吲哚美辛联合泼尼松治疗葡萄膜炎患者的临床研究  

Clinical trial of indomethacin combined with prednisone in the treatment of patients with uveitis

作　　者：应晔 安琪 洪浩 YING Ye;ANQi;HONG Hao(Department of Ophthalmology,Nanjing SecondHospital,Nanjing 210003,Jiangsu Province,China)

机构地区：[1]南京市第二医院眼科,江苏南京210003

出　　处：《中国临床药理学杂志》2023年第19期2744-2747,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察吲哚美辛滴眼液联合泼尼松滴眼液治疗葡萄膜炎患者的临床疗效及安全性。方法将急性葡萄膜炎患者随机分为对照组和试验组。对照组给予醋酸泼尼松龙滴眼液治疗,每次2滴,tid;试验组在对照组治疗的基础上,联合吲哚美辛滴眼液治疗,每次1滴,tid。2组患者均治疗1个月。比较2组患者的临床疗效、视力、眼内压、白细胞计数(WBC)、中性粒细胞计数(NEU)、血清中肿瘤坏死因子-α(TNF-α)、白细胞介素-16(IL-16)和IL-32的表达水平,以及不良事件的发生情况。结果试验组入组47例,脱落3例,最终44例纳入分析;对照组入组47例,脱落4例,最终43例纳入分析。治疗后,试验组和对照组的总有效率分别为97.73%(43例/44例)和86.05%(37例/43例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组的裸眼视力分别为0.87±0.14和0.76±0.15,眼内压分别为(15.11±1.50)和(15.87±1.77)mmHg,WBC分别为(6.95±0.84)×10^(9)和(7.45±1.14)×10^(9)·L^(-1),NEU分别为(2.21±0.63)×10^(9)和(2.51±0.66)×10^(9)·L^(-1),TNF-α分别为(17.23±2.76)和(19.17±2.95)pg·mL^(-1),IL-16分别为(68.23±9.31)和(74.41±10.01)pg·mL^(-1),IL-32分别为(78.32±9.35)和(83.15±10.53)pg·mL^(-1),差异均有统计学意义(均P<0.05)。2组患者的不良事件均以头痛、肝功能损害、白细胞减少、皮疹及睡眠障碍为主。试验组和对照组的总不良事件发生率分别为13.64%和18.60%,差异无统计学意义(P>0.05)。结论吲哚美辛滴眼液联合泼尼松滴眼液可显著改善葡萄膜炎患者的眼部症状及视力受损情况,降低患者体内的炎症水平,且不增加不良事件的发生率。Objective To observe the clinical efficacy and safety of indomethacin eye drops combined with prednisone eye drops in the treatment of patients with uveitis.Methods Patients with acute uveitis were randomly divided into control group and treatment group.The control group was given prednisolone acetate eye drops with 2 drops each time,tid;and the treatment group received indomethacin eye drops with1 drop each time,tid,on the basis of control group.Two groups were treated for 1 month.The clinical efficacy,visual acuity,intraocular pressure,white blood cell count(WBC),neutrophil count(NEU),the expression levels of tumor necrosis factor-α(TNF-α),interleukin-16(IL-16)and IL-32 in serum,and adverse events were compared between two groups.Results There were 47 cases in the treatment group,3 cases fell out,44 cases were included in the analysis;47 cases in the control group,4 cases fell out,and 43 cases were included in the analysis.After treatment,the total effective rates of the treatment group and the control group were 97.73%(43 cases/44 cases)and86.05%(37 cases/43 cases)without significant difference(P<0.05).After treatment,the visual acuities of the treatment and control groups were 0.87±0.14 and 0.76±0.15,the intraocular pressure were(15.11±1.50)and(15.87±1.77)mm Hg,the WBC were(6.95±0.84)×10^(9)and(7.45±1.14)×10^(9)·L^(-1),the NEU were(2.21±0.63)×10^(9)and(2.51±0.66)×10^9·L^(-1),the TNF-αwere(17.23±2.76)and(19.17±2.95)pg·m L^(-1),the IL-16 were(68.23±9.31)and(74.41±10.01)pg·m L^(-1),the IL-32 were(78.32±9.35)and(83.15±10.53)pg·m L^(-1),and the differences were statistically significant(all P<0.05).The adverse events of the two groups were headache,liver function damage,leukopenia,rash and sleep disturbance.The total incidences of adverse events in the treatment and control groups were 13.64%and 18.60%,but the difference was not statistically significant(P<0.05).Conclusion Indomethacin eye drops combined with prednisone eye drops can significantly improve the ocular symptoms and visual im

关 键 词：吲哚美辛滴眼液 泼尼松滴眼液 葡萄膜炎 促炎性细胞因子 安全性评价 

分 类 号：R988.1[医药卫生—药品]