Neylan J F
Emory University, Atlanta, Georgia 30322, USA.
Transplantation. 1998 Feb 27;65(4):515-23. doi: 10.1097/00007890-199802270-00011.
Results of a multicenter, randomized, clinical trial demonstrated that tacrolimus was more effective than cyclosporine in preventing acute rejection in cadaveric renal transplant patients. As African-Americans comprised approximately 25% of the study population, their outcome was analyzed relative to the experience of Caucasian patients.
Of the 205 patients randomized to tacrolimus, 56 (27.3%) were African-American and 114 (55.6%) were Caucasian. Of the 207 patients randomized to cyclosporine, 48 (23.2%) were African-American and 123 (59.4%) were Caucasian. The efficacy variables were 1-year patient survival, graft survival, and incidence of acute rejection.
The incidence of acute rejection was significantly lower in African-American and Caucasian patients treated with tacrolimus than with cyclosporine. Additionally, no African-American patient who was treated with tacrolimus experienced moderate or severe acute rejection, as determined by blinded independent review. The incidence of nephrotoxicity, cardiovascular and gastrointestinal events, malignancies, and opportunistic infections was similar between treatments and race groups. However, there was an increased incidence of posttransplant diabetes mellitus in tacrolimus-treated patients, particularly in African-Americans, and tacrolimus was associated with significantly lower lipid levels in both Caucasians and African-Americans. African-American patients required a 37% mean higher dose of tacrolimus than Caucasian patients to achieve comparable blood concentrations.
Tacrolimus is more effective than cyclosporine in preventing acute rejection in both African-American and Caucasian patients. However, tacrolimus was associated with an increased risk of posttransplant diabetes mellitus, particularly in African-Americans, which was reversible in some patients.
一项多中心、随机临床试验的结果表明，在尸体肾移植患者中，他克莫司在预防急性排斥反应方面比环孢素更有效。由于非裔美国人约占研究人群的25%，因此对他们的结果与白人患者的情况进行了对比分析。
在随机分配接受他克莫司治疗的205例患者中，56例（27.3%）为非裔美国人，114例（55.6%）为白人。在随机分配接受环孢素治疗的207例患者中，48例（23.2%）为非裔美国人，123例（59.4%）为白人。疗效变量包括1年患者生存率、移植物生存率和急性排斥反应发生率。
接受他克莫司治疗的非裔美国人和白人患者的急性排斥反应发生率显著低于接受环孢素治疗的患者。此外，经独立盲法评估，接受他克莫司治疗的非裔美国患者均未发生中度或重度急性排斥反应。治疗组和种族组之间的肾毒性、心血管和胃肠道事件、恶性肿瘤及机会性感染的发生率相似。然而，接受他克莫司治疗的患者，尤其是非裔美国人，移植后糖尿病的发生率有所增加，且他克莫司使白人和非裔美国人的血脂水平显著降低。非裔美国患者达到可比血药浓度所需的他克莫司平均剂量比白人患者高37%。
他克莫司在预防非裔美国人和白人患者急性排斥反应方面比环孢素更有效。然而，他克莫司与移植后糖尿病风险增加有关，尤其是在非裔美国人中，部分患者的这种情况是可逆的。
