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评估癌症预防药物研发中的上皮内瘤变及药物安全性。

Assessing intraepithelial neoplasia and drug safety in cancer-preventive drug development.

作者信息

Kelloff Gary J, Sigman Caroline C

机构信息

National Institutes of Health, National Cancer Institute, Division of Cancer Treatment and Diagnosis, Executive Plaza North Room 6058, 6130 Executive Boulevard, Rockville, Maryland 20852, USA.

出版信息

Nat Rev Cancer. 2007 Jul;7(7):508-18. doi: 10.1038/nrc2154.

DOI:10.1038/nrc2154
PMID:17568791
Abstract

Despite significant interest from the research community and the population in general, drug approvals for cancer prevention and/or cancer risk reduction are few. This is due, in part, to the requirement that new cancer-preventive drugs must first be shown to be efficacious in reducing cancer incidence or mortality. Moreover, such drugs need to have proven safety for long-term administration. This process can be improved by focusing on precancer (intraepithelial neoplasia) to identify subjects at risk and prove efficacy in shorter, smaller trials as well as on detecting early markers of potential toxicities of chronic exposure to cancer-preventive drug regimens.

摘要

尽管研究界和普通民众对此兴趣浓厚,但用于癌症预防和/或降低癌症风险的药物获批情况却很少。部分原因在于,新的癌症预防药物必须首先证明在降低癌症发病率或死亡率方面有效。此外,此类药物需要证明长期服用的安全性。通过关注癌前病变(上皮内瘤变)以识别高危人群,并在规模较小的短期试验中证明疗效,以及检测长期接触癌症预防药物方案潜在毒性的早期标志物,可以改进这一过程。

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Assessing intraepithelial neoplasia and drug safety in cancer-preventive drug development.评估癌症预防药物研发中的上皮内瘤变及药物安全性。
Nat Rev Cancer. 2007 Jul;7(7):508-18. doi: 10.1038/nrc2154.
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