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.
揹景 非甾體類抗炎藥廣汎應用于榦眼的治療,但缺乏相關的多中心的臨床研究. 目的 觀察非甾體類抗炎藥普拉洛芬治療榦眼的臨床療效.方法 採取多中心、隨機開放的臨床對照試驗方法,于2011年7月至2012年7月在中國58箇臨床研究分中心按照統一的診斷標準納入1 023例榦眼患者,每箇中心20例.按照隨機數字錶法將患者分為試驗組和對照組,試驗組患者使用質量分數0.1%普拉洛芬滴眼液點眼聯閤質量分數0.1%玻璃痠鈉滴眼液點眼,均為每日4次,每次1滴;對照組患者僅使用0.1%玻璃痠鈉滴眼液點眼,每日4次,每次1滴.在患者治療前、治療第14天及第28天時進行複查,主要療效評價指標包括角膜熒光素染色及淚膜破裂時間(BUT),次要療效指標包括榦眼癥狀評分、瞼結膜充血程度、瞼結膜乳頭評分及淚液分泌試驗Ⅰ (SⅠt),併評價2箇組患者的藥物不良反應. 結果 2箇組間患者治療前人口基線特徵比較差異均無統計學意義(均P>0.05).治療後14 d和28 d,試驗組角膜熒光素染色評分分彆為0.76±0.66和0.35±0.54,對照組分彆為0.84±0.65和0.45 ±0.60,均明顯低于術前試驗組的1.41 ±0.58和對照組的1.41±0.62,差異均有統計學意義(試驗組:t=24.439、37.236,均P=0.000;對照組:t=19.702、29.517,P=0.000),治療後28 d試驗組角膜熒光素染色評分明顯低于對照組,差異有統計學意義(t=8.384,P=0.004).治療後14 d和28 d,試驗組BUT分彆為(4.88±2.40)s和(6.03±3.25)s,較治療前的(3.47±2.10)s均明顯延長,差異均有統計學意義(t=-13.358、-17.734,均P=0.000);治療後14d和28 d,對照組BUT分彆為(4.62±2.21)s和(5.42±2.70)s,明顯長于治療前的(3.50±1.52)s,差異均有統計學意義(t=-13.984、-17.879,均P=0.000),治療後28 d,試驗組BUT明顯長于對照組,差異有統計學意義(t=10.483,P=0.001).治療後14 d和28 d,試驗組患者瞼結膜充血、瞼結膜乳頭及榦眼癥狀評分均明顯低于對照組,差異均有統計學意義(均P<0.05);治療後28 d,試驗組SⅠt值明顯高于對照組,差異有統計學意義(t=9.732,P=0.002).治療後28 d,試驗組患者最佳矯正視力(BCVA)較治療前提高,差異有統計學意義(t=-3.687,P=0.000),但對照組與治療前比較差異無統計學意義(t=-1.383,P=0.167).治療期間2箇組均有少數患者齣現輕度眼部刺激癥狀,組間差異無統計學意義(P>0.05). 結論 普拉洛芬具有抑製榦眼炎癥的作用,0.1%普拉洛芬滴眼液與0.1%玻璃痠鈉滴眼液聯閤應用能有效改善榦眼癥狀癥狀及體徵,對有眼錶炎癥及上皮細胞損傷的輕中度榦眼患者作用更為明顯.
배경 비치체류항염약엄범응용우간안적치료,단결핍상관적다중심적림상연구. 목적 관찰비치체류항염약보랍락분치료간안적림상료효.방법 채취다중심、수궤개방적림상대조시험방법,우2011년7월지2012년7월재중국58개림상연구분중심안조통일적진단표준납입1 023례간안환자,매개중심20례.안조수궤수자표법장환자분위시험조화대조조,시험조환자사용질량분수0.1%보랍락분적안액점안연합질량분수0.1%파리산납적안액점안,균위매일4차,매차1적;대조조환자부사용0.1%파리산납적안액점안,매일4차,매차1적.재환자치료전、치료제14천급제28천시진행복사,주요료효평개지표포괄각막형광소염색급루막파렬시간(BUT),차요료효지표포괄간안증상평분、검결막충혈정도、검결막유두평분급루액분비시험Ⅰ (SⅠt),병평개2개조환자적약물불량반응. 결과 2개조간환자치료전인구기선특정비교차이균무통계학의의(균P>0.05).치료후14 d화28 d,시험조각막형광소염색평분분별위0.76±0.66화0.35±0.54,대조조분별위0.84±0.65화0.45 ±0.60,균명현저우술전시험조적1.41 ±0.58화대조조적1.41±0.62,차이균유통계학의의(시험조:t=24.439、37.236,균P=0.000;대조조:t=19.702、29.517,P=0.000),치료후28 d시험조각막형광소염색평분명현저우대조조,차이유통계학의의(t=8.384,P=0.004).치료후14 d화28 d,시험조BUT분별위(4.88±2.40)s화(6.03±3.25)s,교치료전적(3.47±2.10)s균명현연장,차이균유통계학의의(t=-13.358、-17.734,균P=0.000);치료후14d화28 d,대조조BUT분별위(4.62±2.21)s화(5.42±2.70)s,명현장우치료전적(3.50±1.52)s,차이균유통계학의의(t=-13.984、-17.879,균P=0.000),치료후28 d,시험조BUT명현장우대조조,차이유통계학의의(t=10.483,P=0.001).치료후14 d화28 d,시험조환자검결막충혈、검결막유두급간안증상평분균명현저우대조조,차이균유통계학의의(균P<0.05);치료후28 d,시험조SⅠt치명현고우대조조,차이유통계학의의(t=9.732,P=0.002).치료후28 d,시험조환자최가교정시력(BCVA)교치료전제고,차이유통계학의의(t=-3.687,P=0.000),단대조조여치료전비교차이무통계학의의(t=-1.383,P=0.167).치료기간2개조균유소수환자출현경도안부자격증상,조간차이무통계학의의(P>0.05). 결론 보랍락분구유억제간안염증적작용,0.1%보랍락분적안액여0.1%파리산납적안액연합응용능유효개선간안증상증상급체정,대유안표염증급상피세포손상적경중도간안환자작용경위명현.
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 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).S Ⅰ t 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).Conclusions Pranoprofen 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.