Narumi Shunji, Watarai Yoshihiko, Goto Norihiko, Hiramitsu Takahisa, Tsujita Makoto, Okada Manabu, Futamura Kenta, Tomosugi Toshihide, Nishihira Morikuni, Sakamoto Shintarou, Kobayashi Takaaki
Transplant Surgery, Kidney Disease Center, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan.
Transplant Surgery, Kidney Disease Center, Japanese Red Cross Nagoya Daini Hospital, Aichi, Japan.
Transplant Proc. 2019 Jun;51(5):1378-1381. doi: 10.1016/j.transproceed.2019.03.019. Epub 2019 May 2.
We evaluated de novo donor-specific antibody (DSA) production of everolimus (EVR)-based immunosuppression for primary kidney transplant recipients involved in the A1202 study at our institute.
From March 2008 to August 2009, 24 recipients were prospectively randomized into 2 groups. The EVR group received reduced cyclosporin A and EVR. The standard protocol (STD) group received standard cyclosporin A and mycophenolate mofetil. Both groups received basiliximab and steroids. De novo DSA was identified using LABScreen single antigen beads (One Lambda, Canoga Park, Calif., United States). Mean fluorescence intensity (MFI) values > 1000 were considered positive. P < .05 was considered significant.
Graft survival was 100% in the EVR group and 90.9% in the STD group. All patients remained on the primary protocol in the EVR group, but 3 patients in the STD group (27.3%) were converted to tacrolimus due to DSA and non-adherence. Estimated glomerular filtration rate was similar in both groups. No EVR group recipients and 9.1% of STD group recipients were treated for T-cell-mediated rejection. No recipients of the EVR group exhibited peritubular capillaritis, while 9.1% in STD group developed chronic active antibody-mediated rejection. LABScreen revealed an accumulative class II DSA production rate of 15.4% in the EVR group and 18.3% in the STD group at 10 years. When the MFI cut-off level was set to 6000, anti-HLA antibody and de novo DSA-free survival was significantly better in the EVR group.
EVR-based immunosuppression provided equivalent or even better clinical outcomes. EVR suppressed de novo DSA production at 10 years follow-up; however, further follow-up is inevitable.
我们评估了我院参与A1202研究的初次肾移植受者基于依维莫司（EVR）的免疫抑制方案中供者特异性新抗体（DSA）的产生情况。
2008年3月至2009年8月，24名受者被前瞻性随机分为两组。EVR组接受减量环孢素A和EVR。标准方案（STD）组接受标准剂量环孢素A和霉酚酸酯。两组均接受巴利昔单抗和类固醇。使用LABScreen单抗原微珠（美国加利福尼亚州卡诺加帕克市One Lambda公司）鉴定新产生的DSA。平均荧光强度（MFI）值>1000被视为阳性。P<0.05被认为具有统计学意义。
EVR组移植肾存活率为100%，STD组为90.9%。EVR组所有患者均维持原方案治疗，但STD组有3例患者（27.3%）因DSA和不依从转为使用他克莫司。两组的估计肾小球滤过率相似。EVR组无受者接受T细胞介导的排斥反应治疗，STD组有9.1%的受者接受了此类治疗。EVR组无受者出现肾小管周围毛细血管炎，而STD组有9.1%的受者发生慢性活动性抗体介导的排斥反应。LABScreen检测显示，10年时EVR组II类DSA累积产生率为15.4%，STD组为18.3%。当MFI截断水平设定为6000时，EVR组抗HLA抗体和无新产生DSA的生存率明显更好。
基于EVR的免疫抑制方案提供了相当甚至更好的临床结果。EVR在10年随访中抑制了新DSA的产生；然而进一步随访是不可避免的。
