3%地夸磷索钠滴眼液治疗干眼前后自觉症状改善和体征变化关系的临床研究  

The correlation of changes of subjective symptoms with objective signs in patients with dry eye before and after 3%sodium diquafosol eye drops treatment

作　　者：王文莹 田磊 潘志强 Wang Wenying;Tian Lei;Pan Zhiqiang(Beijing Tongren Eye Center,Beijing Tongren Hospital,Capital Medical University,Beijing Key Laboratory of Ophthalmology and Visual Science,Beijing 100730,China)

机构地区：[1]首都医科大学附属北京同仁医院,北京同仁眼科中心,北京市眼科研究所,眼科学与视觉科学北京市重点实验室,100730

出　　处：《中华眼科医学杂志（电子版）》2023年第5期279-284,共6页Chinese Journal of Ophthalmologic Medicine(Electronic Edition)

基　　金：国家自然科学基金青年基金项目(31600758)。

摘　　要：目的探讨3%地夸磷索钠滴眼液治疗干眼前后自觉症状改善与体征变化的关系。方法多中心、前瞻性及大样本的Ⅳ期临床试验研究。纳入2019年5月至2021年6月在首都医科大学附属北京同仁医院眼科中心等30家眼科机构就诊的干眼患者2660例(2660只眼)。其中,男性680例(680只眼),女性1980例(1980只眼);年龄21~69岁,平均年龄(44.0±15.3)岁。所有患者使用3%地夸磷索钠滴眼液单药治疗,1滴/1次点眼,6次/d,治疗30 d。于治疗前、治疗后14 d及治疗后30 d时行裂隙灯显微镜、泪膜破裂时间(BUT)、角膜荧光素染色(CFS)及SchirmmerⅠ试验(SⅠt)等体征检查和干眼相关生活质量评分(DEQS)等自觉症状评估。DEQS总分和总体感觉评分符合正态分布,采用x±s表示,两组比较采用独立样本t检验,多组比较采用单因素方差分析,当差异有统计学意义时,采用SNK法进行两两比较。治疗后自觉症状改善与体征变化的相关性分析采用Pearson相关分析。结果治疗14 d和30 d后,BUT>5 s组患者DEQS总分和总体感觉改善分别为(-17.57±17.29)分、(-20.15±17.39)分、(-1.00±0.89)分及(-1.00±0.89)分;BUT≤5 s组患者DEQS总分和总体感觉改善分别为(-12.36±15.67)分、(-14.38±16.07)分、(-0.70±0.82)分及(-0.70±0.80)分,组间患者DEQS总分改善差异均有统计学意义(t=-2.87,-3.34;P<0.05)。SⅠt>10 mm组、5 mm<SⅠt≤10 mm组及SⅠt≤5 mm组患者DEQS总体感觉改善分别为(-0.60±0.72)分、(-0.80±0.82)分、(-0.80±0.77)分、(-1.00±0.86)分、(-0.80±0.87)分及(-1.10±0.93)分;总分改善分别为(-9.83±12.95)分、(-15.37±15.32)分、(-14.32±15.22)分、(-20.14±16.80)分、(-13.75±17.36)分及(-18.72±18.57)分,组间总体感觉改善的差异均有统计学意义(F=23.68,23.31,18.36,14.80;P<0.05)。1分≤CFS评分<6分、6分≤CFS评分<10分及≥10分组患者DEQS总体感觉改善分别为(0.70±0.80)分、(0.90±0.87)分、(0.90±0.85)分、(1.20±0.95)分、(0.90±0.78)分及(0Objective To evaluate the correlation between changes of subjective symptoms and objective signs before and after 3%diquafosol sodium eye drops treatment in patients with dry eyes.Methods This was a multi-center,prospective large scale phaseⅣclinical trial.A total of 2660 patients(2660 eyes)with dry eye were included in Beijing Tongren Eye Center,Beijing Tongren Hospital affiliated with Capital Medical University and others 30 ophthalmology clinics nationwide from May 2019 to June 2021.Among them,there were 680 males(680 eyes)and 1980 females(1980 eyes),aged 21 to 69 years with an average age of(44.0±15.3)years.Patients were treated with 3%diquafosol sodium eye drops 6 times a day alone for 30 days.The objective signs,including slit-lamp microscopic examination,tear film breakup time(BUT),corneal fluorescein staining(CFS),SchirmerⅠtest(SⅠt)and subjective symptoms,including dry eye-related quality-of-life score(DEQS),were perfomed before and after treatment for 14 days and 30 days.The DEQS total score and DEQS total perception followed a normal distribution and were expressed as±s,compared by independent sample t-test between two groups,and by one-way analysis of variance among multiple groups.When the difference was statistically significant,SNK method was further used for pairwise comparison.Pearson correlation analysis was used to analyze the correlation between changes of subjective symptoms and objective signs after treatment.Results After treatment for 14 days and 30 days,the changes of DEQS total score and DEQS total perception in BUT>5 s subgroup were(-17.57±17.29)scores,(-20.15±17.39)scores,(-1.00±0.89)scores,(-1.00±0.89)scores,respectively;the changes in BUT≤5 s subgroup were(-12.36±15.67)scores,(-14.38±16.07)scores,(-0.70±0.82)scores,(-0.70±0.80)scores,respectively.There were significant differences in changes of DEQS total score between two groups(t=-2.87,-3.34;P<0.05).After treatment for 14 days and 30 days,the changes of DEQS total perception in SⅠt>10 mm,5 mm<SⅠt≤10 mm,SⅠt�

关 键 词：干眼 干眼症状评估问卷 泪膜破裂时间 角膜荧光素染色 SchirmerⅠ试验 

分 类 号：R777.34[医药卫生—眼科]