阿柏西普和雷珠单抗治疗早产儿视网膜病变的疗效和安全性。

Efficacy and Safety of Aflibercept and Ranibizumab in the Treatment of Retinopathy of Prematurity.

机构信息

Department of Neonatal Pediatrics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.

出版信息

Clin Ther. 2024 Oct;46(10):773-777. doi: 10.1016/j.clinthera.2024.08.011. Epub 2024 Oct 5.

DOI:10.1016/j.clinthera.2024.08.011

PMID:39368879

Abstract

PURPOSE

To compare the efficacy, recurrence rate, and recurrence interval of intravitreal injection of aflibercept (IVA) and ranibizumab (IVR) in patients with retinopathy of prematurity (ROP).

METHODS

This is a single-center retrospective study of neonates hospitalized from January 2018 to March 2023 in the Department of Neonatology of the First Affiliated Hospital of Zhengzhou University who received intravitreal injection of anti-vascular endothelial growth factor owing to type 1 prethreshold ROP, threshold ROP, or aggressive posterior ROP. Clinical data were collected to record the cure, recurrence, number of injections, and side effects of ROP.

FINDINGS

A total of 224 neonates (444 eyes) were enrolled in this study, of which 121 (241 eyes) received IVA and 103 (203 eyes) received IVR. There were no significant differences in the general characteristics of infants between the two groups (P > 0.05). The corrected gestational age of the first injection was 37.27 ± 3.07 weeks in the IVA group and 37.20 ± 4.89 weeks in the IVR group (P = 0.582). The recurrence rate was 15.8% in the IVA group and 14.9% in the IVR group (P = 0.841). For relapsed infants, the postmenstrual age (PMA) was 34.89 ± 3.49 weeks in the IVA group and 35.28 ± 4.43 weeks in the IVR group at the first treatment. The PMA was 43.69 ± 4.57 and 40.96 ± 4.98 weeks at the second treatment in the IVA and IVR groups, respectively (P = 0.185). There were two children in the IVA group that required a third treatment, with PMAs of 58.71 and 57.29 weeks at the time of surgery, and one child in the IVR group, with a PMA of 43.14 weeks at the time of injection (P = 0.221). No complications were recorded in either group.

IMPLICATIONS

The efficacies of aflibercept and ranibizumab in treating ROP are similar, and the safety of the medications was good. Further research should be conducted in large-scale, prospective clinical trials, providing ophthalmologists with new options for the treatment of ROP.

摘要

目的

比较玻璃体内注射阿柏西普（IVA）和雷珠单抗（IVR）治疗早产儿视网膜病变（ROP）的疗效、复发率和复发间隔。

方法

这是一项单中心回顾性研究，纳入了 2018 年 1 月至 2023 年 3 月在郑州大学第一附属医院新生儿科住院的新生儿，他们因 1 型阈值前 ROP、阈值 ROP 或侵袭性后部 ROP 接受了玻璃体内注射抗血管内皮生长因子治疗。收集临床数据以记录 ROP 的治愈、复发、注射次数和副作用。

结果

本研究共纳入 224 名新生儿（444 只眼），其中 121 名（241 只眼）接受 IVA 治疗，103 名（203 只眼）接受 IVR 治疗。两组婴儿的一般特征无显著差异（P＞0.05）。IVA 组首次注射的矫正胎龄为 37.27±3.07 周，IVR 组为 37.20±4.89 周（P=0.582）。IVA 组的复发率为 15.8%，IVR 组为 14.9%（P=0.841）。对于复发的婴儿，IVA 组首次治疗时的校正后胎龄（PMA）为 34.89±3.49 周，IVR 组为 35.28±4.43 周。IVA 组和 IVR 组第二次治疗时的 PMA 分别为 43.69±4.57 周和 40.96±4.98 周（P=0.185）。IVA 组有 2 名儿童需要第三次治疗，手术时的 PMA 分别为 58.71 和 57.29 周，IVR 组有 1 名儿童注射时的 PMA 为 43.14 周（P=0.221）。两组均未记录到任何并发症。