玻璃体内注射雷珠单抗与康柏西普在中国增殖性糖尿病视网膜病变患者玻璃体切割术前的疗效和安全性比较：一项前瞻性随机对照试验。
Comparison of efficacy and safety of intravitreal ranibizumab and conbercept before vitrectomy in Chinese proliferative diabetic retinopathy patients: a prospective randomized controlled trial.
作者信息
Li Siying, Guo Lili, Zhou Pingping, Tang Jiyang, Wang Zongyi, Zhang Linqi, Zhao Mingwei, Qu Jinfeng
机构信息
Department of Ophthalmology, Peking University People's Hospital, Beijing, China.
Eye Diseases and Optometry Institute, Beijing, China.
出版信息
Eye Vis (Lond). 2022 Dec 1;9(1):44. doi: 10.1186/s40662-022-00316-z.
BACKGROUND
To compare the efficacy and safety of preoperative intravitreal injections of ranibizumab and conbercept in Chinese proliferative diabetic retinopathy (PDR) patients.
METHODS
This prospective randomized controlled trial enrolled 90 eyes of 80 patients with PDR. Forty-four eyes of 40 patients that received intravitreal ranibizumab (IVR) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVR group. Forty-six eyes of 40 patients that received intravitreal conbercept (IVC) injections (0.5 mg/0.05 mL) before vitreous surgeries were assigned to the IVC group. Intraoperative and postoperative indices were assessed for further comparison between the two groups.
RESULTS
There were no statistically significant differences in all surgery indices, including intraoperative indices (surgery time, P = 0.225; intraoperative bleeding, P = 0.808; endodiathermy use, P = 0.693; incidence of iatrogenic retinal breaks, P = 0.740; relaxing retinotomy, P = 0.682; retinal reattachment, P = 0.682 and silicone oil tamponade, P = 0.814) and postoperative indices (postoperative vitreous hemorrhage (VH), P = 0.808; neovascular glaucoma (NVG), P = 0.964; recurrent retinal detachment, P = 0.531; postoperative fibrovascular proliferation progression, P = 0.682 and reoperation, P = 0.955) between the two groups. There were no statistically significant differences in best-corrected visual acuity (BCVA) at each follow-up visit (P = 0.939, 0.669, 0.741 and 0.717, respectively) or in central retinal thickness (CRT) (P = 0.976, 0.699, 0.551 and 0.686, respectively). As for safety profile, both groups had no ocular or system adverse events during the observation period.
CONCLUSIONS
IVR and IVC as a pretreatment of vitrectomy had similar efficacy and safety profile for Chinese PDR patients.
TRIAL REGISTRATION
Registered at ClinicalTrials.gov ( NCT05414149 ).
背景
比较术前玻璃体内注射雷珠单抗和康柏西普对中国增殖性糖尿病视网膜病变（PDR）患者的疗效和安全性。
方法
这项前瞻性随机对照试验纳入了80例PDR患者的90只眼。40例接受玻璃体内雷珠单抗（IVR）注射（0.5mg/0.05mL）的患者的44只眼在玻璃体手术前被分配到IVR组。40例接受玻璃体内康柏西普（IVC）注射（0.5mg/0.05mL）的患者的46只眼在玻璃体手术前被分配到IVC组。评估术中及术后指标以进一步比较两组。
结果
两组在所有手术指标上均无统计学显著差异，包括术中指标（手术时间，P = 0.225；术中出血，P = 0.808；内凝使用，P = 0.693；医源性视网膜裂孔发生率，P = 0.740；视网膜松解切开术，P = 0.682；视网膜复位，P = 0.682和硅油填充，P = 0.814）和术后指标（术后玻璃体出血（VH），P = 0.808；新生血管性青光眼（NVG），P = 0.964；复发性视网膜脱离，P = 0.531；术后纤维血管增殖进展，P = 0.682和再次手术，P = 0.955）。两组在每次随访时的最佳矫正视力（BCVA）（分别为P = 0.939、0.669、0.741和0.717）或中心视网膜厚度（CRT）（分别为P = 0.976、0.699、0.551和0.686）上均无统计学显著差异。至于安全性，两组在观察期内均未出现眼部或全身不良事件。
结论
对于中国PDR患者，IVR和IVC作为玻璃体切除术的预处理具有相似的疗效和安全性。
试验注册
在ClinicalTrials.gov注册（NCT05414149）。
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