T细胞多克隆抗体和巴利昔单抗在DD供肾移植中有效性及安全性的对照研究

Comparison of efficacy and safety of T lymphocyte polyclonal antibodies versus basiliximab in DD kidney transplantation:a retrospective control study

目的 对比分析T细胞多克隆抗体和巴利昔单抗在公民逝世后器官捐献(deceased donation,DD)肾移植中应用的有效性和安全性。方法 本研究为回顾性、单中心、对照研究。回顾性分析自2015年8月20日至2020年2月28日昆明市第一人民医院符合纳入标准的402例成人肾移植受者的临床资料,依据其免疫诱导方案将其分为兔抗人胸腺细胞免疫球蛋白(rabbit anti human thymocyte immunoglobulin,rATG)组(A组),抗人T细胞兔免疫球蛋白(anti-human T lymphocyte rabbit immunoglobulin,ATG-F)组(B组)和巴利昔单抗组(C组),主要结局包括三组患者的急性排斥反应(acute rejection,AR)发生情况、移植物功能延迟恢复(delayed graft function,DGF)的累计发生率。次要结局指标包括肺部感染、骨髓抑制、巨细胞病毒(cytomegalovirus,CMV)感染的发生率。结果 A组、B组、C组在术后1年内AR累计发生率分别为32.65%、16.94%、26.92%,其中B组较C组发生率低(χ^(2)=4.30,P <0.05)。三组患者DGF发生率分别为25.17%(37/147)、12.42%(22/177)、17.9%(14/78)。三组DGF持续时间分别为(14.86±6.15)d(、15.63±4.56)d、(13.7±4.24)d,组间无显著差异。发生DGF患者术后1个月血清肌酐(serum creatinine,SCr)分别为(223.39±129.18)μmol/L、(225.62±182.97)μmol/L、(170.76±50.30)μmol/L,A组与C组相比,差异具有统计学意义(t=2.6789,P <0.05)。术后1年内骨髓抑制累计发生率分别为8.8%、6.8%及2.6%,组间无显著性差异。肺部感染累计发生率分别为11.56%、7.9%及2.6%,A组发生率高于C组(P <0.05)。A、B两组CMV感染累计发生率均高于C组(P <0.01)。结论 r ATG和ATG-F与巴利昔单抗作为DD肾移植术早期排斥反应的预防均显示安全、有效。与巴利昔单抗相比,T细胞多克隆抗体增加肺部感染及CMV感染风险。

Objective This study aimed to compare and analyze the efficacy and safety of T-cell polyclonal antibody and basiliximab in deceased donor kidney transplants.Methods This study was a retrospective,single center,controlled study.The clinical data of 402 adult kidney transplant recipients who met the inclusion criteria at Kunming First People's Hospital from August 20,2015 to February 28,2020 were retrospectively analyzed.Patients were placed into rabbit anti-human thymocyte immunoglobulin(rATG)group(147 patients,group A),anti-human T lymphocyte rabbit immunoglobulin(ATG-F)group(177 patients,group B),and basiliximab(78 patients,group C)group.The incidences of acute rejection(AR),delayed graft function(DGF),lung infection,bone marrow suppression,cytomegalovirus(CMV)infection were retrospectively analyzed.Results The total incidences of AR in groups A,B and C post-transplantation within one year were 32.65%,16.94%and 26.92%,respectively(group B vs.group C:χ^(2)=4.30,P<0.05).The proportion of DGF in the three groups was 25.17%,12.42%and 17.9%,respectively.The durations of DGF in each group were(14.86±6.15)d,(15.63±4.56)d and(13.7±4.24)d,respectively.There were no significant differences among three groups.The serum creatinine(SCr)levels of patients with DGF one month after transplantation was(223.39±129.18)μmol/L,(225.62±182.97)μmol/L,(170.76±50.30)μmol/L,respectively.The incidence of bone marrow suppression one year after surgery was 8.8%(13/147),6.8%(12/177),2.6%(2/78).There were no statistically significant differences among groups.The prevalence of pulmonary infection in each group was 11.56%,7.9%,2.6%,respectively.The incidence rate of group A was higher than that of group C(P<0.05).The incidence of CMV infection in both groups A and group B were higher than that in group C(P<0.01).Conclusion Both T-cell polyclonal antibodies and basiliximab can be safely and effectively used in the induction therapy of DD kidney transplantation.Compared with basiliximab,T-cell polyclonal antibodies can increase the risk of pneumonia and CMV infection.