目的 應(yīng)用全身體積描記法觀察注射用重組人成纖維細(xì)胞生長因子-21（rhFGF-21）對大鼠呼吸系統(tǒng)的影響，確定藥物可能關(guān)系到人的安全性的非期望出現(xiàn)的藥物效應(yīng)，為臨床研究和安全用藥提供參考。方法 SD大鼠40只，雌雄各半。實驗設(shè)置4個組，分別為溶媒對照組、rhFGF-21 1.5、3.0、6.0 mg/kg劑量組，應(yīng)用全身體積描記法采集清醒無束縛大鼠給藥前、給藥后0.25、1、2、4 h的呼吸功能指標(biāo)。結(jié)果 與溶媒對照組比較，各劑量組動物藥后0.25、1、2、4 h均未見潮氣量、每分鐘通氣量、呼吸頻率出現(xiàn)統(tǒng)計學(xué)差異。結(jié)論 大鼠單次皮下注射給予6.0 mg/kg的rhFGF-21，未見藥物對大鼠呼吸系統(tǒng)指標(biāo)產(chǎn)生明顯影響。

Objective Reaserch on the effect of recombinant human fibroblast growth factor-21 (rhFGF-21) on respiratory system in rats by whole body plethysmography, to determine the undesired drug effects that may be related to human safety, and provide reference for clinical research and safe medication. Methods 40 SD rats were used in this study, 20 males and 20 females. Four groups were set up, which were vehicle control group, rhFGF-21 1.5, 3.0 and 6.0 mg/kg dose groups. Respiratory function indexes of conscious and unconstrained rats before and 0.25, 1, 2 and 4 hours after administration were collected by whole body plethysmography. Results Compared with the vehicle control group, there was no statistical difference in tidal volume, minute ventilation, and respiratory rate at 0.25, 1, 2, and 4 h after treatment. Conclusion Rats were given a single subcutaneous injection of 6.0 mg/kg rhFGF-21, there was no significant effect on the respiratory index in rats.

國家科技重大新藥創(chuàng)制項目（2015ZX09501004），天津市科技計劃項目（16PTGCCX00090）