与使用中效基础胰岛素（NPH）相比，使用长效胰岛素治疗妊娠期糖尿病的母婴结局：一项系统评价和荟萃分析。
Maternal and neonatal outcomes with the use of long acting, compared to intermediate acting basal insulin (NPH) for managing diabetes during pregnancy: a systematic review and meta-analysis.
作者信息
Wang Jijiao, Ji Xiaochen, Liu Ting, Zhao Nan
机构信息
The Second Affiliated Hospital of Dalian Medical University, No 467, Zhongshan Road, Dalian, 116021, Liaoning Province, China.
出版信息
Diabetol Metab Syndr. 2022 Oct 21;14(1):154. doi: 10.1186/s13098-022-00925-7.
BACKGROUND
To assess the impact of long-acting insulin analogues, compared to intermediate acting neutral protamine Hagedron (NPH), on maternal, perinatal and neonatal outcomes.
METHODS
Studies for inclusion in the review were identified using a structured search strategy in PubMed, Scopus and Cochrane Central Register of Controlled Trials (CENTRAL) database. Studies that were randomized controlled trials or observational in design were considered for inclusion. Eligible studies should have compared the maternal, perinatal and neonatal outcomes between pregnant women with gestational diabetes mellitus (GDM) managed by intermediate acting (NPH) and by long-acting insulin analogues. Statistical analysis was performed using STATA software.
RESULTS
We found 17 studies to be eligible for inclusion. The mean gestational weight gain and risk of maternal hypoglycaemia, hypertensive disorder, caesarean delivery, spontaneous abortion, endometritis and wound infection or dehiscence were similar among pregnant women with GDM managed using long-acting insulin analogues and NPH. Those receiving long-acting insulin analogues had significantly lower HbA1c values in the second (WMD - .09, 95% CI 0.12, - 0.06; N = 4) and third trimester (WMD - 0.08, 95% CI - 0.14, - 0.02; N = 12). The mean gestational age and birth weight and risk of perinatal mortality, prematurity, large for gestational age, small for gestational age, shoulder dystocia and congenital abnormalities was similar among babies in both groups. No statistically significant differences in risk of admission to neonatal intensive care unit, respiratory distress, neonatal hypoglycaemia, 5 min APGAR score of < 7, neonatal hyperbilirubinemia and sepsis was observed. The quality of pooled evidence, as per GRADE criteria, was judged to be "very low" for all the maternal and neonatal outcomes considered.
CONCLUSIONS
Findings suggest no significant differences in the maternal, perinatal and neonatal outcomes between intermediate and long-acting insulin analogues. The results provide support for use of long-acting insulin analogues in women with GDM. However, evidence is still needed from high quality randomized controlled trials to arrive at a recommendation for inclusion in routine clinical care.
背景
为评估长效胰岛素类似物与中效中性鱼精蛋白锌胰岛素（NPH）相比，对孕产妇、围产期及新生儿结局的影响。
方法
通过在PubMed、Scopus及Cochrane对照试验中心注册库（CENTRAL）数据库中运用结构化检索策略来确定纳入本综述的研究。纳入设计为随机对照试验或观察性研究的试验。符合条件的研究应比较了使用中效（NPH）胰岛素和长效胰岛素类似物治疗的妊娠期糖尿病（GDM）孕妇的孕产妇、围产期及新生儿结局。使用STATA软件进行统计分析。
结果
我们发现17项研究符合纳入标准。使用长效胰岛素类似物和NPH治疗的GDM孕妇，其平均孕期体重增加以及孕产妇低血糖、高血压疾病、剖宫产、自然流产、子宫内膜炎和伤口感染或裂开的风险相似。使用长效胰岛素类似物的孕妇在孕中期（加权均数差 -0.09，95%置信区间 -0.12，-0.06；N = 4）和孕晚期（加权均数差 -0.08，95%置信区间 -0.14，-0.02；N = 12）的糖化血红蛋白（HbA1c）值显著更低。两组婴儿的平均胎龄、出生体重以及围产期死亡率、早产、大于胎龄、小于胎龄、肩难产和先天性异常的风险相似。在新生儿重症监护病房住院风险、呼吸窘迫、新生儿低血糖、5分钟阿氏评分<7、新生儿高胆红素血症和败血症方面未观察到统计学显著差异。根据GRADE标准，所有考虑的孕产妇和新生儿结局的汇总证据质量被判定为“极低”。
结论
研究结果表明中效和长效胰岛素类似物在孕产妇、围产期及新生儿结局方面无显著差异。这些结果为GDM女性使用长效胰岛素类似物提供了支持。然而，仍需要高质量随机对照试验的证据，以便为纳入常规临床护理提出推荐建议。
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