妊娠期抗甲状腺药物应用的安全性评价  

Safety assessment of antithyroid drugs used in gestation period

作　　者：余靓平[1] 马玉平[2] 余兴华[1] 杜瑜[1] YU Liang-ping;MA Yu-ping;YU Xing-hua;DU Yu(Department of Pharmacy,Xiamen University Affiliated Zhongshan Hospital,Fujian Xiamen 361004,China;Department of Obstetrics and Gynecology,Xiamen University Affiliated Zhongshan Hospital,Fujian Xiamen 361004,China)

机构地区：[1]厦门大学附属中山医院药学部,福建厦门361004 [2]厦门大学附属中山医院妇产科,福建厦门361004

出　　处：《中国医院药学杂志》2022年第11期1138-1141,1146,共5页Chinese Journal of Hospital Pharmacy

基　　金：中国药学会全国医药经济信息网科技传播创新工程2021年重点项目[编号:CMEI2021KPYJ(JZX)00206]。

摘　　要：目的:评价真实世界中妊娠期甲状腺功能亢进(简称“甲亢”)患者应用抗甲状腺药物(ATDs)的安全性。方法:收集厦门大学附属中山医院2016年1至2020年12月收治的妊娠期甲亢患者的临床资料,分别根据妊娠期使用ATDs后甲状腺功能(简称“甲功”)情况以及妊娠期ATDs暴露情况进行分组,比较各组组内安全性指标的差异。结果:共收集102例孕产妇及其分娩的103例新生儿的资料,按3种不同情形分组并进行安全性评价,结果显示:(1)妊娠期甲亢组的早产发生率比甲功正常组更高(P<0.05);(2)妊娠早期使用甲巯咪唑治疗组(M组)比使用丙硫氧嘧啶治疗组(P组)的新生儿出生缺陷发生率更高(P<0.05);(3)P组中,妊娠中晚期使用丙硫氧嘧啶治疗组(PP组)的肝功能异常发生率高于妊娠中晚期使用甲巯咪唑治疗组(PM组),但两者之间的差异无统计学意义(P>0.05)。以上3组组内之间其余安全性评价指标比较,均无统计学差异(P>0.05)。结论:妊娠期甲亢和ATDs的应用均可能对孕产妇和新生儿的安全性产生影响。因此建议妊娠期甲亢应合理选择ATDs开展个体化治疗,同时注意监测相关实验室指标以及ATDs的不良反应,以保障整个妊娠期治疗的安全性和有效性。OBJECTIVE To assess the safety of antithyroid drugs(ATDs) used in hyperthyroid women during pregnancy in the real world.METHODS The clinical data of patients with hyperthyroidism during pregnancy admitted in a third-class hospital during 2016 and 2020 were analyzed retrospectively. According to the maternal thyroid function after using ATDs and the exposure of ATDs during pregnancy, they were divided into different groups, and the differences of safety indicators among the groups were compared.RESULTS The data of 102 pregnant women and their 103 newborns were collected, and then divided into different groups according to three different situations. Safety evaluation was carried out and the results showed that:(1) The incidence of preterm birth in the hyperthyroidism group during pregnancy was higher than that in the normal thyroid function group(P<0.05);(2) Treated during the 1 st trimester(T1) of pregnancy, the incidence of birth defects in the methimazole treatment group(M group) was higher than that in the propylthiouracil treatment group(P group)(P<0.05);(3)Treated during the 2 nd(T2) and 3 rd trimester(T3) of pregnancy, the incidence of abnormal liver function in the propylthiouracil treatment group(PP group) was higher than that in the methimazole treatment group(PM group), but there was no statistical difference(P>0.05).There was no statistical difference in the other safety evaluation indicators among the above three groups(P>0.05).CONCLUSION Hyperthyroidism and exposure to propylthiouracil during pregnancy may affect the safety of pregnant women and newborns. Therefore, it is suggested that ATDs should be reasonably selected for the individualized treatment of hyperthyroidism during pregnancy, and attention should be paid to monitoring relevant laboratory indicators and adverse reactions of ATDs to ensure the safety and effectiveness of treatment throughout pregnancy.

关 键 词：妊娠期 抗甲状腺药物 安全性 甲状腺功能 

分 类 号：R977.14[医药卫生—药品]