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赖脯胰岛素对孕妇是否安全:它会对婴儿或母亲造成任何不良后果吗?

Is insulin lispro safe in pregnant women: Does it cause any adverse outcomes on infants or mothers?

作者信息

Aydin Yusuf, Berker Dilek, Direktör Nafiye, Ustün Ihsan, Tütüncü Yasemin Ateş, Işik Serhat, Delibaşi Tuncay, Guler Serdar

机构信息

Ankara Numune Education and Research Hospital, Department of Endocrinology and Metabolism, 06610 Ankara, Turkey.

出版信息

Diabetes Res Clin Pract. 2008 Jun;80(3):444-8. doi: 10.1016/j.diabres.2008.02.004. Epub 2008 Mar 21.

Abstract

AIM

To determine the rate of major congenital anomalies and complications retrospectively in offspring of women with diabetes mellitus treated insulin lispro.

MATERIAL AND METHODS

Twenty-seven patients had used insulin lispro (ILYS) and 59 patients had used regular human insulin (RHI) during the pregnancy period were evaluated. We also evaluated and analyzed the results of 53 of the 86 women who had gestational diabetes mellitus only. They were not using insulin aspart or insulin glarjine. We evaluated the birth weight, congenital anamolies, mode of delivery, abortus and stillbirth rates.

RESULTS

Mean HbA1c level was 6.27+2.23 for ILYS group and 7.07+2.09 for RHI group (p: 0.067). The duration of diabetes, gestational age, mode of delivery, type of diabetes, number of liveborn, stillbirth and miscarriages were not stastically different between all groups (p>0.05). Nine (15.25%) of 59 infants treated with RHI had congenital anomalies and one stillborn. The infants in ILYS-receiving group had no congenital anomalies but one pregnant (3.70%) had a stillborn. The difference in incidence of congenital anomalies between those using ILYS and RHI was not statistically significant (p: 0.157). There was also no difference in respect to congenital anomalies of gestational diabetic groups which used either ILYS or RHI.

CONCLUSION

Major congenital anomalies for offspring of mothers treated with ILYS are similar with RHI group. Although HbA1c levels were lower in ILYS group, all outcomes are similar with RHI. So ILYS is an alternative choice in treatment of pregnant women with DM.

摘要

目的

回顾性确定接受赖脯胰岛素治疗的糖尿病女性后代中主要先天性异常和并发症的发生率。

材料与方法

对27例孕期使用赖脯胰岛素(ILYS)和59例使用常规人胰岛素(RHI)的患者进行评估。我们还评估并分析了86例仅患有妊娠期糖尿病的女性中的53例的结果。她们未使用门冬胰岛素或甘精胰岛素。我们评估了出生体重、先天性异常、分娩方式、流产和死产率。

结果

ILYS组的平均糖化血红蛋白水平为6.27 + 2.23,RHI组为7.07 + 2.09(p:0.067)。糖尿病病程、孕周、分娩方式、糖尿病类型、活产数、死产和流产在所有组之间无统计学差异(p>0.05)。59例接受RHI治疗的婴儿中有9例(15.25%)有先天性异常,1例死产。接受ILYS治疗的组中婴儿无先天性异常,但1例孕妇(3.70%)有死产。使用ILYS和RHI的患者之间先天性异常发生率的差异无统计学意义(p:0.157)。使用ILYS或RHI的妊娠期糖尿病组在先天性异常方面也无差异。

结论

接受ILYS治疗的母亲的后代中主要先天性异常与RHI组相似。尽管ILYS组的糖化血红蛋白水平较低,但所有结果与RHI组相似。因此,ILYS是治疗糖尿病孕妇的一种替代选择。

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