Kim Jong Man, Joh Jae-Won, Choi Gyu-Seong, Lee Suk-Koo
Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Drug Des Devel Ther. 2019 Dec 31;13:4431-4438. doi: 10.2147/DDDT.S229114. eCollection 2019.
Generic tacrolimus (Tacrobell) is commonly used in liver transplant patients in Korea. No previous studies have assessed the long-term efficacy and safety of generic tacrolimus for adult deceased donor liver transplantation (DDLT) patients. The aim of the present study was to evaluate the long-term efficacy and safety of generic tacrolimus compared to brand-name tacrolimus (Prograf) in adult DDLT recipients.
Two hundred sixty-five adult DDLTs were performed in our center between 2003 and 2017. To determine the efficacy and safety of generic tacrolimus, renal function (estimated glomerular filtration rate [eGFR] and creatinine), infectious complications, rejection-free survival rates, and patient survival rates were investigated.
Of 265 patients, 193 were selected and divided into a generic tacrolimus group (n=147) and a brand-name group (n=46). Mean follow-up duration was 63.2 ± 44.3 months. The 1-year, 3-year, 5-year, and 10-year patient survival rates were 89.1%, 86.9%, 84.5%, and 75.2%, respectively, in the generic tacrolimus group and 95.7%, 88.9%, 86.3%, and 83.7% in the brand-name tacrolimus group. There were no statistically significant differences in the infectious complications, new-onset diabetes, and renal dysfunction included mean serum creatinine level or eGFR after DDLT between the two groups. Increased recipient age, continuous renal replacement therapy (CRRT) in the pre-transplant phase, and acute rejection were predisposing factors for patient death.
The present study shows that generic tacrolimus is an alternative comparable to brand-name tacrolimus in adult DDLT patients.
在韩国，通用型他克莫司（Tacrobell）常用于肝移植患者。此前尚无研究评估通用型他克莫司用于成人尸体供肝肝移植（DDLT）患者的长期疗效和安全性。本研究的目的是评估通用型他克莫司与品牌名他克莫司（普乐可复）相比，在成人 DDLT 受者中的长期疗效和安全性。
2003 年至 2017 年期间，我们中心进行了 265 例成人 DDLT 手术。为确定通用型他克莫司的疗效和安全性，对肾功能（估计肾小球滤过率[eGFR]和肌酐）、感染并发症、无排斥生存率和患者生存率进行了调查。
265 例患者中，193 例被选中并分为通用型他克莫司组（n = 147）和品牌名组（n = 46）。平均随访时间为 63.2 ± 44.3 个月。通用型他克莫司组的 1 年、3 年、5 年和 10 年患者生存率分别为 89.1%、86.9%、84.5%和 75.2%，品牌名他克莫司组分别为 95.7%、88.9%、86.3%和 83.7%。两组之间在感染并发症、新发糖尿病以及 DDLT 后平均血清肌酐水平或 eGFR 所包括的肾功能障碍方面，无统计学显著差异。受者年龄增加、移植前阶段的持续肾脏替代治疗（CRRT）和急性排斥是患者死亡的易感因素。
本研究表明，通用型他克莫司在成人 DDLT 患者中是一种与品牌名他克莫司相当的替代品。
