Department of Internal Medicine, Division of Clinical Pharmacology and Toxicology, University of Genoa, Viale Benedetto XV, 2, I-16132 Genoa, Italy.
Mutat Res. 2012 Jan-Mar;750(1):1-51. doi: 10.1016/j.mrrev.2011.09.002.
This survey is a compendium of information retrieved on carcinogenicity in animals and humans of 535 marketed pharmaceuticals whose expected clinical use is continuous for at least 6 months or intermittent over an extended period of time. Of the 535 drugs, 530 have the result of at least one carcinogenicity assay in animals, and 279 (52.1%) of them gave a positive response in at least one assay. Only 186 drugs (34.8%) have retrievable information on carcinogenicity in humans, and 104 of them gave to a variable extent evidence of a potential carcinogenic activity. Concerning the correlation between results obtained in animals and epidemiological findings, 58 drugs gave at least one positive result in carcinogenicity assays performed in animals and to a variable extent displayed evidence of carcinogenicity in humans, but 97 drugs tested positive in animals and were noncarcinogenic in humans or vice versa. Our findings, which are in agreement with previous studies, indicate that the evaluation of the benefit/carcinogenic risk ratio should be always made in prescribing a drug.
本调查汇集了 535 种已上市药物的致癌性在动物和人类中的信息，这些药物的预期临床应用至少持续 6 个月或间歇性延长一段时间。在这 535 种药物中，有 530 种在动物中有至少一种致癌性检测结果，其中 279 种（52.1%）在至少一种检测中呈阳性反应。只有 186 种药物（34.8%）有人类致癌性的可检索信息，其中 104 种在不同程度上显示出潜在致癌活性的证据。关于动物实验结果与流行病学发现之间的相关性，有 58 种药物在动物致癌性检测中至少有一个阳性结果，并且在不同程度上在人类中显示出致癌性证据，但有 97 种药物在动物中呈阳性而在人类中是非致癌性的，或者反之亦然。我们的发现与先前的研究一致，表明在开处方时应始终对药物的获益/致癌风险比进行评估。
