隨著醫(yī)藥科技的飛速發(fā)展，新藥研發(fā)與上市進(jìn)程日益加速，藥物安全性評(píng)價(jià)的科學(xué)性與準(zhǔn)確性愈發(fā)凸顯其關(guān)鍵地位。系統(tǒng)梳理2013—2025年不同藥物安全性評(píng)價(jià)技術(shù)的研究進(jìn)展，重點(diǎn)聚焦實(shí)驗(yàn)新技術(shù)、計(jì)算機(jī)輔助技術(shù)與數(shù)據(jù)庫(kù)，以及非哺乳類模式動(dòng)物在該領(lǐng)域的創(chuàng)新應(yīng)用。其中，類器官、微流控芯片、代謝流分析、質(zhì)譜成像、轉(zhuǎn)基因技術(shù)等實(shí)驗(yàn)新技術(shù)，通過(guò)構(gòu)建高度仿生的研究平臺(tái)，從多維度探究并驗(yàn)證毒性發(fā)生的分子及細(xì)胞機(jī)制，不僅顯著提升了藥物評(píng)價(jià)的精準(zhǔn)度，還降低了對(duì)動(dòng)物實(shí)驗(yàn)的依賴；定量結(jié)構(gòu)-活性關(guān)系建模、實(shí)時(shí)無(wú)標(biāo)記細(xì)胞分析、高內(nèi)涵細(xì)胞影像分析及人工智能預(yù)測(cè)模型等技術(shù)，有效提高了藥物評(píng)價(jià)效率與早期毒性預(yù)測(cè)能力；線蟲(chóng)、斑馬魚(yú)等非哺乳類模式動(dòng)物因繁殖迅速、成本低廉、胚胎透明等獨(dú)特優(yōu)勢(shì)，在嚴(yán)格遵循3R原則的基礎(chǔ)上得到廣泛應(yīng)用。這些技術(shù)的協(xié)同發(fā)展，共同推動(dòng)藥物安全性評(píng)價(jià)向更高效、更符合倫理的方向邁進(jìn)，為保障藥物的安全性與有效性奠定了堅(jiān)實(shí)基礎(chǔ)。

With the rapid development of medical science and technology, the process of new drug research and development is accelerating, and the scientificity and accuracy of drug safety evaluation have become increasingly crucial. This article systematically reviews the research progress of different drug safety evaluation technologies from 2013 to 2025, focusing on experimental new technologies, computer-aided technologies and databases, as well as innovative applications of non-mammalian model animals in this field. Among them, experimental new technologies such as organoids, microfluidic chips, metabolic flow analysis, mass spectrometry imaging and transgenic technology, by constructing highly biologically similar research platforms, explore and verify the molecular and cellular mechanisms of toxicity occurrence from multiple dimensions, not only significantly improving the accuracy of drug evaluation, but also reducing the reliance on animal experiments; quantitative structure-activity relationship modeling, real-time unlabeled cell analysis, high-content cell imaging analysis and artificial intelligence prediction models, effectively improve the efficiency of drug evaluation and the ability to predict early toxicity; nematodes, zebrafish, etc., non-mammalian model animals, due to their unique advantages such as rapid reproduction, low cost, and transparent embryos, have been widely used on the basis of strictly following the 3R principles. The collaborative development of these technologies jointly promote drug safety evaluation towards a more efficient and more ethical direction, laying a solid foundation for ensuring the safety and reliability of drugs.

R969.3

國(guó)家自然科學(xué)基金委員會(huì)青年科學(xué)基金項(xiàng)目（82204938）；河南省醫(yī)學(xué)科技攻關(guān)計(jì)劃聯(lián)合共建項(xiàng)目（LHGJ20240427）