Kim S J, Huh K H, Han D-J, Moon I S, Kim S-J, Kim Y-L, Kim H C, Lee S, Kang C-M, Cho B-H, Kim Y S
Department of Transplantation Surgery, Severance Hospital Transplantation Center, Yonsei University Health System, Seoul, Korea.
Transplant Proc. 2009 Jun;41(5):1671-4. doi: 10.1016/j.transproceed.2009.03.061.
Tacrolimus has been shown to be an important immunosuppressive agent in organ and bone marrow transplantation. Previously, we reported that there were no statistically significant differences between the pharmacokinetic parameters of the oral formulation of generic tacrolimus (TacroBell) and the conventional formulation (Prograf). This study was designed to evaluate the efficacy and safety of oral capsules of TacroBell in de novo renal transplantation.
Ninety-six renal transplant recipients from 9 transplantation centers in South Korea were enrolled between November 2005 and July 2007. De novo renal recipients ranged from 19-65 years old. Ninety-four patients who underwent renal transplantation were administered study drug at least one time in the intent-to-treat (ITT) analysis. This phase 4 clinical trial was a 26-week, open-label, noncomparative, multicenter study.
An acute rejection episode developed in 10/94 recipients (10.6%, 95% confidence interval, 4.4%-16.9%). There were no patient deaths during the study. The 6-month graft survival rate was 96.8%.
Based on this study, treatment with TacroBell is considered to be efficient and safe after primary renal transplantation.
他克莫司已被证明是器官和骨髓移植中一种重要的免疫抑制剂。此前，我们报道过，通用型他克莫司口服制剂（TacroBell）与传统制剂（普乐可复）的药代动力学参数之间无统计学显著差异。本研究旨在评估TacroBell口服胶囊在初次肾移植中的疗效和安全性。
2005年11月至2007年7月期间，招募了来自韩国9个移植中心的96名肾移植受者。初次肾移植受者年龄在19至65岁之间。在意向性治疗（ITT）分析中，94名接受肾移植的患者至少接受了一次研究药物治疗。这项4期临床试验是一项为期26周的开放标签、非对照、多中心研究。
94名受者中有10名（10.6%，95%置信区间，4.4%-16.9%）发生了急性排斥反应。研究期间无患者死亡。6个月时移植物存活率为96.8%。
基于本研究，初次肾移植后使用TacroBell治疗被认为是有效且安全的。
