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妊娠合并 1 型糖尿病患者采用持续皮下胰岛素输注与多次皮下注射胰岛素治疗的效果比较:随机对照试验和观察性研究的系统评价和荟萃分析。

Continuous subcutaneous insulin infusion vs multiple daily injections in pregnant women with type 1 diabetes mellitus: a systematic review and meta-analysis of randomised controlled trials and observational studies.

机构信息

HTA ConsultingKrakow, Poland.

Center for Medical Genomics OMICRON Jagiellonian University Medical CollegeKrakow, Poland.

出版信息

Eur J Endocrinol. 2018 May;178(5):545-563. doi: 10.1530/EJE-17-0804. Epub 2018 Mar 15.

DOI:10.1530/EJE-17-0804
PMID:29545258
Abstract

BACKGROUND

Randomised controlled trials (RCTs) have shown an advantage of continuous subcutaneous insulin infusion (CSII) over multiple daily injections (MDI) in the general type 1 diabetes mellitus (T1DM) population. RCT data on T1DM management in pregnancy remain limited.

OBJECTIVE

We performed a systematic review of both RCTs and non-RCTs evaluating CSII vs MDI in T1DM-complicated pregnancy.

STUDY DESIGN

Electronic databases were searched for studies comparing CSII with MDI in T1DM-complicated pregnancy.

METHODS

A meta-analysis provided point estimates with 95% confidence intervals (CI). Continuous outcomes were reported as weighted mean differences (WMD) or standardised mean differences (SMD), and dichotomous data as relative risk (RR).

RESULTS

The search identified 47 studies, including 43 non-RCTs, reporting on 7824 pregnancies. The meta-analysis showed a lower HbA1c level with CSII vs MDI in the first trimester (WMD: -0.45%; 95%CI: -0.62, -0.27). This difference decreased in subsequent trimesters. Compared to MDI, therapy with CSII resulted in higher gestational weight gain (GWG) (WMD: 1.02 kg; 95%CI: 0.41, 1.62), and lower daily insulin dose requirements in the first (SMD: -0.46; 95%CI: -0.68, -0.24) and subsequent trimesters. Moreover, infants from the CSII group were more likely to be large for gestational age (LGA) (RR: 1.16; 95%CI: 1.07, 1.24) and less likely to be small for gestational age (SGA) (RR: 0.66; 95%CI: 0.45; 0.97).

CONCLUSIONS

In T1DM-complicated pregnancy, CSII compared to MDI therapy resulted in better first trimester glycaemic control; this difference decreased in subsequent trimesters. CSII therapy was associated with lower insulin requirements, higher GWG and altered risk for infants being LGA and SGA.

摘要

背景

随机对照试验(RCT)表明,在 1 型糖尿病(T1DM)患者中,持续皮下胰岛素输注(CSII)优于多次皮下胰岛素注射(MDI)。但有关妊娠期间 T1DM 管理的 RCT 数据仍然有限。

目的

我们对评估 T1DM 合并妊娠中 CSII 与 MDI 的 RCT 和非 RCT 进行了系统综述。

研究设计

电子数据库检索比较 T1DM 合并妊娠中 CSII 与 MDI 的研究。

方法

Meta 分析提供了 95%置信区间(CI)的点估计值。连续结果以加权均数差(WMD)或标准化均数差(SMD)表示,二分类数据以相对风险(RR)表示。

结果

搜索共确定了 47 项研究,其中包括 43 项非 RCT,共报道了 7824 例妊娠。Meta 分析显示,CSII 组在孕早期的糖化血红蛋白(HbA1c)水平较 MDI 组低(WMD:-0.45%;95%CI:-0.62,-0.27)。这一差异在随后的孕中期逐渐减小。与 MDI 相比,CSII 治疗导致更高的妊娠期体重增加(GWG)(WMD:1.02kg;95%CI:0.41,1.62),且在孕早期(SMD:-0.46;95%CI:-0.68,-0.24)和随后的孕中期,CSII 治疗所需的每日胰岛素剂量也较低。此外,CSII 组的婴儿更易出现巨大儿(LGA)(RR:1.16;95%CI:1.07,1.24),而更小儿(SGA)的发生率较低(RR:0.66;95%CI:0.45;0.97)。

结论

在 T1DM 合并妊娠中,与 MDI 治疗相比,CSII 治疗可更好地控制孕早期的血糖水平;这一差异在随后的孕中期逐渐减小。CSII 治疗与较低的胰岛素需求、更高的 GWG 以及婴儿更易出现 LGA 和 SGA 风险相关。

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