Shale John H, Shale Christopher M, Mastin William D
Adult Mental Health Services, San Diego County Health and Human Services Agency, 3255 Camino Del Rio South, San Diego, CA 92110, USA.
Expert Opin Drug Saf. 2004 Jul;3(4):369-78. doi: 10.1517/14740338.3.4.369.
By the year 2000, droperidol had become a standard drug for the treatment of behavioural emergencies in both psychiatric and medical settings. In 2001, the US FDA issued a 'black box' warning, citing cases of QT prolongation and/or torsades de pointes. As a result, the use of droperidol has been sharply circumscribed. The authors will review the literature on antipsychotic medications in general, focusing on droperidol in particular, with regard to QT interval prolongation, dysrhythmia, and sudden death. In addition, the mechanism of drug-induced QT interval prolongation will be discussed. The authors will then review their extensive experience with droperidol. The authors conclude that, while in theory droperidol may prolong the QT interval to an extent similar to thioridazine, its long history of clinical use has shown no pattern of sudden deaths analogous to those that provoked the FDA warning. Although the numbers presented by the FDA initially appear alarming, after further evaluation it is clear that more definitive studies should have been carried out. Droperidol is safe, extremely effective, and now underused as a treatment for severely agitated or violent patients.
到2000年，氟哌利多已成为精神科和内科治疗行为紧急情况的标准药物。2001年，美国食品药品监督管理局（FDA）发布了“黑框”警告，列举了QT间期延长和/或尖端扭转型室速的病例。结果，氟哌利多的使用受到了严格限制。作者将综述关于抗精神病药物的文献，尤其关注氟哌利多在QT间期延长、心律失常和猝死方面的情况。此外，还将讨论药物诱导QT间期延长的机制。然后作者将回顾他们在氟哌利多方面的丰富经验。作者得出结论，虽然理论上氟哌利多可能会使QT间期延长到与硫利达嗪相似的程度，但其长期的临床使用并未显示出与引发FDA警告的猝死情况类似的模式。尽管FDA公布的数据最初看起来令人担忧，但经过进一步评估后很明显，本应进行更具确定性的研究。氟哌利多是安全且极其有效的，目前在治疗严重躁动或暴力患者方面未得到充分利用。
