毒理性
在上市前临床试验中，接受黄体酮治疗的患者的血清转氨酶水平升高了多达10%，但是高于正常上限3倍的升高只发生在1%到2%的患者中。然而，自从该药物上市以来，已经有多份报告称出现了临床明显的急性肝损伤，归因于黄体酮。大多数病例发生在女性身上，她们可能更倾向于使用黄体酮。发病时间从1个月到5个月不等，酶水平升高的模式通常是肝细胞型或混合型。大多数病例的严重程度为中度，没有报告急性肝衰竭或死亡的情况。停止使用黄体酮后，病情在1到3个月内得到解决。一些患者出现了免疫过敏特征，但症状轻微，自身抗体并不常见。至少有一例报告称，在重新使用黄体酮后病情复发。
In premarketing clinical trials, serum aminotransferase elevations occurred in up to 10% of patients on flavocoxid therapy, but elevations above 3 times the upper limit of normal occurred in only 1% to 2% of recipients. Since its release, however, there have been several reports of clinically apparent acute liver injury attributed to flavocoxid. Most cases have occurred in women, who perhaps are more likely to use flavocoxid. The time to onset was 1 to 5 months, and the pattern of enzyme elevations was usually hepatocellular or mixed. Most cases were moderate in severity and no instance of acute liver failure or death has been reported. Resolution upon stopping flavocoxid occurred in 1 to 3 months. Immunoallergic features were present in some patients, but were mild and autoantibodies were not common. At least one instance of recurrence upon rechallenge has been reported.
来源:LiverTox
