Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Department of Ophthalmology, Baqiyatallah University of Medical Sciences, Tehran, Iran.
Eye (Lond). 2019 Feb;33(2):304-312. doi: 10.1038/s41433-018-0208-y. Epub 2018 Sep 10.
To evaluate the relationship between injection site and pain severity following intravitreal injection of bevacizumab (IVB).
Prospective, randomized, four-armed, clinical trial.
The present study was a prospective, randomized, four-armed clinical trial, which included 1004 eyes from 1004 patients. Patients receiving IVB were randomly assigned into four groups: superotemporal (ST); superonasal (SN); inferotemporal (IT); and inferonasal (IN) injections. The visual analog scale (VAS) was used to assess pain. Primary study variables were the relationship between pain severity and injection site, number of previous injections, age, sex, and indication for injection. Secondary variables included best-corrected visual acuity (BCVA) and central macular thickness (CMT) changes 1 month post IVB.
Overall mean pain score was 2.86 ± 2.2. Indications for injection were diabetic macular edema (84.1%), neovascular age-related macular degeneration (7.7%), and macular edema secondary to retinal vein occlusion (8.2%). The mean VAS scores in the SN, IN, ST, and IT groups were 1.5 ± 1.7, 3 ± 2.3, 4 ± 2, and 3 ± 2.1, respectively. Pain severity was significantly correlated with injection site (p < 0.001) and sex (p < 0.001); females showed higher pain scores. A negative correlation existed between pain score and number of previous injections (p = 0.03). Pain severity was not associated with age (p = 0.659), lens status (p = 0.478), vitreous reflux (p = 0.648), or indication for injection (p = 0.390). No significant complications were observed.
ST quadrant was the most painful and SN quadrant was the least painful sites for IVB. Pain severity score was significantly associated with injection site, number of injections, and sex.
评估玻璃体内注射贝伐单抗(IVB)后注射部位与疼痛严重程度的关系。
前瞻性、随机、四臂临床试验。
本研究为前瞻性、随机、四臂临床试验,纳入 1004 例 1004 只眼的患者。接受 IVB 的患者被随机分为四组:上方颞(ST);上方鼻(SN);下方颞(IT);下方鼻(IN)注射。视觉模拟评分(VAS)用于评估疼痛。主要研究变量是疼痛严重程度与注射部位、注射次数、年龄、性别和注射适应证之间的关系。次要变量包括 IVB 后 1 个月最佳矫正视力(BCVA)和中心黄斑厚度(CMT)的变化。
总体平均疼痛评分为 2.86±2.2。注射适应证为糖尿病性黄斑水肿(84.1%)、新生血管性年龄相关性黄斑变性(7.7%)和视网膜静脉阻塞所致黄斑水肿(8.2%)。SN、IN、ST 和 IT 组的平均 VAS 评分分别为 1.5±1.7、3±2.3、4±2 和 3±2.1。疼痛严重程度与注射部位(p<0.001)和性别(p<0.001)显著相关;女性疼痛评分更高。疼痛评分与注射次数呈负相关(p=0.03)。疼痛严重程度与年龄(p=0.659)、晶状体状态(p=0.478)、玻璃体反流(p=0.648)或注射适应证(p=0.390)无关。未观察到明显并发症。
ST 象限是 IVB 最痛的部位,SN 象限是最不痛的部位。疼痛严重程度评分与注射部位、注射次数和性别显著相关。