36,95CI:0.13-1.03,P=0.06,I2=38%),妊娠期高血压(RR=0.91,95CI:0.58-1.43,P=0.69,I2=0%),先兆子痫(RR=1.10,95CI:0.61-1.97,P=0.76,I2=0%),妊娠期糖尿病(RR=0.80,95CI:0.51-1.25,P=0.32,I2=34%),等等。TSA显示,所有结果的结果均不充分且无定论。根据等级,四个结果的证据(流产,妊娠期高血压,妊娠期糖尿病,小于胎龄)被评为中等质量,而其他结局的证据被评为低质量或极低质量。
未经评估:与以前的系统评价和荟萃分析不同,我们的研究没有发现LT4治疗对妊娠有益的证据,孕妇SCH的新生儿和儿童结局。
未经批准:PROSPERO,https://www.crd.约克。AC.uk/prospro/display_record.php?ID=CRD42022321937,标识符CRD42022321937。
UNASSIGNED: Several systematic reviews and meta-analyses have investigated the effect of levothyroxine (LT4) therapy in pregnant women with subclinical hypothyroidism (SCH). However, all these studies have clinical or methodological problems (such as adopting the old 2011 American Thyroid Association [ATA] diagnostic criteria, directly combining randomized controlled trials [RCTs] and cohort studies for meta-analysis, and so on), and cannot provide accurate and satisfactory results. Thus, we performed this updated systematic review, meta-analysis and trial sequential analysis (TSA) to assess the effect of LT4 therapy in pregnant women with SCH, with the goal of providing more accurate and reliable evidence for clinical practice.
UNASSIGNED: We searched nine databases from inception to February 2022. The search strategy targeted the RCTs and cohort studies on pregnancy, neonatal and childhood outcomes following LT4 treatment in pregnant women with SCH based on the new 2017 ATA diagnostic criteria. We performed meta-analyses of RCTs and cohort studies separately, and further performed meta-analyses by excluding studies with high risk of bias. TSA was performed to test whether the current evidence was sufficient, and the quality of evidence was evaluated using the GRADE method.
UNASSIGNED: A total of 9 RCTs and 13 cohort studies comprising 11273 pregnant women with SCH were included. There were no statistically significant differences between LT4 group and control group in all primary and secondary outcomes, such as preterm delivery (RR=0.46, 95%CI: 0.19-1.09, P=0.08, I2 = 65%), miscarriage (RR=0.36, 95%CI: 0.13-1.03, P=0.06, I2 = 38%), gestational hypertension (RR=0.91, 95%CI: 0.58-1.43, P=0.69, I2 = 0%), preeclampsia (RR=1.10, 95%CI: 0.61-1.97, P=0.76, I2 = 0%), gestational diabetes (RR=0.80, 95%CI: 0.51-1.25, P=0.32, I2 = 34%), and so on. TSA showed that the results for all outcomes were insufficient and inconclusive. According to GRADE, the evidences for four outcomes (miscarriage, gestational hypertension, gestational diabetes, and small for gestational age) were rated as moderate quality, while the evidences for the other outcomes were rated as low or very low quality.
UNASSIGNED: Unlike previous systematic reviews and meta-analyses, our study found no evidence of benefit of LT4 therapy on pregnancy, neonatal and childhood outcomes in pregnant women with SCH.
UNASSIGNED: PROSPERO, https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022321937, identifier CRD42022321937.