BACKGROUND Lung transplant recipients have the worst long-term outcomes of all solid organs due to acute rejection and chronic lung allograft dysfunction (CLAD). Our objective was to investigate the efficacy of extracorporeal photopheresis (ECP) as a prophylactic treatment to prevent acute cellular rejection (ACR), cytomegalovirus (CMV) infections and reduce the risk of CLAD. METHODS This was a single-centre prospective randomised controlled trial conducted at the Medical University of Vienna (Vienna, Austria) between 2018 and 2020. It included 31 COPD recipients per group. The treatment group underwent ECP in addition to a standard triple-drug immunosuppression protocol after lung transplantation. The control group received standard triple-drug immunosuppressive therapy. The primary outcome was a composite outcome defined as incidence of high-grade ACR, CMV infection or CLAD within 24 months after lung transplantation. RESULTS In the control group, 19 patients (61.3%) achieved the primary combined end-point compared with only six patients (19.4%) in the treatment group (p<0.001). Freedom from high-grade ACR was significantly greater in the ECP group (p=0.045). Cumulative A scores were significantly lower in the ECP group than in the control group at 3 months (0.18±0.44 versus 0.56±0.94; p<0.05) and at 12 months (0.25±0.48 versus 1.0±1.45; p=0.002). The rate of infections was lower in the ECP group with five cases and 67 cumulative hospital days compared with 22 cases and 309 days in the control group (p=0.002). Freedom from CLAD at 3 years was significantly greater in the ECP group (p=0.015). CONCLUSION Adding ECP to standard triple immunosuppression resulted in a significant reduction of the number of ACR episodes and significantly lower incidence of CLAD.

中文翻译：

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体外光分离疗法预防肺移植后排斥反应：一项前瞻性随机对照试验。


背景 由于急性排斥反应和慢性肺同种异体移植物功能障碍 （CLAD），肺移植受者的长期结果在所有实体器官中是最差的。我们的目的是研究体外光分离疗法 （ECP） 作为预防性治疗预防急性细胞排斥反应 （ACR） 、巨细胞病毒 （CMV） 感染和降低 CLAD 风险的疗效。方法 这是 2018 年至 2020 年在维也纳医科大学 （Vienna， Austria） 进行的一项单中心前瞻性随机对照试验。它包括每组 31 名 COPD 受者。治疗组在肺移植后除了标准的三药免疫抑制方案外，还接受了 ECP。对照组接受标准的三联药物免疫抑制治疗。主要结局是定义为肺移植后 24 个月内高级别 ACR 、 CMV 感染或 CLAD 发生率的复合结局。结果 对照组 19 例患者 （61.3%） 达到主要联合终点，而治疗组仅 6 例患者 （19.4%） 达到主要联合终点 （p<0.001）。ECP 组高级别 ACR 的自由率显著更高 （p=0.045）。ECP 组在 3 个月时 （0.18±0.44 vs 0.56±0.94;p<0.05） 和 12 个月时 （0.25±0.48 vs 1.0±1.45;p=0.002） 的累积 A 评分显著低于对照组。ECP 组感染率较低，为 5 例，累计住院天数为 67 例，而对照组为 22 例，累计住院天数为 309 天 （p=0.002）。ECP 组 3 年无 CLAD 的发生率显著更高 （p=0.015）。结论 在标准三重免疫抑制中加入 ECP 导致 ACR 发作次数显着减少，CLAD 的发生率显着降低。