异体和自体血清滴眼液：一项双盲随机交叉试验的初步研究。
Allogeneic and autologous serum eye drops: a pilot double-blind randomized crossover trial.
机构信息
Department of Product and Process Development, Sanquin Blood Bank, Amsterdam, The Netherlands.
Department of Clinical Transfusion Research, Sanquin Research, Leiden, The Netherlands.
出版信息
Acta Ophthalmol. 2021 Dec;99(8):837-842. doi: 10.1111/aos.14788. Epub 2021 Feb 15.
PURPOSE
Serum eye drops (SEDs) are used to treat a variety of ocular surface defects. Serum eye drops (SEDs) are normally produced from the patient's blood. However, not all patients can donate sufficient or suitable blood, and logistics can be challenging. Allogeneic blood from voluntary blood donors does not have these disadvantages. Our aim was to evaluate whether autologous and allogeneic SEDs have comparable efficacy and tolerability.
METHODS
In a prospective, double-blind crossover trial, patients with severe dry eyes were randomized to first receive autologous SEDs for one month, followed by one-month washout, before receiving allogeneic SEDs for 1 month; or receive the SED preparations in reverse order. The Ocular Surface Disease Index (OSDI) was the primary endpoint, and various secondary endpoints were determined. A linear mixed model with random intercept for each patient was applied per treatment group to compare the pre- and postoutcome measurements.
RESULTS
Nineteen patients were enrolled, of whom 15 completed the trial. When autologous SEDs were used, the mean ± SD OSDI improved from 62 ± 19 to 57 ± 18. For allogeneic SEDs, the OSDI changed from 59 ± 20 to 56 ± 23. The estimated mean difference (95% confidence interval) was -4.2 (-9.5 to 1.2) for autologous and -4.5 (-9.8 to 0.9) for allogeneic SEDs (both, not significant). Adverse events were mild and resolved completely.
CONCLUSION
Autologous and allogeneic SEDs have comparable efficacy and tolerability for use in patients with severe dry eyes. Allogeneic SEDs are therefore an attractive alternative for patients who need SEDs but are clinically or logistically unable to donate blood.
目的
血清滴眼液（SED）用于治疗各种眼表缺陷。SED 通常由患者的血液制成。然而，并非所有患者都能捐献足够或合适的血液，物流也具有挑战性。来自自愿献血者的同种异体血液没有这些缺点。我们的目的是评估自体和同种异体 SED 的疗效和耐受性是否相当。
方法
在一项前瞻性、双盲交叉试验中，严重干眼症患者被随机分为两组，一组先接受自体 SED 治疗一个月，然后进行一个月的洗脱期，再接受异体 SED 治疗一个月；另一组则相反。主要终点为眼表疾病指数（OSDI），并确定了各种次要终点。每个治疗组都采用具有随机截距的线性混合模型来比较治疗前后的测量结果。
结果
19 名患者入组，其中 15 名完成了试验。当使用自体 SED 时，平均 OSDI 从 62±19 改善至 57±18。对于异体 SED，OSDI 从 59±20 变为 56±23。自体 SED 的估计平均差值（95%置信区间）为-4.2（-9.5 至 1.2），异体 SED 的差值为-4.5（-9.8 至 0.9）（均无统计学意义）。不良事件轻微且完全缓解。
结论
自体和同种异体 SED 对严重干眼症患者的疗效和耐受性相当。因此，对于需要 SED 但由于临床或物流原因无法献血的患者，同种异体 SED 是一种有吸引力的替代方案。
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