摘要
目的探讨环孢素联合重组人表皮生长因子(rh-EGF)衍生物滴眼液治疗中重度干眼患者的临床疗效。方法采用前瞻性研究方法,选取佛山市高明区人民医院2023年1月至2024年12月予以针对性治疗的156例中重度干眼症患者为此次试验对象,按随机数字表法分成对照组和观察组,对照组(78例)采用环孢素滴眼液治疗,观察组(78例)采用环孢素滴眼液联合rh-EGF衍生物滴眼液治疗,均治疗8周。比较对照组和观察组临床疗效、泪膜破裂时间(BUT)、泪液分泌试验(SIT)、角膜荧光素染色(CFS)评分、眼表疾病指数(OSDI)评分、泪液细胞因子[白细胞介素6(IL-6)、肿瘤坏死因子α(TNF-α)、乳铁蛋白]水平以及不良反应发生率。结果在治疗总有效率方面,观察组89.74%(70/78)高于对照组75.64%(59/78)(χ^(2)=5.419,P<0.05)。对照组和观察组患者治疗后的BUT、SIT均较治疗前升高,且观察组BUT、SIT[分别为(6.36±0.92)s、(8.15±1.14)mm/5 min]均高于对照组[分别为(4.89±0.75)s、(6.46±1.22)mm/5 min](t=10.938、8.939,均P<0.05)。对照组和观察组患者治疗后的CFS、OSDI评分均较治疗前下降,且观察组CFS、OSDI评分[分别为(3.42±0.78)分、(19.28±4.57)分]均低于对照组[分别为(4.56±0.89)分、(23.21±4.68)分](t=8.508、5.306,均P<0.05)。对照组和观察组患者治疗后的IL-6、TNF-α水平均较治疗前下降,乳铁蛋白水平较治疗前上升,且观察组IL-6、TNF-α水平[分别为(42.96±8.17)ng/L、(23.20±4.35)ng/L]均低于对照组[分别为(46.14±8.06)ng/L、(29.29±4.26)ng/L](t=2.447、8.834,均P<0.05),乳铁蛋白水平(2.06±0.58)mg/L高于对照组(1.59±0.45)mg/L(t=5.654,P<0.05)。在不良反应发生率方面,对照组为7.69%(6/78),观察组为6.41%(5/78),组间比较差异无统计学意义(χ^(2)=0.098,P>0.05)。结论环孢素联rh-EGF衍生物滴眼液治疗可有效改善中重度干眼症泪膜功能、减轻角膜损伤、调节炎症因子和乳铁蛋白水平,且安全性良好。
Objective To investigate the clinical efficacy of cyclosporine combined with recombinant human epidermal growth factor(rh-EGF)derivative eye drops in the treatment of patients with moderate to severe dry eye disease.Methods A total of 156 patients with moderate to severe dry eye disease who received targeted treatment at Gaoming District People’s Hospital,Foshan City between January 2023 and December 2024 were prospectively selected and randomly allocated into the control group and the observation group via the random number table method.The control group(78 cases)received cyclosporine eye drops,while the observation group(78 cases)received cyclosporine eye drops combined with rh-EGF derivative eye drops.Both groups were treated for 8 weeks.Clinical efficacy,tear break-up time(BUT),Schirmer I test(SIT),corneal fluorescein staining(CFS)score,Ocular Surface Disease Index(OSDI)score,tear cytokine levels(interleukin-6(IL-6),tumor necrosis factor-α(TNF-α),lactoferrin),and the incidence of adverse reactions were compared between the two groups.Results The total effective rate was 89.74%(70/78)in the observation group,significantly higher than 75.64%(59/78)in the control group(χ^(2)=5.419,P<0.05).After treatment,BUT and SIT values increased in both groups compared to pre-treatment levels,with the observation group showing higher BUT and SIT((6.36±0.92)s,(8.15±1.14)mm/5 min,respectively)than the control group((4.89±0.75)s,(6.46±1.22)mm/5 min,respectively)(t=10.938,8.939,both P<0.05).After treatment,CFS and OSDI scores decreased in both groups compared to pre-treatment levels,with the observation group showing lower CFS and OSDI scores((3.42±0.78)points,(19.28±4.57)points,respectively)than the control group((4.56±0.89)points,(23.21±4.68)points,respectively)(t=8.508,5.306,both P<0.05).After treatment,IL-6 and TNF-αlevels decreased while lactoferrin levels increased in both groups compared to pre-treatment levels.The observation group showed lower IL-6 and TNF-αlevels((42.96±8.17)ng/L,(23.20±4.35)ng/L,respectively)than the control group((46.14±8.06)ng/L,(29.29±4.26)ng/L,respectively)(t=2.447,8.834,both P<0.05),and higher lactoferrin levels((2.06±0.58)mg/L)than the control group((1.59±0.45)mg/L)(t=5.654,P<0.05).The incidence of adverse reactions was 7.69%(6/78)in the control group and 6.41%(5/78)in the observation group,with no statistically significant difference between the two groups(χ^(2)=0.098,P>0.05).Conclusion The combination of cyclosporine and rhEGF derivative eye drops effectively improves tear film function,reduces corneal damage,and modulates inflammatory factors and lactoferrin levels in patients with moderate to severe dry eye disease,with a favorable safety profile.
作者
徐亚娟
林少君
李家欢
XU Yajuan;LIN Shaojun;LI Jiahuan(Department of Ophthalmology and Otorhinolaryngology,Gaoming District People’s Hospital,Foshan City,Foshan 528500,China)
出处
《中国药物应用与监测》
2025年第9期1565-1569,共5页
Chinese Journal of Drug Application and Monitoring
基金
2022年佛山市自筹经费类科技创新项目(2220001005326)。
关键词
环孢素
重组人表皮生长因子
中重度干眼症
临床疗效
泪膜功能
炎症因子
cyclosporine
recombinant human epidermal growth factor
moderate to severe dry eye syndrome
clinical efficacy
tear film function
inflammatory factors
