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脐带血血小板裂解液滴眼液治疗耐药性角膜溃疡的安全性和有效性。

Safety and efficacy of eye drops from umbilical cord blood platelet lysate to treat resistant corneal ulcer.

作者信息

Kamel Farag Rania, Dawood Mervat, Elesawi Maher

机构信息

Ophthalmology Center, Faculty of Medicine, Mansoura University, Mansoura, Egypt.

Clinical Pathology, Mansoura Research Center for Cord Stem Cells (MARC-CSC), Faculty of Medicine, Mansoura University, Mansoura, Egypt.

出版信息

Med Hypothesis Discov Innov Ophthalmol. 2023 Feb 3;11(4):189-202. doi: 10.51329/mehdiophthal1463. eCollection 2022 Winter.

Abstract

BACKGROUND

Umbilical cord blood (UCB) is a novel treatment of resistant corneal ulcers owing to the unique anti-inflammatory molecules and growth factors it contains. Platelet lysates are a potential future alternative. The aim of the present study was to assess the role of human UCB platelet lysate in treating resistant corneal ulcers.

METHODS

This was prospective, non-comparative, interventional case series involving 40 eyes of patients aged 6 - 65 years with persistent corneal ulcers from the Mansoura Ophthalmic Center and Mansoura Research Center for Cord Stem Cells. Patients were classified according to the cause of persistent corneal ulcer into four groups: group I, including 14 eyes with dry eye disease; group II, including six eyes post-keratoplasty; group III, including four eyes with corneal chemical burn; and group IV, including 16 eyes with persistent corneal ulcer from other causes. All participants underwent detailed ophthalmic examinations, and baseline and final best-corrected distance visual acuity (BCDVA) were recorded. Eye drops were prepared from UCB platelet lysate and administered to all patients along with detailed meticulous instructions for the method of use. Clinical progression of wound healing was continuously observed. The treatment response was identified as complete healing, improvement, or treatment failure.

RESULTS

BCDVA improved significantly in all studied groups (all < 0.05). In group I, complete healing, improvement, and treatment failure occurred in 71%, 29%, and 0% of cases. In group II, complete healing, improvement, and treatment failure occurred in 67%, 33%, and 0% of cases. In group III, complete healing, improvement, and treatment failure occurred in 50%, 50%, and 0% of cases. In group IV, complete healing, improvement, and treatment failure occurred in 63%, 12%, and 25% of cases. No adverse events associated with the treatment were observed or subjectively self-reports in the study period.

CONCLUSIONS

Eye drops from UCB platelet lysate were a novel therapeutic blood component with unique growth factors and anti-inflammatory compounds that could be an effective and safe treatment option in managing persistent corneal ulcers of different causes. A future randomized clinical trial with a large sample size and a longer follow-up is required to confirm these preliminary outcomes.

摘要

背景

脐带血(UCB)因其所含独特的抗炎分子和生长因子,是治疗耐药性角膜溃疡的一种新型疗法。血小板裂解物是未来一种潜在的替代方法。本研究的目的是评估人脐带血血小板裂解物在治疗耐药性角膜溃疡中的作用。

方法

这是一项前瞻性、非对比性、干预性病例系列研究,涉及来自曼苏拉眼科中心和曼苏拉脐带干细胞研究中心的40例年龄在6至65岁之间患有持续性角膜溃疡的患者的眼睛。根据持续性角膜溃疡的病因,将患者分为四组:第一组,包括14只患有干眼症的眼睛;第二组,包括6只角膜移植术后的眼睛;第三组,包括4只角膜化学烧伤的眼睛;第四组,包括16只由其他原因导致的持续性角膜溃疡的眼睛。所有参与者均接受了详细的眼科检查,并记录了基线和最终最佳矫正远视力(BCDVA)。用脐带血血小板裂解物制备眼药水,并连同详细的使用方法说明一起给予所有患者。持续观察伤口愈合的临床进展情况。治疗反应分为完全愈合、改善或治疗失败。

结果

所有研究组的BCDVA均有显著改善(均P<0.05)。在第一组中,71%、29%和0%的病例分别出现完全愈合、改善和治疗失败。在第二组中,67%、33%和0%的病例分别出现完全愈合、改善和治疗失败。在第三组中,50%、50%和0%的病例分别出现完全愈合、改善和治疗失败。在第四组中,63%、12%和25%的病例分别出现完全愈合、改善和治疗失败。在研究期间未观察到与治疗相关的不良事件,也无患者主观上报此类情况。

结论

脐带血血小板裂解物眼药水是一种新型治疗性血液成分,含有独特的生长因子和抗炎化合物,在治疗不同病因的持续性角膜溃疡方面可能是一种有效且安全的治疗选择。需要开展一项样本量更大、随访时间更长的未来随机临床试验来证实这些初步结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c2f/10460244/61788655004b/mehdiophth-11-189-g002.jpg

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