Wang Y, Lang L J, Xu L M, Rong J B, Guo K X, Zhang L X, Zhang J, Li Z G, Li L
Department of Ophthalmology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China.
Department of Ophthalmology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China.
Zhonghua Yan Ke Za Zhi. 2024 Jan 11;60(1):49-55. doi: 10.3760/cma.j.cn112142-20231104-00209.
To observe the efficacy and safety of botulinum toxin A (BTA) injection in the treatment of acute comitant esotropia (ACE) with different doses. This retrospective cohort study included data from patients with ACE who received BTA injection treatment at the First Affiliated Hospital of Zhengzhou University from June 2019 to June 2022. All patients underwent routine ophthalmic examinations, including best-corrected visual acuity (BCVA), spherical equivalent (SE), as well as specialized examinations for strabismus, including the degree of esotropia, eye movement status, and binocular visual function. Patients were categorized into small esotropia [≤60 prism diopters (PD)] and large esotropia (>60 PD) groups based on the pre-treatment degree of esotropia. Each group was further divided into 2.5 U and 5.0 U dose subgroups. Monocular injections were administered to the non-dominant eye. The esotropia degree was recorded and compared at 1, 2, 3, and 6 months of follow-up. The proportion of effectively treated patients in each group was documented. The number of cases with various levels of visual functions (including simultaneous vision, near stereopsis, and distance stereopsis) at 6 months post-treatment was compared, and complications during the follow-up period were observed. Statistical analyses were conducted using -tests, Mann-Whitney tests, and tests. A total of 70 patients were included in the study, comprising 46 males and 24 females, with a median age of 5.0 (4.0, 8.3) years. Among them, 37 patients had small esotropia, with 25 in the 2.5 U group and 12 in the 5.0 U group. Thirty-three patients had large esotropia, with 18 in the 2.5 U group and 15 in the 5.0 U group. There were no statistically significant differences in baseline data, including age, duration of the condition, pre-treatment esotropia degree, BCVA and SE, between the two dose groups in both small and large esotropia patients (all >0.05). In small esotropia patients, at 1 and 2 months post-treatment, the esotropia degree in the 5.0 U group was -20.00 (-37.50, -7.00) and 0.00 (0.00, 0.00) PD, respectively, which was significantly lower than the 0.00 (-10.00, 4.50) and 5.00 (0.00, 6.50) PD in the 2.5 U group (all <0.05). At 3 and 6 months post-treatment, the esotropia degree in the 2.5 U group was 5.00 (0.00, 15.00) and 2.00 (0.00, 6.00) PD, respectively, while in the 5.0 U group, it was 0.00 (0.00, 4.50) and 0.00 (0.00, 3.75) PD, with no statistically significant differences between the two groups (all >0.05). In the 2.5 U group, 20 cases were effectively treated, accounting for 80.0%, while in the 5.0 U group, 10 cases were effective, accounting for 10/12, with no significant difference between the two groups (>0.05). In the 2.5 U group and the 5.0 U group, the proportions of cases with various levels of visual functions were as follows: simultaneous vision, 76.0% (19/25) and 10/12; near stereopsis, 48.0% (12/25) and 7/12; distance stereopsis, 44.0% (11/25) and 7/12, respectively. No statistically significant differences were observed in these proportions (all >0.05). In patients with large esotropia, the esotropia degrees in the 5.0 U group at various follow-up times were -5.00 (-25.00, 5.00), 0.00 (0.00, 7.00), 2.00 (0.00, 10.00), and 5.00 (0.00, 7.00) PD, respectively. For the 2.5 U group, the corresponding values were 5.00 (2.75, 27.75), 10.00 (3.75, 24.75), 12.00 (3.75, 38.75), and 14.00 (3.50, 54.00) PD, respectively. The esotropia degrees in the 5.0 U group were consistently lower than those in the 2.5 U group (all <0.05). The proportion of effective treatment in the 5.0 U group (13/15) was higher than that in the 2.5 U group (9/18), and the proportion of cases with distance stereopsis in the 5.0 U group (9/15) was higher than that in the 2.5 U group (4/18), both showing statistically significant differences (all 0.05). The number of cases with simultaneous vision and near stereopsis showed no significant differences between the two groups (all 0.05). The proportion of complications in the 2.5 U and 5.0 U groups in both large and small esotropia patients was 9/18, 13/15, 80.0% (20/25), and 10/12, respectively, with no statistically significant differences (all 0.05). All complications spontaneously resolved within 3 months post-treatment. BTA injection is effective in the treatment of ACE, and for ACE patients with esotropia degrees greater than 60 PD, increasing the injection dose to 5.0 U can achieve better therapeutic outcomes.
观察不同剂量A型肉毒杆菌毒素(BTA)注射治疗急性共同性内斜视(ACE)的疗效和安全性。这项回顾性队列研究纳入了2019年6月至2022年6月在郑州大学第一附属医院接受BTA注射治疗的ACE患者的数据。所有患者均接受常规眼科检查,包括最佳矫正视力(BCVA)、等效球镜度(SE),以及斜视专科检查,包括内斜视度数、眼球运动状态和双眼视功能。根据治疗前内斜视度数,将患者分为小度数内斜视[≤60三棱镜度(PD)]和大度数内斜视(>60 PD)组。每组再进一步分为2.5 U和5.0 U剂量亚组。对非优势眼进行单眼注射。在随访的1、2、3和6个月记录并比较内斜视度数。记录每组有效治疗患者的比例。比较治疗后6个月不同水平视功能(包括同时视、近立体视和远立体视)的病例数,并观察随访期间的并发症。采用t检验、Mann-Whitney检验和χ²检验进行统计分析。本研究共纳入70例患者,其中男性46例,女性24例,中位年龄为5.0(4.0,8.3)岁。其中,37例为小度数内斜视,2.5 U组25例,5.0 U组12例。33例为大度数内斜视,2.5 U组18例,5.0 U组15例。小度数和大度数内斜视患者的两个剂量组之间,包括年龄、病程、治疗前内斜视度数、BCVA和SE在内的基线数据均无统计学显著差异(均>0.05)。在小度数内斜视患者中,治疗后1个月和2个月,5.0 U组的内斜视度数分别为-20.00(-37.50,-7.00)和0.00(0.00,0.00)PD,显著低于2.5 U组的0.00(-10.00,4.50)和5.00(0.00,6.50)PD(均<0.05)。治疗后3个月和6个月,2.5 U组的内斜视度数分别为5.00(0.00,15.00)和2.00(0.00,6.00)PD,而5.0 U组分别为0.00(0.00,4.50)和0.00(0.00,3.75)PD,两组之间无统计学显著差异(均>0.05)。在2.5 U组中,20例得到有效治疗,占80.0%,而在5.0 U组中,10例有效,占10/12,两组之间无显著差异(>0.05)。在2.5 U组和5.0 U组中,不同水平视功能的病例比例如下:同时视分别为76.0%(19/25)和10/12;近立体视分别为48.0%(12/25)和7/12;远立体视分别为44.0%(11/25)和7/12。这些比例之间未观察到统计学显著差异(均>0.05)。在大度数内斜视患者中,5.0 U组在各随访时间的内斜视度数分别为-5.00(-25.00,5.00)、0.00(0.00,7.00)、2.00(0.00,10.00)和5.00(0.00,7.00)PD。对于2.5 U组,相应的值分别为5.00(2.75,27.75)、10.00(3.75,24.75)、12.00(3.75,38.75)和14.00(3.50,54.00)PD。5.0 U组的内斜视度数始终低于2.5 U组(均<0.05)。5.0 U组的有效治疗比例(13/15)高于2.5 U组(9/18),5.0 U组的远立体视病例比例(9/15)高于2.5 U组(4/18),两者均显示出统计学显著差异(均<0.05)。两组之间同时视和近立体视的病例数无显著差异(均>0.05)。小度数和大度数内斜视患者中,2.5 U组和5.0 U组的并发症比例分别为9/18、13/15、80.0%(20/25)和10/12,无统计学显著差异(均>0.05)。所有并发症在治疗后3个月内均自行缓解。BTA注射治疗ACE有效,对于内斜视度数大于60 PD的ACE患者,将注射剂量增加至5.0 U可取得更好的治疗效果。