口服递法明片对近视儿童眼轴增长、屈光进展及黄斑区结构参数的短期影响OA

Objective To assess the short-term effects of oral Difrarel tablets on axial elongation,refractive progres-sion,and macular structural parameters in children with myopia,and to analyze the short-term trend of myopia progression after drug discontinuation.Methods In this prospective randomized controlled study,112 myopic children(112 eyes)who visited our hospital from September 2023 to March 2025 were enrolled and randomly divided into an early-treatment group(58 children)and a late-treatment group(54 children).All children wore single-vision spectacles.In the early-treat-ment group,oral Difrarel tablets were administered during months 0-6 at a dose of 3 tablets,twice daily,and were discon-tinued during months 6-12.In the late-treatment group,children wore spectacles alone during months 0-6 and received oral Difrarel tablets during months 6-12.All children were followed up for 12 months.The primary outcome was axial length(AL),and the secondary outcomes included spherical equivalent(SE),central retinal thickness(CRT),and subfo-veal choroidal thickness(SFCT).Data were analyzed using SPSS 26.0 statistical software.Results A total of 100 children completed the follow-up,including 51 in the early-treatment group and 49 in the late-treatment group.At the 6-month follow-up,the AL difference(defined as the value at the 6-month follow-up minus the baseline value)was(0.13±0.09)mm in the early-treatment group,smaller than that[(0.20±0.11)mm]in the late-treatment group(P＜0.001).The SE difference was also smaller in the early-treatment group than in the late-treatment group[(-0.15±0.33)D vs.(-0.35±0.28)D,P=0.001].In the early-treatment group,there was no significant difference in AL difference or SE difference between the treatment period and the non-treatment period(P=0.647 and 0.486,respectively).In the late-treatment group,the AL difference(defined as the value at the 12-month follow-up minus the value at the 6-month follow-up)during the treatment period was(0.12±0.10)mm,which was smaller than that during the non-treatment period[(0.20±0.11)mm,P＜0.001].The absolute value of the SE difference during the treatment period also decreased compared with the non-treat-ment period[(-0.18±0.37)D vs.(-0.35±0.28)D,P=0.01].In the late-treatment group,the SFCT difference during the treatment period was greater than that during the non-treatment period[(2.71±4.56)μm vs.(1.87±4.04)μm,P=0.043],whereas the CRT difference showed no statistically significant difference(P=0.354).One child in the early-treat-ment group withdrew because of mild gastrointestinal discomfort,and no serious adverse events occurred.Conclusion Oral Difrarel tablets may delay AL elongation and SE progression in children with myopia in the short term,with no obvious rebound trend within 6 months after drug discontinuation.The effect may be associated with a slight increase in SFCT after oral Difrarel treatment,while no obvious effect on CRT is observed.