目的 观察局部使用0.5%氯替泼诺滴眼液在治疗中度干眼病的安全性与疗效.方法 2009年3月至2010年9月我院门诊按照国际干眼症研究组(DEWS)标准分级为2及3级干眼病患者34例(68只眼),按级分层后随机分为两组:实验组38只眼(氯替泼诺组)、对照组30只眼(环孢素A组),分别予以0.5%氯替泼诺滴眼液或1%环孢素A滴眼液(2次/d)以及0.2%卡波姆眼用凝胶(4~6次/d)治疗.在治疗前及治疗后2、4、6、8周观察患者的自觉症状、角膜荧光素染色(FL)、眼表炎症体征、泪膜破裂时间BUT、Schirmer Ⅰ试验(SⅠt)及眼压,并在治疗前及治疗后第8周行结膜印迹细胞检测.各项指标比较采用x2检验和t检验.结果 治疗2周后,氯替泼诺组与环孢素A组患者症状评分均值明显降低(14.7±3.4、21.9 ±5.2),较治疗前(37.2±5.6、35.8±6.7)差异有统计学意义(t=5.36,3.63; P<0.01).治疗4周后两组眼表炎症体征均减轻,FL评分均值为4.5±1.6和4.8±1.7、较治疗前(6.9±3.2、7.6±2.4)明显降低.治疗8周后氯替泼诺组与环孢霉素组的杯状细胞平均密度分别由(181.2±16.1)和(179.4±17.5)个/mm2增至(348.6±22.5)和(360.4±27.8)个/mm2,平均BUT均较治疗前延长(t=16.9,16.3;P <0.05).两组各时间点的SⅠt及NCT均值无明显变化,差异无统计学意义(t =0.76,P>0.05).结论 局部使用0.5%氯替泼诺滴眼液治疗干眼病安全有效.
Objective To observe the efficacy and safety of 0.5% Loteprednol Etabonate ophthalmic suspension in the treatment of moderate dry eye.Methods Totally 34 dry eye patients (68 eyes) in grade 2 or grade 3 (DEWS standard) enrolled in our hospital from March 2009 to September 2010 were randomly divided into two groups:the experimental group ( Loteprednol Etabonate Group) and the control group (Cyclosporine A,CsA group).0.5% Loteprednol Etabonate ophthalmic suspension or 1% CsA eye drops was applied 2 times a day respectively together with 0.2% Liposic eye drops (4-6 times/day).Questionnaire was used in these patients before the treatment and repeated every 2 weeks during the treatment till 8 weeks.Slit lamp microscope examination,fluorescent staining,tear break-up time ( BUT),Schirmer Ⅰ test ( S Ⅰ t) and intraocular pressure measurement were carried out at the same time point.The conjunctival impression cytology (IC) was performed before the treatment and 8 weeks after the treatment.The mean of the results were compared by t-tests and x2 test.Results After 2 weeks of the treatment,the mean score of the questionnaire was significantly lower than that before the treatment in each group ( t =5.36,3.63,P 〈0.01 ).After 4 weeks of the treatment,the inflammation of the ocular surface was relieved obviously in both group and the mean score of the corneal fluorescein staining (FL) was lower than that before the treatment in each group.The average density of the goblet cells before the treatment was ( 181.2± 16.1 )/mm2 and (179.4 ± 17.5 )/mm2 in each group respectively.After 8 weeks of the treatment,this increased to (348.6 ± 22.5 )/mm2 and ( 360.4 ± 27.8 )/mm2 significantly ( t =16.9,16.3,P 〈 0.05 ).BUT was significantly prolonged in each group after the treatment ( P 〈 0.01 ).There was no significant change in ST Ⅰ or NCT in each group (P 〉 0.05 ).Conclusions Topical 0.5% Loteprednol Etabonate ophthalmic suspension is safe and effective fo