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治疗性孤儿药的产生——或者说,我们从黛本多克斯事件中学到了什么?

The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?

作者信息

Sheffield L J, Batagol R

出版信息

Med J Aust. 1985 Aug 19;143(4):143-7. doi: 10.5694/j.1326-5377.1985.tb122871.x.

DOI:10.5694/j.1326-5377.1985.tb122871.x
PMID:3927122
Abstract

The drug combination Debendox has been very widely used for the treatment of nausea and vomiting in pregnancy. Recently its manufacturer ceased world-wide production owing to the increasing costs of litigation associated with claims of teratogenicity. Teratogenicity claims were widespread in the media but the overwhelming scientific evidence was that Debendox was not teratogenic. In the interests of preventing other drugs (and drug companies) being subjected to similarly unfounded claims, the literature relating to the effects of Debendox on the fetus has been reviewed and evaluated against well known epidemiological principles of establishing causality. This evaluation consistently demonstrates that Debendox is not in fact teratogenic. It is recommended that appropriate professional bodies be more aware of the criteria by which causation is established and be prepared publicly to state their considered views of the effects of particular drugs in pregnancy.

摘要

复方多西拉敏已被广泛用于治疗妊娠期间的恶心和呕吐。最近,由于与致畸性索赔相关的诉讼成本不断增加,其制造商停止了全球生产。致畸性索赔在媒体上广泛传播,但压倒性的科学证据表明复方多西拉敏没有致畸性。为了防止其他药物(以及制药公司)遭受同样毫无根据的索赔,已根据确定因果关系的著名流行病学原则,对有关复方多西拉敏对胎儿影响的文献进行了审查和评估。该评估一致表明,复方多西拉敏实际上并无致畸性。建议相关专业机构更加了解确立因果关系的标准,并准备好公开陈述他们对特定药物在妊娠期间影响的审慎看法。

相似文献

1
The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?治疗性孤儿药的产生——或者说,我们从黛本多克斯事件中学到了什么?
Med J Aust. 1985 Aug 19;143(4):143-7. doi: 10.5694/j.1326-5377.1985.tb122871.x.
2
Debendox.胃复安(一种药物名称,含苯海拉明和氯丙嗪)
Med J Aust. 1986 Jan 6;144(1):51-2. doi: 10.5694/j.1326-5377.1986.tb113641.x.
3
Debendox in the dock.复方晕海宁(乘晕宁)被送上了法庭。
Nurs Mirror. 1980 Feb 21;150(8):8-9.
4
Fetal malformation after Debendox treatment in early pregnancy.孕早期服用苯双香豆素后出现胎儿畸形。
Br Med J. 1978 Apr 22;1(6119):1055-6. doi: 10.1136/bmj.1.6119.1055-a.
5
[2 cases of malformations of a limb in infants of mothers treated with an antiemetic in a very early phase of pregnancy].[孕期极早期使用止吐药治疗的母亲所生婴儿出现2例肢体畸形]
Pediatr Med Chir. 1981 Jan-Feb;3(1):97-9.
6
Debendox in pregnancy.孕期使用多西环素。
Med J Aust. 1980 Mar 8;1(5):197. doi: 10.5694/j.1326-5377.1980.tb134762.x.
7
Debendox in early pregnancy and fetal malformation.早期妊娠中的多西拉敏与胎儿畸形
Br Med J (Clin Res Ed). 1981 Jul 11;283(6284):99-101. doi: 10.1136/bmj.283.6284.99.
8
Debendox and limb reduction deformities.复方苯乙哌啶与肢体短小畸形
Med J Aust. 1981 Apr 18;1(8):417-8. doi: 10.5694/j.1326-5377.1981.tb135685.x.
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Debendox and congenital malformations in Northern Ireland.北爱尔兰的地苯多司与先天性畸形
Br Med J. 1980 Nov 22;281(6252):1379-81. doi: 10.1136/bmj.281.6252.1379.
10
Bendectin and fetal development. A study of Boston City Hospital.苯海拉明与胎儿发育。波士顿市医院的一项研究。
Am J Obstet Gynecol. 1982 Jan 15;142(2):209-13. doi: 10.1016/s0002-9378(16)32338-9.

引用本文的文献

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Pharmacological Agents Affecting Emesis : A Review (Part II).影响呕吐的药物制剂:综述(第二部分)
Drugs. 1992 Apr;43(4):443-463. doi: 10.2165/00003495-199243040-00003.
2
Assessment of antihistamine use in early pregnancy and birth defects.评估抗组胺药物在早孕和出生缺陷中的应用。
J Allergy Clin Immunol Pract. 2013 Nov-Dec;1(6):666-74.e1. doi: 10.1016/j.jaip.2013.07.008. Epub 2013 Sep 12.
3
Improving adverse drug reaction monitoring.
Med Toxicol Adverse Drug Exp. 1987 Nov-Dec;2(6):398-404. doi: 10.1007/BF03259874.