Objective: To observe the efficacy and safety of botulinum toxin A (BTA) injection in the treatment of acute comitant esotropia (ACE) with different doses. Methods: 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 t-tests, Mann-Whitney U tests, and χ2 tests. Results: 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 P>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 P<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 P>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 (P>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 P>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 P<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 P<0.05). The number of cases with simultaneous vision and near stereopsis showed no significant differences between the two groups (all P>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 P>0.05). All complications spontaneously resolved within 3 months post-treatment. Conclusions: 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.
目的： 观察不同剂量的A型肉毒毒素（BTA）注射治疗急性共同性内斜视（ACE）的效果和安全性。 方法： 回顾性队列研究。纳入2019年6月至2022年6月于郑州大学第一附属医院就诊并接受BTA注射治疗的ACE患者资料。所有患者行最佳矫正视力（BCVA）、等效球镜度数（SE）等常规眼科检查和斜视专科检查，包括斜视度数、眼球运动状况和双眼视功能。将患者按治疗前斜视度数分为小斜视度数［≤60三棱镜度（PD）］和大斜视度数（>60 PD），两种类型的患者均按注射剂量分为2.5 U组和5.0 U组。单眼注射者均为非主导眼注射。记录并比较各组患者治疗前和治疗后1、2、3、6个月随访时的斜视度数。记录各组治疗有效患者占比。比较治疗后6个月时具有各级视功能（包括同时视、近立体视和远立体视）的例数，观察随访期间内并发症的情况。采用t检验、Mann-Whitney U检验和χ2检验进行统计学分析。 结果： 共纳入患者70例，其中男性46例，女性24例，年龄为5.0（4.0，8.3）岁。小斜视度数患者37例，其中2.5 U组25例，5.0 U组12例；大斜视度数患者33例，其中2.5 U组18例，5.0 U组15例。小斜视度数和大斜视度数ACE患者中2个组的年龄、病程、治疗前斜视度数、BCVA、SE等基线资料差异均无统计学意义（均P>0.05）。小斜视度数患者中，治疗后1和2个月时，5.0 U组的斜视度数分别为-20.00（-37.50，-7.00）和0.00（0.00，0.00）PD，小于2.5 U组的0.00（-10.00，4.50）和5.00（0.00，6.50）PD，差异均有统计学意义（均P<0.05）；治疗后3和6个月时2.5 U组的斜视度数分别为5.00（0.00，15.00）和2.00（0.00，6.00）PD，5.0 U组分别为0.00（0.00，4.50）和0.00（0.00，3.75）PD，差异均无统计学意义（均P>0.05）。2.5 U组20例治疗有效，占80.0%，5.0 U组10例有效，占10/12，差异无统计学意义（P>0.05）。2.5 U组和5.0 U组具有各级视功能的例数占比分别为同时视76.0%（19/25）和10/12，近立体视48.0%（12/25）和7/12；远立体视44.0%（11/25）和7/12，差异均无统计学意义（均P>0.05）。大斜视度数患者中，5.0 U组治疗后各随访时间的斜视度数分别为-5.00（-25.00，5.00）、0.00（0.00，7.00）、2.00（0.00，10.00）、5.00（0.00，7.00）PD；2.5 U组分别为5.00（2.75，27.75）、10.00（3.75，24.75）、12.00（3.75，38.75）、14.00（3.50，54.00）PD；5.0 U组均小于2.5 U组（均P<0.05）。5.0 U组的治疗有效例数占比（13/15）大于2.5 U组（9/18），5.0 U组具有远立体视的例数占比（9/15）大于2.5 U组（4/18），差异均有统计学意义（均P<0.05）。2个组具有同时视的例数分别占10/18和10/15，具有近立体视的例数分别占6/18和9/15，差异均无统计学意义（均P>0.05）。大、小斜视度数患者中2.5 U组和5.0 U组出现并发症的例数占比分别为9/18、13/15和80.0%（20/25）、10/12，差异均无统计学意义（均P>0.05），所有并发症于治疗后3个月内自行消失。 结论： BTA注射治疗ACE效果良好，且对于斜视度数>60 PD的ACE患者，增加注射剂量至5.0 U可获得更好的疗效。.