隨著醫(yī)藥科技的飛速發(fā)展，新藥研發(fā)與上市進程日益加速，藥物安全性評價的科學性與準確性愈發(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價技術(shù)的研究進展，重點聚焦實驗新技術(shù)、計算機輔助技術(shù)與數(shù)據(jù)庫，以及非哺乳類模式動物在該領(lǐng)域的創(chuàng)新應用。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)等實驗新技術(shù)，通過構(gòu)建高度仿生的研究平臺，從多維度探究并驗證毒性發(fā)生的分子及細胞機制，不僅顯著提升了藥物評價的精準度，還降低了對動物實驗的依賴；定量結(jié)構(gòu)-活性關(guān)系建模、實時無標記細胞分析、高內(nèi)涵細胞影像分析及人工智能預測模型等技術(shù)，有效提高了藥物評價效率與早期毒性預測能力；線蟲、斑馬魚等非哺乳類模式動物因繁殖迅速、成本低廉、胚胎透明等獨特優(yōu)勢，在嚴格遵循3R原則的基礎(chǔ)上得到廣泛應用。這些技術(shù)的協(xié)同發(fā)展，共同推動藥物安全性評價向更高效、更符合倫理的方向邁進，為保障藥物的安全性與有效性奠定了堅實基礎(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

國家自然科學基金委員會青年科學基金項目（82204938）；河南省醫(yī)學科技攻關(guān)計劃聯(lián)合共建項目（LHGJ20240427）