遺傳毒性評價是藥物安全性評價的重要組成部分。如何早期、快速地獲得藥物可能的毒性反應(yīng)數(shù)據(jù)，是當前遺傳毒理學(xué)領(lǐng)域的研究熱點之一。介紹幾種目前應(yīng)用比較廣泛或有較好應(yīng)用前景的早期、快速的遺傳毒性評價方法，包括Ames II試驗、Gadd45 GreenScreen試驗、高通量體外彗星試驗和流式細胞術(shù)檢測微核試驗，主要圍繞這些方法的基本原理、簡要操作流程、預(yù)測毒性的可信度以及與傳統(tǒng)方法相比的優(yōu)缺點等展開。同時簡要介紹計算機輔助毒性預(yù)測模型以及基因芯片技術(shù)在遺傳毒性評價中的應(yīng)用。

Genotoxicity assessment is an important component of drug safety evaluation. Recently, how to obtain the data of potential side effects rapidly in early phase of drug research is one of the hot points in genetic toxicology. This review summarized several prospective approaches including Ames II test, Gadd45 GreenScreen test, high-throughput in vitro comet test, and micronucleus test using flow cytometry, and their principles, brief procedure, validation, advantages, and potential problems. Additionally, this review gave a brief introduction of computer-assisted toxicity prediction model and application of microarray in genotoxicity evaluation.

國家自然科學(xué)基金（20807045/B070701）；國家科技重大專項“重大新藥創(chuàng)制”（2008ZX09305-007，2009ZX09501-033，2009ZX09301-001）