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[摘要]
目的:探究自体血清滴眼液联合醋酸泼尼松龙治疗重度干眼合并Ⅱ-Ⅲ级角膜损伤的短期疗效。
方法:本研究为前瞻性随机对照的单中心研究。选取2023年3月至2025年3月于武汉大学附属爱尔眼科医院就诊的重度干眼合并Ⅱ-Ⅲ级角膜损伤患者122例122眼(所纳入的患者均为双眼患病,选择症状较重的眼睛作为研究眼,若双眼症状严重程度相同,则选右眼为研究眼),按照随机数字表法分为对照组(使用玻璃酸钠滴眼液联合自体血清滴眼液治疗)和观察组(使用玻璃酸钠滴眼液联合自体血清滴眼液及醋酸泼尼松龙滴眼液治疗)。连续给药2 wk,比较两组患者治疗前后的泪液中炎症反应\〖白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)\〗、主观症状\〖眼表疾病指数量表(OSDI)评分\〗、泪腺功能\〖泪膜破裂时间(TBUT)及泪液分泌试验(SⅠt)\〗、角膜损伤程度\〖角膜荧光素染色(CFS)评分\〗及角膜神经功能\〖角膜上皮下神经(SBN)总数量及密度\〗,并记录两组治疗期间不良反应发生情况。
结果:本研究纳入患者122例122眼均完成随访。对照组61例61眼中男24例,女37例,平均年龄43.87±5.12岁; 观察组61例61眼中男21例,女40例,平均年龄42.15±4.76岁。治疗后1、2 wk,两组患者泪液中IL-6、TNF-α水平、OSDI评分、CFS评分均较治疗前显著下降,且观察组均低于对照组(均P<0.05); 两组患者TBUT、SⅠt、SBN总数量、SBN密度均较治疗前显著增加,且观察组均大于对照组(均P<0.05)。两组患者治疗期间不良反应发生率比较无差异(P=0.717)。
结论:自体血清滴眼液联合醋酸泼尼松龙治疗重度干眼合并Ⅱ-Ⅲ级角膜损伤的疗效确切,可减轻患者炎症反应、主观症状及角膜损伤程度,促进泪腺功能及角膜神经功能改善,为患者角膜神经修复提供新策略,且联合疗法不会增加不良反应发生风险,短期应用安全性良好。
[Key word]
[Abstract]
AIM:To investigate the short-term efficacy of autologous serum eye drops combined with prednisolone acetate in the treatment of severe dry eye with grade II-III corneal injury.
METHODS:Prospective, randomized, controlled single center study. Totally 122 patients(122 eyes, all enrolled patients had bilateral disease, with the more severely affected eye selected as the study eye; if the severity was similar between both eyes, the right eye was chosen as the study eye)with severe dry eye and grade II-III corneal injury who were treated at Wuhan University Affiliated Aier Eye Hospital from March 2023 to March 2025 were randomly divided into a control group(treated with sodium hyaluronate eye drops combined with autologous serum eye drops)and an observation group(treated with sodium hyaluronate eye drops, autologous serum eye drops combined with prednisolone acetate eye drops)using a random number table method. After continuous administration for 2 wk, the tear inflammatory reaction \〖interleukin-6(IL-6), tumor necrosis factor-α(TNF-α)\〗, subjective symptoms \〖ocular surface disease index(OSDI)score\〗, lacrimal gland function \〖tear film break-up time(TBUT)and Schirmer tear secretion test(SⅠt)\〗, corneal injury degree \〖corneal fluorescein staining(CFS)score\〗 and corneal nerve function \〖total number and density of corneal subepithelial nerve(SBN)\〗 before and after treatment were compared between the two groups, and the occurrence of adverse reactions during treatment was recorded.
RESULTS:All patients have completed follow-up. The control group consisted of 61 cases and 61 eyes, with 24 males and 37 females, with an average age of 43.87±5.12y. There were 61 cases and 61 eyes in the observation group, including 21 males and 40 females, with an average age of 42.15±4.76y. At 1 and 2 wk after treatment, the levels of IL-6 and TNF-α in tears, OSDI score, and CFS score of the two groups were significantly lower than those before treatment, and those in the observation group were lower than those in the control group(all P<0.05). The total number of TBUT, SⅠt, SBN, and SBN density in both groups of patients increased significantly compared to before treatment, and the observation group was higher than the control group(all P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups of patients during treatment(P=0.717).
CONCLUSION:The combination of autologous serum eye drops and prednisolone acetate is effective in treating severe dry eye with grade II-III corneal injury. It can reduce patients' inflammatory reactions, subjective symptoms, and degree of corneal injury, promote the improvement of lacrimal gland function and corneal nerve function, providing a new strategy for corneal nerve repair. Furthermore, the combination therapy does not increase the risk of adverse reactions and shows good safety in short-term application.
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