Department of Medicine, Division of Pulmonology, Indiana University, Bloomington, Indiana, USA.
Department of Medicine, Division of Pulmonology, University of Iowa, Iowa City, Iowa, USA.
Transfus Med. 2021 Aug;31(4):292-302. doi: 10.1111/tme.12779. Epub 2021 May 5.
This study was designed to prospectively evaluate the efficacy of extracorporeal photopheresis (ECP) to attenuate the rate of decline of FEV in lung transplant recipients with refractory bronchiolitis obliterans. Due to an observed higher than expected early mortality, a preliminary analysis was performed.
Subjects from 10 lung transplant centres were assigned to ECP treatment or to observation based on spirometric criteria, with potential crossover for those under observation. The primary endpoint of this study was to assess response to ECP (i.e., greater than a 50% decrease in the rate of FEV decline) before and 6 months after initiation of ECP. Mortality was also evaluated 6 and 12 months after enrolment as a secondary endpoint.
Of 44 enrolled subjects, 31 were assigned to ECP treatment while 13 were initially assigned to observation on a non-random basis using specific spirometric inclusion criteria (seven of the observation patients subsequently crossed over to receive ECP). Of evaluable patients, 95% of patients initially assigned to treatment responded to ECP with rates of FEV decline that were reduced by 93% in evaluable ECP-treated patients. Mortality rates (percentages) at 6 and 12 months after enrolment was 32% and 41%, respectively. The most common (92%) primary cause of death was respiratory or graft failure. Significantly (p = 0.002) higher rates of FEV decline were observed in the non-survivors (-212 ± 177 ml/month) when compared to the survivors (-95 ± 117 ml/month) 12 months after enrolment. In addition, 18 patients with bronchiolitis obliterans syndrome (BOS) diagnosis within 6 months of enrolment had lost 38% of their baseline lung function at BOS diagnosis and 50% of their lung function at enrolment.
These analyses suggest that earlier detection and treatment of BOS should be considered to appreciate improved outcomes with ECP.
本研究旨在前瞻性评估体外光化学疗法（ECP）对肺移植受者难治性细支气管炎闭塞的 FEV 下降率的减缓作用。由于观察到早期死亡率高于预期，因此进行了初步分析。
根据肺量计标准，来自 10 个肺移植中心的受试者被分配到 ECP 治疗组或观察组，观察组的潜在交叉。本研究的主要终点是评估 ECP 开始前后 6 个月时的 ECP 反应（即 FEV 下降率降低 50%以上）。死亡率也作为次要终点在登记后 6 和 12 个月进行评估。
在 44 名入组的受试者中，31 名被分配到 ECP 治疗组，而 13 名最初根据特定的肺量计纳入标准被分配到观察组（观察组中的 7 名患者随后交叉接受 ECP）。在可评估的患者中，95%最初分配到治疗组的患者对 ECP 有反应，可评估的 ECP 治疗患者的 FEV 下降率降低了 93%。登记后 6 和 12 个月的死亡率（百分比）分别为 32%和 41%。最常见（92%）的原发性死亡原因是呼吸或移植物衰竭。登记后 12 个月，非幸存者（-212±177ml/月）的 FEV 下降率明显（p=0.002）高于幸存者（-95±117ml/月）。此外，在登记后 6 个月内诊断为细支气管炎闭塞综合征（BOS）的 18 名患者在 BOS 诊断时已经失去了 38%的基线肺功能，在登记时已经失去了 50%的肺功能。
这些分析表明，应考虑更早地发现和治疗 BOS，以实现 ECP 的更好结果。
