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早产儿视网膜病变玻璃体内注射贝伐单抗治疗后的神经发育结局:一项前瞻性病例对照研究。

Neurodevelopmental Outcomes after Intravitreal Bevacizumab Therapy for Retinopathy of Prematurity: A Prospective Case-Control Study.

机构信息

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

Department of Child Psychiatry and Sleep Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan.

出版信息

Ophthalmology. 2019 Nov;126(11):1567-1577. doi: 10.1016/j.ophtha.2019.03.048. Epub 2019 Apr 5.

Abstract

PURPOSE

To evaluate the neurodevelopmental and ocular developmental outcomes in premature children who have undergone intravitreal bevacizumab injection (IVB) for treatment of type 1 retinopathy of prematurity (ROP).

DESIGN

Prospective case-control study.

PARTICIPANTS

We enrolled 3 groups of premature patients: premature children who had no history of ROP (group 0), premature children with history of ROP without treatment (group 1), and premature children with ROP who had received a single IVB (0.625 mg; group 2).

METHODS

Ocular developmental assessment, including cycloplegic refractometry, axial length, Cardiff acuity, and neurodevelopmental assessment via the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III), were performed at 1 to 3 years of age and were compared between groups.

MAIN OUTCOME MEASURES

Ocular developmental outcomes and Bayley III scores.

RESULTS

A total of 148 patients (85 boys and 63 girls) were included. The mean age at assessment was 1.49±0.59 years. Group 0 patients demonstrated significantly higher gestational age (GA), birth weight, and Apgar scores compared with group 1 and 2 patients. There were no significant differences between groups 1 and 2 in demographics or systemic risk factors except for lower GA in group 2. The cylindrical power was significantly larger in groups 1 and 2 compared with group 0. The spherical equivalent was significantly more myopic and the Cardiff acuity was significantly poorer in group 2 than in group 0. There were no significant differences between groups 1 and 2 in refractive status, axial length, or Cardiff acuity. Neurodevelopmental assessment using Bayley III showed no significant difference among the 3 groups in any aspect after adjusting for GA and other systemic risk factors. The risks for poor neurodevelopmental outcomes also were not significantly different.

CONCLUSIONS

At the mean age of 1.5 years, children with prior history of IVB (group 2) showed similar refractive and visual outcomes and similar neurodevelopmental outcomes compared with premature patients with ROP without requirement of treatment (group 1), although there is a possibility that a small but clinically significant difference may not have been detected in the current study.

摘要

目的

评估接受玻璃体内注射贝伐单抗(IVB)治疗 1 型早产儿视网膜病变(ROP)的早产儿的神经发育和眼部发育结局。

设计

前瞻性病例对照研究。

参与者

我们纳入了 3 组早产儿:无 ROP 病史的早产儿(组 0)、ROP 病史未经治疗的早产儿(组 1)和接受单次 IVB(0.625mg)治疗的 ROP 早产儿(组 2)。

方法

对早产儿进行眼部发育评估,包括睫状肌麻痹验光、眼轴长度、加的夫视力和使用贝利婴幼儿发育量表第三版(Bayley III)进行神经发育评估,并在 1 至 3 岁时进行比较。

主要观察指标

眼部发育结果和 Bayley III 评分。

结果

共纳入 148 例患者(85 例男孩,63 例女孩),评估时的平均年龄为 1.49±0.59 岁。与组 1 和 2 相比,组 0 患者的胎龄(GA)、出生体重和阿普加评分明显更高。组 1 和 2 患者在人口统计学或系统性危险因素方面无显著差异,除组 2 的 GA 较低外。与组 0 相比,组 1 和 2 的柱镜力明显更大。组 2 的等效球镜度数明显更近视,加的夫视力明显更差。组 1 和 2 之间的屈光状态、眼轴长度或加的夫视力无显著差异。在调整 GA 和其他系统性危险因素后,3 组之间的 Bayley III 神经发育评估在任何方面均无显著差异。不良神经发育结局的风险也无显著差异。

结论

在平均年龄为 1.5 岁时,与不需要治疗的 ROP 早产儿(组 1)相比,有 IVB 治疗史的儿童(组 2)的屈光和视力结果以及神经发育结果相似,尽管目前的研究可能没有检测到较小但临床上有意义的差异。

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