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增殖性糖尿病视网膜病变患者玻璃体切除术前和术中玻璃体内注射雷珠单抗手术效果的前瞻性比较

Prospective Comparison of Surgery Outcome Between Preoperative and Intraoperative Intravitreal Injection of Ranibizumab for Vitrectomy in Proliferative Diabetic Retinopathy Patients.

作者信息

Li Siying, Tang Jiyang, Han Xinyao, Wang Zongyi, Zhang Linqi, Zhao Mingwei, Qu Jinfeng

机构信息

Department of Ophthalmology, Peking University People's Hospital, No. 11 South Avenue of XiZhiMen, Xi Cheng District, Beijing, 100044, People's Republic of China.

Eye Diseases and Optometry Institute, Beijing, 100044, China.

出版信息

Ophthalmol Ther. 2022 Oct;11(5):1833-1845. doi: 10.1007/s40123-022-00550-7. Epub 2022 Jul 29.

Abstract

INTRODUCTION

To compare the efficacy and safety of intravitreal injections of ranibizumab (IVR) before and at the end of vitrectomy in proliferative diabetic retinopathy (PDR) patients.

METHODS

A prospective comparative study was performed on 60 eyes of 52 PDR patients who received ranibizumab injection (0.5 mg/0.05 ml) 3-5 days before vitrectomy (preoperative group) and 55 eyes of 50 PDR patients who received ranibizumab injection (0.5 mg/0.05 ml) at the end of vitrectomy (intraoperative group). Intra- and postoperative indices were collected for further comparison.

RESULTS

Postoperative best-corrected visual acuity (BCVA) in preoperative group was better than in intraoperative group at 1 week after surgery (P < 0.05) but comparable at 1- and 3-month follow-up (P = 0.20 and P = 0.37, respectively). Central retinal thickness (CRT) in preoperative group was lower than in intraoperative group at 1 week postoperatively (P < 0.05), but comparable at 1- and 3-month follow-up (P = 0.39 and P = 0.77, respectively). The average surgery time was significantly shorter in preoperative group than in intraoperative group (61.50 ± 11.44 min vs. 74.49 ± 12.01 min, P < 0.01). The incidence of intraoperative bleeding was significant lower in preoperative group than in intraoperative group (21.7% vs. 40.0%, P < 0.05). Moreover, the incidence of intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade were all significantly lower in preoperative group than that in intraoperative group (P < 0.05, respectively). The incidences of postoperative vitreous hemorrhage (VH), neovascular glaucoma (NVG), recurrent retinal detachment, postoperative fibrovascular proliferation progression and reoperation showed no statistical differences between the two groups (P > 0.05, respectively). Both groups had no ocular or system adverse events during observation period.

CONCLUSION

In vitrectomy for PDR, preoperative IVR can significantly reduce surgery time and lower the incidence of intraoperative bleeding, intraocular electrocoagulation use, iatrogenic retinal breaks, relaxing retinotomy and silicone oil tamponade during surgery and gain short-term better postoperative BCVA and thinner CRT.

TRIAL REGISTRATION

ClinicalTrials.gov (identifier, NCT05408416).

摘要

引言

比较增殖性糖尿病视网膜病变(PDR)患者在玻璃体切割术前及术末玻璃体腔内注射雷珠单抗(IVR)的疗效和安全性。

方法

对52例PDR患者的60只眼进行前瞻性对照研究,这些患者在玻璃体切割术前3 - 5天接受雷珠单抗注射(0.5mg/0.05ml)(术前组),以及对50例PDR患者的55只眼在玻璃体切割术末接受雷珠单抗注射(0.5mg/0.05ml)(术中组)。收集术中和术后指标进行进一步比较。

结果

术后1周时,术前组的术后最佳矫正视力(BCVA)优于术中组(P < 0.05),但在1个月和3个月随访时相当(分别为P = 0.20和P = 0.37)。术后1周时,术前组的中央视网膜厚度(CRT)低于术中组(P < 0.05),但在1个月和3个月随访时相当(分别为P = 0.39和P = 0.77)。术前组的平均手术时间显著短于术中组(61.50 ± 11.44分钟 vs. 74.49 ± 12.01分钟,P < 0.01)。术前组术中出血的发生率显著低于术中组(21.7% vs. 40.0%,P < 0.05)。此外,术前组眼内电凝使用、医源性视网膜裂孔、视网膜松解切开术和硅油填充的发生率均显著低于术中组(分别为P < 0.05)。两组术后玻璃体出血(VH)、新生血管性青光眼(NVG)、复发性视网膜脱离、术后纤维血管增生进展和再次手术的发生率无统计学差异(分别为P > 0.05)。两组在观察期内均未发生眼部或全身不良事件。

结论

在PDR的玻璃体切割术中,术前IVR可显著缩短手术时间,降低术中出血、眼内电凝使用、医源性视网膜裂孔、视网膜松解切开术和硅油填充的发生率,并在术后短期内获得更好的BCVA和更薄的CRT。

试验注册

ClinicalTrials.gov(标识符,NCT05408416)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c7e/9437166/8e2c0724e617/40123_2022_550_Fig1_HTML.jpg

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