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Abstract：
OBJECTIVE: To evaluate the clinical efficacy of dexamethasone (DEX) implant, for the treatment of macular edema (ME) caused by retinal vein occlusion (RVO) and diabetic retinopathy (DR) through a systematic review and meta-analysis.
METHODS: The PubMed, Embase and Cochrane Library databases were comprehensively searched from inception to November 21, 2022, for studies evaluating the clinical efficacy of DEX implant for patients with retinal vein occlusion macular edema (RVO-ME) or diabetic macular edema (DME). Randomized controlled trials (RCTs) published in English were considered eligible. The Cochrane Collaboration tool was applied to assess the risk of bias in each study. Effect estimates with 95% confidence intervals (CIs) were pooled using the random effects model. We also conducted subgroup analyses to explore the sources of heterogeneity and the stability of the results.
RESULTS: This meta-analysis included 8 RCTs (RVO-ME [n = 2] and DME [n = 6]) assessing a total of 336 eyes. Compared with anti-VEGF therapy, DEX implant treatment achieved superior outcomes in terms of best corrected visual acuity (BCVA) (mean difference [MD] = -3.68 ([95% CI, -6.11 to -1.25], P = 0.003), and no heterogeneity was observed (P = 0.43, I2 = 0%). DEX implant treatment also significantly reduced central macular thickness (CMT) compared with anti-VEGF treatment (MD = -31.32 [95% CI, -57.92 to -4.72], P = 0.02), and there was a high level of heterogeneity between trials (P = 0.04, I2 = 54%). In terms of severe adverse events, DEX implant treatment had a higher risk of elevated intraocular pressure than anti-VEGF therapy (RR = 6.98; 95% CI: 2.16 to 22.50; P = 0.001), and there was no significant difference in cataract progression between the two groups (RR = 1.83; 95% CI: 0.63 to 5.27, P = 0.31).
CONCLUSIONS: Compared with anti-VEGF therapy, DEX implant treatment is more effective in improving BCVA and reducing ME. Additionally, DEX implant treatment has a higher risk of elevated intraocular pressure. Due to the small number of studies and the short follow-up period, the results should be interpreted with caution. The long-term effects of the two treatments need to be further determined.
BACKGROUND: Prospero Registration Number CRD42021243185.
METHODS: The PubMed, Embase and Cochrane Library databases were comprehensively searched from inception to November 21, 2022, for studies evaluating the clinical efficacy of DEX implant for patients with retinal vein occlusion macular edema (RVO-ME) or diabetic macular edema (DME). Randomized controlled trials (RCTs) published in English were considered eligible. The Cochrane Collaboration tool was applied to assess the risk of bias in each study. Effect estimates with 95% confidence intervals (CIs) were pooled using the random effects model. We also conducted subgroup analyses to explore the sources of heterogeneity and the stability of the results.
RESULTS: This meta-analysis included 8 RCTs (RVO-ME [n = 2] and DME [n = 6]) assessing a total of 336 eyes. Compared with anti-VEGF therapy, DEX implant treatment achieved superior outcomes in terms of best corrected visual acuity (BCVA) (mean difference [MD] = -3.68 ([95% CI, -6.11 to -1.25], P = 0.003), and no heterogeneity was observed (P = 0.43, I2 = 0%). DEX implant treatment also significantly reduced central macular thickness (CMT) compared with anti-VEGF treatment (MD = -31.32 [95% CI, -57.92 to -4.72], P = 0.02), and there was a high level of heterogeneity between trials (P = 0.04, I2 = 54%). In terms of severe adverse events, DEX implant treatment had a higher risk of elevated intraocular pressure than anti-VEGF therapy (RR = 6.98; 95% CI: 2.16 to 22.50; P = 0.001), and there was no significant difference in cataract progression between the two groups (RR = 1.83; 95% CI: 0.63 to 5.27, P = 0.31).
CONCLUSIONS: Compared with anti-VEGF therapy, DEX implant treatment is more effective in improving BCVA and reducing ME. Additionally, DEX implant treatment has a higher risk of elevated intraocular pressure. Due to the small number of studies and the short follow-up period, the results should be interpreted with caution. The long-term effects of the two treatments need to be further determined.
BACKGROUND: Prospero Registration Number CRD42021243185.
摘要：
目的：评价地塞米松（DEX）植入物的临床疗效，通过系统评价和荟萃分析，对视网膜静脉阻塞（RVO）和糖尿病视网膜病变（DR）引起的黄斑水肿（ME）进行治疗。
方法：PubMed，从开始到2022年11月21日，对Embase和CochraneLibrary数据库进行了全面搜索，以评估DEX植入物对视网膜静脉阻塞黄斑水肿（RVO-ME）或糖尿病性黄斑水肿（DME）患者的临床疗效。以英文发表的随机对照试验（RCT）被认为是合格的。Cochrane协作工具用于评估每个研究中的偏倚风险。使用随机效应模型合并具有95%置信区间(CI)的效应估计。我们还进行了亚组分析，以探索异质性的来源和结果的稳定性。
结果：该荟萃分析包括8项RCT（RVO-ME[n=2]和DME[n=6]），评估了总共336只眼。与抗VEGF治疗相比，DEX植入治疗在最佳矫正视力（BCVA）方面取得了优异的结果（平均差异[MD]=-3.68（[95%CI，-6.11至-1.25]，P=0.003),未观察到异质性(P=0.43,I2=0%)。与抗VEGF治疗相比，DEX植入治疗也显著降低了黄斑中心厚度（CMT）（MD=-31.32[95%CI，-57.92至-4.72]，P=0.02),并且试验之间存在高度异质性(P=0.04,I2=54%).就严重不良事件而言，DEX植入治疗的眼内压升高风险高于抗VEGF治疗(RR=6.98;95%CI:2.16~22.50;P=0.001),两组间白内障进展无显著差异(RR=1.83;95%CI:0.63~5.27,P=0.31)。
结论：与抗VEGF治疗相比，DEX植入治疗在改善BCVA和减少ME方面更有效。此外,DEX植入治疗具有较高的眼内压升高的风险。由于研究数量少，随访时间短，结果应谨慎解释.两种治疗的长期效果需要进一步确定。
背景：Prospero注册号CRD42021243185。
方法：PubMed，从开始到2022年11月21日，对Embase和CochraneLibrary数据库进行了全面搜索，以评估DEX植入物对视网膜静脉阻塞黄斑水肿（RVO-ME）或糖尿病性黄斑水肿（DME）患者的临床疗效。以英文发表的随机对照试验（RCT）被认为是合格的。Cochrane协作工具用于评估每个研究中的偏倚风险。使用随机效应模型合并具有95%置信区间(CI)的效应估计。我们还进行了亚组分析，以探索异质性的来源和结果的稳定性。
结果：该荟萃分析包括8项RCT（RVO-ME[n=2]和DME[n=6]），评估了总共336只眼。与抗VEGF治疗相比，DEX植入治疗在最佳矫正视力（BCVA）方面取得了优异的结果（平均差异[MD]=-3.68（[95%CI，-6.11至-1.25]，P=0.003),未观察到异质性(P=0.43,I2=0%)。与抗VEGF治疗相比，DEX植入治疗也显著降低了黄斑中心厚度（CMT）（MD=-31.32[95%CI，-57.92至-4.72]，P=0.02),并且试验之间存在高度异质性(P=0.04,I2=54%).就严重不良事件而言，DEX植入治疗的眼内压升高风险高于抗VEGF治疗(RR=6.98;95%CI:2.16~22.50;P=0.001),两组间白内障进展无显著差异(RR=1.83;95%CI:0.63~5.27,P=0.31)。
结论：与抗VEGF治疗相比，DEX植入治疗在改善BCVA和减少ME方面更有效。此外,DEX植入治疗具有较高的眼内压升高的风险。由于研究数量少，随访时间短，结果应谨慎解释.两种治疗的长期效果需要进一步确定。
背景：Prospero注册号CRD42021243185。
