心血管疾病仍是全球主要死亡原因，而许多药物在临床中引发的心脏毒性不仅危及患者，也因早期未能预测风险而导致研发失败和经济损失，因此迫切需要更精准的心脏毒性评估与药物筛选工具。心脏类器官作为一种由多能干细胞衍生的三维微器官，能够高度模拟人类心脏的细胞异质性、空间结构和生理功能，为心血管疾病建模、药物筛选与安全性评价带来了革命性突破。系统阐述心脏类器官的构建策略，涵盖工程化构建与自组装构建。进一步总结涵盖形态学、电生理学、代谢组学与基因表达的多维度评估体系，探讨类器官在药物活性筛选与心脏毒性评价中的成功应用。尽管心脏类器官前景广阔，该技术迈向临床转化仍面临标准化、血管化、功能成熟度等科学与技术的挑战，以及监管路径尚不清晰等问题。未来，通过推动技术标准化、构建高级功能化模型并与监管科学深度结合，心脏类器官有望重塑心血管药物的研发范式，实现从基础研究向临床决策的可靠跨越。

Cardiovascular diseases remain a leading cause of death worldwide. Moreover, many drugs induce cardiotoxicity in clinical settings, which not only threatens patient safety but also leads to drug development failures and economic losses due to the inability to predict risks at an early stage. As such, there is an urgent need for more precise tools for cardiotoxicity assessment and drug screening. Cardiac organoids, derived from pluripotent stem cells, are three-dimensional micro-organs that can faithfully simulate the cellular heterogeneity, spatial structure, and physiological functions of the human heart. These organoids have brought revolutionary breakthroughs in cardiovascular disease modeling, drug screening, and safety evaluation. This review systematically discusses the strategies for constructing cardiac organoids, including engineered and self-assembled approaches. The article further summarizes a multidimensional assessment system that includes morphological, electrophysiological, metabolomic, and gene expression evaluations, and highlights the successful applications of cardiac organoids in drug efficacy screening and cardiotoxicity evaluation. Despite their vast potential, the clinical translation of cardiac organoids faces challenges in standardization, vascularization, and functional maturity, as well as issues with unclear regulatory pathways. In the future, by advancing technological standardization, developing higher-functionality models, and integrating with regulatory science, cardiac organoids are expected to reshape the paradigm of cardiovascular drug development and enable a reliable transition from basic research to clinical decision-making.

R965