叶黄素对缓解视疲劳人体试食功能试验的研究  

Experimental Study of Lutein in Health Food on Alleviating Eye-Fatigue

作　　者：刘霁[1] 白鸿[1] 夏立营[2] 

机构地区：[1]国家食品药品监督管理局保健食品审评中心,北京100070 [2]中国中医科学院西苑医院

出　　处：《中国药事》2012年第8期902-905,共4页Chinese Pharmaceutical Affairs

摘　　要：目的在对已批准注册缓解视疲劳保健食品叶黄素的应用情况进行分析的基础上,进一步开展人体试食功能试验,以探讨单一食用一定剂量叶黄素对视疲劳的缓解作用。方法采用随机双盲法,将120名视力易疲劳的受试者分为试食组和安慰剂对照组,每组各60人,试食组服用叶黄素片,对照组服用安慰剂,均为每日1次,每次1片(10mg),服用时间为30d。进行下列检查:体征观察、安全性检查、眼科常规检查、眼部自觉症状检查、明视持久度测定、视力检查。结果试食组视疲劳感明显减轻,明视持久度平均提高21.90%,总有效率为62.00%,症状积分减少2.66±1.44;对照组明视持久度平均提高0.25%,总有效率为14.00%,症状积分减少1.30±1.16。试食前后试食组自身比较及组间比较经统计学处理有显著性差异;与对照组比较,试食组受试者视物模糊、眼干涩、眼胀、眼痛、畏光等症状有改善。结论每日食用10mg叶黄素对视力易疲劳者安全、有效。Objective To further study the function of lutein of a certain dose for alleviating eye- fatigue by human experiment on the basis of analyzing the application of lutein in health food for alleviating eye-fatigue. Methods A total of 120 subjects with eye-fatigue were divided into test group and placebo control group （n=60, each group） by the randomized double-blind method. The test group took one lutein tablet （10 mg） per day and the control group took one placebo per day, the administration lasted for 30 days. All the subjects underwent the following examinations before and after the administration： general observation, security check, routine eye examination, eye symptom inspection, photopic durability determination and vision screening. Results The symptom of fatigue was significantly reduced. The test group had an average increase of 21.90% in the photopic durability, with the total efficiency of 62.00% and the decrease of 2.66±1.44 in symptom score; the control group had an average increase of 0.25% in the photopic durability, with the total efficiency of 14.00% and the decrease of 1.30±1.16 in symptom score. Both intra-group comparison and intergroup comparison before and after the administration showed a statistically significant difference. Compared with the control group, symptoms of the subjects in the test group were improved, such as blurred vision, dry eye, eye swelling, eye pain, photophobia and so on. Conclusion The daily consumption of 10mg lutein is safe and effective for persons with eye-fatigue.

关 键 词：叶黄素 视疲劳 保健食品 人体试食试验 

分 类 号：R988.1[医药卫生—药品]