摘要
目的 观察0.1％氟米龙滴眼液治疗干眼的临床效果.方法 前瞻性随机对照研究.纳入永康医院2022年5月至2023年6月干眼患者108例(108眼),随机分为两组,对照组(53例)予以玻璃酸钠滴眼液治疗,观察组(55例)予以玻璃酸钠滴眼液联合0.1％氟米龙滴眼液治疗,两组患者均治疗4周.采用角膜荧光染色(CFS)、泪液分泌试验(SIt)和泪膜破裂时间(TBUT)评估治疗前后泪膜稳定性;化学发光免疫法测定泪液中白细胞介素-1β(IL-1β)、肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)质量浓度评估治疗前后眼表炎症.记录患者临床治疗总有效率以及不良反应发生率.结果 最终106例干眼患者被纳入研究,其中观察组54例,对照组52例.治疗后,总有效率观察组92.59％(50/54),对照组 76.92％(40/52),差异有统计学意义(x2=5.08,P=0.024).治疗后,CFS 评分观察组(1.44±0.42)分,对照组(3.02±0.84)分,差异有统计学意义(t=12.32,P＜0.001);SIt值观察组(10.33±1.78)mm/5 min,对照组(9.23±1.50)mm/5 min,差异有统计学意义(t=3.43,P=0.001);TBUT 值观察组(11.07±2.10)s,对照组(8.98±1.26)s,差异有统计学意义(t=6.18,P＜0.001).治疗后,IL-1β质量浓度观察组(38.02±9.24)ng/L,对照组(57.03±12.15)ng/L,差异有统计学意义(t=9.09,P＜0.001);TNF-α 质量浓度观察组(15.34±3.05)ng/L,对照组(22.42±4.46)ng/L,差异有统计学意义(t=9.57,P＜0.001);IL-6质量浓度观察组(45.61±8.76)ng/L,对照组(63.08±13.31)ng/L,差异有统计学意义(t=8.01,P＜0.001).治疗后,不良反应发生率观察组7.41％(4/54),对照组5.77％(3/52),差异无统计学意义(x2=0.00,P=0.959).结论 0.1％氟米龙滴眼液联合玻璃酸钠滴眼液应用于干眼患者,可降低泪液炎症因子,增强泪膜稳定性,提高临床疗效,且未发生明显不良反应.
Abstract
Objective To observe the clinical efficacy of 0.1％fluorometholone eye drops in the treatment of dry eye.Methods This was a prospective randomized controlled study.A total of 108 eyes of 108 patients with dry eye in Yongkang Hospital from May 2022 to Jun.2023 were randomly divided into two groups.The control group(53 cases)was treated with sodium hyaluronate eye drops,and the observation group(55 cases)was treated with sodium hyaluronate eye drops combined with 0.1％fluorometholone eye drops.Both groups were treated for 4 weeks.Corneal fluorescence staining(CFS),Schirmer Ⅰ test(SIt)and tear film break-up time(TBUT)were used to evaluate the stability of tear film before and after treatment.Mass concentrations of interleukin-1β(IL-1β),tumor necrosis factor-α(TNF-α)and IL-6 in tear were measured by chemiluminescence immunoassay to evaluate ocular surface inflammation before and after treatment.The total effective rate of clinical treatment and the incidence of adverse reactions were recorded.Results A total of 106 cases with dry eye were enrolled.Finally,54 cases were included in the observation group and 52 cases were included in the control group.After treatment,the total effective rate was 92.59％(50/54)in the observation group and 76.92％(40/52)in the control group,and the difference was statistically significant(x2=5.08,P=0.024).After treatment,CFS score was(1.44±0.42)points in the observation group and(3.02±0.84)points in the control group,and the difference was statistically significant(t=12.32,P＜0.001).SIt value was(10.33±1.78)mm/5 min in the observation group and(9.23±1.50)mm/5 min in the control group,and the difference was statistically significant(t=3.43,P=0.001).TBUT value was(11.07±2.10)s in the ovservation group and(8.98±1.26)s in the control group,and the difference was statistically significant(t=6.18,P＜0.001).After treatment,IL-1β mass concentration was(38.02±9.24)ng/L in the observation group and(57.03±12.15)ng/L in the control group,and the difference was statistically significant(t=9.09,P＜0.001).The concentration of TNF-α was(15.34±3.05)ng/L in the observation group and(22.42±4.46)ng/L in the control group,and the difference was statistically significant(t=9.57,P＜0.001).IL-6 concentration was(45.61±8.76)ng/L in the observation group and(63.08±13.31)ng/L in the control group,and the difference was statistically significant(t=8.01,P＜0.001).After treatment,the incidence of adverse reactions was 7.41％(4/54)in the observation group and 5.77％(3/52)in the control group,with no significant difference(x2=0.00,P=0.959).Conclusion 0.1％fluorometholone eye drops combined with sodium hyaluronate eye drops can reduce tear inflammatory factors,enhance tear film stability,and improve clinical efficacy in dry eye patients without significant adverse reactions.
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