Efficacy and safety of different doses of a slow-release corticosteroid implant for macular edema: meta-analysis of randomized controlled trials.

Efficacy and safety of different doses of a slow-release corticosteroid implant for macular edema: meta-analysis of randomized controlled trials.
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不同剂量的缓释皮质类固醇植入物治疗黄斑水肿的疗效和安全性:随机对照试验的荟萃分析

DOI:
10.2147/dddt.s82929
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发表时间:
2015
期刊:
Drug design, development and therapy
影响因子:
--
通讯作者:
Yu J
Yu J
中科院分区:
其他
文献类型:
--
作者:
Liu Q;He M;Shi H;Wang Q;Du Y;Liu J;Ren C;Xu D;Yu J

文献摘要

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背景 本荟萃分析的目的是评估玻璃体内皮质类固醇植入物治疗黄斑水肿的有效性和安全性。方法 纳入了先前报道的随机对照试验中总共 3,586 名患者。使用 RevMan 5.2 进行荟萃分析。根据研究间异质性,采用随机效应或固定效应模型计算总结比值比 (OR) 和 95% 置信区间 (CI)。主要结果指标是玻璃体内皮质类固醇植入物的效果和安全性的 OR。结果 纳入了四项符合条件的研究。与假手术组相比,高剂量组和低剂量组视力改善≥15个字母的OR分别为1.89(95% CI 1.33-2.69,P=0.0004)和1.62(95% CI 1.10-2.41,P=0.02)。中央视网膜厚度增加的权重平均差异分别为-75.46 (95% CI -90.29, -60.63, P<0.0001)和-46.47 (95% CI -92.08, -0.86, P=0.05)。然而,两个干预组眼压升高的OR值均高于假手术组,分别为11.50(95% CI 7.24-18.28,P<0.00001)和10.30(95% CI 6.49-16.36,P<0.00001)。两个干预组的白内障发病率分别为7.25(95% CI 5.68-9.25,P<0.00001)和3.56(95% CI 1.28-9.96,P=0.02)。除白内障发生率 OR 为 1.59(95% CI 1.28-1.97,P<0.001)外,干预组之间没有显着差异。结论玻璃体内皮质类固醇植入治疗黄斑水肿有效。然而,疗效与皮质类固醇剂量无关。
Background The purpose of this meta-analysis was to assess the efficacy and safety of intravitreal corticosteroid implants for macular edema. Methods A total of 3,586 patients from previously reported randomized controlled trials were included. The meta-analysis was performed using RevMan 5.2. Summary odds ratios (ORs) and 95% confidence intervals (CIs) were calculated, employing random-effects or fixed-effects models according to between-study heterogeneity. The main outcome measures were the ORs for effects and safety of intravitreal corticosteroid implants. Results Four eligible studies were included. Compared with the sham group, the ORs for ≥15 letter improvement of visual acuity in the high-dose and low-dose groups were 1.89 (95% CI 1.33–2.69, P=0.0004) and 1.62 (95% CI 1.10–2.41, P=0.02), respectively. The weight mean differences in central retinal thickness increases were −75.46 (95% CI −90.29, −60.63, P<0.0001) and −46.47 (95% CI −92.08, −0.86, P=0.05), respectively. However, the ORs for increased intraocular pressure in both intervention groups were higher than in the sham group, and were 11.50 (95% CI 7.24–18.28, P<0.00001) and 10.30 (95% CI 6.49–16.36, P<0.00001), respectively. The incidence of cataract was 7.25 (95% CI 5.68–9.25, P<0.00001) and 3.56 (95% CI 1.28–9.96, P=0.02) in the two intervention groups, respectively. There was no significant difference between the intervention groups except for the incidence of cataract in which the OR was 1.59 (95% CI 1.28–1.97, P<0.001). Conclusion Intravitreal corticosteroid implants are effective in treating macular edema. However, the efficacy is not related to corticosteroid dose.