论文部分内容阅读
为了表明消化系统药物产生分娩缺陷的程度,美国FDA把这类药物确定分成A、B、C、D、X5类:A组,在母体中经充分对照试验证明对胎儿无危险。虽然这些研究不能完全排除危险性,但可以断定妊娠期应用这些药物对胎儿损害的可能性是极小的。当然,药物必须在确实需要时应用;B组,1.动物研究未证明对胎儿有危险,但是妇女中无充分研究2.动物试验有某些损害,但在妇女中未对照研究;C组,1.动物试验对胎儿有不良作用,但妇女中无充分对照研究。2.人和动物研究都表明不吸收;D组,实验证明可产生分娩缺陷,由于本类药物对某些疾病有高效,可允许在危及性命或严重
To demonstrate the extent of birth defects in digestive system drugs, the FDA determined these drugs to be in categories A, B, C, D, and X5: Group A, which is proven in the mother’s body to be non-fetal via adequate controlled trials. Although these studies do not completely exclude the risk, one can conclude that the potential for damaging the fetus with these drugs during pregnancy is minimal. Of course, the drug must be used when it is really needed; Group B, 1. Animal studies have not been shown to be at risk for the fetus, but not adequately studied in women 2. Some damage to animal tests but not to women; C, 1. Animal tests have adverse effects on the fetus, but women do not have adequate control studies. 2. Human and animal studies have shown no absorption; Group D, the experiment proved to produce birth defects, due to the class of drugs are effective for certain diseases, may allow life-threatening or serious