目的：探讨角膜基质透镜联合0.1%环孢素A滴眼液治疗蚕食性角膜溃疡患者的临床疗效及对眼表炎症因子的影响。方法：前瞻性随机对照临床试验。选取2022年1月至2024年1月在我院接受治疗的蚕食性角膜溃疡患者200例272眼作为研究对象。按照随机数字表法将患者等分为对照组100例136眼单纯采用角膜基质透镜治疗，观察组100例136眼采用角膜基质透镜联合0.1%环孢素A滴眼液治疗。术后随访3 mo，比较两组患者手术前后的临床疗效、视力改善情况、术后恢复时间、疼痛评分、并发症发生率以及泪液中IL-1β、IL-6、TNF-α水平的变化。结果：随访期间，两组各失访2例2眼(失访率为2.0%)，最终纳入196例268眼。观察组总有效率为95.5%，显著高于对照组的83.6%(P<0.05)； 术后3 mo观察组最佳矫正视力(LogMAR)优于对照组( 0.42±0.15 vs 0.65±0.18， P<0.001)； 观察组角膜上皮愈合时间(5.24±1.15 d)和基质透明时间(12.35±2.46 d)均短于对照组(7.86±1.43和16.72±3.15 d)(均P<0.001)； 观察组术后疼痛评分以及并发症发生率显著低于对照组(均P<0.001)。术后，两组泪液中IL-1β、IL-6、TNF-α水平均显著降低，且观察组降低程度更为显著(P<0.001)。结论：角膜基质透镜联合0.1%环孢素A滴眼液治疗蚕食性角膜溃疡具有显著的临床效果，可有效改善患者视力，促进角膜愈合，减轻术后疼痛，降低并发症发生率，其作用机制可能与抑制眼表炎症因子的表达有关。

AIM:To evaluate the efficacy of corneal stromal lenses combined with 0.1% cyclosporine A eye drops in patients with Mooren's ulcer and its effect on ocular surface inflammatory factors.METHODS:In this prospective randomized controlled trial, 200 patients(272 eyes)with Mooren's ulcer were enrolled from January 2022 to January 2024. Patients were randomly assigned to receive either corneal stromal lenses alone(control group: 100 patients, 136 eyes)or combined with 0.1% cyclosporine A eye drops(observation group: 100 patients, 136 eyes). All patients were followed up for 3 mo. Clinical efficacy, visual acuity improvement, recovery time, pain score, complications, and tear levels of interleukin(IL)-1β, IL-6, and tumor necrosis factor-α(TNF-α)were compared between the two groups.RESULTS:A total of 196 patients(268 eyes)completed follow-up, with 2 cases(2 eyes)lost to follow-up in each group and a lost to follow-up rate of 2.0%. The observation group showed a higher total effective rate(95.5% vs 83.6%, P<0.05). Postoperative best corrected visual acuity(LogMAR)of the observation group was significantly better than that of the control group(0.42±0.15 vs 0.65±0.18, P<0.001). Epithelial(5.24±1.15 vs 7.86±1.43 d)and stromal recovery(12.35±2.46 vs 16.72±3.15 d)were faster in the observation group(both P<0.001). Pain scores and complication rates of the observation group were lower than those of the control group(both P<0.001). Both groups showed reduced tear IL-1β, IL-6, and TNF-α levels postoperatively, with greater reductions in the observation group(P<0.001).CONCLUSION: Corneal stromal lenses combined with 0.1% cyclosporine A eye drops provide superior outcomes for Mooren's ulcer by enhancing visual recovery, accelerating corneal healing, reducing pain, and lowering complications, potentially through inhibition of ocular surface inflammatory factors.

自贡市科技计划项目(No.2023YKY08)