七叶洋地黄双苷滴眼液治疗LASIK术后视疲劳的有效性和安全性

摘要

目的 评估七叶洋地黄双苷滴眼液在准分子激光原位角膜磨镶术(LASIK)后视疲劳患者中的治疗作用,评价其临床有效性和安全性.方法 这是一项前瞻性的开放性、多中心、随机对照研究.上海复旦大学附属眼耳鼻喉科医院等7家医院多中心联合开展临床研究.选取2008年7月至2009年1月就诊的LASIK手术患者.采用随机数字表法将患者随机分入对照组和治疗组,对照组常规用药,治疗组在给予对照组相同治疗药物的基础上,从术后第1天开始增加使用七叶洋地黄双苷滴眼液.术后第1、第2、第4周复诊,评价指标包括主觉症状、裸眼视力、屈光度、调节幅度、调节滞后量、调节灵敏度和正/负相对调节.符合入选标准患者共195例,其中男88例,女107例,平均年龄为(25.4±5.9)岁.对照组86例,治疗组109例.对所得数据采用嵌套模型的方差分析进行统计学处理.结果 对视疲劳主觉症状分析提示,LASIK术后使用七叶洋地黄双苷滴眼液可改善阅读时字体变模糊(F=4.099,P＜0.05)及近距离工作后头痛或恶心症状(F=4.344,P＜0.05).治疗组术后调节灵敏度改善较对照组明显,差异有统计学意义(左眼:F=5.895,P＜0.05;右眼:F=7.440,P＜0.05;双眼:F=5.323,P＜0.05).治疗组术后负相对调节改善较对照组明显,差异有统计学意义(F=5.561,P＜0.05).结论 七叶洋地黄双苷滴眼液对LASIK术后主观不适症状、调节灵敏度、负相对调节有明显改善作用.七叶洋地黄双苷滴眼液治疗LASIK术后早期视疲劳安全、有效.%Objective To evaluate the clinical effect and safety of esculin and digitalisglycosides eye drops in patients with asthenopia after laser in situ keratomileusis (LASIK) surgery.Methods This was an open,multicenter,random and antithetical prospective clinical trial. Post-LASIK surgery patients were chosen from seven hospitals across China from July 2008 to January 2009.Some patients received esculin and digitalisglycosides eye drops and others served as controls. Symptoms of asthenopia,uncorrected visual acuity (UCVA),refraction,amplitude of accommodation,lag of accommodation,accommodative sensitivity and positiveegative relative accommodation were compared between the two groups at different time points.A total of 195 patients (88 males and 107 females) were included in the study with a mean age of (25.4±5.9)years.Among the 195 patients,109 were in the treatment group and 86 were in the control group.Data were analyzed using a nested ANOVA.Results Blurred vision after reading (F=4.099,P＜0.05) and headache or sickness following near work (F=4.344,P＜0.05) improved in the treatment group compared to the control group.Accommodative sensitivity (left eye:F=5.895,P＜0.05;right eye:F=7.440,P＜0.05;both eyes:F=5.323,P＜0.05) and negative relative accommodation (F=5.561,P＜0.05) were also better in the treatment group.Conclusion Esculin and digitalisglycosides eye drops can significantly alleviate the symptoms of asthenopia in patients following LASIK surgery.It can also improve the accommodative sensitivity and negative relative accommodation in post-LASIK surgery patients.