纵向观察儿童近视发展的危险因素

Investigation of risk factors for myopia development in children

:74-79
 

目的:探讨近视与双眼视功能状态以及用眼时间的关系。方法:对广州市花都区 219 名 10~12 岁学生进行纵向队列研究,研究对象均于2016年基线检查时进行了眼部生物测定、散瞳下自动验光、主观验光、配镜,并在戴镜2周后测量散瞳验光结果,2017年11月再次重复上述检查。同时做调查问卷收集户外、户内活动时间,进一步比对。结果:219 名学生1年后近视度数加深值为 -1.05±0.44(P < 0.001),眼轴长度1年后增长 0.44±0.31,两者呈正相关(P < 0.001);近视度数与调节滞后、调节幅度有相关性,同时与周一至周五户外活动时间呈负相关。结论:近视加深速度与调节滞后、调节幅度有关。在用眼时间方面,户外活动时间越短,近视加深越快;户内活动时间越长,近视加深越快。

Objective: To evaluate the relationship between myopia progression and binocular vision functions and the relationship between myopia progression and outdoor/indoor activities. Methods: A 1-year longitudinal study was carried out and 219 subjects were included. Subjects lived in Huadu District, Guangzhou, China. Binocular functions measurements, ocular biometry measurements and cycloplegic refraction were done at the first visit in 2016. Cycloplegic refraction were done 2 weeks after dispensing. The measurements were repeated in November 2017 and information about outdoor activities and indoor activities was gathered by questionnaires for comparison. Results: The myopia progression was measured to be -1.05±0.44 (< 0.001) in 219 subjects, which was positively correlated with axial length elongation for 0.44±0.31 (< 0.001) and correlated with accommodative lag and accommodative amplitude. Myopia progression was observed to be negatively related to outdoor activitytime. Conclusion: Myopia progression rate is related to accommodative lag and accommodative amplitude. Outdoor activities could be a protective factor for myopia progression.

论著

我国眼科新药临床试验发展趋势分析

Analysis of trends in clinical trials of ophthalmologic drugs

:401-407
 
目的:宏观了解2015—2020年中国眼科药物临床试验情况,为我国眼科药物的研发和临床研究提供最新数据参考,为相关决策提供依据。方法:自国家药品监督管理总局药物临床试验登记与信息公示平台登记数据库提取2015—2020年登记的眼科药物临床试验和相关试验药物信息,汇总分析眼科药物临床试验数量、试验分期、试验范围、适应证、药物类型等。结果:2015年1月1日至2020年12月31日共登记98项眼科临床试验。统计每年眼科药物临床试验登记数量,2020年登记的数量最多(28项,占28.57%);申办方类型中,国内制药企业(75项,占76.53%)发起的眼科药物临床试验数量远高于外资制药企业(23项,占23.47%);试验分期中,I期临床试验最多(35项,占35.71%),III期次之(30项,占30.61%);药物类型中,生物制品数量最多(55项,占56.12%),化学药物次之(36项,占36.73%)。结论:近6年来,我国眼科药物临床试验进入蓬勃发展时期,尤其是眼底科领域,近2年发展迅速。在创新药领域,国内制药企业已成为眼科新药研发的中坚力量。但创新药大部分集中在眼底科领域,在青光眼、干眼等领域仍需要继续创新。
Objective: To get a macro understanding of the clinical trials of ophthalmic drugs in China from 2015 to 2020, provide the latest data reference for development of ophthalmic drugs and clinical research in China, and provide the basis for relevant decision-making. Methods: The number of clinical trials and related investigational products from 2015 to 2020 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies. Characteristics on number, stage, scope, indications, type were summarized and depicted. Results: There were 98 ophthalmic clinical trials registered in China from January 1, 2015 and December 31, 2020. The year of 2020 hit the highest record of registered ophthalmic clinical trials for 28, accounting for 28.57%. Among sponsor, 75 (accounting for 76.53%) were initiated by domestic pharmaceutical enterprises, much higher than initiated by foreign pharmaceutical enterprises (23, accounting for 23.47%). Among stage, the quantity of phase I (35, accounting for 35.71%) was the largest, followed by phase III (30, accounting for 30.61%). Among type, the quantity of biological product was the largest (55, accounting for 56.12%), followed by chemical product (36, accounting for 36.73%). Conclusion: The past 6 years have seen vigorous growth of ophthalmic clinical trials, particularly in the last 2 years in the field of fundus. Domestic pharmaceutical enterprises have become the central pillar of ophthalmic drugs renovation. However, their focus is limited to fundus, innovation is still needed in areas such as glaucoma xerophthalmia.
其他期刊
  • 眼科学报

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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  • Eye Science

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
    浏览
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