角膜塑形术控制儿童近视有效性与安全性的Meta分析

目的 评价不同治疗时长的角膜塑形术(OK)延缓学龄儿童近视进展的有效性及安全性。 方法 系统检索了PubMed、Cochrane Library、Embase、OVID、中国知网(CNKI)、万方数据库、维普中文期刊数据库(VIP)及中国生物医学文献服务系统(CBM)中随机对照试验(RCT)和前瞻性非随机对照研究(PNC),检索时限为建库至2020年10月31日,结果不受语言限制。2位研究者按照纳入和排除标准进行文献筛选、数据提取及质量评价。使用Rev Man5.3版软件对符合标准的文献进行统计分析。 结果 共纳入4项RCT和12项PNC,涉及1 453名学龄儿童。OK组在0.5年、1年、1.5年、2年随访期延缓眼轴增长方面均有显著差异［0.5年:MD:-0.10 mm,95%CI(-0.12,-0.08),P<0.001;1年:MD:-0.18 mm,95%CI(-0.19,-0.17),P<0.000 1;1.5年:MD:-0.21 mm,95%CI(-0.26,-0.15),P<0.000 1;2年:MD:-0.26 mm,95%CI(-0.30,-0.22),P<0.001］。近视控制比率随着治疗持续时间的延长而降低。0.5年随访期,OK对东亚儿童的眼轴延长减缓效果优于白种儿童,其余随访期两种族均无统计学差异(P>0.05)。随访2年OK组和对照组不良事件发生率的RR=5.75,95%CI(2.23,14.81),P=0.000 3。 结论 角膜塑形镜是控制学龄儿童近视进展的有效、安全的方法,但仍需要更多长期RCT研究评价其持续有效性。

The effectiveness and safety of orthokeratology on controlling myopia of children: a meta-analysis

Objective To access the effectiveness and safety of orthokeratology(OK)on slowing myopia progression in school-aged children in different treatment duration. Methods PubMed, Cochrane Library, Embase, OVID, CNKI, Wanfang database, VIP, and CBM were searched, including randomized controlled trials(RCT)and prospective non-randomized control studies(PNC). Two reviewers independently screened literature, extracted data, and assessed the quality of included studies. The Meta-analysis was performed using RevMan 5.3 version for statistical analysis. Results 4 RCTs and 12 PNCs involving 1 453 participants were included. There were significant differences in the effect of OK group versus control group on slowing axial elongation at 0.5, 1, 1.5, 2 years follow-up periods(0.5a:MD:-0.10 mm, 95%CI: -0.12 to -0.08, P<0.001; 1a: MD: -0.18 mm, 95%CI:-0.19 to -0.17, P<0.001; 1.5a: MD: -0.21 mm, 95%CI: -0.26 to -0.15, P<0.001; 2a: MD:-0.26 mm, 95%CI: -0.30 to -0.22, P<0.001). The myopia control rate decreased with the duration of treatment. Except for the 0.5 years follow-up period, when the effect of OK lens on the reduction of axial elongation in Asian children was better than that in Caucasian, there was no statistical difference in other follow-up periods(P>0.05). The RR of incidence of adverse events in the OK and the control groups at 2-year was 5.75(95%CI:2.23 to 14.81, P=0.000 3). Conclusion Orthokeratology is an effective and safe method on controlling the progression of myopia for school-aged children. However, long-term and additional RCT studies are required to find out its continuing effectiveness.