目的探讨应用塞奈吉明滴眼液治疗神经营养性角膜炎(NK)的临床疗效。
方法采用系列病例观察研究，收集2021年6—11月在西安市第一医院确诊为中度及重度NK的患者22例26眼，给予塞奈吉明滴眼液点眼治疗，患眼角膜上皮愈合后结束治疗。患者在治疗前和治疗结束后进行眼部检查获取相关指标数据，其中主要指标包括经Cochet-Bonnet角膜知觉计测得的角膜知觉纤维长度、通过活体共聚焦显微镜对角膜神经进行的形态学检查及定量检查指标(如角膜神经纤维密度和神经分叉点数量)以及使用Keratograph眼表分析仪测得的泪河高度，次要指标包括最佳矫正视力(BCVA)及不良反应。
结果患者接受塞奈吉明滴眼液的平均治疗时间为(4.42±1.86)周，中重度患者角膜上皮完全愈合。治疗后角膜上皮缺损区及缺损区上方角膜知觉纤维长度较治疗前增加，差异均有统计学意义( Z＝－2.45、－3.22，均 P<0.05)。缺损区下方、鼻侧、颞侧角膜知觉纤维长度与治疗前相比差异均无统计学意义( Z＝－1.89、－0.31、－1.86，均 P>0.05)。治疗后患眼平均角膜神经纤维密度及角膜神经纤维分叉点数量较治疗前显著增加，差异均有统计学意义( Z＝－3.95、－3.48，均 P<0.01)。治疗后泪河高度与治疗前相比差异无统计学意义( Z＝－1.58， P＝0.11)。治疗后患眼BCVA(LogMAR)为0.22(0.10，0.40)，较治疗前的0.52(0.30，0.70)提高，差异有统计学意义( Z＝－3.63， P<0.01)。在接受塞奈吉明滴眼液治疗期间，3眼用药后出现短暂性疼痛，1眼眼压升高，给予对症处理，均恢复正常。
结论塞奈吉明滴眼液点眼治疗可修复NK患者角膜神经的形态及功能。
ObjectiveTo explore the clinical efficacy of cenegermin in the treatment of neurotrophic keratitis (NK).
MethodsAn observational case series study was adopted.Twenty-two patients (26 eyes) with moderate and severe NK diagnosed in Xi'an No.1 Hospital from June to November 2021 were collected and locally treated with cenegermin eye drop.After the corneal epithelium of the affected eye healed, the treatment ended.Relevant index data of patients before and after treatment were obtained through eye examination.The main indicators were the fiber length of corneal sensation measured by Cochet-Bonnet aesthesiometer, the morphological and quantitative indexes of corneal nerves by in vivo confocal microscopy, including the density of corneal nerve fibers and the number of nerve bifurcation points, and tear meniscus height measured by Keratograph Ocular Surface Analyzer.The secondary indicators were best corrected visual acuity (BCVA) and adverse reactions.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Xi'an No.1 Hospital (No.2021-11). Written informed consent was obtained from each subject.
ResultsThe average treatment duration of patients receiving cenegermin was (4.42±1.86) weeks.After treatment, the corneal epithelial defect of moderate and severe patients healed completely.After treatment, the fiber length of sensation of corneal epithelial defect area and superior defect area were improved, the differences were statistically significant ( Z=-2.45, -3.22; both at P<0.05). There was no significant difference in corneal sensation in inferior, nasal and temporal of corneal epithelial defect area between before and after treatment ( Z=-1.89, -0.31, -1.86; all at P>0.05). After treatment, the average corneal nerve fiber density and the number of corneal nerve fiber bifurcation points in the affected eyes were significantly increased ( Z=-3.95, -3.48; both at P<0.01). There was no significant difference in the tear meniscus height between before and after treatment ( Z=-1.58, P=0.11). After treatment, the BCVA (LogMAR) of patients was 0.22(0.10, 0.40), which was higher than 0.52(0.30, 0.70) at baseline, and the difference was statistically significant ( Z=-3.63, P<0.01). During the treatment of cenegermin eye drops, transient pain occurred in 3 eyes, and intraocular pressure increased in 1 eye, which all returned to normal after symptomatic treatment.
ConclusionsTopical application of cenegermin can repair corneal nerve morphology and function in patients with NK.
郝咪,程燕,程钰,等. 塞奈吉明滴眼液治疗神经营养性角膜炎效果评估[J]. 中华实验眼科杂志,2024,42(02)：159-164.
DOI:10.3760/cma.j.cn115989-20220924-00450版权归中华医学会所有。
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除非特别声明，本刊刊出的所有文章不代表中华医学会和本刊编委会的观点。
郝咪：直接参与选题、酝酿和设计试验、实施研究、采集数据、分析/解释数据、起草文章；程燕、程钰、王竞：直接参与选题、酝酿和设计试验、实施研究、采集数据、分析/解释数据；吴洁：直接参与选题、酝酿和设计试验、对文章的知识性内容进行审阅及定稿
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