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贝伐单抗治疗早产儿视网膜病变的效果和并发症:台湾多中心研究。

Effects and complications of bevacizumab use in patients with retinopathy of prematurity: a multicenter study in taiwan.

机构信息

Department of Ophthalmology, Chang Gung Memorial Hospital, Taoyuan, Taiwan.

出版信息

Ophthalmology. 2011 Jan;118(1):176-83. doi: 10.1016/j.ophtha.2010.04.018. Epub 2010 Jul 29.

DOI:10.1016/j.ophtha.2010.04.018
PMID:20673589
Abstract

PURPOSE

To investigate the effects and complications of the anti-vascular endothelial growth factor agent bevacizumab in the treatment of retinopathy of prematurity (ROP) in Taiwanese patients.

DESIGN

A multicenter, retrospective case series study.

PARTICIPANTS

Twenty-seven patients (49 eyes) from 4 medical centers across Taiwan.

METHODS

This study included patients receiving intravitreal injections of bevacizumab (IVB) (0.625 mg) for the treatment of ROP between 2007 and 2009 at 4 major medical centers in Taiwan. The effects and complications associated with this treatment were analyzed. Patients were followed for at least 6 months after bevacizumab injection.

MAIN OUTCOME MEASURES

Regression of ROP and the complications associated with the injection of bevacizumab.

RESULTS

Forty-nine eyes of 27 patients (18 male and 9 female) were included in the study. Mean gestational age and birth weight were 26.0 ± 2.4 weeks and 971.6 ± 589.6 g, respectively. There were 41 eyes (23 patients) with stage 3 ROP, 6 eyes (3 patients) with stage 4A ROP, and 2 eyes (1 patient) with stage 5 ROP. All of the eyes received only a single injection of IVB. The mean injection time was 36.8 ± 2.6 weeks postmenstrual age for eyes with stage 3 ROP. A total of 37 of 41 eyes (90%) with stage 3 ROP regressed after bevacizumab injection only. Four eyes (10%) required additional laser treatment to regress the ROP. Of 6 eyes (3 patients) with stage 4A ROP, 2 eyes (1 patient; 33%) regressed after bevacizumab injection and 4 eyes (67%) regressed after bevacizumab injection and subsequent vitrectomy. The 2 eyes with stage 5 ROP exhibited decreased vascular tortuosity after bevacizumab injection, but the retina failed to reattach after vitrectomy surgeries. Major complications included vitreous or pre-retinal hemorrhage in 4 eyes (8%) and transient vascular sheathing in 2 eyes (4%).

CONCLUSIONS

Bevacizumab injection seems effective and well tolerated in some cases of ROP, especially in stage 3 ROP. Ocular complications could result from the injection of bevacizumab in pediatric eyes.

摘要

目的

探讨抗血管内皮生长因子药物贝伐单抗治疗台湾早产儿视网膜病变(ROP)的效果和并发症。

设计

多中心回顾性病例系列研究。

参与者

来自台湾 4 家医疗中心的 27 名患者(49 只眼)。

方法

本研究纳入了 2007 年至 2009 年间在台湾 4 家主要医疗中心接受贝伐单抗(IVB)(0.625mg)玻璃体腔内注射治疗 ROP 的患者。分析了与这种治疗相关的效果和并发症。在接受贝伐单抗注射后,患者至少随访 6 个月。

主要观察指标

ROP 消退情况以及与贝伐单抗注射相关的并发症。

结果

本研究纳入了 27 名患者(18 名男性和 9 名女性)的 49 只眼。平均胎龄和出生体重分别为 26.0±2.4 周和 971.6±589.6g。其中 41 只眼(23 名患者)患有 3 期 ROP,6 只眼(3 名患者)患有 4A 期 ROP,2 只眼(1 名患者)患有 5 期 ROP。所有患者均仅接受单次 IVB 注射。对于 3 期 ROP 患者,注射时间平均为矫正胎龄后 36.8±2.6 周。接受贝伐单抗注射后,仅 41 只眼中的 37 只(90%)眼的 ROP 消退。4 只眼(10%)需要额外的激光治疗来消退 ROP。6 只眼中的 2 只(1 名患者;33%)眼的 4A 期 ROP 在接受贝伐单抗注射后消退,4 只眼(67%)眼在接受贝伐单抗注射和随后的玻璃体切除术后退缩。2 只患有 5 期 ROP 的眼在接受贝伐单抗注射后血管迂曲程度降低,但玻璃体切除术失败后视网膜未再附着。主要并发症包括 4 只眼(8%)玻璃体积血或视网膜前出血和 2 只眼(4%)短暂血管鞘。

结论

贝伐单抗注射在某些 ROP 病例中似乎有效且耐受良好,尤其是在 3 期 ROP 中。在儿科眼中,眼内注射贝伐单抗可能会导致眼部并发症。

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