The Key Laboratory of Drug Metabolism and Pharmacokinetics, Beijing Institute of Pharmacology and Toxicology, Beijing, China (X.-M.Z., G.-L.S., W.-B.X., Y.T., H.L.); and Millennium, The Takeda Oncology Company, Cambridge, Massachusetts (C.L.).
Drug Metab Dispos. 2013 Dec;41(12):2158-65. doi: 10.1124/dmd.113.054056. Epub 2013 Sep 24.
Triptolide (TP), a main bioactive component of Tripterygium wilfordii Hook F., is a promising agent for treatment of autoimmune diseases. However, a high incidence of dose-limiting hepatotoxicity was observed in the clinic. Sandwich-cultured rat hepatocyte model was used in this study to identify the involvement of P-glycoprotein (P-gp) in TP disposition and to evaluate TP-induced hepatotoxicity after modulation of P-gp by the known inhibitors, ritonavir and tariquidar, and known inducers, phenobarbital, quercetin, and H(2)O(2). Our data showed that biliary clearance of TP reduced 73.7% and 84.2% upon treatment of ritonavir (25 µM) and tariquidar (5 µM), respectively. In contrast, increases of 346%, 280%, and 273% in biliary clearance of TP were observed with treatment of phenobarbital (1.0 mM), quercetin (20 µM), and H(2)O(2) (0.5 mM), respectively. The TP-induced hepatotoxicity increased by twofold when CYP activity was blocked by 1-aminobenzotriazole, suggesting that CYP and P-gp may both contribute to the detoxification of TP in the SCRH model. In addition, hepatotoxicity and the expression of apoptosis proteins Bax and Bcl-2 were correlated qualitatively with the TP exposure duration and its intracellular concentration, which, in turn, can be modulated by P-gp inhibitors or inducers. Our results for the first time demonstrated that in addition to CYP-mediated metabolism, P-gp also plays an important role in the disposition of TP and TP-induced hepatotoxicity. Thus, the modulation of canalicular P-gp has a potential to cause drug-drug interaction between TP and the coadministered P-gp inhibitors or inducers in the clinic.
雷公藤红素(TP)是雷公藤的主要生物活性成分,是治疗自身免疫性疾病的有前途的药物。然而,在临床上观察到高发生率的剂量限制肝毒性。本研究采用夹心培养大鼠肝细胞模型,鉴定 P-糖蛋白(P-gp)在 TP 处置中的作用,并评价已知抑制剂利托那韦和塔里奎达,以及已知诱导剂苯巴比妥、槲皮素和 H(2)O(2)对 P-gp 调节后 TP 诱导的肝毒性。我们的数据表明,利托那韦(25μM)和塔里奎达(5μM)处理后,TP 的胆汁清除率分别降低了 73.7%和 84.2%。相比之下,用苯巴比妥(1.0mM)、槲皮素(20μM)和 H(2)O(2)(0.5mM)处理后,TP 的胆汁清除率分别增加了 346%、280%和 273%。当 CYP 活性被 1-氨基苯并三唑阻断时,TP 诱导的肝毒性增加了两倍,这表明 CYP 和 P-gp 可能都有助于 SCRH 模型中 TP 的解毒。此外,肝细胞毒性和凋亡蛋白 Bax 和 Bcl-2 的表达与 TP 暴露时间及其细胞内浓度呈定性相关,而 P-gp 抑制剂或诱导剂可以调节这些参数。我们的研究结果首次表明,除了 CYP 介导的代谢外,P-gp 还在 TP 的处置和 TP 诱导的肝毒性中发挥重要作用。因此,调节胆小管 P-gp 有可能导致 TP 与同时给予的 P-gp 抑制剂或诱导剂在临床上发生药物相互作用。