中藥注射劑（TCMIs）起效快、療效確切、臨床應用廣泛，但其類過敏反應（ARs）等不良事件已成為中藥安全性研究的熱點和難點。近年來，為加快推進TCMIs安全性再評價，深入了解TCMIs相關ARs的癥狀特點、致敏成分、作用機制等，研究者采用體內實驗（ARs癥狀觀察法、伊文思藍藍染法、組織病理學檢查法）、體外實驗（甲基四氮唑與細胞計數試劑盒-8法、染色法、膜黏連蛋白V結合法等）方法對ARs進行了評估，可為建立可靠的評價方法提供依據，為臨床TCMIs相關ARs的早期識別、風險防控提供新思路。

Traditional Chinese medicine injections (TCMIs) have been widely used in clinical because of their rapid onset of action and precise efficacy, while their anaphylactoid reactions (ARs) and other adverse events have become a hot spot and a difficult area for safety research on traditional Chinese medicine. In recent years, in order to accelerate the safety re-evaluation of TCMIs and to gain a deeper understanding of the symptom characteristics, allergenic components and mechanisms of TCMIs-related ARs. The reseachers evaluated ARs using in vivo experiments (ARs symptom observation method, Evans blue staining method, histopathological examination method) and in vitro experiments (methyl tetrazolium and cell counting kit-8 method, staining method, membrane adhesion protein V binding method). It can provide a basis for establishing scientific and reliable evaluation methods, and provide new ideas for early identification, risk prevention and control of of clinical TCMIs-related ARs.

R969.3；R285.5

國家自然科學基金資助項目（82174069）；湖南省教育廳科學研究項目（21B0375）；湖南省衛(wèi)健委科研計劃課題（C202313057956）