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激光光凝联合或不联合玻璃体内注射雷珠单抗治疗糖尿病性黄斑水肿的有效性和安全性:一项系统评价和Meta分析

Efficiency and safety of laser photocoagulation with or without intravitreal ranibizumab for treatment of diabetic macular edema: a systematic review and Meta-analysis.

作者信息

Qian Tian-Wei, Zhao Meng-Ya, Li Xin-Xin, Xu Xun

机构信息

Department of Ophthalmology, Shanghai General Hospital; Shanghai Key Laboratory of Ocular Fundus Diseases, Shanghai 200080, China.

出版信息

Int J Ophthalmol. 2017 Jul 18;10(7):1134-1143. doi: 10.18240/ijo.2017.07.18. eCollection 2017.

Abstract

AIM

To compare the therapeutic effect and safety of laser photocoagulation along with intravitreal ranibizumab (IVR) versus laser therapy in treatment of diabetic macular edema (DME).

METHODS

Pertinent publications were identified through comprehensive searches of PubMed, EMBASE, Web of Science, Cochrane Library, and ClinicalTrials.gov to identify randomized clinical trials (RCTs) comparing IVR+laser to laser monotherapy in patients with DME. Therapeutic effect estimates were determined by weighted mean differences (WMD) of change from baseline in best corrected visual acuity (BCVA) and central retinal thickness (CRT) at 6, 12, or 24mo after initial treatment, and the risk ratios (RR) for the proportions of patients with at least 10 letters of improvement or reduction at 12mo. Data regarding major ocular and nonocular adverse events (AEs) were collected and analyzed. The Review Manager 5.3.5 was used.

RESULTS

Six RCTs involving 2069 patients with DME were selected for this Meta-analysis. The results showed that IVR+laser significantly improved BCVA compared with laser at 6mo (WMD: 6.57; 95% CI: 4.37-8.77; <0.00001), 12mo (WMD: 5.46; 95% CI: 4.35-6.58; <0.00001), and 24mo (WMD: 3.42; 95% CI: 0.84-5.99; =0.009) in patients with DME. IVR+laser was superior to laser in reducing CRT at 12mo from baseline with statistical significance (WMD: -63.46; 95% CI: -101.19 to -25.73; =0.001). The pooled RR results showed that the proportions of patients with at least 10 letters of improvement or reduction were in favor of IVR+laser arms compared with laser (RR: 2.13; 95% CI: 1.77-2.57; <0.00001 and RR: 0.37; 95% CI: 0.22-0.62; =0.0002, respectively). As for AEs, the pooled results showed that a significantly higher proportion of patients suffering from conjunctival hemorrhage (study eye) and diabetic retinal edema (fellow eye) in IVR+laser group compared to laser group (RR: 3.29; 95% CI: 1.53-7.09; =0.002 and RR: 3.02; 95% CI: 1.24-7.32; =0.01, respectively). The incidence of other ocular and nonocular AEs considered in this Meta-analysis had no statistical difference between IVR+laser and laser alone.

CONCLUSION

The results of our analysis show that IVR+laser has better availability in functional (improving BCVA) and anatomic (reducing CRT) outcomes than laser monotherapy for the treatment of DME. However, the patients who received the treatment of IVR+laser may get a higher risk of suffering from conjunctival hemorrhage (study eye) and diabetic retinal edema (fellow eye).

摘要

目的

比较激光光凝联合玻璃体内注射雷珠单抗(IVR)与单纯激光治疗糖尿病性黄斑水肿(DME)的疗效和安全性。

方法

通过全面检索PubMed、EMBASE、科学网、Cochrane图书馆和ClinicalTrials.gov等数据库,查找比较IVR联合激光与单纯激光治疗DME患者的随机临床试验(RCT)。治疗效果评估通过初始治疗后6、12或24个月时最佳矫正视力(BCVA)和中心视网膜厚度(CRT)相对于基线变化的加权平均差(WMD),以及12个月时视力至少提高或降低10行的患者比例的风险比(RR)来确定。收集并分析有关主要眼部和非眼部不良事件(AE)的数据。使用Review Manager 5.3.5软件进行分析。

结果

本Meta分析选取了6项涉及2069例DME患者的RCT。结果显示,在DME患者中,IVR联合激光治疗在6个月时(WMD:6.57;95%CI:4.37 - 8.77;<0.00001)、12个月时(WMD:5.46;95%CI:4.35 - 6.58;<0.00001)和24个月时(WMD:3.42;95%CI:0.84 - 5.99;=0.009)的BCVA改善情况均显著优于单纯激光治疗。IVR联合激光治疗在12个月时使CRT相对于基线的降低幅度优于单纯激光治疗,差异具有统计学意义(WMD:-63.46;95%CI:-101.19至-25.73;=0.001)。汇总的RR结果显示,视力至少提高或降低10行的患者比例,IVR联合激光治疗组优于单纯激光治疗组(RR:2.13;95%CI:1.77 - 2.57;<0.00001和RR:0.37;95%CI:0.22 - 0.62;=0.0002)。关于AE,汇总结果显示,IVR联合激光治疗组结膜出血(患眼)和糖尿病性视网膜水肿(对侧眼)的患者比例显著高于单纯激光治疗组(RR:3.29;95%CI:1.53 - 7.09;=0.002和RR:3.02;95%CI:1.24 - 7.32;=0.01)。本Meta分析中考虑的其他眼部和非眼部AE的发生率在IVR联合激光治疗组和单纯激光治疗组之间无统计学差异。

结论

我们的分析结果表明,对于DME的治疗,IVR联合激光治疗在功能(改善BCVA)和解剖(降低CRT)结局方面比单纯激光治疗具有更好的效果。然而,接受IVR联合激光治疗的患者发生结膜出血(患眼)和糖尿病性视网膜水肿(对侧眼)的风险可能更高。

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Vascular endothelial growth factor and diabetic macular edema.血管内皮生长因子与糖尿病性黄斑水肿
Surv Ophthalmol. 2016 Nov-Dec;61(6):759-768. doi: 10.1016/j.survophthal.2016.03.010. Epub 2016 Apr 1.
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A multimodal approach to diabetic macular edema.糖尿病性黄斑水肿的多模式治疗方法。
J Diabetes Complications. 2016 Apr;30(3):545-53. doi: 10.1016/j.jdiacomp.2015.11.008. Epub 2015 Nov 14.

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