Qi Hui-Jun, Li Xiao-Xin, Zhang Jun-Yan, Zhao Ming-Wei
Department of Ophthalmology, People's Hospital, Peking University, Beijing 100044, China.
Clinical Study Consultant, Bothwin Pte. Ltd., Shanghai 200232, China; Branch of Clinical Epidemiology and Evidence-Based Medicine, Shanghai Medical Association, Shanghai 200240, China.
Int J Ophthalmol. 2017 Jan 18;10(1):91-97. doi: 10.18240/ijo.2017.01.15. eCollection 2017.
To evaluate the clinical efficacy and safety of ranibizumab for wet age-related macular degeneration (wAMD) in Chinese patients and to determine the mean number of injections administered over one year of follow-up.
This single centre, retrospective observational case series study included data from 121 patients with wAMD (121 eyes) who were diagnosed by indirect ophthalmoscopy, fluorescence fundus angiography (FFA), indocyanine green angiography, and optical coherence tomography. Ranibizumab was injected into the vitreous cavities once per month for 3mo and as needed afterwards. Changes in visual acuity and central foveal thickness (CFT) during the follow-up period were compared, and the mean number of injections over the year was calculated. Patients with one or more adverse events related to the drugs and injections were recorded for further adverse events analysis.
The study population included 70 males and 51 females aged between 50 and 87y (mean: 71.32±9.41y). The mean number of injections over the first year was 5±1 (range: 3-9). The mean best-corrected visual acuity by Early Treatment Diabetic Retinopathy Study increased from 43.2±19.3 (95%CI: 39.8-46.7) at baseline to 51.7±20.1 (95%CI: 48.1-55.3), and central foveal thickness (CFT) decreased from 526.5±277.0 µm (95%CI: 476.6-576.4) to 258.2±161.6 µm (95%CI: 229.2-287.3) at 12mo. The differences were statistically significant (<0.001). Visual acuity significantly improved in 34.1% of the patients (38 eyes), stabilized in 66.1% of the patients (80 eyes), and significantly decreased in 2.5% of the patients (3 eyes). CFT at baseline was an independent risk factor of decreased CFT and increased visual acuity. None of the patients had severe adverse events during the follow-up period.
Ranibizumab can effectively control disease progression and improve visual acuity in patients with wAMD. The disease conditions of most patients stabilized after a one-year treatment with an average of 5 injections.
评估雷珠单抗治疗中国湿性年龄相关性黄斑变性（wAMD）患者的临床疗效和安全性，并确定随访一年期间的平均注射次数。
本单中心回顾性观察病例系列研究纳入了121例wAMD患者（121只眼）的数据，这些患者通过间接检眼镜、荧光素眼底血管造影（FFA）、吲哚菁绿血管造影和光学相干断层扫描进行诊断。雷珠单抗每月一次玻璃体腔注射，共3个月，之后按需注射。比较随访期间视力和中心凹厚度（CFT）的变化，并计算一年中的平均注射次数。记录发生一次或多次与药物及注射相关不良事件的患者，以便进一步分析不良事件。
研究人群包括70名男性和51名女性，年龄在50至87岁之间（平均：71.32±9.41岁）。第一年的平均注射次数为5±1次（范围：3 - 9次）。根据早期糖尿病性视网膜病变研究，平均最佳矫正视力从基线时的43.2±19.3（95%CI：39.8 - 46.7）提高到51.7±20.1（95%CI：48.1 - 55.3），中心凹厚度（CFT）从526.5±277.0 µm（95%CI：476.6 - 576.4）降至12个月时的258.2±161.6 µm（95%CI：229.2 - 287.3）。差异具有统计学意义（<0.001）。34.1%的患者（38只眼）视力显著改善，66.1%的患者（80只眼）视力稳定，2.5%的患者（3只眼）视力显著下降。基线时的CFT是CFT降低和视力提高的独立危险因素。随访期间无患者发生严重不良事件。
雷珠单抗可有效控制wAMD患者的疾病进展并提高视力。大多数患者经一年治疗、平均注射5次后病情稳定。
