背景:神经营养性角膜病变(NK)是一种罕见的退行性眼部疾病,可能难以治疗。对于由眼部移植物抗宿主病(oGVHD)和病毒感染引起的严重NK,没有有效的解决方法。为了解决这个问题,我们设计了一项前瞻性队列研究,以评估局部应用重组人神经生长因子(rhNGF)治疗oGVHD顽固性NK和病毒感染患者的疗效和安全性.
方法:这项前瞻性队列研究纳入了诊断为oGVHD并接受rhNGF治疗的顽固性NK患者。临床评估包括上皮缺损的范围,最佳矫正视力,眼内压,裂隙灯检查,和角膜荧光素染色。检查中央角膜厚度,角膜敏感度,并在4、8、12、20周和6个月时进行神经纤维再生,分别,在开始rhNGF治疗后。
结果:所有入选患者均在2期被诊断为NK(7只眼,63.6%)或第3阶段(4眼,36.4%),对rhNGF治疗有反应。11只眼中的5只眼(45.5%)和11只眼中的9只眼(81.8%)在4周和8周后实现了完全的角膜上皮愈合,分别。11只眼(100%)均在12周后角膜完全愈合。在每次访视期间角膜溃疡面积也显著减少(P<0.001),以及角膜荧光素染色评分(P<0.010)。与基线相比,角膜感觉有显著改善(P<0.050)。
结论:rhNGF局部治疗可有效促进OGVHD和病毒感染顽固性NK患者持续性上皮缺损和角膜溃疡的完全角膜愈合。
BACKGROUND: Neurotrophic keratopathy (NK) is a rare degenerative ocular disease that can be difficult to treat. There were no effective resolutive treatments for severe NK caused by ocular graft-versus-host disease (oGVHD) along with virus infection. To address this question, we designed a prospective cohort study to evaluate the efficacy and safety of topical recombinant human nerve growth factor (rhNGF) in patients with recalcitrant NK of oGVHD and viral infection.
METHODS: This prospective cohort study enrolled patients with recalcitrant NK diagnosed with oGVHD and treated with rhNGF. Clinical evaluations included the range of epithelial defects, best corrected visual acuity, intraocular pressure, slit-lamp examination, and corneal fluorescein staining. Examinations of the central corneal thickness, corneal sensitivity, and nerve fiber regeneration were performed at each visit at 4, 8, 12, 20 weeks and 6 months, respectively, after initiating rhNGF treatment.
RESULTS: All enrolled patients were diagnosed with NK at stage 2 (7 eyes, 63.6%) or stage 3 (4 eyes, 36.4%) and responded to rhNGF treatment. Five of 11 (45.5%) and 9 of 11 eyes (81.8%) achieved complete corneal epithelial healing after 4 and 8 weeks, respectively. All 11 eyes (100%) achieved complete corneal healing after 12 weeks. There was also a significant reduction in the corneal ulcer area during each visit (P < 0.001), as well as in the corneal fluorescein staining score (P < 0.010). There was a significant improvement in corneal sensation when compared to the baseline (P < 0.050).
CONCLUSIONS: Topical treatment with rhNGF effectively promoted the complete corneal healing of persistent epithelial defects and corneal ulcers in patients with recalcitrant NK in oGVHD and viral infection.