为了比较肾移植患者使用阿伦单抗后撤除钙调神经蛋白抑制剂（CNI）和CNI继续使用的结果，我们进行了该飞行随机临床试验，这些患者为肾移植后2个月，采用CNI、霉酚酸衍生物以及激素治疗。40名患者被随机分为撤除CNI和继续使用2组，随访超过1年。撤除组有4名患者因为急性排斥反应接受治疗，而对照组无患者发生排斥反应。2名对照组患者因为肾脏毒性撤除了CNI。两组间1年后的的估算GFR值相似。CD4(+)CD25(+)CTLA-4(+)FoxP3(+)调节T细胞（Treg）流式细胞仪检测提示采用阿仑单抗治疗且移植后早期使用CNI的患者其外周血Treg百分率升高。此外，CNI撤除组的Treg百分率在入选后的6个月未有改变，但是CNI维持的患者则有明显下降。患者在采用阿仑单抗后撤除CNI似乎后增加排斥反应的趋势，但是大多数患者能够完全撤除CNI。除了Treg水平持续增高外，该短期的随访未发现明显的效益，因此需要更大型的随机研究证实。

To address the results of calcineurin inhibitor (CNI) withdrawal after alemtuzumab induction relative to CNI continuation, we performed a pilot randomized clinical trial in renal allograft recipients on CNI, a mycophenolic acid derivative and steroids after the first 2 months posttransplantation. Forty patients were randomized to taper off CNI or to maintain it, and followed for at least 1 year. Four patients in the withdrawal group were treated for acute rejection while no patient received antirejection treatment in the control group. Two control patients withdrew CNI due to nephrotoxicity. Estimated GFR was similar in both groups after 1 year. Flow cytometry of CD4(+)CD25(+)CTLA-4(+)FoxP3(+) regulatory T cells (Treg) demonstrated a significant increase in Treg percentages in the peripheral blood of alemtuzumab-treated patients on CNI early postransplant. Furthermore, the increased Treg percentages in the withdrawal cohort were unchanged at month 6 postenrollment, whereas they decreased significantly in those patients maintained on CNI. Patients withdrawn from CNI after alemtuzumab trend toward a higher rejection rate, but most patients can be weaned from a CNI using this regimen. With the exception of maintaining increased Treg levels, the benefits are not appreciable in this short follow-up, and a larger randomized trial is justified.