聚乙二醇联合普拉洛芬滴眼液对干燥综合征患者干眼的随机单盲对照研究

Efficacy of polyethylene glycol combined with pranoprofen drops on dry eye in patients with Sjogren＇s syndrome and effect in content of interleukin-6 and tumor necrosis factor-α in tears

目的 探讨普拉洛芬滴眼液对pSS患者干眼的疗效及泪液中IL-6、TNF-α含量的变化.方法 采用前瞻性研究.在山西省汾阳医院风湿免疫科住院并确诊为pSS的68例患者,按随机数字表法分为试验组和对照组,均取右眼为试验眼,每组各34例34眼.试验组给予普拉洛芬滴眼液联合聚乙二醇滴眼液治疗;对照组仅使用聚乙二醇滴眼液.分别于治疗前和治疗后1、2、4周在同一时间由同一人行角膜荧光素染色（FL）、泪膜破裂时间（BUT）及基础泪液分泌试验（SIT）检测,收集泪液,用ELISA检测IL-6和TNF-α含量,并分别进行t检验、重复测量的方差分析.结果 试验组治疗前和治疗后1、2、4周相比,FL、BUT、SIT及泪液中IL-6和TNF-α含量差异均有统计学意义（F=4.65,7.53,6.43,9.96,10.87;P＜0.05）;对照组治疗前和治疗后1、2、4周相比,FL、BUT、SIT及泪液中IL-6和TNF-α含量差异均有统计学意义（F=3.27,5.85,4.36,8.36,7.23;P＜0.05）;2组间BUT、SIT治疗前和治疗后1周差异均无统计学意义（P＞0.05）,治疗后2周[BUT：试验组为（11.1±2.5）s,对照组为（9.7±1.9）s,t=2.594 8,P＜0.05;SIT：试验组为（7.3±1.7） mm,对照组为（5.9±1.7） mm,t=3.571 8,P＜0.05]、4周[BUT：试验组为（14.4±2.8）s,对照组为（11.4±2.6）s,t=4.469 4,P＜0.05; SIT：试验组为（9.9±2.1） mm,对照组为（8.7±1.9） mm,t=2.568 0,P＜0.05]差异均有统计学意义;2组间FL及泪液中IL-6和TNF-α在治疗前差异无统计学意义（P＞0.05）,治疗后1、2、4周差异均有统计学意义（tFL=4.173 9,3.190 7,4.072 6;tIL-6=2.131 5,2.316 4,5.310 1;tINF-α=2.216 4,4.871 9,8.175 0;P＜0.05）;2组均未见明显用药后不适感与不良反应.结论 普拉洛芬滴眼液联合聚乙二 醇滴眼液可明显改善pSS患者干眼的症状,可能与其能抑制眼表的炎性因子IL-6和TNF-α的表达从而减轻眼表炎症反应有关.

Objective To investigate the efficacy of pranoprofen drops on dry eye of patients with Sjogren＆#39;s syndrome （SS）.Methods This is a prospective study.Sixty-eight inpatients with dry eye in our hospital were randomly divided into the experimental and control groups.Right eyes were taken for the trial,with 34 cases in each group.The experimental group was given pranoprofen eye drops combined with polyethylene glycol eye drops.Eyes of the control group were given polyethylene glycol drops only.Corneal fluorescein staining （FL）,tear film breakup time （BUT） and Schirmer test （SIT） were tested before treatment and 1,2,4 weeks after treatment by the same care giver.The levels of IL-6 and TNF-α in tears were detected by ELISA.Analysis of variance of repeated data and t test were used for statistical analysis.Results The difference of FL,BUT,SIT and content IL-6 and TNF-α in tears in the experimental group patients before treatment and 1,2,4 weeks after treatment were signifcant （F=4.65,7.53,6.43,9.96,10.87; P〈0.05）,which were statistically significantly different between the experimental group and the control group patients （F=3.27,5.85,4.36,8.36,7.23; P〈0.05）.One week after treatment and before treatment,the difference of BUT and SIT of the two groups was not statistically significant （P〉0.05）,those of the 2 weeks after treatment were statistically significantly different [BUT of the experimental group was （11.1±2.5） s,BUT of the control group was （9.7±1.9） s,t=2.594 8,P〈0.05; the SIT of the experimental group was （7.3±1.7） mm,the SIT of the control group was （5.9±1.7） mm,t=3.571 8,P〈0.05].BUT of the two groups at 4 weeks after treatment was statistically significantly different [BUT of the experimental group was （14.4±2.8） s,BUT of the control group was （11.4±2.6） s,t=4.469 4,P〈0.05; the SIT of the experimental group was （9.9±2.1） mm,the SIT of the control group was （8.7±1.9） mm,t=2.568 0,P〈0.05].The difference of FL and IL-6 and TNF-α in tears pretreatment between the two groups was not statistically significant （P〉0.05）.At week 1,2,4 after treatment,the differences between the two groups were statistically significant （tFL=4.173 9,3.190 7,4.072 6; tIL-6=2.131 5,2.316 4,5.310 1; tTNF-α=2.216 4,4.871 9,8.175 0; P〈0.05）.No significant discomfort and side effects were observed in the two groups.Conclusion Pranoprofen drops can significantly improve symptoms of dry eye in patients with pSS,in particular,the repair of the cornea,may be related to the inhibition of the expression of ocular inflammatory cytokines IL-6 and TNF-α,and thus reduce the ocular surface inflammatory reaction.