妊娠期妇女使用中成药的疗效及子代安全性评价

Efficacy and offspring safety evaluation of Chinese patent medicines in pregnant women

目的:通过评价妊娠期妇女使用中成药的疗效及子代安全性,探讨建立中成药妊娠期循证医学证据体系的必要性。方法:选取2016年某院门诊使用中成药的妊娠期妇女纳入研究,随访周期为1年,从药品、患者年龄、妊娠情况、生产方式、新生儿情况等方面进行统计分析,与课题研究期间某院全部出生新生儿的数据为对照,统计两组之间是否存在显著性差异。结果:研究组入组患者720人,随访结果204人,分析结果显示研究组和研究亚组新生儿体质量、性别比例和流产情况与对照组无统计学差异。结论:本研究所涉及的10种中成药对妊娠期妇女使用总体上是安全的,个别品种出现的异常情况还需进一步研究。

OBJECTIVE To explore the necessity for establishing an evidence-based medicine system of Chinese patent medicines,by evaluating the efficacy and offspring safety of Chinese patent medicine in pregnant women.METHODS The pregnant women who used Chinese patent medicines in a hospital in 2016 were included in the study.The follow-up period was one year.The statistical analysis was made from the aspects of medicines,age,pregnancy,mode of production,and conditions of newborns.In comparison with the data of all newborn babies born in the hospital during the study period,significant difference between the two groups were examined.RESULTS A total of 720 patients was enrolled in the study groups and 204 of them were followed up.The results showed that there was no significant difference in weight,sex ratio and abortion between the study group and the control group.CONCLUSION The 10 Chinese patent medicines involved in this study are generally safe for pregnant women.The abnormal conditions of individual varieties need further study.