Department of Ophthalmology, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
Department of Rheumatology, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
Eye (Lond). 2021 Nov;35(11):3071-3076. doi: 10.1038/s41433-020-01300-4. Epub 2021 Jan 11.
To compare botulinum neurotoxin (BNT) injections to surgery as first-line therapy in large-angle essential infantile esotropia (IE).
Children between the ages 6 months and 6 years with IE of ≥40 prism dioptres (PD) were randomised to either a maximum of three BNT injections or surgical intervention of bimedial rectus muscle recession for angles ≤60 PD and augmented with BNT injection in angles >60 PD. Time taken for each procedure was documented. Orthophoria or misalignment of ≤10 PD was regarded as a complete response (CR). Follow-up visits were done at 3, 6, 12 and 24 weeks.
Mean (SD) age and baseline angle of esotropia were 26.9 (14.5) months and 61.9 PD (12.8), respectively, for the overall cohort. The proportion of children who achieved CR was significantly higher in the surgery arm compared to the BNT injection arm (OR = 4.01, 95% CI 1.74-9.22) but the time taken was six times longer (p < 0.0001). In the BNT arm, 55.2% of children aged ≤24 months and 16% of children >24 months achieved CR. In children with esotropia ≤60 PD, CR was achieved in 50% while those with esotropia >60 PD CR was achieved in 25%.
Surgery remains the gold standard for treatment of esotropia but BNT injection is a safe and effective alternative in children ≤24 m and with smaller angles of esotropia ≤60 PD in resource-limited centres.
比较肉毒毒素(BTX)注射与手术作为治疗大角度先天性内斜视(IE)的一线疗法。
6 个月至 6 岁、斜视度≥40 三棱镜度(PD)的患儿随机分为 BTX 注射组(最多 3 次注射)或手术组(双眼内直肌后退,斜视度≤60 PD 者,BTX 注射加强治疗)。记录每个手术的时间。斜视度≤10 PD 为完全反应(CR)。在 3、6、12 和 24 周进行随访。
总体队列的平均(SD)年龄和斜视初始角度分别为 26.9(14.5)月龄和 61.9 PD(12.8)。手术组的 CR 比例明显高于 BTX 注射组(OR=4.01,95%CI 1.74-9.22),但所需时间长 6 倍(p<0.0001)。BTX 注射组中,≤24 月龄儿童的 55.2%和>24 月龄儿童的 16%达到 CR。斜视度≤60 PD 的儿童中,50%达到 CR,而斜视度>60 PD 的儿童中,25%达到 CR。
手术仍是治疗斜视的金标准,但 BTX 注射是资源有限中心≤24 月龄儿童和斜视度较小的≤60 PD 儿童的安全有效替代疗法。