Kondo Shoko, Okano Yoshiko, Iraha Satoshi, Tokunaga Shoji
Department of Ophthalmology, National Sanatorium Kikuchi Keifuen, Koshi, Japan.
Department of Ophthalmology, National Sanatorium Oshima Seishoen, Takamatsu, Japan.
Ophthalmol Sci. 2024 Oct 21;5(2):100634. doi: 10.1016/j.xops.2024.100634. eCollection 2025 Mar-Apr.
Neurotrophic keratopathy is part of the leprosy sequelae and causes progressive deterioration of visual acuity. Although leprosy is bacteriologically curable, there is currently no efficient treatment. Eye drops containing tetrapeptides, phenylalanine-glycine-leucine-methionine-amide (FGLM-NH) and serine-serine-serine-arginine (SSSR), derived from substance P and insulin-like growth factor 1, are clinically efficacious in the treatment of corneal epithelial disorders caused by neurotrophic keratopathy. To further investigate the effect of this treatment on leprosy sequalae, we evaluated the clinical efficacy of FGLM-NH+SSSR eye drops for treating neurotrophic keratopathy.
Clinical trial: interventional, multicenter, exploratory, single-arm, before and after comparison.
The eyes (12) of 11 patients, aged >60 years, were studied from 2 leprosy sanatoriums in Japan.
Patients with neurotrophic keratopathy in leprosy sanatorium, specifically those with corneal perception of <40 mm, assessed by the Cochet-Bonnet corneal esthesiometer, and persistent corneal epithelial defects (PEDs) or corneal stromal thinning, or both, were included in this study. Those treated for infection in the acute phase were excluded from the study. Eye drops containing FGLM-NH 0.05% and SSSR 5 × 10% were administered 4 times daily for up to 3 months. Fluorescein staining and optical corneal sections were photographed using a slit lamp microscope at protocol-set intervals. Where possible, anterior segment OCT was performed before and after the intervention.
The primary outcome measured was improvement in neurotrophic keratopathy. The patient was judged to have improved when ≥1 of the following criteria were met: (1) healing epithelial defects or (2) increased thickness in the thin area of the cornea. Secondary end points were visual acuity, subjective findings, and time to complete healing for a PED.
Neurotrophic keratopathy on epithelial defects or stromal thickness improved in 83.3% of the patients (90% confidence interval 56.2%-97.0%, < 0.00001). The mean value of corrected visual acuity increased -0.16 by logarithm of the minimum angle of resolution. There were no adverse events reported in association with the treatment.
We confirmed that FGLM-NH+SSSR eye drops are effective for neurotrophic keratopathy without any adverse reaction in leprosy. These results should be disseminated to any parties who could need this information.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
神经营养性角膜病变是麻风后遗症的一部分，可导致视力逐渐下降。尽管麻风在细菌学上可治愈，但目前尚无有效的治疗方法。含有源自P物质和胰岛素样生长因子1的四肽（苯丙氨酸 - 甘氨酸 - 亮氨酸 - 甲硫氨酸 - 酰胺，FGLM - NH）和丝氨酸 - 丝氨酸 - 丝氨酸 - 精氨酸（SSSR）的眼药水在临床上对治疗神经营养性角膜病变引起的角膜上皮疾病有效。为了进一步研究这种治疗对麻风后遗症的影响，我们评估了FGLM - NH + SSSR眼药水治疗神经营养性角膜病变的临床疗效。
临床试验：干预性、多中心、探索性、单臂、前后对照。
从日本的2家麻风疗养院选取了11名年龄大于60岁患者的12只眼睛进行研究。
麻风疗养院中患有神经营养性角膜病变的患者，特别是那些通过Cochet - Bonnet角膜知觉计评估角膜知觉<40 mm，并且存在持续性角膜上皮缺损（PEDs）或角膜基质变薄，或两者皆有的患者纳入本研究。急性期因感染接受治疗的患者被排除在研究之外。含有0.05% FGLM - NH和5×10% SSSR的眼药水每天给药4次，持续3个月。按照预定时间间隔使用裂隙灯显微镜拍摄荧光素染色和角膜光学切片。在可能的情况下，在干预前后进行眼前节光学相干断层扫描（OCT）。
测量的主要结果是神经营养性角膜病变的改善情况。当满足以下标准中的≥1项时，判断患者病情有所改善：（1）上皮缺损愈合或（2）角膜变薄区域厚度增加。次要终点是视力、主观结果以及PED完全愈合的时间。
83.3%的患者上皮缺损或基质厚度方面的神经营养性角膜病变有所改善（90%置信区间56.2% - 97.0%，<0.00001）。矫正视力的平均值以最小分辨角对数表示增加了 - 0.16。未报告与治疗相关的不良事件。
我们证实FGLM - NH + SSSR眼药水对神经营养性角膜病变有效，且在麻风患者中无任何不良反应。这些结果应传播给任何可能需要此信息的各方。
专有或商业披露信息可在本文末尾的脚注和披露内容中找到。
