普拉洛芬治疗轻中度干眼的多中心随机对照临床试验  

Clinical effect of pranoprofen eye drops for mild and moderate dry eye-a multicenter, randomized,controlled clinical trial

作　　者：陈景尧[1] 谢立信[2] 刘祖国[1] 毕宏生[1] 陈蔚[1] 戴三友[1] 邓应平[1] 傅培[1] 顾扬顺[1] 洪晶[1] 黄一飞[1] 贾卉[1] 蒋莉[1] 李冰[1] 李林[1] 李明顺[1] 廖荣丰[1] 凌士奇[1] 刘大川[1] 刘方毅[1] 刘汉强[1] 刘红[1] 刘治蓉[1] 刘子雁[1] 马林[1] 秦洪仁 荣军博[1] 邵运良[1] 申育华[1] 司马晶[1] 苏冠芳[1] 孙红[1] 孙松[1] 孙旭光[1] 王海林[1] 王杰[1] 王丽娅[1] 王林农[1] 吴洁[1] 吴群[1] 谢汉平[1] 谢立科[1] 徐巍华[1] 晏晓明[1] 杨燕宁[1] 姚晓明[1] 叶娟[1] 袁进[1] 张虹[1] 张立军[1] 张丽琼[1] 张明昌[1] 张玉环[1] 赵桂秋 赵少贞[1] 郑金华[1] 周宏健[1] 朱永唯[1] 朱豫钟[1] 桃玲珑[1] 

机构地区：[1]厦门大学眼科研究所附属厦门眼科中心福建省眼科与视觉科学重点实验室,361001 [2]山东省眼科研究所,青岛266071

出　　处：《中华实验眼科杂志》2015年第9期834-839,共6页Chinese Journal Of Experimental Ophthalmology

基　　金：卫生行业科研专项项目（201302015）

摘　　要：背景 非甾体类抗炎药广泛应用于干眼的治疗,但缺乏相关的多中心的临床研究. 目的 观察非甾体类抗炎药普拉洛芬治疗干眼的临床疗效.方法 采取多中心、随机开放的临床对照试验方法,于2011年7月至2012年7月在中国58个临床研究分中心按照统一的诊断标准纳入1 023例干眼患者,每个中心20例.按照随机数字表法将患者分为试验组和对照组,试验组患者使用质量分数0.1％普拉洛芬滴眼液点眼联合质量分数0.1％玻璃酸钠滴眼液点眼,均为每日4次,每次1滴;对照组患者仅使用0.1％玻璃酸钠滴眼液点眼,每日4次,每次1滴.在患者治疗前、治疗第14天及第28天时进行复查,主要疗效评价指标包括角膜荧光素染色及泪膜破裂时间（BUT）,次要疗效指标包括干眼症状评分、睑结膜充血程度、睑结膜乳头评分及泪液分泌试验Ⅰ （SⅠt）,并评价2个组患者的药物不良反应. 结果 2个组间患者治疗前人口基线特征比较差异均无统计学意义（均P＞0.05）.治疗后14 d和28 d,试验组角膜荧光素染色评分分别为0.76±0.66和0.35±0.54,对照组分别为0.84±0.65和0.45 ±0.60,均明显低于术前试验组的1.41 ±0.58和对照组的1.41±0.62,差异均有统计学意义（试验组：t=24.439、37.236,均P=0.000;对照组：t=19.702、29.517,P=0.000）,治疗后28 d试验组角膜荧光素染色评分明显低于对照组,差异有统计学意义（t=8.384,P=0.004）.治疗后14 d和28 d,试验组BUT分别为（4.88±2.40）s和（6.03±3.25）s,较治疗前的（3.47±2.10）s均明显延长,差异均有统计学意义（t=-13.358、-17.734,均P=0.000）;治疗后14d和28 d,对照组BUT分别为（4.62±2.21）s和（5.42±2.70）s,明显长于治疗前的（3.50±1.52）s,差异均有统计学意义（t=-13.984、-17.879,均P=0.000）,治疗后28 d,试验组BUT明显长于对照组,差异有统计学意义（t=10.483,P=0.001）.治疗后14 d和28 d,试验组患者睑结膜充血、睑结膜Background Nonsteroidal anti-inflammatory drugs are widely used in the treatment of dry eye,but the related multicenter clinical study is lack.Objective This study aimed to evaluate the clinic efficacy of pranoprofen eye drops for dry eye.Methods This study protocol followed the Declaration of Helsinki,and oral informed consent was obtained from each patient prior to entering the cohort.A randomized,open,parallel,controlled,multi-center clinical trial was conducted.Total 1 023 patients with dry eye were enrolled based on the same diagnosis criteria in 58 eye institutes of China from July 2011 to July 2012.The patients was randomized into trial group and control group.The combination of 0.1% pranoprofe dry drops （4 times per day） with 0.1% sodium hyaluronate eye drops （4 times per day） was used in the trial group,and only 0.1% sodium hyaluronate eye drops was used in the same way in the control group.The primary evaluated indexes included corneal fluorescence staining scores and breakup time of tear film （BUT）,and secondary outcome measurements were the dry eye symptom scores and palpebral conjunctiva congestion and papilla scores as well as Shirmer Ⅰ test （S Ⅰ t）.The best corrected visual acuity （BCVA） and adverse response were compared between the two groups.Results The demography was matched between the two groups （both at P〉0.05）.The corneal fluorescence staining scores were 0.76±0.66 and 0.35±0.54 in 14 days and 28 days after treatment in the trial group,which were lower than 1.41 ±0.58 before treatment （t =24.439,37.236,both at P =0.000）;those in the control group were 0.84 ±0.65 and 0.45 ±0.60 in 14 and 28 days after treatment,with significant reduce in comparison with before treatment （1.41 ±0.62） （t =19.702,29.517,both at P =0.000）.The corneal fluorescence staining score was significantly lower in the trial group compared with the control group in 28 days after treatment （t=8.384,P=0.004）.The BUT was significantly delayed in 14 and 28 days after treatmen

关 键 词：干眼 非甾体类抗炎药 普拉洛芬 炎症 

分 类 号：R777.34[医药卫生—眼科]