0.01%阿托品滴眼液预防儿童近视发生的随机双盲对照试验  

Effects of 0.01% atropine eye drops on the prevention of myopia onset among schoolchildren:a randomized,double-blind,controlled trial

作　　者：于世傲 吕勇[1] 王卫群[1] 崔璨 魏丽 黄聪聪 马娜娜 赵兵新 张俊杰[3] 符爱存[1] Yu Shiao;Lyu Yong;Wang Weiqun;Cui Can;Wei Li;Huang Congcong;Ma Nana;Zhao Bingxin;Zhang Junjie;Fu Aicun(Department of Ophthalmology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Department of Ophthalmology,The Second Affiliated Hospital of Zhengzhou University,Zhengzhou 450000,China;Henan Provincial People's Hospital,Henan Eye Hospital,Henan Eye Institute,Zhengzhou 450003,China)

机构地区：[1]郑州大学第一附属医院眼科,郑州450000 [2]郑州大学第二附属医院眼科,郑州450000 [3]河南省人民医院河南省立眼科医院河南省眼科研究所,郑州450003

出　　处：《中华实验眼科杂志》2022年第6期533-540,共8页Chinese Journal Of Experimental Ophthalmology

基　　金：河南省教育厅高等学校重点科研项目(19A320066);河南省卫生计生科技英才海外研修工程项目(2018038)。

摘　　要：目的观察质量分数0.01%阿托品滴眼液预防儿童近视发生和发展的安全性和有效性。方法采用随机双盲对照研究,招募2020年7—10月就诊于郑州大学第一附属医院的中国汉族儿童60例60眼。将睫状肌麻痹验光后双眼等效球镜度(SE)为+0.50~-0.75 D(近视前期)的儿童采用随机数表法分为0.01%阿托品组和对照组,每组30例30眼。2个组儿童分别于每晚睡前双眼各点1滴0.01%阿托品滴眼液或空白溶媒滴眼液,比较治疗前及治疗3个月和6个月后2个组的SE、眼轴长度(AL)、瞳孔直径、调节幅度变化量,记录整个治疗期间儿童不适症状。结果治疗后6个月,0.01%阿托品组和对照组各有26例和25例受试者完成随访,分别有3例和9例儿童发生近视,分别占11.5%和36.0%,差异有统计学意义(χ^(2)=4.238,P=0.040)。治疗前后不同时间点SE和AL总体比较,差异均有统计学意义(F_(时间)=10.981、81.854,均P<0.001),其中治疗后3个月和6个月,对照组SE和AL以及0.01%阿托品组AL均较治疗前增加,差异均有统计学意义(均P<0.05);0.01%阿托品组治疗后3个月和6个月SE与治疗前比较,差异均无统计学意义(均P>0.05)。治疗后6个月,0.01%阿托品组SE向近视化方向进展(-0.15±0.26)D,小于对照组的(-0.34±0.35)D,差异有统计学意义(t=2.207,P=0.032);0.01%阿托品组AL增加量为(0.17±0.11)mm,小于对照组的(0.28±0.14)mm,差异有统计学意义(t=3.127,P=0.003)。治疗前后不同时间点瞳孔直径总体比较,差异有统计学意义(F时间=2.263,P=0.032),其中治疗后3个月和6个月,0.01%阿托品组瞳孔直径大于治疗前,差异均有统计学意义(均P<0.05)。2个组治疗前后不同时间点调节幅度总体比较,差异均有统计学意义(F_(分组)=0.882,P=0.042;F_(时间)=0.337,P=0.033),其中治疗后3个月和6个月,0.01%阿托品组调节幅度小于治疗前和对照组,差异均有统计学意义(均P<0.05)。治疗后1个月内,0.01%阿托品组和对照组各有5例和2�Objective To observe the safety and efficacy of 0.01%atropine eye drops in the prevention of myopia onset in schoolchildren.Methods A randomized double-blind controlled study was conducted.Sixty Chinese Han children(60 eyes)with binocular spherical equivalent(SE)between+0.50 D and-0.75 D(pre-myopia)by cycloplegic autorefraction treated in The First Affiliated Hospital of Zhengzhou University were enrolled from July to October 2020.Aged 6-12 years old,the children were divided into 0.01% atropine group and control group according to a random number table,with 30 cases(30 eyes)in each group.The children were given one drop of 0.01% atropine or placebo eye drops in both eyes once a night.The SE,axial length(AL),accommodative amplitude and pupil diameter were compared before and after 3-month,6-month of treatment between the two groups.Discomforts were recorded.This study adhered to the Declaration of Helsinki.The study protocol was approved by an Ethics Committee of The First Affiliated Hospital of Zhengzhou University(No.2020-KY-286).Written informed consent was obtained from guardian of each subject.Results After treatment,26 and 25 subjects completed the 6-month follow-up in 0.01% atropine group and control group,respectively,among which 3 subjects in 0.01% atropine group accounting for 11.5% and 9 in control group accounting for 36.0% developed myopia,showing a statistically significant difference(χ^(2)=4.238,P=0.040).There were significant differences in the overall comparison of SE and AL at different time points between before and after treatment(F_(time)=10.981,81.854;both at P<0.001).At 3 and 6 months after treatment,there were significant increases in the SE and AL of control group and AL of 0.01% atropine group compared with respective baseline values(all at P<0.05).There was no significant difference in SE at 3 and 6 months after treatment compared with baseline SE in 0.01% atropine group(both at P>0.05).At 6 months after treatment,the change in SE in 0.01% atropine group was(-0.15±0.26)D,which was sig

关 键 词：阿托品 近视 防控 儿童 安全性 有效性 

分 类 号：R778.11[医药卫生—眼科]