Pirsch J D, Miller J, Deierhoi M H, Vincenti F, Filo R S
Department of Surgery, University of Wisconsin, Madison 53792, USA.
Transplantation. 1997 Apr 15;63(7):977-83. doi: 10.1097/00007890-199704150-00013.
Tacrolimus (FK506), a macrolide molecule that potently inhibits the expression of interleukin 2 by T lymphocytes, represents a potential major advance in the management of rejection following solid-organ transplantation. This randomized, open-label study compared the efficacy and safety of tacrolimus-based versus cyclosporine-based immunosuppression in patients receiving cadaveric kidney transplants.
A total of 412 patients were randomized to tacrolimus (n=205) or cyclosporine (n=207) after cadaveric renal transplantation and were followed for 1 year for patient and graft survival and the incidence of acute rejection.
One-year patient survival rates were 95.6% for tacrolimus and 96.6% for cyclosporine (P=0.576). Corresponding 1-year graft survival rates were 91.2% and 87.9% (P=0.289). There was a significant reduction in the incidence of biopsy-confirmed acute rejection in the tacrolimus group (30.7%) compared with the cyclosporine group (46.4%, P=0.001), which was confirmed by blinded review, and in the use of antilymphocyte therapy for rejection (10.7% and 25.1%, respectively; P<0.001). Impaired renal function, gastrointestinal disorders, and neurological complications were commonly reported in both treatment groups, but tremor and paresthesia were more frequent in the tacrolimus group. The incidence of posttransplant diabetes mellitus was 19.9% in the tacrolimus group and 4.0% in the cyclosporine group (P<0.001), and was reversible in some patients.
Tacrolimus is more effective than cyclosporine in preventing acute rejection in cadaveric renal allograft recipients, and significantly reduces the use of antilymphocyte antibody preparations. Tacrolimus was associated with a higher incidence of neurologic events, which were rarely treatment limiting, and with posttransplant diabetes mellitus, which was reversible in some patients.
他克莫司（FK506）是一种大环内酯类分子，能有效抑制T淋巴细胞白细胞介素2的表达，是实体器官移植后抗排斥治疗方面潜在的重大进展。这项随机、开放标签研究比较了接受尸体肾移植患者中，以他克莫司为基础的免疫抑制与以环孢素为基础的免疫抑制的疗效和安全性。
412例患者在尸体肾移植后被随机分为他克莫司组（n = 205）或环孢素组（n = 207），随访1年，观察患者和移植物存活情况以及急性排斥反应的发生率。
他克莫司组1年患者生存率为95.6%，环孢素组为96.6%（P = 0.576）。相应的1年移植物生存率分别为91.2%和87.9%（P = 0.289）。与环孢素组（46.4%，P = 0.001）相比，他克莫司组经活检证实的急性排斥反应发生率显著降低（30.7%），这一点经盲法评估得到证实，且抗淋巴细胞治疗用于排斥反应的情况也显著减少（分别为10.7%和25.1%；P < 0.001）。两个治疗组均常见肾功能损害、胃肠道疾病和神经并发症，但他克莫司组震颤和感觉异常更为频繁。他克莫司组移植后糖尿病的发生率为19.9%，环孢素组为4.0%（P < 0.001），部分患者的糖尿病是可逆的。
在尸体肾移植受者中，他克莫司在预防急性排斥反应方面比环孢素更有效，并显著减少了抗淋巴细胞抗体制剂的使用。他克莫司与较高的神经事件发生率相关，这些事件很少限制治疗，还与移植后糖尿病相关，部分患者的糖尿病是可逆的。
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