de Jong-van den Berg L T, Rutgers J, Cornel M C
Afd. Sociale Farmacie en Farmaco-epidemiologie, Groninger Institute for Drug Studies, Rijksuniversiteit, Ant., Groningen.
Ned Tijdschr Geneeskd. 1998 Nov 14;142(46):2509-12.
Thalidomide was withdrawn from the market in the early sixties because of major teratogenic effects such as reduction defects of the limbs. Since, however, it has been found to be an effective drug in erythema nodosum leprosum. In the United States it was decided in September 1997 to admit thalidomide to the market for this indication, and in South America it has been available for this indication all the time. Thalidomide is also efficacious in other major disorders (e.g. aphtae and ulcers in aids) or its efficacy is being investigated in clinical trials (e.g. autoimmune diseases, other complications in aids). The American Food and Drug Administration has imposed conditions for the use of thalidomide. Users have to sign an informed consent and to take adequate contraceptive measures. Physicians should inform the patients and monitor side effects. Pharmacists should record and control the use.
沙利度胺在20世纪60年代初因肢体短小等严重致畸作用而退出市场。然而,后来发现它对麻风结节性红斑是一种有效的药物。1997年9月,美国决定批准沙利度胺用于该适应症上市,而在南美洲,它一直可用于该适应症。沙利度胺对其他一些主要病症也有效(如艾滋病中的口疮和溃疡),或者其疗效正在临床试验中进行研究(如自身免疫性疾病、艾滋病中的其他并发症)。美国食品药品监督管理局对沙利度胺的使用规定了条件。使用者必须签署知情同意书并采取充分的避孕措施。医生应告知患者并监测副作用。药剂师应记录并管控其使用情况。