毒理性
在获得许可前的对照试验中，使用Dalbavancin、Oritavancin或Telavancin治疗期间，血清ALT升高是常见的，发生在多达25%的患者中。然而，血清转氨酶升高超过正常上限三倍的情况并不常见，接受Dalbavancin、Oritavancin或Telavancin治疗的患者中，这种情况的发生率为0.8%至6%。此外，这些肝脏测试异常的发生率与比较组并没有太大差异。在糖肽类抗生素治疗期间ALT升高通常是短暂的、无症状的，严重程度仅为轻至中度，很少导致剂量调整或提前终止治疗。在这些药物的注册试验中没有报告出现黄疸的临床明显肝损伤。自从这些药物获得批准并更广泛使用以来，没有公开发表的报告将肝损伤归因于糖肽类抗生素，尽管有报道过敏反应，有时可能与轻至中度的肝损伤有关。尽管如此，这三种药物相对较新，使用并不广泛，且使用时间相对较短，没有与严重肝损伤案例相关联。
In prelicensure controlled trials, serum ALT elevations during therapy with dalbvancin, oritavancin or telavancin were common, occurring in up to 25% of patients. Serum aminotransferase elevations above three times the upper limit of normal, however, were uncommon, occurring in 0.8% to 6% of patients receiving dalbavancin, oritavancin or telavancin. Furthermore, these rates of liver test abnormalities were not very different from those in comparator arms. The ALT elevations during glycopeptide antibiotic therapy were in general transient, asymptomatic and only mild-to-moderate in severity, rarely leading to dose modifications or early discontinuations. There were no reports of clinically apparent liver injury with jaundice in the registration trials of these agents. Since their approval and more wide scale use, there have been no published reports of liver injury attributed to glycopeptide antibiotics, although hypersensitivity reactions have been reported which can sometimes be associated with a mild-to-moderate degree of liver injury. Regardless, these three agents are relatively new, have not been widely used and when used, are given for a relatively short period of time and none have been linked to serious cases of liver injury.
来源:LiverTox
