硫酸镁注射液致胎儿骨骼异常的风险分析与措施

中国药物警戒 ›› 2014, Vol. 11 ›› Issue (7): 429-431.

硫酸镁注射液致胎儿骨骼异常的风险分析与措施

王春婷, 郑明节

国家食品药品监督管理总局药品评价中心,北京 100045

收稿日期:2016-02-03 修回日期:2016-02-03 出版日期:2014-07-08 发布日期:2016-03-02
作者简介:王春婷,女,副主任药师,药品不良反应监测与评价。

Risk Analysis and Measures of Fetal Skeletal Abnormalities Caused by Magnesium Sulfate Injection

WANG Chun-ting, ZHENG Ming-jie

Center For Drug Reevaluation, CFDA, Beijing 100045, China

Received:2016-02-03 Revised:2016-02-03 Online:2014-07-08 Published:2016-03-02

摘要/Abstract

摘要： 根据国内外对硫酸镁注射液风险控制措施的情况,进一步分析其安全警告的背景和依据,探讨硫酸镁注射液和胎儿骨骼异常之间的关联性。同时硫酸镁注射液新暴露的风险,导致风险/效益平衡的变化,需要引起各方的重视并采取相应措施。

关键词: 硫酸镁注射液, 胎儿, 骨骼异常, 风险管理

Abstract: According to the situation of magnesium sulfate injection risk control measures at home and abroad, the background and basis of its safety warnings are further analyzed so as to explore the correlation between magnesium sulfate injection and fetal skeletal abnormalities. The newly exposed risk and the magnesium sulfate injection, which leads to change the balance of risk/benefit, need each side to give more attention and take corresponding measures.

Key words: magnesium sulfate injection, fetus, skeletal abnormalities, risk management

中图分类号:

R971.6

王春婷, 郑明节. 硫酸镁注射液致胎儿骨骼异常的风险分析与措施[J]. 中国药物警戒, 2014, 11(7): 429-431.

WANG Chun-ting, ZHENG Ming-jie. Risk Analysis and Measures of Fetal Skeletal Abnormalities Caused by Magnesium Sulfate Injection[J]. Chinese Journal of Pharmacovigilance, 2014, 11(7): 429-431.

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