0.05%阿托品滴眼液对小学生近视控制的有效性和安全性

Efficacy and safety of 0.05% atropine eye drops for retarding myopia progression in Chinese primary school students

目的评估0.05%阿托品滴眼液对小学生近视控制的有效性和安全性,为制定近视的相关防控措施提供参考依据。方法选取2016年1月至2019年1月云南省第二人民医院儿童眼科门诊收治的8~12岁近视小学生共计188例,随机均分为实验组(93例)和对照组(95例)。在第1~24个月,阿托品组儿童每晚睡前双眼滴1次0.05%阿托品滴眼液。对照组儿童每晚睡前双眼滴1次0.3%玻璃酸钠滴眼液。第25~36个月,实验组及对照组儿童均停止用药。在随访期内,每组儿童均在用药前、用药后每6个月检查其等效球镜度、眼轴长度、眼压变化,问卷调查药物相关不良反应发生率。结果在用药期间,实验组等效球镜度年进展值[(-0.35±0.21)D/年]及眼轴长度年进展值[(0.11±0.07)mm/年]明显少于对照组[(-0.83±0.26)D/年,(0.37±0.22)mm/年](t值分别为1.29,-1.37,P值均<0.05)。停用阿托品滴眼液后,实验组的等效球镜进展值[(-0.40±0.29)D/年]及眼轴长度进展值[(0.10±0.04)mm/年]明显低于对照组[(0.73±0.40)D/年,(0.30±0.11)mm/年]。在整个随访期间,没有发现与阿托品相关的严重不良事件。停用阿托品后,瞳孔大小、近视力和调节幅度逐渐恢复到治疗前水平。结论局部使用0.05%阿托品滴眼液可有效延缓青少年近视进展,且不导致眼压异常及严重不良反应,具有较好的应用安全性。

Objective To evaluate the efficacy and safety of 0.05% atropine eye drops for retarding myopia progression and ocular axial elongation in school children,and to provide a reference for the relevant prevention and control measures of myopia. Methods A total of 188 children with myopia were randomly assigned to the experimental group(93) or to the control group(95). During the phase(first 24 months) I,children received treatment in each eye once a day. During the phase II(from 25 th to the 36 th month),no treatment was given. Standardized eye examinations including spherical equivalent(SE),axial length(AL),intraocular pressure(IOP) and potential atropine-related side effect assessment were performed every 6 months. Results In phase I, the annual progression rates of equivalent spherical degree [(-0.35±0.21)D/year] and axial length [(0.11±0.07)mm/year] in the experimental group were significantly lower than those in the control group [(-0.83±0.26)D/year and(0.37±0.22)mm/year](P<0.05). After withdrawal of atropine eye drops(phase II), the equivalent spherical degree progression rate [(-0.40±0.29)D/year] and axial length progression rate [(0.10±0.04)mm/year] in the experimental group were significantly lower than those in the control group [(0.73±0.40)D/year and(0.30±0.11)mm/year]. No serious adverse events associated with atropine were found during the follow-up period. After the withdrawal of atropine, the pupil size, near visual acuity and adjustment gradually returned to the pre-treatment level. Conclusion 0.05% atropine eye drops may not only maintain the efficacy and reduce potential side effects of atropine but also significantly increase the compliance of children,0.05% atropine is a safe and effective treatment for retarding myopic progression in moderate myopia.