人胚胎干细胞（hESCs）是来源于胚胎发育早期内细胞团的一类未分化的多能干细胞，具有自我更新和多向分化的生物学特性，在发育生物学、再生医学以及细胞治疗领域等方面已开展了广泛的研究。与常规药物毒性评估所采用的癌细胞或原代细胞不同，干细胞不仅能满足基础毒性评估，由于其多向分化的特点，可经诱导产生各种正常人体器官或组织细胞，为药物临床前评估提供多方面数据。与动物实验模型相比，hESCs不仅避免了种属差异，还具备高通量、低成本的优势，在预测药物毒性效应方面具有广阔的前景。对目前hESCs在药物毒性风险评估中的研究进展进行总结，为体外药物毒性筛选试验提供新思路。

Human embryonic stem cells (hESCs) are undifferentiated pluripotent stem cells derived from the inner cell mass in the early stages of embryonic development, have properties of self-renewal and multi-differentiation. Owing to their unique properties, they have been extensively used in developmental biology, regenerative medicine and cell therapies. Different from cancer cells or primary cells in regular drug risk assessments, stem cells can not only assess the basic toxicity, but also can be induced to various normal human organs or tissue cells due to their multi-directional differentiation characteristics, which can provide various data for pre-clinical drug assessments. Compared with animal models, hESCs-derived cell lines or organs are more powerful drug screening tools, having the advantages of high throughput and low cost, as well as overcoming the problem of species specificity. hESCs has a promising development prospect in the future. The research progress on hESCs in drug toxicity risk assessments is summarized in this paper, and provides a new idea for drug toxicity screening tests in vitro.

国家自然科学基金青年科学基金资助项目（21707160）；国家自然科学基金面上资助项目（21577166、21876197）