0.05%环孢素A与0.1%他克莫司滴眼液治疗cGVHD相关重度干眼的疗效评价  

Efficacy evaluation of 0.05%cyclosporine A and 0.1%tacrolimus eye drops in the treatment of severe dry eye associated with chronic graft-versus-host disease

作　　者：刘姝婉 赵英涵 马骄 申展 胡博浩 彭荣梅[1] 洪晶[1] Liu Shuwan;Zhao Yinghan;Ma Jiao;Shen Zhan;Hu Bohao;Peng Rongmei;Hong Jing(Department of Ophthalmology,Peking University Third Hospital,Beijing Key Laboratory of Restoration of Damaged Ocular Nerve,Beijing 100191,China)

机构地区：[1]北京大学第三医院眼科眼、部神经损伤的重建保护与康复北京市重点实验室,北京100191

出　　处：《中华眼科杂志》2023年第10期805-813,共9页Chinese Journal of Ophthalmology

基　　金：国家自然科学基金(81970768);白求恩·干眼诊疗与研究科研项目基金(BJ-GY2021003J)。

摘　　要：目的评估0.05%环孢素A及0.1%他克莫司滴眼液治疗眼部慢性移植物抗宿主病(cGVHD)相关重度干眼的有效性和安全性。方法前瞻性非随机同期对照试验。连续纳入2020年4至2021年6月于北京大学第三医院眼科门诊被诊断为cGVHD相关重度干眼的患者,纳入单眼进行研究。将纳入的患者分为A、B两组:前3个月A组局部给予0.05%环孢素A+0.1%氟米龙+玻璃酸钠+小牛血去蛋白提取物,B组在此基础上增加0.1%他克莫司;后3个月两组均只使用0.05%环孢素A和玻璃酸钠。观察两组患者治疗前和治疗后1、3、6个月的眼表疾病指数(OSDI)评分、角膜荧光素染色(CFS)评分和泪膜破裂时间(BUT),以及视力和眼压,并统计患者用药后的刺激症状。结果共纳入83例(83只眼)眼部cGVHD患者,其中男性52例,女性31例,年龄为(28.57±15.67)岁;其中A组44例,B组39例。治疗后1个月,A组CFS由10.0(6.0,14.0)分降低至5.0(3.0,8.5)分(P<0.001);B组CFS由10.0(6.0,15.0)分降低至6.0(2.0,10.0)分(P<0.001),BUT由2.0(1.0,2.0)s增加至2.0(1.8,3.3)s(P<0.001);两组OSDI均无明显降低(均P>0.05),两组间OSDI、CFS、BUT的差异亦均无统计学意义(均P>0.05)。治疗3个月时,A组OSDI由治疗前的32.5(10.7,51.1)分降低至15.9(7.5,33.7)分(P<0.05),CFS降低至6.0(2.0,9.5)分(P<0.05),BUT增加至2.0 s(1.0,3.5)(P<0.05);B组CFS降低至5.0(3.0,12.0)分(P<0.05),BUT增加至2.0(2.0,3.0)s(P<0.05),OSDI无明显降低(P>0.05);A组OSDI低于B组(P<0.05);两组间CFS、BUT比较差异无统计学意义(均P>0.05)。治疗6个月,A组OSDI评分、CFS评分和BUT分别为18.9(9.3,34.2)分、7.0(3.0,8.5)分和2.0(1.0,3.0)s,B组分别为10.9(3.6,35.4)分、5.5(2.8,10.0)和2.0(1.0,2.0)s。与治疗前相比,A组CFS降低、BUT增加,B组OSDI降低,差异均有统计学意义(P<0.05);CFS、BUT较治疗前无明显改善。安全性:治疗1个月时B组眼压由13.2(11.0,19.0)mmHg(1 mmHg=0.133 kPa)升高至14.8(12.8,18.8)mmHg(P<0.05),但治疗期间两组眼压波动均在正常范围Objective To evaluate the effectiveness and safety of 0.05%cyclosporine A and 0.1%tacrolimus eye drops in treating severe dry eye associated with chronic graft-versus-host disease(cGVHD).Methods This non-randomized concurrent control trial enrolled 83 eyes from 83 patients with cGVHD-associated severe dry eye.The treatment had two phases.During the initial shock treatment period(0-3 months),44 patients received 0.05%cyclosporine A eye drops(4 times/day;group A)and 39 patients received 0.1%tacrolimus eye drops(twice/day;group B)alongside basic treatment.In the maintenance treatment period(3-6 months),both groups used 0.05%cyclosporine A eye drops(twice/day)and sodium hyaluronate.Examinations were conducted at 1,3,and 6 months after treatment initiation,assessing the Ocular Surface Disease Index(OSDI),corneal fluorescein staining(CFS)score,and fluorescein tear break-up time(BUT)for efficacy.visual acuity and intraocular pressure(IOP)were evaluated for safety,and patients′post-medication irritation symptoms were recorded.Results The study included 52 males and 31 females,aged(28.57±15.67)years.After 1 month of treatment,the CFS score in group A significantly decreased from 10.0(6.0,14.0)to 5.0(3.0,8.5)(P<0.001).in group B,the CFS score also significantly decreased from 10.0(6.0,15.0)to 6.0(2.0,10.0),and the BUT increased from 2.0(1.0,2.0)s to 2.0(1.8,3.3)s(P<0.001).No significant OSDI decrease was observed in either group.No significant differences were found in OSDI,CFS score,and BUT between the two groups.After 3 months,group A showed significant improvement in OSDI,CFS score,and BUT(P<0.05),while group B only demonstrated significant CFS score decrease(P<0.05).OSDI was significantly lower in group A than group B(P<0.05).No significant differences were noted in CFS score and BUT between groups.After 6 months,OSDI,CFS score,and BUT were 18.9(9.3,34.2),7.0(3.0,8.5),and 2.0(1.0,3.0)s in group A,and 10.9(3.6,35.4),5.5(2.8,10.0),and 2.0(1.0,10.0)s in group B.In both groups,CFS scores significantly decreased and BUT

关 键 词：移植物抗宿主病 干眼综合征 环孢菌素 他罗利姆 眼药水 前瞻性研究 

分 类 号：R777.34[医药卫生—眼科]