近视儿童应用0．01％硫酸阿托品滴眼液的不良反应  

Adverse effects of O. 01% atropine sulfate eye drops on myopic children

作　　者：符爱存[1] 赵兵新 张俊杰[2] 张金嵩[1] 李彬彬[1] 李秀红[1] 尚利娜[1] 吕勇[1] Fu Aieun;Zhao Bingxin;Zhang Junjie;Zhang Jinsong;Li Binbin;Li Xiuhong;Shang Lina;Lyu Yong(Department of Ophthalmology,the First Affiliated Hospital of Zhengzhou University,Zhengzhoa 450052,China;Henan Eye Institute,Henan Eye Hospital,Henan Provincial People＇s Hospital,Zhengzhou 450003,China)

机构地区：[1]郑州大学第一附属医院眼科,450052 [2]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》2018年第6期449-453,共5页Chinese Journal Of Experimental Ophthalmology

基　　金：河南省卫计委医学科技攻关项目（201602073）;河南省科技厅重点研发与推广专项项目（201801591）;河南省教育厅高等学校重点科研项目

摘　　要：目的 观察中国大陆近视儿童应用质量分数0.01％硫酸阿托品滴眼液的不良反应.方法 前瞻性非随机对照研究.99例99眼（均取右眼数据分析）近视儿童分为试验组和对照组,试验组55例近视儿童配戴全矫单焦框架眼镜,同时睡前双眼各点0.01％硫酸阿托品滴眼液1滴.对照组44例近视儿童配戴全矫单焦框架眼镜.2个组儿童均随访4个月,观察2个组治疗前后以及治疗后2个组最佳矫正远视力（BCDVA）、最佳矫正近视力（BCNVA）（LogMAR视力）、眼压、瞳孔直径和调节幅度等变化情况及试验组的不适症状.结果 试验组和对照组治疗前与治疗后4个月BCDVA、BCNVA、眼压比较,差异均无统计学意义（BCDVA：F组别=3.880,P=0.112;F时间=27.220,P=0.413.BCNVA：F组别=5.200,P=0.311;F时间=38.200,P=0.116.眼压：F组别=12.350,P=0.214;F时何=22.300,P=0.146）.治疗后4个月试验组瞳孔直径为（6.99±0.64） mm,较治疗前平均增加约0.92 mm,与治疗前比较差异有统计学意义（P＜0.01）;治疗后4个月,试验组较对照组瞳孔直径增大,差异有统计学意义（P＜0.01）.治疗后4个月试验组调节幅度为（14.01±3.98）D,较治疗前平均下降约1.20 D,与治疗前比较差异有统计学意义（P＜0.01）;治疗后4个月,试验组较对照组调节幅度下降,差异有统计学意义（P＜0.01）.试验组共4例（占8％）儿童出现畏光,2例畏光持续2周,2例畏光持续1周,户外活动时戴太阳镜或遮阳帽缓解症状.1例（占2％）用药1个月后,晨起出现眼痒、眼肿,停药后消失.无视近模糊等其他不适症状. 结论 中国大陆近视儿童应用0.01％硫酸阿托品滴眼液4个月后,最佳矫正远、近视力和眼压未变化;瞳孔直径轻度散大和调节幅度轻度下降,10％儿童用药后初期出现畏光等不适,但对学习和生活无影响.Objective To observe the adverse effects of 0.01% atropine sulfate eye drops on myopic children.Methods A prospective non-randomized controlled trial was conducted.Ninety-nine myopic children （99 right eyes） were randomly assigned to experimental group（55 cases） and control group（44 cases）.Myopic children of experimental group wore completely corrected frame glasses,while 0.01% atropine sulfate eye drop was dropped into each eye once a day before going to bed.Myopic children in control group only wore completely corrected frame glasses.The follow-up time was 4 months.Best corrected visual acuity （BCVA）,intraocular pressure （IOP）,change of pupil diameter （PD） and amplitude of accommodation,symptoms of discomfort after medication were observed.This study followed the Helsinki declaration and was approved by Ethic Committee of the First Affiliated Hospital of Zhengzhou University.Informed consent was signed by the parents of each patient.Results No significant differences were found in best corrected distance visual acuity （BCDVA）,best corrected near visual acuity（BCNVA） and IOP between the two groups before and 4 months after treatment （BCDVA：Fgroup =3.880,P =0.112;Ftime =27.220,P =0.413;BCNVA：Fgroup =5.200,P =0.311;Ftime =38.200,P =0.116,IOP：Fgroup =12.350,P=0.214;Ftime =22.300,P =0.146）.After 4 months treatment,the PD was （6.99 ±0.64） mm in the experimental group,which was significantly higher than that before treatment（P〈0.001）.The PD of the experimental group was higher than that of the control group after 4 months treatment,and the difference was statistically significant （P〈0.01）.The amplitude of accommodation in the experimental group was 14.01 ±3.98 after 4 months treatment.which was 1.20 D lower than that before treatment,the difference was statistically significant （P〈0.01）.The amplitude of accommodation of the experimental group was lower than that of the control group after 4 months treatment,the difference was statistically significant �

关 键 词：0.01%硫酸阿托品滴眼液 近视儿童 不良反应 瞳孔直径 调节幅度 非随机对照试验 

分 类 号：R778.11[医药卫生—眼科]