Rosa F W, Bosco L A, Graham C F, Milstien J B, Dreis M, Creamer J
Food and Drug Administration, Rockville, Maryland.
Obstet Gynecol. 1989 Sep;74(3 Pt 1):371-4.
The use of angiotensin-converting enzyme inhibitors as antihypertensives has increased rapidly since the introduction of captopril in 1981. Seven cases of neonatal renal failure have been reported in patients with exposure to angiotensin-converting enzyme inhibitors that continued to the time of delivery. Two cases resulted in death of the newborn; the other five patients recovered after peritoneal dialysis. Because the relative frequency of normal outcomes is unknown, these data are insufficient for incidence-rate estimates or risk/benefit analyses. However, given the potential neonatal morbidity and mortality associated with late-pregnancy exposure to angiotensin-converting enzyme inhibitors, alternative therapies in the third trimester should be given consideration. If these drugs must be used in this context, the clinician should be prepared to deal with renal failure and hypotension in the newborn. The Food and Drug Administration invites reports of adverse pregnancy outcomes associated with such exposure.
自1981年卡托普利问世以来，血管紧张素转换酶抑制剂作为抗高血压药物的使用迅速增加。有报道称，7例在分娩时仍持续接触血管紧张素转换酶抑制剂的患者出现新生儿肾衰竭。其中2例导致新生儿死亡；其他5例患者在腹膜透析后康复。由于正常结局的相对频率未知，这些数据不足以进行发病率估计或风险/效益分析。然而，鉴于妊娠晚期接触血管紧张素转换酶抑制剂可能导致新生儿发病和死亡，应考虑在妊娠晚期使用替代疗法。如果必须在此情况下使用这些药物，临床医生应做好处理新生儿肾衰竭和低血压的准备。美国食品药品监督管理局要求报告与此类接触相关的不良妊娠结局。
