五酯胶囊对肾移植术后早期他克莫司药代动力学和肝肾功能的影响

Effect of Wuzhi Capsule on the Pharmacokinetics and Liver Function, Renal Function of Tacrolimus

摘要: 目的：五味子，木兰科的多年生草本植物北五味子属的成熟果实，其在许多国家广泛用作滋补类营养品和恢复性加强肝脏及其他器官的功能。五酯胶囊，一种五味子醇提制剂，是一个著名的中药，在中国广泛使用。五酯胶囊及其活性成分木酚素/木脂素显著保护肝损伤，在中国通常与TAC联合应用来防止药物引起的肝炎。本研究旨在探讨五酯胶囊对肾移植术后早期他克莫司血药浓度和肝肾功能的影响。方法：回顾性研究113名肾移植受者，未用五酯胶囊者55人，匹配年龄和性别后应用五酯胶囊者58人，所有患者接受Tac + MMF + Pred三联免疫抑制治疗。检测3天、7天和30天时Tac的血药浓度的变化，使用微粒酶免疫测定(MEIA)法。与此同时，测试所有患者的肝脏、肾脏功能。肝功能、肾功能、全血他克莫司浓度进行了两组之间的分析比较。结果：我们发现五酯胶囊可以显著提高3天、7天和30天时TAC血药浓度。3天、7天和30天时，五酯胶囊组全血Tac浓度平均增加了40.1%、23.3%、15.0%。更重要的是，直接胆红素也显著降低。两组之间其他的肝肾功能指标没有显著的差异(P > 0.05)。结论：五酯胶囊可以显著提高肾移植受者的Tac血药浓度，且具有保护肝脏的作用，没有明显的不良反应。

Abstract: Objective: Fructus Schisandrae, the ripe fruits of perennial plant of Schisandra chinensis (Turcz.) Baill, perennial herb of family Magnoliaceae, is widely used as a restorative, tonic nutrition to enhance the function of liver and other organs in many countries. Wuzhi capsule, an ethanol extract preparation of Fructus Schisandrae, is a well-known herbal medicine widely used in China. Wuzhi capsule and its active lignans significantly protect liver injury, and are often prescribed with TAC to prevent drug-induced hepatitis in China. This study aimed to investigate the effects of Wuzhi capsule on blood concentration of tacrolimus and liver function, renal function after renal transplantation. Methods: One hundred and thirteen renal transplant recipients were randomly assigned to two groups, i.e., 58 in the WC group and 55 in the control group. All patients received Tac + MMF + Pred triple immunosuppressive therapy. One month was taken as one therapeutic course. Changes of the blood concentration of Tac were detected 3, 7, 30 d after medication in the two groups using microparticle enzyme immune assay (MEIA). Meanwhile, the liver and kidney functions were tested. Liver function, renal function, and whole-blood concentrations of tacrolimus were analyzed to compare between the two groups. Results: We found that WZ capsule could significantly increase TAC blood concentration at 3, 7, 30 d. At 3, 7, 30 d after the application of WC capsule, the blood Tac concentration increased 40.1%, 23.3%, 15.0% averagely. More importantly, serum DBIL was also remarkably reduced. There was no significant difference in the liver and renal functions between the two groups (P > 0.05). Conclusion: WC capsule could significantly increase the blood Tac concentration of renal transplant recipients with liver protection, and has no obvious adverse reaction.