Objective: To observe the efficacy and feasibility of a new therapy using a combination of different anticholinergic eyedrops in controlling myopia progression and axial prolongation in adolescents. Methods: Between July 2013 and June 2014, a total of 150 myopia adolescents aged 6-12 years were recruited at the clinic of Tongji Hospital in Shanghai. Participants were assigned in a 1∶2∶2 ratio to placebo group (no medication), combined treatment group (0.5% racanisodamine eyedrops were used twice a day during semesters, 1% atropine eyedrops were used before sleep during vacation) and atropine group (1% atropine eyedrops were used before sleep everyday). All subjects wore glasses. Visual acuity, best corrected visual acuity, cycloplegic refraction, corneal curvature, axial length, intraocular pressure, fundus and adverse events were recorded every 6 months during follow-up for 24 months. Results: At baseline, there was no significant difference in age,equivalent spherical mirror number and axial length among the three groups (all P>0.05). At the end of the second year,the mean myopia progression (changes of spherical equivalent) was -2.34 (-2.93,-1.75) D,-0.63 (-1.00,-0.50) D and -0.25 (-0.50,-0.06) D in placebo group, combined treatment group and atropine group, respectively (P<0.001), and there was statistically significant difference between each two groups (all P<0.001). The axial length change of each group were (1.51±0.23) mm, (0.69±0.30) mm and (0.31±0.30) mm, respectively (P<0.001), and there was statistically significant difference between each two groups (all P<0.001). Conclusion: Therapy using a combination of different anticholinergic eyedrops can effectively control the progression of myopia and axial prolongation in adolescents, and increase the compliance of children and the safety of drug use.
目的： 观察消旋山莨菪碱联合阿托品滴眼液对控制青少年近视进展和眼轴延长的有效性和可行性。 方法： 随机对照临床试验。2013年7月至2014年6月招募150名6~12岁在上海市同济医院眼科门诊就诊的近视青少年。"信封法"顺序编码对应计算机随机方案，按1∶2∶2分为对照组（不使用药物）、联合组（0.5%消旋山莨菪碱滴眼液早晚学期内使用，联合1%阿托品眼用凝胶假期每晚使用）和阿托品组（每晚使用1%阿托品眼用凝胶）。所有研究对象均戴镜足矫。随访24个月，每6个月记录双眼裸眼视力、最佳矫正视力、等效球镜度数、角膜曲率、眼轴长度及不良事件。 结果： 三组入组时年龄、等效球镜度数、眼轴长度比较差异均无统计学意义（均P>0.05）。24个月时三组等效球镜度数变化量分别为：对照组－2.34（-2.93，-1.75）D、联合组－0.63（-1.00，-0.50）D、阿托品组－0.25（-0.50，-0.06）D（P<0.001），两两比较差异均有统计学意义（均P<0.001）；眼轴变化量分别为：对照组（1.51±0.23）mm、联合组（0.69±0.30）mm、阿托品组（0.31±0.30）mm（P<0.001），两两比较差异均有统计学意义（均P<0.001）。 结论： 消旋山莨菪碱联合阿托品滴眼液能有效控制青少年近视进展及眼轴增长，同时增加患儿的依从性和药物使用的安全性。.
Keywords: Adolescent; Atropine; Cholinergic antagonists; Myopia; Racanisodamine.