目的比较0.05%环孢素滴眼液和0.1%氟米龙滴眼液对中重度干眼患者的治疗效果。
方法采用随机对照研究设计，纳入2021年8月至2022年12月就诊于天津医科大学眼科医院的中重度干眼患者52例52眼，采用随机数字表法将其随机分成0.05%环孢素组和0.1%氟米龙组，每组26例26眼，分别给予0.05%环孢素滴眼液(2次/d)和0.1%氟米龙滴眼液(2次/d)点眼，2个组均联合小牛血去蛋白提取物滴眼液(4次/d)治疗。治疗前和治疗1、3、6个月随访观察临床症状和体征，记录眼表疾病指数(OSDI)量表评分、角膜荧光素染色(CFS)评分、泪液分泌试验Ⅰ(SⅠT)、非侵入性首次泪膜破裂时间(NIBUTf)、结膜杯状细胞(CGC)密度；治疗前、治疗6个月采用活体共聚焦显微镜(IVCM)观察角膜神经及树突状细胞(DC)变化。
结果与0.1%氟米龙组相比，0.05%环孢素组治疗1个月CFS评分降低，治疗3个月SⅠT升高、NIBUTf升高、CFS评分降低，治疗6个月OSDI评分降低、SⅠT升高、CFS评分降低；与基线相比，0.05%环孢素组治疗1个月NIBUTf升高、CFS评分降低，治疗3和6个月OSDI评分降低、SⅠT升高、NIBUTf升高、CFS评分降低；0.1%氟米龙组治疗3个月CFS评分降低，治疗6个月OSDI评分降低、SⅠT升高、CFS评分降低；与治疗3个月相比，0.05%环孢素组治疗6个月OSDI评分降低、SⅠT升高、CFS评分降低，差异均有统计学意义(均 P<0.05)。基线，治疗1、3、6个月0.05%环孢素组CGC密度分别为(147.66±17.29)、(195.44±15.46)、(210.36±19.15)和(282.09±22.63)个/mm 2，0.1%氟米龙组分别为(138.09±17.29)、(95.67±15.46)、(117.77±19.15)和(109.13±22.63)个/mm 2，总体比较差异均有统计学意义( F 分组＝11.724， P<0.001； F 时间＝4.837， P＝0.005)，其中与0.1%氟米龙组相比，0.05%环孢素组治疗1、3、6个月CGC密度增加；与各自基线相比，0.05%环孢素组治疗1、3、6个月CGC密度增加，差异均有统计学意义(均 P<0.05)。与0.1%氟米龙组比较，0.05%环孢素组治疗6个月角膜神经纤维密度增加，角膜DC密度、面积、树突数均降低，差异均有统计学意义(均 P<0.05)。
结论0.05%环孢素滴眼液联合小牛血去蛋白提取物滴眼液可改善中重度干眼患者的症状和体征，长期效果优于0.1%氟米龙滴眼液联合小牛血去蛋白提取物滴眼液。
ObjectiveTo compare the therapeutic effects of 0.05% cyclosporine and 0.1% fluorometholone eye drops in patients with moderate and severe dry eye.
MethodsA randomized controlled study was conducted.Fifty-two patients (52 eyes) with moderate to severe dry eye in Tianjin Medical University Eye Hospital from August 2021 to December 2022 were enrolled and randomly divided into 0.05% cyclosporine group and 0.1% fluorometholone group by random number table method, with 26 cases (26 eyes) in each group.Patients received 0.05% cyclosporine eye drops (2 times/day) and 0.1% fluorometholone eye drops (2 times/day) combined with calf blood deproteinized extract eye drops (4 times/day) according to the grouping.Before and 1, 3 and 6 months after treatment, clinical symptoms and signs were observed and Ocular Surface Disease Index (OSDI) score, corneal fluorescein staining (CFS) score, Schirmer Ⅰ test (SⅠT), non-invasive first tear film break-up time (NIBUTf), and conjunctival goblet cell (CGC) density were recorded.Before treatment and after 6 months of treatment, changes in corneal nerves and dendritic cells (DC) were observed by in vivo confocal microscopy (IVCM).This study adhered to the Declaration of Helsinki and was approved by the Medical Ethics Committee of Eye Hospital of Tianjin Medical University (No.2021KY-17).Written informed consent was obtained from each subject.
ResultsCompared with the 0.1% fluorometholone group, CFS score decreased after 1 month of treatment, but SⅠT, NIBUTf and CFS score increased after 3 months of treatment, and OSDI score, SⅠT and CFS score decreased after 6 months of treatment in the 0.05% cyclosporine group, showing statistically significant differences (all at P<0.05).Compared with baseline, in the 0.05% cyclosporine group, NIBUTf increased and CFS score decreased after 1 month of treatment, OSDI score and CFS score decreased, SⅠT and NIBUTf increased after 3 and 6 months of treatment, showing statistically significant differences (all at P<0.05).In the 0.1% fluorometholone group, CFS score decreased after 3 months of treatment, OSDI score and CFS score decreased, SⅠT increased after 6 months of treatment compared to baseline, showing statistically significant differences (all at P<0.05).OSDI score and CFS score decreased, SⅠT increased after 6 months of treatment compared to 3 months of treatment in the 0.05% cyclosporine group, and the differences were statistically significant (all at P<0.05).Baseline and CGC densities after 1, 3 and 6 months of treatment were (147.66±17.29), (195.44±15.46), (210.36±19.15) and (282.09±22.63)cells/mm 2 in the 0.05% cyclosporine group and (138.09±17.29), (95.67±15.46), (117.77±19.15) and (109.13±22.63)cells/mm 2 in the 0.1% fluorometholone group, respectively, with a statistically significant overall difference ( F group=11.724, P<0.001; F time=4.837, P=0.005).Compared with the 0.1% fluorometholone group, CGC density in the 0.05% cyclosporine group increased after 1, 3 and 6 months of treatment, with statistically significant differences (all at P<0.05).Compared with baseline, the CGC density increased in the 0.05% cyclosporine group after 1, 3 and 6 months of treatment, and the differences were statistically significant (all at P<0.05).Compared with the 0.1% fluorometholone group, the corneal nerve fiber density in the 0.05% cyclosporine group increased after 6 months of treatment, and corneal DC density, area and dendrite number decreased, showing statistically significant differences (all at P<0.05).
ConclusionsCyclosporine 0.05% eye drops combined with calf blood deproteinized extract eye drops can improve symptoms and signs in patients with moderate to severe dry eye, and the long-term effect is better than that of 0.1% fluorometholone plus calf blood deproteinized extract eye drops.
Gao Huijuan and Zhang Chengyuan contributed equally to this article
高惠娟,张程远,张侠,等. 0.05%环孢素与0.1%氟米龙滴眼液治疗中重度干眼效果比较[J]. 中华实验眼科杂志,2024,42(11)：1012-1019.
DOI:10.3760/cma.j.cn115989-20240307-00068版权归中华医学会所有。
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高惠娟、张程远：参与选题、研究实施、数据采集及分析、论文撰写及修改；张侠、赵璐、何晴、解偲媛、孟子琪：研究实施、参数测量、数据采集及分析；刘琳、苏龙：参与课题临床技术指导；魏瑞华：参与选题、研究设计和研究标准化制定、数据分析结果的审核、论文智力性内容的修改及定稿
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