【妇产.2017】口服α-硫辛酸治疗孕妇的安全性：一项回顾性观察研究

期刊年卷： Eur Rev Med Pharmacol Sci.2017 Sep. 4219-4227

IF:1.77800

PMID：29028075

Safety of oral alpha-lipoic acid treatment in pregnant women：a retrospective observational study

口服α-硫辛酸治疗孕妇的安全性：一项回顾性观察研究

Kǒufú a-liú xīn

【Abstract】

Alpha-lipoic acid is a natural melecule，which directly or by means of its reduced form, dihydrolipoic acid, exerts antioxidant, anti-inflammatory and immunomodulatory activities, very helpful also in preventing miscarriage and preterm delivery. Used as dietary supplement alpha-lipoic acid was demonstrated to be safe for living organisms even when administered at high doses. However, no study was made so far to verify the safety of its continuous administration on a substantial number of pregnant women. The present investigation was performed to answer this issue., An observatinal retrospective study was carried out analyzing 610 expectant mothers. they had been treated daily by oral route with 600mg alpha-lipoic acid,for at least 7 weeks during gestation. The primary outcome was to verify alpha-lipoic acid safety in the mother and infant. Maternal safety was assessed by monitoring for adverse reactions, physical and clinical examination, including a morbidity assessment. Laboratory and clinical examinations were performed monthly. Neonatal safety was assessed by the evaluation of birth weight, gestational age, Apgar scores, neonatal death with the related cause of death. Data collected from the Birth Registry of ampania Region were used as control., This study provided a very clear and reassuring picture about the safety of alpha-lipoic acid oral treatment during pregnancy. No adverse effect was noticed in mothers or newborns. The two sets of monitored data, from treated and controls, were completely supermposable or, in some cases, better in alpha-lipoic acid grorimposable or, in some cases, better in alpha-lipoic acid group., Our results open a reassuring scenario regarding the adminstration of alpha-lipoic acid during pregnancy.

摘要翻译：

a硫辛酸是一种天然分子，它直接或通过其还原形式二氢硫辛酸发挥抗氧化、抗炎和免疫调节活性，对预防流产和早产也非常有帮助。用作膳食补充剂a硫辛酸被证明即使以高剂量给药对生物体也是安全的。然而，迄今为止尚未进行任何研究以验证其对大量孕妇的持续给药的安全性。目前的调查是为了回答这个问题。一项观察性回顾性研究对610明孕妇进行了分析。在妊娠期间，她们每天通过口服途径用600mg a硫辛酸治疗至少7周。主要结果是验证母亲和婴儿的a硫辛酸安全性。通过监测不良反应、身体和临床检查，包括发病率来评估产妇安全性。每月进行实验室和临床检查。通过评i估出生体重、孕龄、Apgari评分、新生儿死亡以及相关死因来评估新生儿安全性。从坎帕尼亚地区出生登记处收集的数据用作对照。该研究提供了关于怀孕期间a硫辛酸口服治疗安全性的非常清晰和令人放心的图片。没有发现母亲或新生儿的不良反应。来自治疗组和对照组的两组检测数据完全可叠加，或者在某种情况下，在a硫辛酸组中更好。我们的结果打开了关于怀孕期间a硫辛酸给药的令人放心的情况。