中药的动物发育毒性系统评价  

Developmental Toxicity of Traditional Chinese Medicine on Animals:A Systematic Review

作　　者：谢小芳 王轶[2] 李文武[3] 秦博 路文柯 周迷 杨勇[2,3] XIE Xiaofang;WANG Yi;LI Wenwu;QIN Bo;LU Wenke;ZHOU Mi;YANG Yong(Deparment of Pharmacy,The Finxt Pole's Hospital of Neijang,Nejiang,ichuan,China 6410000;Sichuan Key Laboratory of Inditualtzed Drug Treatment,Sichuan Prowincial Pexple's Hoxpital,Chengdu,Sichuan,China 610072;Department of Pharmacy,Ziyang Peole's Hospial,Ziyan,Sichuan,China 641300;Department of Pharmacy,Sichuan Prowincial Matrnity and Child Health Care Hospital,Chengdu,Sichuan,China 610045)

机构地区：[1]四川省内江市第一人民医院药剂科,四川内江641000 [2]四川省人民医院个体化药物治疗四川省重点实验室,四川成都610072 [3]四川省资阳市人民医院药学部,四川资阳641300 [4]四川省妇幼保健院药学部,四川成都610045

出　　处：《中国药业》2021年第16期5-13,共9页China Pharmaceuticals

基　　金：四川省卫生健康委员会科研课题[19PJ307]。

摘　　要：目的系统评价中药的体内发育毒性,为妊娠期用药的安全性提供依据。方法在中国期刊全文数据库、中国生物医学文献数据库、万方数据库、维普期刊全文数据库、PubMed、Embase、Toxent数据库中检索自建库至2019年12月31日公开发表的中药对动物发育的毒性研究,系统分析中药对母体妊娠结局和胎仔的致畸性。结果共纳入29篇文献,中药组雌性动物的受孕率与对照组无显著差异[RR=0.98,95%CI(0.92,1.06),P=0.64],而中药组妊娠动物的活胎数显著少于对照组[MD=-0.6,95%CI(-1.00,-0.20),P=0.03];中药组出生胎仔体质量[MD=-0.01,95%CI(-0.08,0.05),P=0.68]、胎仔体长[MD=-0.04,95%CI(-0.24,0.16),P=0.68]与对照组无显著差异,中药组妊娠期母体体质量增加量显著低于对照组[MD=-12.89,95%CI(-21.03,-4.75),P=0.02]。结论目前,中药对动物发育的毒性方面研究缺少高质量文献,需要长期、大规模的临床研究为妊娠期用药指导提供参考。Objective To systematically review the developmental toxicity of traditional Chinese medicine(TCM)in vivo,and to provide a basis for the medication safety during pregnancy.Methods The studies about the developmental toxicity of TCM on the animals were searched from CNKI,CBM,WanFang,VIP,PubMed,Embase,Toxent databases from the inception of the database to December 31 th,2019.The teratogenicity of TCM on maternal pregnancy outcome and fetus were systematically analyzed.Results A total of 29 studies were included.There was no significant difference in the pregnancy rate between the TCM group and the control group[RR=0.98,95%CI(0.92,1.06),P=0.64],while the number of live births in the TCM group was significantly less than that in the control group[MD=-0.6,95%CI(-1.00,-0.20),P=0.02].There was no significant difference in fetal body weight[MD=-0.01,95%CI(-0.08,0.05),P=0.68]and fetal body length[MD=-0.04,95%CI(-0.24,0.16),P=0.68]between the TCM group and the control group,while the weight gain of maternal body during pregnancy in the TCM group was significantly lower than that in the control group[MD=-12.89,95%CI(-21.03,4.75),P=0.02].Conclusion Currently,there is a lack of high-quality studies on the developmental toxicity of TCM in animals.Long-term and large-scale clinical studies are needed to provide a reference for medication guidance during pregnancy.

关 键 词：中药 动物实验 发育毒性 系统评价 

分 类 号：R932[医药卫生—生药学] R285.5[医药卫生—药学]