目的 評(píng)價(jià)注射用替加環(huán)素的安全性。方法 對(duì)注射用替加環(huán)素進(jìn)行血管刺激、肌肉刺激、溶血性及被動(dòng)皮膚過(guò)敏、全身主動(dòng)過(guò)敏性、類過(guò)敏性試驗(yàn)。結(jié)果 注射用替加環(huán)素對(duì)血管無(wú)明顯刺激性、對(duì)肌肉組織產(chǎn)生輕度可逆性的刺激，對(duì)家兔紅細(xì)胞無(wú)溶血、凝聚作用，大鼠被動(dòng)皮膚過(guò)敏反應(yīng)（PCA）試驗(yàn)未出現(xiàn)過(guò)敏反應(yīng)；豚鼠全身主動(dòng)過(guò)敏反應(yīng)（ASA）試驗(yàn)部分豚鼠出現(xiàn)過(guò)敏反應(yīng)；注射用替加環(huán)素與已上市藥品Tygacil 在同等劑量下，豚鼠出現(xiàn)同等程度的類過(guò)敏反應(yīng)。結(jié)論 注射用替加環(huán)素可能會(huì)引起肌肉刺激性及過(guò)敏、類過(guò)敏反應(yīng)，臨床應(yīng)用時(shí)應(yīng)關(guān)注患者給藥后的反應(yīng)。

Objective To evaluate the safety of Tigecycline for injection. Methods The reactions of stimulation on blood vessel and muscle of rabbit, hemolysis, PCA on SD rat, ASA and anaphylactoid on Guinea pig were studied. Results No hypersensitive action was found on blood vessel, red cell, and PCA of rabbit, and mild reversible reactions on muscle tissue was observed. Anaphylactic and anaphylactoid reactions were found on some Guinea pigs. Tigecycline for injection and marketed drug Tygacil can cause anaphylactoid reaction in Guinea pigs with the same degree at an equivalent dose. Conclusion Tigecycline for injection may cause muscle stimulation, allergy, and anaphylactoid reaction, and the patients should be followed after taking the medicine.