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目的评价注射用替加环素的安全性。方法对注射用替加环素进行血管刺激、肌肉刺激、溶血性及被动皮肤过敏、全身主动过敏性、类过敏性试验。结果注射用替加环素对血管无明显刺激性、对肌肉组织产生轻度可逆性的刺激,对家兔红细胞无溶血、凝聚作用,大鼠被动皮肤过敏反应(PCA)试验未出现过敏反应;豚鼠全身主动过敏反应(ASA)试验部分豚鼠出现过敏反应;注射用替加环素与已上市药品Tygacil在同等剂量下,豚鼠出现同等程度的类过敏反应。结论注射用替加环素可能会引起肌肉刺激性及过敏、类过敏反应,临床应用时应关注患者给药后的反应。
Objective To evaluate the safety of tigecycline for injection. Methods Tigecycline injection for vascular stimulation, muscle stimulation, hemolytic and passive skin allergies, systemic anaphylactic, allergic tests. RESULTS: Tigecycline for injection had no obvious irritation on blood vessels, slight reversible stimulation on muscular tissue, no hemolysis and agglutination on erythrocytes, and no allergic reaction in passive cutaneous anaphylaxis (PCA) in rats. Guinea pigs experienced anaphylactic reaction in some guinea pigs with active systemic anaphylaxis (ASA) test; the same level of allergic reaction was observed in guinea pigs at the same dosage with tigecycline for injection and Tygacil, which is already on the market. Conclusion Tigecycline for injection may cause muscle irritation, allergic reaction and allergic reaction. The clinical application should be concerned with the response after administration.