【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。更多还原

【Abstract】 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.更多还原