七叶洋地黄双苷滴眼液治疗屈光性视疲劳有效性和安全性的临床研究

The clinical efficacy and safety study of Esculin and Digitalisglycosides Eye Drops in treating ametropic asthenopia

目的 研究七叶洋地黄双苷滴眼液在屈光性视疲劳患者中应用的临床有效性和安全性研究.方法 上海复旦大学附属眼耳鼻喉科医院等11家医院多中心联合开展临床研究.选取2008年7月至2009年1月在全国11家医院就诊的属光性视疲劳患者,使用七叶洋地黄双苷滴眼液点眼4周,在治疗前、治疗后1周及治疗后4周分别评估患者主觉症状、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进行观察,对所得数据采用方差分析进行统计学比较.结果 七叶洋地黄双苷滴眼液使用4周疗程,可明显减轻患者的各项主觉症状（F=353.30,P＜0.05）.治疗前、治疗1周和冶疗4周,左眼裸眼视力分别为4.51±0.50、4.52±0.50和4.54±0.49（F=23.39,P＜0.05）,右眼分别为4.50±0.52、4.50±0.53和4.51±0.52（F=15.62,P＜0.05）;左眼屈光度数分别为（-2.03±2.84）、（-1.98±2.82）和（-2.03±2.84）D（F=10.34,P＜0.05）,右眼分别为（-2.16±3.00）、（-2.13±3.00）和（-2.10±3.00）D（F=17.13,P＜0.05）;双眼调节幅度分别为（6.60±4.19）、（6.86±4.57）和（7.22±4.76）D（F=13.86,P＜0.05）;调节滞后量分别为（0.57±0.81）、（0.51±0.72）和（0.46±0.67）D（F=14.89,P＜0.05）;双眼调节灵敏度分别为（9.12±5.40）、（10.68±6.20）和（11.57±6.37）D（F=82.74,P＜0.05）.所有受试者均未发生不良反应,安全性指标检查无异常.结论 七叶洋地黄双苷滴眼液对屈光性视疲劳主觉症状及客观调节指标都有明显改善作用,其治疗屈光性视疲劳安全、有效.

Objective To study the clinical efficacy and safety of the Esculin and Digitalisglycosides Eye Drops used in the patients of ametropic asthenopia. Methods Multicenter clinical trial. Asthenopia patients were chosen from eleven hospitals cross China from July, 2008 to January, 2009.The experiment was conducted asthenopia patients who used the Esculin and Digitalisglycosides Eye Drops for 4 weeks continuously. Symptoms of asthenopia, UCVA （uncorrected vision acuity ）, refraction,amplitude of accommodation, accommodative lag, accommodative sensitivity and positive/negative relative accommodation were measured at different time points, such as treated before, 1 week and 4 week in treated after. Results After the 4-week＇s use of Esculin and Digitalisglycosides Eye Drops, each subjective symptom of the patients was decreased significantly （ F = 353.30, P 〈 0. 05 ）. In addition, most of the objective exams of accommodation ability were significantly improved, such as UCVA （ left eye： F = 23. 39,P 〈 0. 05; right eye： F = 15.62, P 〈 0. 05 ）, refraction （ left eye： F = 10. 34, P 〈 0. 05; right eye： F =17. 13 ,P 〈 0. 05 ）, amplitude of accommodation （ left eye： F = 14.46, P 〈 0. 05; right eye： F = 8. 29, P 〈0. 05 ;eyes： F = 13.86, P 〈 0. 05 ）, accommodative lag （ F = 14. 89, P 〈 0. 05 ） and accommodative sensitivity （ left eye： F = 62. 67, P 〈 0. 05; right eye： F = 68. 77, P 〈 0. 05; eyes： F = 82.74, P 〈 0. 05 ）.And no patient appeared any adverse reaction in whole experiment. Conclusions Esculin and Digitalisglycosides Eye Drops is effective and safety for use in the patients of ametropia asthenopia.