妊娠期使用奥美拉唑对新生儿的安全性影响的Meta分析

Meta-analysis on the effects of omeprazole on neonatal Safety During Early Pregnancy

关键词:  奥美拉唑  质子泵抑制剂  妊娠期  新生儿  安全性  meta分析

Key words:  omeprazole  proton pump inhibitors  pregnancy  newborn  safety  meta-analysis

摘要:

目的 通过系统的文献回顾分析质子泵抑制剂（proton pump inhibitors，PPIs）中的奥美拉唑在早期妊娠期时使用对新生儿的安全性影响。方法 文献检索范围为英文文献，发表时间从1998年起至今。2位研究者分析文献并比较结果，讨论解决分歧。用Downs-Black评分法评价文献质量。Meta分析采用随机效果法。结果 6篇文献符合分析标准，共有2 161例使用PPIs的病例组和125 723例对照组被选入进行meta分析。病例组和对照组新生儿不良率差异无统计学意义，OR=1.07，CI 95%：0.82~1.40，P=0.61。对奥美拉唑的安全性进行二次评价，共有728例病例组和2 676例对照组被选入进行meta分析。结果显示病例组和对照组新生儿不良率差异无统计学意义，OR=0.98，CI 95%：0.61~1.59，P=0.94。结论 在所检索到的数据背景下，妊娠期严重的胃肠道类疾病采用奥美拉唑治疗对新生儿是比较安全的。

Abstract:

OBJECTIVE to analyze the effects of omeprazole on neonatal safety during early pregnancy through systematic literature review. METHODS The scope of the literature was English literature, published from 1998 to date. The two researchers analyzed the literature and compared the results to discuss the differences. Document quality was evaluated by Downs-Black scoring method. Random effects models were used by meta-analysis. RESULTS A total of six literature met the analytical criteria. A total of 2 161 cases exposed to PPIs in treatment group and 125 723 cases in control groups were selected for meta-analysis. There was no significant difference in neonatal malignancy between treatment group and control group, OR=1.07, CI 95%:0.82-1.40, P=0.61. In addition, evaluated the safety of omeprazole, a total of 728 cases and 2 676 cases respectively were selected for meta-analysis. The results showed that there was no significant difference in neonatal malignancy between treatment group and control group, OR=0.98, CI 95%:0.61-1.59, P=0.94. CONCLUSION As the papers included, omeprazole in the treatment of severe gastrointestinal diseases during pregnancy is relatively safe for newborns.