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25G玻璃体切割术结束时玻璃体腔内注射康柏西普辅助治疗重度增殖性糖尿病视网膜病变的效果:一项随机对照试验的6个月结果

Effect of Adjunctive Intravitreal Conbercept Injection at the End of 25G Vitrectomy on Severe Proliferative Diabetic Retinopathy: 6-Month Outcomes of a Randomised Controlled Trial.

作者信息

Li Houshuo, Niu Yunli, Rong Ao, Bi Yanlong, Xu Wei, Cui Hongping

机构信息

Department of Ophthalmology, Tongji Hospital, School of Medicine, Tongji University, 389 Xincun Road, Shanghai, 200065, China.

Department of Ophthalmology, Shanghai East Hospital, School of Medicine, Tongji University, 150 Jimo Road, Shanghai, 200120, China.

出版信息

Ophthalmol Ther. 2023 Apr;12(2):1173-1180. doi: 10.1007/s40123-023-00664-6. Epub 2023 Feb 8.

Abstract

INTRODUCTION

This study aimed to evaluate the effect of pre-operative versus pre-operative plus post-operative intravitreal conbercept (IVC) injection on severe proliferative diabetic retinopathy (PDR).

METHODS

This was a prospective, comparative and randomised study. A total of 84 patients who underwent vitrectomy for severe PDR were included in this study. Patients were randomly divided into control (41 eyes) and experiment (43 eyes) groups. Patients in the experiment group received adjunctive pre-operative and post-operative IVC injection, whereas patients in the control group only received pre-operative IVC injection. The incidence of post-operative vitreous haemorrhage (POVH), best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were determined.

RESULTS

The incidence of early POVH was significantly different between the two groups, but no significant difference was observed between groups at 3 and 6 months. In the experiment group, the BCVA was significantly improved 1 month after surgery when compared with the control group (p 0.019). There was no marked difference in the mean post-operative BCVA at 3 and 6 months between groups (p 0.063 and 0.082). CRT was significantly lower in the experiment group than in the control group at 1 and 3 months after surgery (p 0.037 and 0.041), but there was no significant difference at 6 months (p 0.894).

CONCLUSION

Additional IVC injected at the end of surgery improves the POVH and BCVA at the early stage after surgery in severe PDR, but this benefit is absent at 6 months. Further studies are needed to investigate the effect of IVC at the end of vitrectomy.

TRIAL REGISTRATION

chictr.org.cn identifier: ChiCTR2200060735. Retrospectively registered, register date: 9 June 2022.

摘要

引言

本研究旨在评估术前玻璃体腔注射康柏西普(IVC)与术前加术后IVC注射对重度增殖性糖尿病视网膜病变(PDR)的影响。

方法

这是一项前瞻性、对比性随机研究。本研究共纳入84例因重度PDR接受玻璃体切除术的患者。患者被随机分为对照组(41只眼)和实验组(43只眼)。实验组患者在术前和术后接受辅助性IVC注射,而对照组患者仅在术前接受IVC注射。测定术后玻璃体出血(POVH)的发生率、最佳矫正视力(BCVA)和视网膜中央厚度(CRT)。

结果

两组早期POVH的发生率有显著差异,但在3个月和6个月时两组间未观察到显著差异。在实验组,术后1个月时BCVA与对照组相比有显著改善(p 0.019)。两组在术后3个月和6个月时的平均BCVA无显著差异(p 0.063和0.082)。术后1个月和3个月时,实验组的CRT显著低于对照组(p 0.037和0.041),但在6个月时无显著差异(p 0.894)。

结论

在手术结束时额外注射IVC可改善重度PDR术后早期的POVH和BCVA,但在6个月时这种益处消失。需要进一步研究来探讨玻璃体切除术后IVC的效果。

试验注册

中国临床试验注册中心标识符:ChiCTR2200060735。回顾性注册,注册日期:2022年6月9日。

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