Aflibercept和Ranibizumab治疗早产儿视网膜病变的有效性和安全性。

IF 3.2 4区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical therapeutics Pub Date : 2024-10-01 DOI:10.1016/j.clinthera.2024.08.011

Tiantian Yang MSc, Jing Zhang MD, Qingfei Hao MD, Shouhui Ma MBBS, Xiuyong Cheng MD

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引用次数: 0

摘要

目的：比较早产儿视网膜病变（ROP）患者玻璃体内注射阿弗利百普（IVA）和雷尼单抗（IVR）的疗效、复发率和复发间隔：这是一项单中心回顾性研究，研究对象为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型阈前ROP、阈ROP或侵袭性后ROP而接受了抗血管内皮生长因子的玻璃体内注射。收集临床数据以记录 ROP 的治愈、复发、注射次数和副作用：共有 224 名新生儿（444 只眼睛）参与了这项研究，其中 121 名新生儿（241 只眼睛）接受了 IVA 治疗，103 名新生儿（203 只眼睛）接受了 IVR 治疗。两组婴儿的一般特征无明显差异（P>0.05）。IVA 组首次注射的校正胎龄为 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）。对于复发婴儿，首次治疗时，IVA 组的月经后年龄（PMA）为 34.89 ± 3.49 周，IVR 组为 35.28 ± 4.43 周。第二次治疗时，IVA 组和 IVR 组的月经后年龄分别为（43.69 ± 4.57）周和（40.96 ± 4.98）周（P = 0.185）。IVA 组有两名患儿需要进行第三次治疗，手术时的 PMA 分别为 58.71 周和 57.29 周，IVR 组有一名患儿，注射时的 PMA 为 43.14 周（P = 0.221）。两组均未出现并发症：意义：阿弗利百普和雷尼珠单抗治疗视网膜病变的疗效相似，用药安全性良好。应在大规模、前瞻性临床试验中开展进一步研究，为眼科医生提供治疗 ROP 的新选择。

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

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.

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来源期刊

Clinical therapeutics 医学-药学

CiteScore

6.00

自引率

3.10%

发文量

154

审稿时长

9 weeks

期刊介绍： Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.