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进行玻璃体切除术的增生性糖尿病视网膜病变患者的术前雷珠单抗治疗:一项比较间隔变化的随机对照试验

Castillo, J., Aleman, I., Rush, S.W., Rush, R.B

期刊名称:American journal of ophthalmology

卷期:2017年第183卷

摘要

摘要:目的:旨在评估接受玻璃体切割手术治疗活动期增生性糖尿病视网膜病变(PDR)糖尿病患者术前玻璃体腔注射贝伐珠单抗(IVB)的最佳时间间隔。设计:随机临床试验。方法:将56例需要PPV治疗的PDR相关并发症患者随机分为两组:A组在接受PPV1-3天接受IVB2.5mg / 0.1mL),B组在PPV之前5-10天接受IVB2.5mg / 0.1mL)。主要预后指标是随访6个月最佳矫正视力(BCVA)。次要指标为术后6个月随访手术时间,术中并发症,术后并发症及非计划PPV发生率。结果:125例受试者接受PPV并完成6个月随访。与A组患者相比,B组患者的最终BCVAP = .033)更好,术后并发症发生率也更低(P = .018)。组间最终BCVA的平均差异为0.22logMAR95%可信区间:0.02-0.43P = 0.017)。与相比,A组最终BCVA下降1个或更多logMAR的可能性是B组的3.90倍(95%可信区间:1.08-17.31P = .046)。治疗组之间的基线特征,术中手术时间,术中并发症以及计划外PPV发生率没有显着差异。结论:随机临床试验显示,PPV术前5-10IVB治疗PDR相关并发症的术后预后优于术前1-3天治疗。

PURPOSE:To assess the optimal interval of preoperative intravitreal bevacizumab (IVB) administration in diabetic subjects undergoing pars plana vitrectomy (PPV) for severe manifestations of active proliferative diabetic retinopathy (PDR).DESIGN:Randomized clinical trial.METHODS:One hundred and fifty-six patients with PDR-related complications requiring PPV were prospectively randomized into 1 of 2 treatment groups: Group A received IVB (2.5mg/0.1mL) 1-3days before PPV, while Group B received IVB (2.5mg/0.1mL) 5-10days before PPV. The primary outcome was best-corrected visual acuity (BCVA) at 6months follow-up. Secondary outcome measures were intraoperative surgery time, intraoperative complications, postoperative complications, and incidence of unplanned PPV at 6months follow-up.RESULTS:One hundred and twenty-five subjects underwent PPV and completed the 6-month follow-up interval. Group B patients had better final BCVA (P=.033) and were less likely to have a postoperative complication (P= .018) when compared to Group A patients. The mean difference in final BCVA between groups was 0.22 logMAR (95% confidence interval: 0.02-0.43, P= .017). Group A was 3.90 (95% confidence interval: 1.08-17.31, P= .046) times more likely to have a loss of 1 or more logMAR lines of final BCVA when compared to Group B. There were no significant differences among the treatment groups with regard to baseline features, intraoperative surgery time, intraoperative complications, and incidence of unplanned PPV during the study interval.CONCLUSIONS:This randomized clinical trial demonstrated better postoperative outcomes at 6months when subjects received preoperative IVB 5-10days before PPV compared to 1-3days for the treatment of PDR-related complications.


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