Department of Ophthalmology, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand.
Department of Ophthalmology, Mahidol University Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand
BMJ Open Ophthalmol. 2024 Oct 8;9(1):e001857. doi: 10.1136/bmjophth-2024-001857.
The 0bjective is to compare treatment effects between undiluted autologous platelet-rich plasma (APRP) and autologous serum (AS) in patients with moderate-to-severe dry eye disease (DED).
A single-centre, randomised, double-masked, non-inferiority clinical trial was conducted. 96 adult DED patients with an Ocular Surface Disease Index (OSDI) Score of ≥23 and/or Oxford staining grade of ≥2 were randomised to receive either 100% APRP (n=48) or 100% AS (n=48) for 4 weeks. Primary outcomes included OSDI Score and ocular surface staining measured by Oxford grading scale at 4 weeks. Secondary outcomes included fluorescein tear break-up time, Schirmer's test, meibum quality and expressibility, and adverse events. The 95% CI for the mean difference in OSDI scores between groups was estimated to assess non-inferiority of the OSDI score at a prespecified margin of 4.18 points.
At week 4, there was no significant difference in decreased OSDI scores between groups, with the mean difference (100% APRP-100% AS) of 1.41 (95% CI -1.26, 4.08, p=0.299). The upper limit was less than the prespecified margin, indicating non-inferiority of 100% APRP vs 100% AS. The probabilities of achieving an Oxford grade 0-1 after treatment were not significantly different between groups, with an OR of 0.61 (95% CI 0.25, 1.52, p=0.288). No significant differences in secondary outcomes were observed between groups.
In the short-term, 100% APRP was not inferior to 100% AS in reducing dry eye symptoms and ocular surface staining in moderate-to-severe DED.
NCT04683796.
比较未经稀释的自体富血小板血浆（APRP）和自体血清（AS）治疗中重度干眼（DED）患者的疗效。
进行了一项单中心、随机、双盲、非劣效性临床试验。将 96 名 OSDI 评分≥23 分和/或 Oxford 染色等级≥2 分的成年 DED 患者随机分为接受 100% APRP（n=48）或 100% AS（n=48）治疗 4 周。主要结局包括治疗 4 周后 OSDI 评分和 Oxford 分级量表测量的眼表染色。次要结局包括泪膜破裂时间、Schirmer 试验、睑板腺质量和表达力以及不良事件。通过估计两组间 OSDI 评分差值的 95%置信区间，以 4.18 分的预设差值评估 OSDI 评分的非劣效性。
治疗 4 周后，两组间 OSDI 评分降低无显著差异，组间差值（100%APRP-100%AS）为 1.41（95%CI-1.26，4.08，p=0.299）。上限小于预设差值，表明 100%APRP 与 100%AS 相比具有非劣效性。治疗后达到 Oxford 等级 0-1 的概率在两组间无显著差异，OR 为 0.61（95%CI0.25，1.52，p=0.288）。两组间次要结局无显著差异。
在短期治疗中，100%APRP 在减轻中重度 DED 的干眼症状和眼表染色方面并不劣于 100%AS。
NCT04683796。
