Pilot study on the efficacy and safety of 0.01% atropine school children with progressive myopia in Hefei
-
摘要:
目的 观察0.01%阿托品滴眼液对进展性近视学龄儿童的治疗情况,为探寻有效的儿童近视防治措施提供参考。 方法 随机数字表法选取合肥市城区30例进展性近视学龄儿童,年龄中位数为10(7~17)岁,在每晚睡前双眼使用不含防腐剂的0.01%阿托品滴眼液进行局部治疗,12个月后对疗效和安全性进行分析,每6个月对疗效进行1次评估。其中10例患者第二只眼睛的治疗延迟1 d,以便对瞳孔扩大、调节反应、视敏度进行可控的安全性评估。 结果 在近视治疗效果方面,0.01%阿托品治疗12个月后,为0.43 D/年(t=8.66,P < 0.01)。在安全性方面,在10例第二只眼睛治疗延迟1 d的患者中,可观察到的副作用是诱导了1 mm的瞳孔扩大;而在调节力、视近敏度及眼压等观察中,未见明显异常。 结论 0.01%阿托品滴眼液在治疗学龄儿童近视中安全有效,具有一定临床推广价值。 Abstract:Objective To investigate the clinical effict of 0.01% atropine for myopia progression in school children, and to provide a reference for probing into an effective methods of preventing myopia among children. Methods Thirty children, with a median age of 10 years (range 7-17), were given topical treatment with preservative-free 0.01% atropine eye drops in both eyes before going to bed every night, and the efficacy and safety were analyzed 12 months later. Efficacy was assessed every 6 months. In 10 children, treatment of the second eye was delayed by one day to allow for a controlled safety assessment of side effects such as dilated pupils, hypoplasia and decreased myopia. Results In terms of myopia treatment, after 12 months of treatment with 0.01% atropine, it was 0.43 D/year(t=8.66, P < 0.01). In terms of safety, in the 10 children's treatment of the second eye was delayed by one day, the measurable side effect was the induction of 1 mm pupil dilatation, and there was no other significant abnormalities were observed. Conclusion Topical low-dose (0.01%) atropine is safe and effective in school-age children, and it has certain clinical promotion value. -
Key words:
- Myopia /
- Atropine /
- Intervention studies /
- Child
-
表 1 不同年龄儿童使用0.01%阿托品治疗前后近视进展情况比较/(x ±s, D)
Table 1. Myopic progression before and after treatment with 0.01% atropine in children of different ages/(x ±s, D)
年龄/岁 治疗前 治疗6个月后 治疗12个月后 12~17 -0.94±0.18 -0.25±0.11 -0.35±0.09 7~11 -1.28±0.38 -0.38±0.15 -0.47±0.12 t值 2.82 2.36 3.14 P值 0.01 0.03 0.00 表 2 0.01%阿托品滴眼后不同时间眼间的调节反应、视敏度和瞳孔直径变化比较(x ±s)
Table 2. Interocular difference in the accommodative response, visual acuity and the amount of anisocoria at different time points after unilateral application of 0.01% atropine(x ±s)
调查时间 调节反应/D 视敏度/LogMAR 瞳孔直径/mm 8:00 0.00±2.99 0.00±0.06 0.87±0.64 10:00 0.40±2.67 0.00±0.07 0.48±0.33 12:00 2.00±1.83 0.01±0.03 0.46±0.40 F值 2.56 0.20 2.37 P值 0.10 0.82 0.11 -
[1] HOLDEN B A, FRICKE T R, WILSON D A, et al. Global prevalence of myopia and high myopia and temporal trends from 2000 through 2050[J]. Ophthalmology, 2016, 123(5): 1036-1042. doi: 10.1016/j.ophtha.2016.01.006 [2] 宋胜仿, 李华. 近视流行病学调查研究进展[J]. 国际眼科杂志, 2011, 11(3): 453-454. doi: 10.3969/j.issn.1672-5123.2011.03.023SONG S F, LI H. Progress of epidemiologic study of myopia[J]. Int Eye Sci, 2011, 11(3): 453-454. doi: 10.3969/j.issn.1672-5123.2011.03.023 [3] 温跃春, 梁莉, 文磊, 等. 安徽省中小学生视力不良和近视流行现状[J]. 中国学校卫生, 2018, 39(12): 1831-1834. http://2269799.s21d-2.faiusrd.com/61/ABUIABA9GAAg6Ync4AUo7v-J9wc.pdfWEN Y C, LIANG L, WEN L, et al. Epidemiological status of poor vision and myopia among primary and secondary school students in Anhui province[J]. Chin J Sch Health, 2018, 39(12): 1831-1834. http://2269799.s21d-2.faiusrd.com/61/ABUIABA9GAAg6Ync4AUo7v-J9wc.pdf [4] 高璨然. 0.01%阿托品联合角膜塑形镜减缓近视儿童眼轴延长效果的Meta分析[J]. 实用医药杂志, 2020, 27(3): 214-218, 222. https://www.cnki.com.cn/Article/CJFDTOTAL-QEYY202003009.htmGAO C R. The efficacy of 0.01% atropine combined with orthokeratology in slowing axial elongation of myopia children: a meta-analysis[J]. Pra J Med Pharm, 2020, 27(3): 214-218, 222. https://www.cnki.com.cn/Article/CJFDTOTAL-QEYY202003009.htm [5] PARARAJASEGARAM R. VISION 2020-the right to sight: from strategies to action[J]. Am J Ophthalmol, 1999, 128(3): 359-360. doi: 10.1016/S0002-9394(99)00251-2 [6] 姜瑾. 角膜塑形镜, 低浓度阿托品与框架眼镜控制青少年近视的疗效比较[J]. 国际眼科杂志, 2018, 18(7): 1349-1352. https://www.cnki.com.cn/Article/CJFDTOTAL-GJYK201807052.htmJIANG J. Effect of orthokeratology, low concentration atropine and frame glasses on juvenile myopia prevention and control[J]. Int Eye Sci, 2018, 18(7): 1349-1352. https://www.cnki.com.cn/Article/CJFDTOTAL-GJYK201807052.htm [7] CHIA A, CHUA W H, CHEUNG Y B, et al. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2)[J]. Ophthalmology, 2012, 119(2): 347-354. doi: 10.1016/j.ophtha.2011.07.031 [8] 张晓瑾, 周磊. 不同浓度阿托品制剂治疗屈光不正患者的疗效及安全性[J]. 中国生化药物杂志, 2016, 36(11): 106-108. https://www.cnki.com.cn/Article/CJFDTOTAL-SHYW201611031.htmZHANG X J, ZHOU L. Clinical effect and safety of different concentrations of atropine preparations in the treatment of ametropia[J]. Chin J Biochem Pharm, 2016, 36(11): 106-108. https://www.cnki.com.cn/Article/CJFDTOTAL-SHYW201611031.htm [9] 荣军博, 符爱存, 吕勇, 等. 0.01%阿托品滴眼液控制学龄儿童近视发展的疗效[J]. 中华实验眼科杂志, 2020, 38(6): 494-498. doi: 10.3760/cma.j.cn115989-20200329-00223RONG J B, FU A C, LYU Y, et al. Clinical effect of 0.01% atropine eye drops on myopia progression in school-age children[J]. Chin J Exp Ophthalmol, 2020, 38(6): 494-498. doi: 10.3760/cma.j.cn115989-20200329-00223 [10] JOACHIMSEN L, DANIEL BHRINGER, GROSS N J, et al. A pilot study on the efficacy and safety of 0.01% atropine in German schoolchildren with progressive myopia[J]. Ophthalmol Ther, 2019, 8(3): 427-433. doi: 10.1007/s40123-019-0194-6 [11] CHIA A, LU Q S, TAN D. Five-year clinical trial on atropine for the treatment of myopia 2: myopia control with atropine 0.01% eyedrops[J]. Ophthalmology, 2016, 123(2): 391-399. doi: 10.1016/j.ophtha.2015.07.004 [12] POLLING J R, KOK R G W, TIDEMAN J W L, et al. Effectiveness study of atropine for progressive myopia in Europeans[J]. Eye, 2016, 30(7): 998-1004. doi: 10.1038/eye.2016.78 [13] YAM J C, JIANG Y, TANG S M, et al. Low-concentration atropine for myopia progression (LAMP) study: a randomized, double-blinded, placebo-controlled trial of 0.05%, 0.025%, and 0.01% atropine eye drops in myopia control[J]. Ophthalmology, 2019, 126(1): 113-124. doi: 10.1016/j.ophtha.2018.05.029 [14] 索倩, 张德勇, 蔡文茜, 等. 徐州市中小学生屈光不正调查及近视相关因素研究[J]. 中华全科医学, 2020, 18(12): 2054-2056. http://kns.cnki.net/KCMS/detail/detail.aspx?dbcode=CJFD&filename=SYQY202012022SUO Q, ZHAND D Y, CAI W Q, et al. Investigation on refractive error and related factors of myopia among primary and middle school students in Xuzhou City[J]. Chin J Gen Prac, 2020, 18(12), 2054-2056. http://kns.cnki.net/KCMS/detail/detail.aspx?dbcode=CJFD&filename=SYQY202012022 [15] COOPER J, EISENBERG N, SCHULMAN E, et al. Maximum atropine dose without clinical signs or symptoms[J]. Optom Vis Sci, 2013, 90(12): 1467-1472. doi: 10.1097/OPX.0000000000000037 [16] KAYMAK H, FRICKE A, MAURITZ Y, et al. Short-term effects of low-concentration atropine eye drops on pupil size and accommodation in young adult subjects[J]. Graefes Arch Clin Exp Ophthalmol, 2018, 256(11): 2211-2217. doi: 10.1007/s00417-018-4112-8 [17] 钟梅, 吕勇, 符爱存, 等. 质量分数0.01%和0.02%阿托品滴眼液对近视儿童瞳孔直径和调节幅度影响的一年随机、双盲、临床对照试验[J]. 中华实验眼科杂志, 2019, 37(7): 540-545. doi: 10.3760/cma.j.issn.2095-0160.2019.07.009ZHONG M, LYU Y, FU A C, et al. Effects of 0.01% and 0.02% atropine eye drops on pupil diameter and accommodation amplitude in myopic children: one-year, randomized, double blind, controlled trail[J]. Chin J Exp Ophthalmol, 2019, 37(7): 540-545. doi: 10.3760/cma.j.issn.2095-0160.2019.07.009 [18] 郑婕, 廖荣丰, 封利霞, 等. 0.01%阿托品滴眼液控制青少年近视的效果及对调节功能的影响[J]. 临床眼科杂志, 2020, 28(6): 533-537.ZHENG J, LIAO R F, FENG L X, et al. Effect of 0. 01% Atropine eye drops on controlling myopia and accommodation functionin adolescents[J]. Clin Ophthalmol J, 2020, 28(6): 533-537. -

计量
- 文章访问数: 709
- HTML全文浏览量: 516
- PDF下载量: 50
- 被引次数: 0