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首页> 外文期刊>The Canadian journal of clinical pharmacology =: Journal canadien de pharmacologie clinique >The safety of oral hypoglycemic agents in the first trimester of pregnancy: a meta-analysis.
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The safety of oral hypoglycemic agents in the first trimester of pregnancy: a meta-analysis.

机译：妊娠前三个月口服降糖药的安全性：一项荟萃分析。

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OBJECTIVE: To examine the relationship between first-trimester exposure to oral hypoglycemic agents (OHAs), congenital anomalies and neonatal mortality, accounting for the potential confounding effect of maternal glycemic control. METHOD: A meta-analysis was conducted by searching the literature for studies reporting on women with type II diabetes mellitus, first-trimester exposure to OHAs and either major malformations and/or neonatal mortality. Glycemic control monitoring was noted. Studies were reviewed by two reviewers and disagreement was resolved by consensus. Odds ratios and risk differences were calculated to determine the risk of major malformations and neonatal mortality between those exposed and those not exposed to OHAs. RESULTS: Ten studies met the inclusion criteria. There was no significant difference in the rates of major malformations between those exposed and those not exposed to OHAs; the odds ratio was 1.05 (95% CI 0.65 to 1.70) and the risk difference was 0.00 (95% CI -0.03 to 0.03). For studies reporting glycemic control, the odds ratio for major malformations between those exposed and those not exposed to OHAs was 1.06 (95% CI 0.62 to 1.81). For neonatal death, the odds ratio was 1.16 (95% CI 0.67 to 2.00) and the risk difference was -0.03 (95% CI -0.17 to 0.12). The studies did not provide sufficient detail to determine which OHA(s) were associated with adverse neonatal outcomes. CONCLUSIONS: First-trimester exposure to OHAs did not significantly increase rates of major malformations or neonatal death. However, the studies were heterogeneous and care must be taken in interpreting the results. Further studies are needed to address the safety of OHAs in the first trimester with concomitant good glycemic control.
机译：目的：探讨孕早期接触口服降糖药（OHAs），先天性异常与新生儿死亡率之间的关系，以说明孕妇控制血糖的潜在混杂因素。方法：荟萃分析是通过搜索文献进行的荟萃分析，这些研究报告了II型糖尿病妇女，孕早期暴露于OHA以及重大畸形和/或新生儿死亡率的妇女。注意到血糖控制监测。研究由两名审稿人进行审阅，分歧通过共识解决。计算赔率和风险差异，以确定接触OHA者和未接触OHA者之间的重大畸形和新生儿死亡的风险。结果：十项研究符合纳入标准。接触和未接触OHA的人之间的主要畸形率没有显着差异;优势比为1.05（95％CI为0.65至1.70）和风险差为0.00（95％CI为-0.03至0.03）。对于报告血糖控制的研究，暴露于和未暴露于OHA者之间的主要畸形比值比为1.06（95％CI为0.62至1.81）。对于新生儿死亡，优势比为1.16（95％CI为0.67至2.00），风险差为-0.03（95％CI为-0.17至0.12）。该研究没有提供足够的细节来确定哪些OHA与新生儿不良结局相关。结论：孕早期接触OHA并没有显着增加严重畸形或新生儿死亡的发生率。但是，研究是异类的，在解释结果时必须小心。需要进行进一步的研究来解决妊娠中期伴随着良好的血糖控制的OHA的安全性。

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