毒理性
在临床试验中，长期服用孟鲁司特的患者中有1%到2%出现了血清转氨酶水平的轻度升高，但在匹配的安慰剂接受者中也有类似的报道率。ALT异常通常是轻度的、无症状的，并且是自限性的。孟鲁司特引起的临床上明显的肝损伤是罕见的；但文献中报告了超过十几例。在这些病例中，损伤发作的潜伏期差异很大，从几天到几年不等。患者表现为食欲不振、恶心、右上象限疼痛、深色尿和黄疸。酶升高的模式通常是混合型的，但已经报道了肝细胞损伤或胆汁淤积模式。过敏特征和自身抗体的形成是罕见的。嗜酸性粒细胞增多症经常被报道，但这可能是由潜在过敏状况而不是肝损伤引起的。停止药物后，损伤通常在1到4个月内缓解。
In clinical trials, mild elevations in serum aminotransferase levels were found in 1% to 2% of patients taking montelukast chronically, but similar rates are reported in matched placebo recipients. The ALT abnormalities were usually mild, asymptomatic and self limited. Clinically apparent liver injury from montelukast is rare; but more than a dozen cases reported in the literature. In these cases, the latency to onset of injury was highly variable, ranging from a few days to several years. Patients presented with anorexia, nausea, right upper quadrant pain, dark urine, and jaundice. The pattern of enzyme elevation was usually mixed, but both hepatocellular or cholestatic patterns have been reported. Allergic features and autoantibody formation were rare. Eosinophilia was often reported, but this may have been due to the underlying allergic condition rather than the liver injury. The injury usually resolved within 1 to 4 months of stopping the drug.
来源:LiverTox
