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实验动物中毒理学发现对人类的预测价值(作者译)

[The predictive value for man of toxicological findings in experimental animals (author's transl)].

作者信息

Ueberberg H

出版信息

Arzneimittelforschung. 1978;28(11a):1975-6.

PMID:582528
Abstract

The extrapolation of toxicological findings in experimental animals to man is an important and difficult problem. However, experiments on several animal species form the basis for deciding whether or not a new substance should be given to or tested on humans. Compounds which even in low doses lead to dose-dependent organic damage should obviously not be developed any further. There are, however, cases in which no firm conclusion can be reached by the toxicologist on the grounds of the results of animal experiments alone, as to whether or not the substance should be used in man. In such cases close collaboration is necessitated between the pharmacologist, toxicologist, biochemist and physician. Their aim is to decide if preliminary trials may or may not be carried out in human subjects. If the answer is in the affirmative, early administration to man should follow, as there is no clear-cup solution to the question of extrapolating findings in animal experiments to test subjects. Medical progress relies on research which, in the end, has to be supported by experiments on humans.

摘要

将实验动物的毒理学研究结果外推至人类是一个重要且困难的问题。然而,对多种动物物种进行的实验是决定是否应将新物质用于人类或在人类身上进行测试的基础。即使低剂量也会导致剂量依赖性器官损伤的化合物显然不应再进一步研发。然而,在某些情况下,毒理学家仅根据动物实验结果无法就该物质是否应在人类中使用得出确凿结论。在这种情况下,药理学家、毒理学家、生物化学家和医生之间需要密切合作。他们的目的是决定是否可以在人类受试者中进行初步试验。如果答案是肯定的,那么应尽早对人类进行给药,因为将动物实验结果外推至受试对象的问题没有明确的解决方案。医学进步依赖于研究,而最终这些研究必须通过人体实验来支持。

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