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14 d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、睑结膜乳头及干眼症状评分均明显低于对照组，差异均有统计学意义(均 P<0. 05)；治疗后28 d，试验组SⅠt值明显高于对照组，差异有统计学意义( t＝9. 732， P＝0. 002)。治疗后28 d，试验组患者最佳矫正视力(BCVA)较治疗前提高，差异有统计学意义( t＝–3. 687， P＝0. 000)，但对照组与治疗前比较差异无统计学意义( t＝–1. 383， P＝0. 167)。治疗期间2个组均有少数患者出现轻度眼部刺激症状，组间差异无统计学意义( P>0. 05)。
结论普拉洛芬具有抑制干眼炎症的作用，0. 1%普拉洛芬滴眼液与0. 1%玻璃酸钠滴眼液联合应用能有效改善干眼症状症状及体征，对有眼表炎症及上皮细胞损伤的轻中度干眼患者作用更为明显。
BackgroundNonsteroidal anti-inflammatory drugs are widely used in the treatment of dry eye, but the related multicenter clinical study is lack.
ObjectiveThis study aimed to evaluate the clinic efficacy of pranoprofen eye drops for dry eye.
MethodsThis 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 break-up 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 (SⅠt). The best corrected visual acuity (BCVA) and adverse response were compared between the two groups.
ResultsThe 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 treatment compared with before treatment in the trial group (4. 88±2. 40)seconds and (6. 03±3. 25) seconds versus (3. 47±2. 10) seconds ( t=-13. 358, -17. 734, both at P=0. 000), and so were the control group ([4. 62±2. 21] seconds and [5. 42±2. 70] seconds versus [3. 50±1. 52] seconds [ t=-13. 984, t=-17. 879, both at P=0. 000]). The BUT was longer in the trial group compared with the control group in 28 days after treatment ( t=10. 483, P=0. 001). In addition, the scores of dry eye symptom, palpebral conjunctiva congestion and papilla were significantly lower in the trial group than those in the control group in post-treated 14 and 28 days (all at P<0. 05). SⅠt was remarkably elevated and BCVA was considerably improved in the trial group compared with the control group in 28 days ( t=9. 732, P=0. 002; t=-3. 687, P=0. 000). No significant difference was seen in the number of eyes with adverse response between the two groups ( P>0. 05).
ConclusionsPranoprofen has a better anti-inflammatory effect on dry eye. The combination of 0. 1% pranoprofe dry drops with 0. 1% sodium hyaluronate eye drops can relieve dry eye symptoms and signs very well, especially in mild and moderate dry eye patients.
陈景尧,谢立信,刘祖国,等. 普拉洛芬治疗轻中度干眼的多中心随机对照临床试验[J]. 中华实验眼科杂志,2015,33(9)：834-839.
DOI:10.3760/cma.j.issn.2095-0160.2015.09.015版权归中华医学会所有。
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参加临床试验的单位(58所医院)：山东省眼科研究所；厦门大学附属厦门眼科中心；山东中医药大学附属眼科医院；温州医科大学附属眼视光医院；苏州大学附属第一医院；四川大学华西医院；北京大学深圳医院；浙江大学医学院附属第一医院；北京大学眼科中心；中国人民解放军总医院；吉林大学第一医院；本溪市中心医院；山西省眼科医院；解放军第四七四医院；北京医院；安徽医科大学第一附属医院眼科；广州中山三院；首都医科大学宣武医院；山东省临沂市人民医院；中国医科大学附属第一医院；哈尔滨二四二医院；四川省人民医院；大连医科大学附属第二医院；天津眼科医院；唐山市眼科医院；中南大学湘雅医院；汕头国际眼科中心；邯郸市眼科医院；深圳市第二人民医院；吉林大学第二医院；江苏省人民医院；无锡市第二人民医院；北京市眼科研究所；沈阳市第四人民医院；潍坊医学院附属医院；河南省眼科研究所河南省立眼科医院；南京市第一医院；西安市第一医院；大连医科大学附属第一医院；第三军医大学西南眼科医院；中医科学院眼科医院；上海新华医院；北京大学第一医院；武汉大学人民医院；深圳市眼科医院；浙江大学医学院附属第二医院眼科中心；中山大学中山眼科中心；华中科技大学同济医学院附属同济医院；大连医科大学附属第三医院；哈尔滨医科大学附属第一医院；武汉协和医院眼科；山东省济南市眼科医院；青岛大学医学院附属医院眼科；天津医科大学眼科中心；贵州医学院附属医院；宁波市眼科医院；嘉兴市中医院；郑州大学第一附属医院
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