Abdolalizadeh Parya, Kashkouli Mohsen Bahmani, Ghazizadeh Mahya, Pakdel Farzad, Etezad Razavi Mohammad, Nojomi Marzieh, Abri Aghdam Kaveh, Sanjari Mostafa Soltan, Karimi Nasser, Ghahvehchian Hossein, Soleimani Mohammad, Tabatabaei Seyed Ali
Ophthalmology, Urmia University of Medical Sciences, Urmia, Iran (the Islamic Republic of).
Department of Ophthalmology and Visual Sciences, University of Louisville School of Medicine, Louisville, Kentucky, USA
Br J Ophthalmol. 2025 Mar 20;109(4):525-532. doi: 10.1136/bjo-2024-325828.
The aim is to compare the efficacy and safety of three different weight-adjusted intravenous erythropoietin (EPO) doses in patients with indirect traumatic optic neuropathy (TON).
This study is a multicentre, randomised, parallel-group, double-blind, dose-finding trial on patients aged ≥7 years with a confirmed diagnosis of indirect TON in ≤3 weeks. The trial had a 3-day treatment period and a 3-month follow-up period. Patients were randomly allocated (1:1:1) to receive EPO at doses of 900 IU/kg (300 IU/kg/day), 1800 IU/kg (600 IU/kg/day) or 3600 IU/kg (600 IU/kg/day on presentation and then 1 month later) EPO. The changes in the best-corrected visual acuity (BCVA), colour vision and relative afferent pupillary defect (RAPD) were assessed.
Out of 118 eligible patients, 95 were randomised and 93 (31 in each group) completed the follow-ups. Three groups were not different regarding baseline BCVA (p=0.66), colour vision (p=0.25) and RAPD (p=0.79). All three groups showed a significant improvement of BCVA and RAPD with no significant differences among the groups. Colour vision showed a significant improvement only in the group with 3600 IU/kg EPO (p=0.005), even though final colour vision was not significantly different between the groups (p=0.49). Initial vision of no light perception (OR=7.79 (95% CI: 2.98 to 20.36), p<0.001), older age (OR=4.76 (95% CI: 1.92 to 11.76), p<0.001), longer trauma-treatment interval (OR=2.72, 95% CI: 1.16 to 6.33, p=0.02) and posterior orbital fractures (OR=2.63 (95% CI: 1.13 to 6.13), p=0.02) led to a significantly worse visual recovery.
Increasing dose of EPO in patients with TON did not result in a better BCVA, colour vision and RAPD improvement.
NCT03308448.
比较三种不同体重调整剂量的静脉注射促红细胞生成素（EPO）对间接性外伤性视神经病变（TON）患者的疗效和安全性。
本研究是一项多中心、随机、平行组、双盲、剂量探索性试验，针对年龄≥7岁、确诊为间接性TON且病程≤3周的患者。试验为期3天治疗期和3个月随访期。患者被随机分配（1:1:1）接受剂量为900 IU/kg（300 IU/kg/天）、1800 IU/kg（600 IU/kg/天）或3600 IU/kg（就诊时600 IU/kg/天，1个月后）的EPO。评估最佳矫正视力（BCVA）、色觉和相对传入性瞳孔障碍（RAPD）的变化。
118例符合条件的患者中，95例被随机分组，93例（每组31例）完成随访。三组在基线BCVA（p = 0.66）、色觉（p = 0.25）和RAPD（p = 0.79）方面无差异。所有三组的BCVA和RAPD均有显著改善，组间无显著差异。仅3600 IU/kg EPO组的色觉有显著改善（p = 0.005），尽管各组最终色觉无显著差异（p = 0.49）。初始无光感视力（OR = 7.79（95%CI：2.98至20.36），p < 0.001）、年龄较大（OR = 4.76（95%CI：1.92至11.76），p < 0.001）、创伤至治疗间隔较长（OR = 2.72，95%CI：1.16至6.33，p = 0.02）和眼眶后骨折（OR = 2.63（95%CI：1.13至6.13），p = 0.02）导致视力恢复明显较差。
TON患者增加EPO剂量并未带来更好的BCVA、色觉和RAPD改善。
NCT03308448。
