This survey is a compendium of genotoxicity and carcinogenicity information of bronchodilators and antiasthma drugs. Data from 46 marketed drugs were collected. Of these 46 drugs, 25 (54.3%) did not have retrievable genotoxicity or carcinogenicity data. The remaining 21 (45.7%) had at least one genotoxicity or carcinogenicity test result. Of these 21 drugs, 10 had at least one positive finding: three tested positive in at least one genotoxicity assay, eight in at least one carcinogenicity assay, and one of them gave positive results in both genotoxicity assay and carcinogenicity assay. Concerning the predictivity of genetic toxicology findings for the result(s) of long-term carcinogenesis assays, 15 drugs had both genotoxicity and carcinogenicity data: seven of them (46.6%) were neither genotoxic nor carcinogenic, 6 (40.0%) were carcinogenic in at least one sex of mice or rats but tested negative in genotoxicity assays, 1 (6.7%) tested positive in genotoxicity assay but was non-carcinogenic, and 1 (6.7%) gave positive responses in both genotoxicity and carcinogenicity assay. Only 11 (23.9%) of the 46 drugs considered had all data required by current guidelines for testing of pharmaceuticals, but a large fraction of them were developed and marketed prior to the present regulatory climate.

译文

:该调查是支气管扩张剂和抗哮喘药的遗传毒性和致癌性信息的纲要。收集了来自46种上市药物的数据。在这46种药物中,有25种(54.3%)没有可检索的遗传毒性或致癌性数据。其余21个(45.7%)至少具有一项遗传毒性或致癌性测试结果。在这21种药物中,有10种具有至少一项阳性发现:三种在至少一种遗传毒性试验中呈阳性,至少八种在至少一种致癌性试验中呈阳性,其中一种在遗传毒性和致癌性试验中均呈阳性。关于长期致癌试验结果的遗传毒理学发现的可预测性,有15种药物同时具有遗传毒性和致癌性数据:其中7种(46.6%)既没有遗传毒性也不具有致癌性,其中6种(40.0%)既没有致癌性也没有致癌性。至少一种性别的小鼠或大鼠在遗传毒性试验中呈阴性,有1(6.7%)在遗传毒性试验中呈阳性,但无致癌性,另有1(6.7%)在遗传毒性和致癌性试验中均呈阳性反应。在所考虑的46种药物中,只有11种(23.9%)具有当前药物测试指南所要求的所有数据,但是其中很大一部分是在当前监管环境之前开发和销售的。

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