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一项关于0.01%阿托品滴眼液在全球儿童群体中预防近视进展疗效的系统评价与荟萃分析。

A systematic review with meta-analysis on the efficacy of 0.01% atropine eyedrops in preventing myopia progression in worldwide children's populations.

作者信息

Navarra Pierluigi, Buzzonetti Luca, Amico Valentina, Cro Melina, Federico Bruno

机构信息

Section of Pharmacology, Department of Healthcare Surveillance and Bioethics, Catholic University Medical School, Fondazione Policlinico Universitario A. Gemelli-Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy.

Ophthalmology Unit, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.

出版信息

Front Pharmacol. 2025 May 22;16:1497667. doi: 10.3389/fphar.2025.1497667. eCollection 2025.

Abstract

INTRODUCTION

Atropine eyedrops have long been used off-label to prevent myopia progression in children, and many clinical trials have been published on this topic in the past 30 years. Trials initially tested doses ranging from 0.01% to 1%, but more recently, the interest has turned to low doses, mainly 0.01%. Moreover, the first studies were carried out in Asian populations, but the number of trials conducted in other geographical areas has rapidly increased from 2020 onward. This meta-analysis was aimed at summarizing the evidence on the efficacy of 0.01% atropine eyedrops on the reduction of myopia progression, also comparing study findings from different parts of the world.

METHODS

Data were obtained from PubMed, Scopus and Web of Science databases from 1 January 1 2020 to 31 July 2024. Randomized controlled trials involving children receiving 0.01% atropine eyedrops for at least 1 year were included. Heterogeneity was quantified by Q, H, and I2 statistics, and a meta-analysis was performed using a random effect model. The risk for bias was assessed using the Cochrane Collaboration (Chapter 6) aspects of bias scale.

RESULTS AND DISCUSSION

The primary outcomes were the differences in spherical equivalent refractive errors and axial length at baseline and after 12 months of treatment with 0.01% atropine eyedrops or placebo. Eleven studies involving 2,046 children (1,172 receiving 0.01% atropine eyedrops and 874 receiving placebo) were included. Atropine was significantly more effective than placebo, with an average reduction of 0.16/year (95% CI: 0.11-0.22) and -0.07/year (95% CI: -0.09 to -0.05) in spherical equivalent refractive errors and axial length, respectively. The efficacy of 0.01% atropine eyedrops vs. placebo was maintained in a subpopulation of subjects after 24 months of treatment. We found no difference in atropine efficacy between Southeast Asian populations (1,063 children, 52%) and populations in various other countries (983 children, 48%).

摘要

引言

阿托品滴眼液长期以来一直被超适应症用于预防儿童近视进展,在过去30年里,关于这个主题已经发表了许多临床试验。试验最初测试的剂量范围从0.01%到1%,但最近,人们的兴趣转向了低剂量,主要是0.01%。此外,最初的研究是在亚洲人群中进行的,但从2020年起,在其他地理区域进行的试验数量迅速增加。这项荟萃分析旨在总结0.01%阿托品滴眼液在降低近视进展方面疗效的证据,同时比较来自世界不同地区的研究结果。

方法

数据来自2020年1月1日至2024年7月31日的PubMed、Scopus和Web of Science数据库。纳入了涉及接受0.01%阿托品滴眼液至少1年的儿童的随机对照试验。通过Q、H和I²统计量对异质性进行量化,并使用随机效应模型进行荟萃分析。使用Cochrane协作网(第6章)偏倚量表的各个方面评估偏倚风险。

结果与讨论

主要结局是在基线时以及用0.01%阿托品滴眼液或安慰剂治疗12个月后的等效球镜屈光不正和眼轴长度的差异。纳入了11项研究,涉及2046名儿童(1172名接受0.01%阿托品滴眼液,874名接受安慰剂)。阿托品比安慰剂显著更有效,等效球镜屈光不正和眼轴长度平均每年分别降低0.16(95%CI:0.11 - 0.22)和 - 0.07(95%CI: - 0.09至 - 0.05)。在治疗24个月后的一个亚组受试者中,0.01%阿托品滴眼液相对于安慰剂的疗效得以维持。我们发现东南亚人群(1063名儿童,52%)和其他各个国家的人群(983名儿童,48%)之间阿托品的疗效没有差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e483/12137072/3f25d17cc8ce/fphar-16-1497667-g001.jpg

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