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一项评估结膜下注射贝伐单抗在印度患者原发性翼状胬肉手术中的作用的随机对照前瞻性研究。

A randomized controlled prospective study to assess the role of subconjunctival bevacizumab in primary pterygium surgery in Indian patients.

作者信息

Singh Priyanka, Sarkar Lopa, Sethi H S, Gupta V S

机构信息

Department of Ophthalmology, VMMC and Safdarjung Hospital, New Delhi, India.

出版信息

Indian J Ophthalmol. 2015 Oct;63(10):779-84. doi: 10.4103/0301-4738.171508.

DOI:10.4103/0301-4738.171508
PMID:26655003
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4728977/
Abstract

BACKGROUND

Pterygium is an ocular surface disorder with prevalence rates ranges from 0.3% to 29% in different parts of the world. Vascular endothelial growth factor (VEGF) has been detected in increased amounts in pterygium epithelium, compared with normal conjunctiva. Bevacizumab is a recombinant, humanized anti-VEGF antibody suggested as a possible adjunctive therapy for pterygium excision that appears to have a role in prevention of recurrence. We conducted this study to evaluate the role of subconjunctival bevacizumab in primary pterygium surgery in Indian patients.

METHODS

In this randomized prospective clinical study, the patients were randomized into two groups of 30 patients each. Study group received 1.25 mg/0.05 ml subconjunctival bevacizumab 1 week before pterygium surgery with conjunctival autograft. Control group received 1.25 mg (0.05 ml) subconjunctival normal saline 1 week prior to pterygium surgery with conjunctival autograft. Patients were followed up at day 1, day 7, 1 month and 3 months. The main outcome measures were morphology of pterygium after injection, intra-operative ease, recurrence of pterygia, and any complications.

RESULTS

After giving bevacizumab, there was statistically significant improvement in grade, color intensity, size of pterygium, and symptoms of patients. Intra-operatively, less bleeding was observed by the surgeon. No statistically significant difference regarding reduction in astigmatism, improvement of visual acuity, and complications were observed in two groups. Recurrence was noted in five patients (8.33%) in total study population at the end of 3 months. It was present in two patients (6.67%) in Group A and three patients (10%) in Group B.

CONCLUSION

Single preoperative administration of subconjunctival injection bevacizumab given 1 week before the pterygium excision with conjunctival autograft decreases the vascularity of newly formed blood vessels, hence may decrease recurrence rate though not in our study.

摘要

背景

翼状胬肉是一种眼表疾病,在世界不同地区的患病率为0.3%至29%。与正常结膜相比,翼状胬肉上皮中检测到血管内皮生长因子(VEGF)的含量增加。贝伐单抗是一种重组人源化抗VEGF抗体,被认为是翼状胬肉切除术后可能的辅助治疗药物,似乎在预防复发方面有作用。我们进行这项研究以评估结膜下注射贝伐单抗在印度患者原发性翼状胬肉手术中的作用。

方法

在这项随机前瞻性临床研究中,患者被随机分为两组,每组30例。研究组在翼状胬肉手术联合结膜自体移植术前1周接受1.25mg/0.05ml结膜下注射贝伐单抗。对照组在翼状胬肉手术联合结膜自体移植术前1周接受1.25mg(0.05ml)结膜下注射生理盐水。在术后第1天、第7天、1个月和3个月对患者进行随访。主要观察指标为注射后翼状胬肉的形态、术中操作的难易程度、翼状胬肉的复发情况以及任何并发症。

结果

注射贝伐单抗后,翼状胬肉的分级、颜色强度、大小以及患者症状在统计学上有显著改善。术中,外科医生观察到出血较少。两组在散光减少、视力改善和并发症方面未观察到统计学上的显著差异。在3个月结束时,整个研究人群中有5例患者(8.33%)出现复发。A组有2例患者(6.67%)复发,B组有3例患者(10%)复发。

结论

在翼状胬肉切除联合结膜自体移植术前1周单次结膜下注射贝伐单抗可减少新生血管的血管化,因此可能降低复发率,尽管在我们的研究中并非如此。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b02/4728977/5822bf112e20/IJO-63-779-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b02/4728977/5822bf112e20/IJO-63-779-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7b02/4728977/5822bf112e20/IJO-63-779-g006.jpg

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