Jain A B, Kashyap R, Rakela J, Starzl T E, Fung J J
Thomas E. Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Liver Transpl Surg. 1999 Mar;5(2):144-50. doi: 10.1002/lt.500050209.
The introduction of tacrolimus has shown decreased rates of acute and steroid-resistant rejection after liver transplantation (LTx). The aim of the present study is to examine the long-term efficacy and safety of tacrolimus in primary liver transplant recipients. The first 121 consecutive adults (aged >16 years) who underwent primary LTx at a single center from August 1989 to February 1990 were followed up until August 1997. The mean follow-up was 93.2 +/- 1.2 months (range, 90.5 to 96.5 months). Patient survival, graft survival, rate of rejection, and adverse events were examined. The actual 7-year patient survival rate was 67.8%, and the graft survival rate was 63.6%. Infections, recurrence of disease, de novo malignancies, and cardiovascular events constituted the main causes of graft loss and death in the long term. Graft loss related to acute or chronic rejection was rare. The rate of acute rejection beyond 2 years was approximately 3% per year, and most rejections were steroid responsive. Approximately 70% of the patients received only tacrolimus after 1 year. Four patients developed end-stage renal disease, and 2 patients underwent kidney transplantation. Hyperkalemia and hypertension were observed in one third of the patients. New-onset insulin-dependent diabetes mellitus was observed in 9% and 13% of the patients at the 1-year and 7-year follow-up, respectively. Seven patients developed de novo malignancies, including two skin malignancies. Six patients developed posttransplantation lymphoproliferative disorder during the entire follow-up period. Actual patient and graft survival at 7 years was excellent, and few adverse events developed after the first year. Graft loss from acute or chronic rejection was rare under tacrolimus, and approximately 70% of the patients were steroid free on tacrolimus monotherapy after the first year after LTx.
他克莫司的应用已显示肝移植（LTx）后急性和激素抵抗性排斥反应的发生率降低。本研究的目的是检验他克莫司在初次肝移植受者中的长期疗效和安全性。对1989年8月至1990年2月在单一中心接受初次LTx的首批121例连续成人（年龄>16岁）进行随访直至1997年8月。平均随访时间为93.2±1.2个月（范围90.5至96.5个月）。检查了患者生存率、移植物生存率、排斥反应发生率和不良事件。实际7年患者生存率为67.8%，移植物生存率为63.6%。感染、疾病复发、新发恶性肿瘤和心血管事件是长期移植物丢失和死亡的主要原因。与急性或慢性排斥反应相关的移植物丢失很少见。2年后急性排斥反应的发生率约为每年3%，且大多数排斥反应对激素有反应。约70%的患者在1年后仅接受他克莫司治疗。4例患者发展为终末期肾病，2例患者接受了肾移植。三分之一的患者出现高钾血症和高血压。在1年和7年随访时，分别有9%和13%的患者出现新发胰岛素依赖型糖尿病。7例患者发生新发恶性肿瘤，包括2例皮肤恶性肿瘤。在整个随访期间，6例患者发生移植后淋巴细胞增生性疾病。7年时实际患者和移植物生存率良好，且在第1年后很少发生不良事件。在他克莫司治疗下，急性或慢性排斥反应导致的移植物丢失很少见，且在LTx后第1年之后，约70%的患者在他克莫司单药治疗下无需使用激素。
