叶黄素软胶囊缓解视疲劳功能研究

Study on the Function of Lutein Soft Capsules in Relieving Visual Fatigue

目的:研究以蓝莓提取物、叶黄素酯和天然β-胡萝卜素为主要原料制得的叶黄素软胶囊缓解视疲劳的功效。方法:选取106例受试者,按随机双盲法分为试验组和对照组,以症状总积分、总有效率、明视持久度等为功效评价指标,血、尿常规检查,肝、肾功能及血糖检查,腹部B超,心电图等为安全评价指标,研究叶黄素软胶囊缓解视疲劳的功效和安全性。结果:试验组试食前后比较,症状总积分、明视持久度有显著差异(P<0.01),平均明视持久度提高11.32%,左、右眼视力无显著差异(P>0.05)。试验后两组间比较,症状总积分、症状改善有效率、左眼视力改善有效率有显著差异(P<0.05),明视持久度有显著差异(P<0.01),平均明视持久度提高13.46%。对照组和试验组试验前后未见不良反应,各项安全性指标均未见异常。结论:叶黄素软胶囊对人体具有缓解视疲劳功能且对肌体健康无不良影响。

Objective:To study the efficacy of lutein soft capsules prepared from blueberry extract,lutein ester and natural β-carotene as the main raw materials for relieving visual fatigue.Method:A total of 106 subjects were selected and randomly divided into a test group and a control group according to the double-blind method.Taking the total symptom score,total effective rate,and persistence of vision as efficacy evaluation indicators,blood and urine routine examination,liver and kidney function and blood glucose examination,abdominal B-ultrasound,electrocardiogram,etc.are safety evaluation indicators,to study the efficacy and safety of lutein soft capsules in relieving visual fatigue.Result:There were significant differences in the total score of symptoms and the persistence of visual acuity (P<0.01) before and after the experiment in the trial group,and the average persistence of visual acuity increased by 11.32%,and no significant difference in left and right visual acuity(P>0.05).After the test,there were significant differences in the total score of symptoms,the effective rate of symptom improvement,and the effective rate of left visual acuity improvement (P<0.05).There was a significant difference in the persistence of visual acuity (P<0.01),and the average persistence of visual acuity increased by 13.46%.There were no adverse reactions before and after the test in the control group and the test group,and no abnormality was found in various safety indicators.Conclusion:Lutein soft capsules have the function of relieving visual fatigue and no adverse effect on human health.