[Clinical efficacy and safety of combined induction therapy with rituximab and ATG in highly sensitized kidney transplant recipients].

Objective: To summarize the efficacy and safety of the combination of rituximab and ATG as induction therapy in highly sensitized kidney transplant recipients. Methods: Clinical data of patients who received kidney transplantation from donation after cardiac death(DCD) in Organ Transplant Center of Second Affiliated Hospital of Guangzhou Medical University from January 1st 2015 to December 31th 2016 was retrospectively analyzed. Highly sensitized patients with over 30% active panel reactive antibody (PRA>30%) received rituximab, while non-sensitized recipients as controlled group. All selected patients were observed in the renal function, urine protein, hemogram and the variation of PRA at each time point. Acute rejection, infection required hospitalization, delayed graft function(DGF), primary nonfunction (PNF), graft dysfunction, the mortality rate of patients with good allograft function and the graft survival rate were also observed. Results: 46 groups of patients were selected into highly-sensitized group and non-sensitized group. In both groups, there was no statistical difference in the renal function, urine protein and WBC (all P>0.05). Highly sensitized recipients at day 7 and day 14 following the surgery, had a significantly lower percentage of lymphocyte counts and lymphocyte proportion compared to other groups, with statistical differences(all P<0.05). Both groups had a similar incidence of DGF(2.2%) and no occurrence of PNF. 19.5% of highly sensitized recipients experienced acute rejection and 13% in control group. More specifically, no statistical difference was noted in the rate of infection required hospitalization(30.4% vs 22.2%), graft loss(2.2% vs 0) and the mortality rate of patients with good allograft function(4.3% vs 2.2%)(all P>0.05). The graft survival rate was 97.8% in the highly-sensitized group, while 100% in the control group. And the rate of patient survival in these two groups was 95.7% and 97.8%, with no statistical differences(all P>0.05). Conclusions: Immune-induction therapy that combines Rituximab with ATG can significantly inhibit lymphocyte proliferation. It is effective and safe in treating hypersensitive patients. The survival rate of human/kidney of hypersensitive patients in the short and medium term is comparable to those with low immune risk.目的：总结利妥昔单抗联合抗人类胸腺球蛋白（ATG）的免疫诱导策略在高致敏肾移植受者中应用的安全性及有效性。 方法：回顾性分析2015年1月1日至2016年12月31日在广州医科大学附属第二医院器官移植中心实施的公民死亡后器官捐献（DCD）供肾移植群体反应性抗体（PRA）>30%的高致敏并使用利妥昔单抗的受者的临床资料，其对侧供肾的受者作为对照组。统计两组患者各时间点的肾功能、尿蛋白、血象及PRA的变化差异；观察两组急性排斥反应、需住院的感染、移植肾功能延迟恢复（DGF）、移植肾原发无功能（PNF）、移植肾丢失、带功死亡的发生率，统计两组的人/肾生存曲线。 结果：共46对患者入组观察，分为高致敏受者组及对照组，两组的肾功能、尿蛋白、白细胞计数差异均无统计学意义（均P>0.05）。高致敏受者组术后7 d及14 d淋巴细胞绝对值及淋巴细胞比例均低于对照组（均P<0.05）。高致敏受者组DGF发生率与对照组相同，均为2.2%；两组无PNF发生；高致敏受者组急性排斥反应发生率为19.5%，对照组为13.0%；高致敏受者组需住院的感染发生率为30.4%，对照组为22.2%；高致敏受者组移植肾丢失发生率为2.2%，对照组为0；高致敏受者组受者带功死亡率为4.3%，对照组为2.2%（均P>0.05）。高致敏受者的肾存活率为97.8%，对照组为100%，高致敏受者组人生存率为95.7%，对照组为97.8%（均P>0.05）。 结论：利妥昔单抗联合ATG的免疫诱导方案可明显抑制淋巴细胞增殖；在高致敏患者中应用具有有效性及安全性，可使高致敏受者短期及中期人/肾存活率与低免疫风险受者相当。.