系統(tǒng)綜述類器官技術在藥物篩選、安全性評價及藥動學研究中的最新應用，并探討技術標準化與臨床轉化面臨的挑戰(zhàn)。通過文獻研究和案例分析，從藥物篩選、安全性評價及藥動學研究等方面，分別闡述不同類器官模型的應用場景，同時分析類器官的表征標準化體系建立的重要意義。類器官在藥物篩選中優(yōu)勢明顯，腫瘤類器官已成為抗腫瘤藥物篩選的首選模型，在結直腸癌、肝癌和肺癌等藥物篩選中發(fā)揮顯著優(yōu)勢。在安全性評價方面，肝臟、心臟、腎臟和大腦等類器官可有效模擬藥物導致的毒性。藥動學研究中，腸道、肝臟類器官可以助力研究藥物代謝機制。但類器官培養(yǎng)易受多種因素影響，存在培養(yǎng)成本高、技術要求高、標準化體系尚不完善等問題，且其與體內真實器官仍有差異。類器官技術雖有局限，但已展現出高效性和準確性，為藥物研發(fā)提供有力支持，隨著技術的不斷進步，其有望推動藥物研發(fā)的高質量發(fā)展。

To systematically review the latest applications of organoid technology in drug screening, safety evaluation and pharmacokinetic studies, and discuss challenges in technical standardization and clinical translation. Through literature research and case analysis, the application scenarios of different organ models were explained from the aspects of drug screening, safety evaluation and pharmacokinetic studies, and the importance of establishing a standardized system for organoid characterization was analyzed. Organoids demonstrate distinct advantages in drug screening. Tumor organoids have become the preferred model for anti-cancer drug screening, exhibiting remarkable utility in drug screening such as colorectal cancer, liver cancer and lung cancer. In safety evaluation, organoids of the liver, heart, kidney and brain can effectively simulate the toxicity caused by drugs. In pharmacokinetic studies, intestinal and liver organoids can help study drug metabolism mechanisms. However, organoid culture is susceptible to various factors, and there are problems such as high cultivation costs, high technical requirements, and incomplete standardization system, and it is still different from the real organs in the body. Despite current limitations, organoid technology has proven to be a highly efficient and accurate tool for drug development. With the continuous advancement of technology, it is expected to promote the high-quality development of drug research and development.

R965.2

國家重點研發(fā)計劃項目（2022YFC2409702）