两种荧光素钠眼科检测试纸诊断角膜病变的随机对照临床试验

Randomized controlled trial of two kinds of fluorescein sodium ophthalmic strip in the diagnosis of corneal Injury

目的通过与成品荧光素钠眼科检测试纸的比较,评价一种新的荧光素钠眼科检测试纸的有效性、舒适性和安全性。方法采用随机、交叉配对临床设计,招募在安徽医科大学第二附属医院眼科门诊就诊的84例(168只眼)角膜病患者,每一位受试者按照随机顺序,先后接受试验组或对照组试纸检测,分别观察、记录患者检查结果,包括有效性(染色分级、染色位置)、受试者舒适性(染色剂接触角膜后刺激性评分)、安全性(染色前后结膜充血及角膜水肿变化),采用加权Kappa统计值评价两种试纸检查结果的一致性,并对两种试纸的舒适度评分进行比较。总结不良事件的发生情况,包括球结膜充血、角膜水肿等。结果此研究实际入选84例(168只眼),其中角膜损伤0、1、2、3、4级角膜损伤人数分别为19、16、17、17、15人(受试者染色分级依据损伤级别高眼别确定),眼数分别为91、22、23、17、15只眼。试验组和对照组试纸染色分级、染色位置一致性好(Kappa=0. 973、0. 989,P <0. 01),舒适度实验组优于对照组,差异性有统计学意义((P <0. 05),两种试纸染色前与染色后球结膜充血及角膜水肿无变化,没有严重不良事件出现。结论实验组荧光素钠眼科检测试纸与国内已上市同类产品相比对角膜结构损伤检查的有效性和安全性相当,且舒适度更高。

Objective To evaluate the effectiveness,comfort and safety of a new kind of fluorescein sodium ophthalmic strip in the diagnosis of corneal injury by comparing with the gold standard fluorescein sodium ophthalmic strip.Methods This study protocol followed the Declaration of Helsinki,and oral informed consent was obtained from each patient prior to entering the study.A randomized,cross-matched clinical trial was conducted.A total of 84 patients with corneal disease were enrolled from the outpatient service at the Second Affiliated Hospital of Anhui Medical University from November 2017 to December 2017.Each subject received test strips of the test group and control group in a random order.Effectiveness(corneal fluorescence staining grading,position),comfort(comfort score after cornea contacting with the stain),security(conjunctival congestion and corneal edema severity)were assessed and recorded.Weighted kappa values were used to assess the consistency of the two tests.We also compared the comfort score and incidence of adverse events(ie.conjunctiva congestion,corneal edema)in the two groups.Results 84 cases(168 eyes)were enrolled in the study,among whom 19,16,17,17 and 15 cases were classified as having grade 0,1,2,3 and 4 corneal injuries(determined based on the eye with higher degree of injury),and the number of eyes were 91,22,23,17 and 15,respectively.The consistency was excellent for corneal fluorescence staining grading and position(Kappa=0.973 and 0.989,P<0.01).The degree of comfort was higher in the test group than the control group(P<0.05).There was no difference in the pre-and post-staining conjunctival congestion or corneal edema severity between the two groups,and no serious adverse event was observed.Conclusions The fluorescein sodium ophthalmic test strip in the test group has similar effectiveness and safety in the diagnosis of corneal injury and higher comfort degree,as compared with the test strip already on the market.