摘要
目的比较质量分数0.01%和0.02%阿托品滴眼液控制青少年近视进展的效果和安全性。方法采用随机双盲对照研究方法,纳入2016年6月至2017年6月在郑州大学第一附属医院就诊的6~12岁青少年近视患者280例280眼,等效球镜度(SE)为-1.25~-6.0 D。试验前受试者均配戴全矫单焦框架眼镜矫正屈光不正。采用随机数字表法将受试者分为0.01%阿托品组(142例142眼)和0.02%阿托品组(138例138眼),受试者于睡前用相应质量分数阿托品滴眼液点眼1滴,均将右眼研究资料纳入分析。分别于用药后第1、4、8和12个月进行随访。采用电脑验光仪测定受试者用药前后SE以评估屈光度变化;采用IOLMaster测量受试者用药前后前房深度、角膜曲率和眼轴长度;采用问卷调查记录受试者用药后不适症状。结果0.01%阿托品组23例失访,0.02%阿托品组21例失访,随访完成率分别为83.8%和84.8%。用药1年内,SE随用药时间的延长均逐渐增加,0.01%阿托品组和0.02%阿托品组用药1年SE分别进展(-0.47±0.32)D和(-0.38±0.35)D,差异有统计学意义(P=0.040),矫正影响SE增加量的混杂因素,如年龄、体质量指数和基线SE后,经重复测量数据的广义相加混合模型分析,2个组SE增加率分别为-0.039 D/月和-0.032 D/月,差异有统计学意义(P_(交互作用)=0.041)。0.01%阿托品组和0.02%阿托品组的眼轴长度随用药时间的延长均逐渐增加,0.01%阿托品组和0.02%阿托品组用药1年眼轴长度分别增加(0.37±0.20)mm和(0.30±0.17)mm,差异有统计学意义(P=0.004),矫正影响眼轴长度增加量的混杂因素,如年龄、体质量指数、基线眼轴长度后,经重复测量数据的广义相加混合模型分析,2个组的眼轴长度增加率分别为0.031 mm/月和0.025 mm/月,差异有统计学意义(P_(交互作用)=0.032)。用药1~4周内,0.01%阿托品组和0.02%阿托品组分别有26.9%(32/119)和28.2%(33/117)受试者出现畏光症状;用药后2~4周,0.01%阿托品组和
Objective To compare the clinical efficacy and safety of 0.01%and 0.02%atropine eye drops on myopia development in adolescents.Methods A randomized controlled double-blind study was carried out.Two hundred and eighty myopic adolescents(280 eyes)with spherical equivalent(SE)from-1.25 to-6.0 D were enrolled in The First Affiliated Hospital of Zhengzhou University from June 2016 to June 2017.All the subjects wore full-correction single vision spectacle lenses before topical administration of atropine eye drops.The subjects were randomly divided into 0.01%atropine group(142 eyes)and 0.02%atropine group(138 eyes)according to the random number table method.Atropine 0.01%or 0.02%eye drops was topically used in the test eye once per night according to grouping,and the related parameters of the right eyes were collected for data analysis.The subjects were followed up at the 1st,4th,8th and 12th month following administration.The SE was measured with an autorefractor to evaluate the refractive change.The anterior chamber depth,corneal curvature and axial length(AL)were measured with an IOLMaster.The adverse responses of atropine eye drops were investigated via a questionnaire.This study protocol adhered to the Declaration of Helsinki and was approved by an Ethics Committee of The First Affiliated Hospital of Zhengzhou University(No.2016-35).Written informed consent was obtained from subjects and their guardian prior to entering the cohort.Results The follow-up rate of 0.01%atropine group was 83.8%,and the follow-up rate of 0.02%atropine group was 84.8%at the end of following-up.SE and AL increased by(-0.47±0.32)D and(0.37±0.20)mm in 0.01%atropine group,and(-0.38±0.35)D and(0.30±0.17)mm in 0.02%atropine groups during the following-up,respectively,showing statistically significant differences between two groups(P=0.040,0.004).After adjusting age,body mass index and baseline SE,the analysis by generalized additive mixed model showed that the increase rate of SE was-0.039 D/month and-0.032 D/month in 0.01%and 0.02%atropine
作者
符爱存
荣军博
王卫群
魏丽
张俊杰
赵兵新
吕勇
Fu Aicun;Rong Junbo;Wang Weiqun;Wei Li;Zhang Junjie;Zhao Bingxin;Lyu Yong(The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Henan Eye Institute,Henan Eye Hospital,Henan Provincial People's Hospital,Zhengzhou 450003,China)
出处
《中华实验眼科杂志》
CAS
CSCD
北大核心
2022年第3期253-259,共7页
Chinese Journal Of Experimental Ophthalmology
基金
河南省科技厅重点研发与推广专项项目(201801591)
河南省卫计委医学科技攻关项目(201602073)
河南省教育厅高等学校重点科研项目(19A320066)。
关键词
青少年
近视
阿托品
眼轴长度
随机对照临床试验
Adolescents
Myopia
Atropine
Axial length
Randomized controlled clinical trial
