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康柏西普与雷珠单抗治疗新生血管性年龄相关性黄斑变性的有效性和安全性比较。一项回顾性、病例对照、非劣效性、多中心研究。

Comparison of effectiveness and safety between conbercept and ranibizumab for treatment of neovascular age-related macular degeneration. A retrospective case-controlled non-inferiority multiple center study.

机构信息

Center of Integrative Research, The First Hospital of Qiqihaer City, Qiqihaer, Heilongjiang, PR China.

Department of Orthopedic Surgery and BME-Campbell Clinic, University of Tennessee Health Science Center, Memphis, TN, USA.

出版信息

Eye (Lond). 2018 Feb;32(2):391-399. doi: 10.1038/eye.2017.187. Epub 2017 Sep 22.

Abstract

PurposeTo compare the efficacy and safety of conbercept and ranibizumab when administered according to a treat-and-extend (TREX) protocol for the treatment of neovascular age-related macular degeneration (AMD) in China.Patients and methodsBetween May 2014 and May 2015, 180 patients were treated in a 1 : 1 ratio using conbercept or ranibizumab from four hospitals. Patients received either conbercept 0.5 mg or ranibizumab 0.5 mg intravitreal injections. Follow-up time was 1 year and treated based on a TREX approach. Main outcomes and measures include best-corrected visual acuity (BCVA), using Early Treatment Diabetic Retinopathy Study (ETDRS); number of injections; central retinal thickness (CRT); and leakage of choroidal neovascularization before and after the treatment was analyzed by fluorescein fundus angiography and indocyanine green angiography.ResultsThe 1-year visit was completed by 168 (93.3%) of patients. Mean BCVA was equivalent between two cohorts, and were improved by 12.7±7.770 and 12.3±7.269 letters in the conbercept and ranibizumab cohorts, respectively (P=0.624). There was no significant difference in measured CRT, with a mean decrease of 191.5 μm for conbercept and 187.8 μm for ranibizumab (P=0.773). There was a statistically significant difference (P=0.001) between the drugs regarding the number of treatments: 7.4 for conbercept and 8.7 for ranibizumab. The difference in the distribution of injection intervals was statistically significant between two groups (P=0.011). During the study, there were no cases of endophthalmitis or intraocular inflammation.ConclusionBoth drugs had equivalent effects in visual and anatomic gains at 1 year when administered. In the conbercept group, longer treatment intervals were achieved with more patients.

摘要

目的 比较康柏西普和雷珠单抗在我国按照治疗和随访(TREX)方案治疗新生血管性年龄相关性黄斑变性(AMD)的疗效和安全性。

方法 2014 年 5 月至 2015 年 5 月,来自 4 家医院的 180 名患者按 1:1 的比例分别接受康柏西普或雷珠单抗治疗。患者接受康柏西普 0.5mg 或雷珠单抗 0.5mg 玻璃体腔内注射。随访时间为 1 年,采用 TREX 方法进行治疗。主要观察指标和疗效评估包括最佳矫正视力(BCVA),采用早期治疗糖尿病视网膜病变研究(ETDRS)标准;注射次数;中心视网膜厚度(CRT);荧光素眼底血管造影和吲哚青绿血管造影分析治疗前后脉络膜新生血管渗漏。

结果 168 例(93.3%)患者完成了 1 年的随访。两组患者的 1 年 BCVA 相当,康柏西普组和雷珠单抗组的 BCVA 分别提高了 12.7±7.770 和 12.3±7.269 个字母(P=0.624)。两组 CRT 测量值无显著差异,康柏西普组 CRT 平均下降 191.5μm,雷珠单抗组下降 187.8μm(P=0.773)。两种药物在治疗次数上有显著差异(P=0.001):康柏西普组为 7.4 次,雷珠单抗组为 8.7 次。两组注射间隔分布差异有统计学意义(P=0.011)。研究期间,无眼内炎或眼内炎症病例。

结论 两种药物在 1 年时在视力和解剖学上均有等效效果。在康柏西普组,更多患者实现了更长的治疗间隔。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4087/5811706/18849f6a4911/eye2017187f1.jpg

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