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玻璃体切割术联合或不联合术前玻璃体内贝伐单抗治疗增生型糖尿病视网膜病变:一项随机对照试验的荟萃分析。

Vitrectomy with or without preoperative intravitreal bevacizumab for proliferative diabetic retinopathy: a meta-analysis of randomized controlled trials.

机构信息

Department of Ophthalmology, Shanghai First People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China.

出版信息

Am J Ophthalmol. 2013 Jul;156(1):106-115.e2. doi: 10.1016/j.ajo.2013.02.008.

Abstract

PURPOSE

To compare safety and functional outcomes of vitrectomy with or without preoperative intravitreal bevacizumab (IVB) for proliferative diabetic retinopathy (PDR).

DESIGN

A meta-analysis of randomized controlled trials.

METHODS

PubMed, Medline, EMBASE, and Cochrane Controlled Trials Register were searched to identify potentially relevant randomized controlled trials. A total of 394 participants with 414 eyes in 8 trials were analyzed using RevMan 5.1 software. The primary measures included intraoperative bleeding, total surgical time, and early and late recurrent hemorrhage.

RESULTS

Vitrectomy with IVB pretreatment achieved shorter overall surgical time (mean difference = -26.89 minutes, 95% confidence interval [CI] -31.38 to -22.39, P < .00001) and smaller number of endodiathermy applications (mean difference = -3.46, 95% CI -6.43 to -0.49, P = .02) compared to vitrectomy alone. The IVB group was also associated with less intraoperative bleeding (odds ratio [OR] = 0.10; 95% CI 0.02 to 0.46; P = .003) and recurrent vitreous hemorrhage within first month (OR = 0.35; 95% CI 0.21 to 0.58; P < .0001), but the proportion of recurrent vitreous hemorrhage after the first month was comparable between both groups. There were no significant differences in other complication rates between the 2 groups, with the exception of iatrogenic retinal break, which was more likely with the vitrectomy-alone group (OR = 0.27, 95% CI 0.12 to 0.63, P = .003). Results were robust to sensitivity analyses.

CONCLUSIONS

Adjuvant intravitreal injection of bevacizumab prior to vitrectomy in PDR patients significantly eased the procedure, diminished intraoperative complications, and reduced early postoperative hemorrhage without increasing the risk of vision-threatening complications. Further trials should determine the optimal interval and dosage for IVB injection.

摘要

目的

比较增生型糖尿病视网膜病变(PDR)患者行玻璃体切除术联合与不联合术前玻璃体内注射贝伐单抗(IVB)的安全性和功能结局。

设计

随机对照试验的荟萃分析。

方法

检索 PubMed、Medline、EMBASE 和 Cochrane 对照试验注册库,以确定潜在相关的随机对照试验。使用 RevMan 5.1 软件分析 8 项试验中的 394 名参与者(414 只眼)。主要指标包括术中出血、总手术时间以及早期和晚期复发性出血。

结果

与单独玻璃体切除术相比,玻璃体切除术联合 IVB 预处理可显著缩短总手术时间(平均差值=-26.89 分钟,95%置信区间[CI]:-31.38 至-22.39,P<.00001)和减少电凝应用次数(平均差值=-3.46,95%CI:-6.43 至-0.49,P=.02)。IVB 组术中出血量也较少(比值比[OR]:0.10;95%CI:0.02 至 0.46;P=.003),且术后 1 个月内复发性玻璃体积血的发生率较低(OR:0.35;95%CI:0.21 至 0.58;P<.0001),但两组术后第 1 个月后复发性玻璃体积血的比例无显著差异。两组间其他并发症发生率无显著差异,除医源性视网膜裂孔外,单独玻璃体切除术组的发生率更高(OR:0.27,95%CI:0.12 至 0.63,P=.003)。敏感性分析结果稳健。

结论

在 PDR 患者中,玻璃体切除术联合玻璃体内注射贝伐单抗可显著简化手术过程,减少术中并发症,降低术后早期出血风险,且不会增加威胁视力的并发症风险。进一步的试验应确定 IVB 注射的最佳间隔和剂量。

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