比较康柏西普与雷珠单抗治疗早产儿视网膜病变的临床疗效：一项多中心前瞻性随机对照临床试验。
Comparison of clinical outcomes of conbercept versus ranibizumab treatment for retinopathy of prematurity: a multicentral prospective randomised controlled trial.
机构信息
Ophthalmology, Shenzhen Eye Hospital, Shenzhen Key Laboratory of Ophthalmology, Shenzhen University School of Medicine, Shenzhen, Guangdong, China, Shenzhen, Guangdong, China.
Ophthalmology, The University of Hong Kong, Grantham Hospital, Hong Kong, China.
出版信息
Br J Ophthalmol. 2022 Jul;106(7):975-979. doi: 10.1136/bjophthalmol-2020-318026. Epub 2021 Feb 26.
PURPOSE
To compare the recurrence rate and surgical complications of retinopathy of prematurity (ROP) between patients treated with intravitreal injection of conbercept (IVC) and intravitreal injection of ranibizumab (IVR) within 6 months.
METHODS
A multicentral prospective, randomised controlled trial was applied from May 2017 to February 2019 for the infants diagnosed as aggressive posterior-ROP, zone I or posterior zone II treatment-requiring ROP by binocular indirect ophthalmoscope and RetCam3. These infants were assigned to randomly receive either intravitreal injection of 0.25 mg conbercept or 0.25 mg ranibizumab. The recurrence rate, fundus fluorescence angiography (FFA) and surgical complications were examined during the follow-up period of 6 months. Recurrent eyes were retreated by laser or another intravitreal injection within the 72 hours.
RESULTS
A total of 30 infant patients (60 eyes) underwent IVC and 30 patients (60 eyes) underwent IVR. A total of 10 eyes (16.67%) in the IVC group and 14 eyes (23.34%) in the IVR group developed recurrence. There was no significant statistical difference in the recurrence rate between the two groups (χ=0.83, p=0.36). The postmenstrual age (PMA) at first injection was (34.60±3.47) weeks in IVC and (35.14±1.76) in IVR group. In recurrent cases, the mean PMA at second treatment were (43.31±3.85) and (43.43±3.89) weeks in the IVC and IVR group, respectively. The period between two treatments was (8.71±6.62) for the IVC and (8.29±2.56) weeks for the IVR group. All these results showed no significant statistical difference between these two groups. The fluorescein leakage were observed in the eyes of recurrent infants by FFA. There were no other complications in the two groups except for complicated cataract in three eyes.
CONCLUSION
Both IVC and IVR are effective therapies for the treatment of ROP. Conbercept is a new option for treating ROP.
目的
比较经玻璃体腔内注射康柏西普（IVC）和雷珠单抗（IVR）治疗早产儿视网膜病变（ROP）患者在 6 个月内的复发率和手术并发症。
方法
采用多中心前瞻性随机对照试验，对 2017 年 5 月至 2019 年 2 月间经双目间接检眼镜和 RetCam3 诊断为侵袭性后部 ROP、I 区或后极部 II 区治疗性 ROP 的婴儿进行研究。这些婴儿被随机分为玻璃体腔内注射 0.25mg 康柏西普或 0.25mg 雷珠单抗。在 6 个月的随访期间，检查复发率、眼底荧光血管造影（FFA）和手术并发症。复发眼在 72 小时内接受激光或另一次玻璃体腔内注射治疗。
结果
共纳入 30 例婴儿患者（60 只眼）行 IVC 治疗，30 例患者（60 只眼）行 IVR 治疗。IVC 组有 10 只眼（16.67%）和 IVR 组有 14 只眼（23.34%）复发。两组复发率无统计学差异（χ=0.83，p=0.36）。IVC 组首次注射时的矫正胎龄（PMA）为（34.60±3.47）周，IVR 组为（35.14±1.76）周。在复发病例中，第二次治疗时的平均 PMA 分别为 IVC 组（43.31±3.85）周和 IVR 组（43.43±3.89）周。两组之间的治疗间隔时间分别为 IVC 组（8.71±6.62）周和 IVR 组（8.29±2.56）周。这些结果在两组之间均无统计学差异。FFA 显示复发病例的荧光素渗漏。两组均无其他并发症，仅 3 只眼并发复杂性白内障。
结论
IVC 和 IVR 均为治疗 ROP 的有效方法。康柏西普是治疗 ROP 的一种新选择。
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