藥物非臨床毒性試驗周圍神經(jīng)系統(tǒng)（peripheral nervous system，PNS）組織病理學評估分為4種情況：未知或預期無神經(jīng)毒性的一般毒性試驗、可能有軀體神經(jīng)毒性的一般毒性試驗、可能有自主神經(jīng)病的一般毒性試驗以及預期有神經(jīng)毒性作用的專門神經(jīng)毒性試驗。美國毒性病理學會（Society of Toxicologic Pathology，STP）推薦最佳實踐建議的目的是確保在藥物非臨床一般毒性試驗和專門神經(jīng)毒性試驗的4種情況下，對PNS組織進行一致性、高效率取材、處理和評估。綜述了PNS解剖的基本結(jié)構(gòu)、PNS毒性試驗情況分類及取材建議、PNS毒性試驗不同情況下最佳實踐建議、PNS神經(jīng)病理學評估分析策略以及評估結(jié)果的記錄，以期為我國藥物非臨床毒性試驗中周圍神經(jīng)系統(tǒng)組織病理學評估提供一定參考。

There are four different situations encountered in histopathology assessment of peripheral nervous system (PNS) during nonclinical toxicity studies, consisted of general toxicity studies where neurotoxicity is unknown or not anticipated, general toxicity studies where somatic PNS neurotoxicity is suspected, general toxicity studies where autonomic PNS neuropathy is suspected, and dedicated neurotoxicity studies where a neurotoxic effect is expected. Current best practice recommendations of the US Society of Toxicologic Pathology (STP) are designed to ensure consistent and efficient sampling, processing and evaluating of PNS tissues for the four different situations. The basic structure of PNS anatomy, different situations and recommendations for sampling of the PNS during toxicity studies, best practice recommendations for different situations of the PNS during toxicity studies, strategy for PNS neuropathology analysis, as well as neuropathology documentation are reviewed in the paper, in order to provide some references for histopathology assessment of PNS during nonclinical toxicity studies of drugs in China.

江蘇省新藥一站式高效非臨床評價公共服務平臺建設(shè)項目（BM2021002）