Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea; Department of Ophthalmology, Jeju National University Hospital, Jeju-si, Korea; Department of Ophthalmology, Jeju National University School of Medicine, Jeju-si, Korea.
Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea; Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea.
Ophthalmology. 2022 Mar;129(3):322-333. doi: 10.1016/j.ophtha.2021.10.016. Epub 2021 Oct 22.
Comparative efficacy and safety of different concentrations of atropine for myopia control.
Atropine is known to be an effective intervention to delay myopia progression. Nonetheless, no well-supported evidence exists yet to rank the clinical outcomes of various concentrations of atropine.
We searched PubMed, EMBASE, Cochrane Central Register of Controlled Trials, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov on April 14, 2021. We selected studies involving atropine treatment of at least 1 year's duration for myopia control in children. We performed a network meta-analysis (NMA) of randomized controlled trials (RCTs) and compared 8 atropine concentrations (1% to 0.01%). We ranked the atropine concentrations for the corresponding outcomes by P score (estimate of probability of being best treatment). Our primary outcomes were mean annual changes in refraction (diopters/year) and axial length (AXL; millimeters/year). We extracted data on the proportion of eyes showing myopia progression and safety outcomes (photopic and mesopic pupil diameter, accommodation amplitude, and distance and near best-corrected visual acuity [BCVA]).
Thirty pairwise comparisons from 16 RCTs (3272 participants) were obtained. Our NMA ranked the 1%, 0.5%, and 0.05% atropine concentrations as the 3 most beneficial for myopia control, as assessed for both primary outcomes: 1% atropine (mean differences compared with control: refraction, 0.81 [95% confidence interval (CI), 0.58-1.04]; AXL, -0.35 [-0.46 to -0.25]); 0.5% atropine (mean differences compared with control: refraction, 0.70 [95% CI, 0.40-1.00]; AXL, -0.23 [-0.38 to -0.07]); 0.05% atropine (mean differences compared with control: refraction, 0.62 [95% CI, 0.17-1.07]; AXL, -0.25 [-0.44 to -0.06]). In terms of myopia control as assessed by relative risk (RR) for overall myopia progression, 0.05% was ranked as the most beneficial concentration (RR, 0.39 [95% CI, 0.27-0.57]). The risk for adverse effects tended to rise as the atropine concentration was increased, although this tendency was not evident for distance BCVA. No valid network was formed for near BCVA.
The ranking probability for efficacy was not proportional to dose (i.e., 0.05% atropine was comparable with that of high-dose atropine [1% and 0.5%]), although those for pupil size and accommodation amplitude were dose related.
不同浓度阿托品治疗近视的疗效和安全性比较
阿托品已被证实是一种有效延缓近视进展的干预措施。然而，目前尚无充分证据来评估不同浓度阿托品的临床效果。
我们于 2021 年 4 月 14 日检索了 PubMed、EMBASE、Cochrane 中心对照试验注册库、世界卫生组织国际临床试验注册平台和 ClinicalTrials.gov，纳入了至少 1 年阿托品治疗儿童近视控制的研究。我们对随机对照试验（RCT）进行了网络荟萃分析（NMA），比较了 8 种阿托品浓度（1%至 0.01%）。我们通过 P 分（估计最佳治疗的概率）对阿托品浓度进行排名。我们的主要结局是屈光度（年变化量，屈光度/年）和眼轴长度（AXL；年变化量，毫米/年）的平均年变化。我们提取了显示近视进展和安全性结局（明视瞳孔直径、中视瞳孔直径、调节幅度以及远、近视力最佳矫正值）的眼比例数据。
从 16 项 RCT 中获得了 30 项两两比较。我们的 NMA 对 1%、0.5%和 0.05%的阿托品浓度进行了排名，认为这 3 种浓度在评估近视控制的两种主要结局时最有益：1%的阿托品（与对照组相比的平均差异：屈光度，0.81[95%置信区间（CI），0.58-1.04]；AXL，-0.35[-0.46 至-0.25]）；0.5%的阿托品（与对照组相比的平均差异：屈光度，0.70[95% CI，0.40-1.00]；AXL，-0.23[-0.38 至-0.07]）；0.05%的阿托品（与对照组相比的平均差异：屈光度，0.62[95% CI，0.17-1.07]；AXL，-0.25[-0.44 至-0.06]）。在评估总体近视进展的相对风险（RR）方面，0.05%被认为是最有益的浓度（RR，0.39[95% CI，0.27-0.57]）。虽然阿托品浓度增加与不良反应风险呈正相关，但这种趋势在远视力最佳矫正值方面并不明显。对于近视力最佳矫正值，没有形成有效的网络。
虽然阿托品的疗效排名概率与剂量不成比例（即 0.05%阿托品与高剂量阿托品[1%和 0.5%]相当），但瞳孔大小和调节幅度与剂量有关。
