Sachdeva Punam, Patel B G, Patel B K
Department of Pharmacology, A. R. College of Pharmacy, Vallabh Vidyanagar-388 120, India.
Indian J Pharm Sci. 2009 Jan;71(1):1-7. doi: 10.4103/0250-474X.51941.
Pregnancy is a special physiological condition where drug treatment presents a special concern because the physiology of pregnancy affects the pharmacokinetics of medications used and certain medications can reach the fetus and cause harm. Total avoidance of pharmacological treatment in pregnancy is not possible and may be dangerous because some women enter pregnancy with medical conditions that require ongoing and episodic treatment (e.g. asthma, epilepsy, hypertension). Also during pregnancy new medical problems can develop and old ones can be exacerbated (e.g. migraine, headache) requiring pharmacological therapy. The fact that certain drugs given during pregnancy may prove harmful to the unborn child is one of the classical problems in medical treatment. In 1960's pregnant ladies who ingested thalidomide gave birth to children with phocomalia. Various other examples of teratogenic effects of drugs are known. It has been documented that congenital abnormalities caused by human teratogenic drugs account for less than 1% of total congenital abnormalities. Hence in 1979, Food and Drug Administration developed a system that determines the teratogenic risk of drugs by considering the quality of data from animal and human studies. FDA classifies various drugs used in pregnancy into five categories, categories A, B, C, D and X. Category A is considered the safest category and category X is absolutely contraindicated in pregnancy. This provides therapeutic guidance for the clinician. This article focuses on various aspects relating to drug use during pregnancy.
怀孕是一种特殊的生理状态,药物治疗在此情况下需特别关注,因为怀孕的生理状况会影响所用药物的药代动力学,而且某些药物会到达胎儿体内并造成伤害。在孕期完全避免药物治疗既不可能,也可能很危险,因为有些女性在怀孕时就患有需要持续或间断治疗的疾病(如哮喘、癫痫、高血压)。此外,孕期还可能出现新的医疗问题,旧病也可能加重(如偏头痛、头痛),这就需要进行药物治疗。孕期使用某些药物可能对未出生的孩子有害,这是医疗领域的经典问题之一。20世纪60年代,服用沙利度胺的孕妇生下了患海豹肢症的孩子。药物致畸作用的其他各种例子也为人所知。据记载,由人类致畸药物导致的先天性异常在先天性异常总数中所占比例不到1%。因此,1979年美国食品药品监督管理局制定了一个系统,通过考虑动物和人体研究的数据质量来确定药物的致畸风险。美国食品药品监督管理局将孕期使用的各种药物分为五类,即A、B、C、D和X类。A类被认为是最安全的类别,X类在孕期绝对禁用。这为临床医生提供了治疗指导。本文重点关注孕期用药的各个方面。