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中华眼科医学杂志(电子版) ›› 2020, Vol. 10 ›› Issue (02) : 83 -89. doi: 10.3877/cma.j.issn.2095-2007.2020.02.004

论著

A型肉毒毒素注射与手术治疗儿童共同性斜视的临床比较
苏寒1, 付晶2,†(), 吴晓2, 孙阿莉2, 赵博文2, 洪洁2   
  1. 1. 100730　首都医科大学附属北京同仁医院2017级硕士研究生
    2. 100730　首都医科大学附属北京同仁医院　北京同仁眼科中心　北京市眼科学与视觉科学重点实验室
  • 收稿日期:2020-03-13 出版日期:2020-04-28
  • 通信作者: 付晶
  • 基金资助:
    北京市卫生系统高层次卫生技术人才-学科骨干项目(2015-3-023); 北京市卫生和计划生育委员会首都卫生发展科研专项重点攻关项目(首发2018-1-2051)

Comparison of botulinum toxin type A with surgery in the treatment of concomitant strabismus in children

Han Su1, Jing Fu2,†(), Xiao Wu2, Ali Sun2, Bowen Zhao2, Jie Hong2   

  1. 1. Master′s degree 2017, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China
    2. Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University; Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing 100730, China
  • Received:2020-03-13 Published:2020-04-28
  • Corresponding author: Jing Fu
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引用本文：

苏寒, 付晶, 吴晓, 孙阿莉, 赵博文, 洪洁. A型肉毒毒素注射与手术治疗儿童共同性斜视的临床比较[J]. 中华眼科医学杂志(电子版), 2020, 10(02): 83-89.

Han Su, Jing Fu, Xiao Wu, Ali Sun, Bowen Zhao, Jie Hong. Comparison of botulinum toxin type A with surgery in the treatment of concomitant strabismus in children[J]. Chinese Journal of Ophthalmologic Medicine(Electronic Edition), 2020, 10(02): 83-89.

目的

比较A型肉毒毒素(BTA)注射与手术治疗儿童共同性斜视的疗效。

方法

纳入2018年4月至2019年8月就诊于北京同仁医院眼科中心的共同性斜视患儿142例作为研究对象。其中，男性74例，女性68例；年龄3~15岁，平均年龄(7.2±2.6)岁。按照家属的选择意愿分为注射组和手术组。注射组患儿采用BTA眼外肌注射治疗，手术组患儿采用斜视矫正术治疗。检查并记录治疗前与治疗后6个月患儿的斜视度、双眼视觉功能以及并发症情况，治疗后6个月患儿的眼位正位率等指标。注射组和手术组患儿斜视度与双眼视觉功能的定量数据，用均数±标准差描述，采用独立样本t检验进行组间比较，采用配对样本t检验进行组内比较。患儿双眼视觉功能的定性数据，眼位正位率与并发症等指标的描述采用频数和百分率表示，采用卡方检验进行组间比较。

结果

治疗后6个月，注射组患儿的眼位正位率为58.2%，手术组患儿的眼位正位率为69.3%。两组患儿眼位正位率的比较，差异无统计学意义(χ2＝1.90，P>0.05)。注射组患儿斜视度绝对值在注射前和注射后6个月分别为(35.23±6.69)△和(12.35±10.16)△；手术组患儿斜视度绝对值在手术前和手术后6个月分别为(35.40±8.74)△和(9.16±9.43)△。治疗前与治疗后6个月，两组患儿斜视度绝对值的比较，差异无统计学意义(t＝-0.13，1.92；P>0.05)。注射组和手术组患儿在治疗后6个月随访时，具有正常同视机Ⅰ级功能(同时视)的分别有25例(占39.1%)和38例(占50.7%)；具有正常同视机Ⅱ级功能(融合视)的分别有43例(占67.2%)和70例(占93.3%)；具有正常同视机Ⅲ级功能(立体视)的分别有26例(占40.6%)和37例(占49.3%)；具有正常近立体视功能的分别有27例(占42.2%)和38例(占50.7%)，与治疗前相比均有所增加。治疗后6个月，手术组具有同视机Ⅱ级功能(融合视)患儿的比例高于注射组，差异有统计学意义(χ2＝15.52，P<0.05)，其余差异均无统计学意义(χ2＝1.88，1.06，0.99；P>0.05)。注射组所有患儿主诉出现复视，16例患儿表现出轻度上睑下垂和结膜下出血，均于随访1~3个月时消失。

结论

对于斜视度为中低度数(15△~50△)的患儿，BTA注射与手术治疗儿童共同性斜视在治疗后6个月临床疗效相近，是一种安全有效的治疗方法。

关键词: A型肉毒毒素, 共同性斜视, 儿童
Objective

The aim of this study was to evaluate the effectiveness of botulinum toxin type A (BTA) comparing to strabismus surgery in the treatment of children concomitant strabismus.

Methods

Consecutive patients with concomitant strabismus (142 cases) in Beijing Tongren Eye Center of Beijing Tongren Hospital from April 2018 to August 2019 were investigated. Among of them, including 74 male cases and 68 female cases with the average age (7.2±2.6) years-old. According to the choice of family members, patients were divided into injection group (BTA injection) and surgery group (strabismus surgery) . The esotropia deviation, binocular vision function and complications before and after treatment for 6 months and the alignment rate after treatment for 6 months. The esotropia deviation and the quantitative part of the binocular vision before and after treatment were expressed by mean±standard deviation. The paired t-test and independent sample t-test were used to compare within groups. The qualitative part of the binocular vision, alignment rate and complications were described by frequency and percentage, chi-square test was used to compare beteween groups.

Results

After treatment for 6 months, the alignment rate of the injection group and the surgery group was respectivley 58.2% and 69.3% with non-significant difference between groups (χ2=1.90, P>0.05). The absolute values of strabismus before and after injection for6 months were (35.23±6.69)△ and (12.35±10.16)△; (35.40±8.74)△ and (9.16±9.43)△ in the injection group and surgery group, respectivley. There were no significant difference in the degree of strabismus between two groups before and after treatment for 6 months (t=-0.13, 1.92; P>0.05). At the 6 months follow-up after treatment, 25 cases accounting for 39.1% and 38 cases accounting for 50.7% of the subjects in the injection and surgery group had normal synoptophore level-Ⅰ function (simultaneous vision); 43 cases accounting for 67.2% and 70 cases accounting for 93.3% had level-Ⅱ function (fusion function); 26 cases accounting for 40.6% and 37 cases accounting for 49.3% had level-Ⅲ function (far stereopsis); 27 cases accounting for 42.2% and 38 cases accounting for 50.7% had normal near stereopsis, which were increased compared with that before treatment. Only the proportion of subjects with level-Ⅱ fusion function in the surgery group was better than that in the injection group after treatment for 6 months with significant difference between groups (χ2=15.52, P<0.05). There were not statistically different in level-Ⅰand level-Ⅲ fusion function(χ2=1.88, 1.06, 0.99; P>0.05). All patients in injection group complained of diplopia. There were 16 cases with complications in the injection group included ptosis, diplopia and subconjunctival hemorrhage, which disappeared at 1 to 3 months of follow-up.

Conclusion

For children with deviation of moderate to low degree (15△~50△), botulinum toxin type A was as effective as surgery in the treatment of children concomitant strabismus after treatment for 6 months, which is a safe and effective treatment.

Key words: Botulinum toxin type A, Concomitant strabismus, Children
图1 两组患儿治疗前后各时间节点观察记录指标的变化　图A两组内斜视和外斜视患儿手术前后各时间节点的斜视度变化；图B两组患儿治疗前后各时间节点双眼视觉功能与近立体视功能正常例数所占百分比
表1 注射组与手术组患儿治疗前后斜视度绝对值的比较(±s，△)
组别 例数 治疗前 治疗后
1周 1个月 3个月 6个月
注射组 64 35.23±6.96 33.75±18.65 15.31±14.17 4.95±5.67 12.35±10.16
手术组 75 35.40±8.74 1.91± 3.06 4.07± 5.98 6.76±7.54 9.16± 9.43
t值   -0.13 13.30 5.70 -1.58 1.92
P值   >0.05 <0.05 <0.05 >0.05 >0.05
表2 注射组与手术组患儿治疗前后双眼视觉功能的比较[例数(%)]
组别 例数 治疗前 治疗后6个月
同视机Ⅰ级功能 同视机Ⅱ级功能 同视机Ⅲ级功能 近立体视 同视机Ⅰ级功能 同视机Ⅱ级功能 同视机Ⅲ级功能 近立体视
注射组 64 1(1.6) 38(59.7) 24(37.5) 25(39.1) 25(39.1) 43(67.2) 26(40.6) 27(42.2)
手术组 75 4(5.3) 42(56.0) 22(29.3) 23(30.7) 38(50.7) 70(93.3) 37(49.3) 38(50.7)
χ2值   1.42 0.16 1.04 1.08 1.88 15.52 1.06 0.99
P值   >0.05 >0.05 >0.05 >0.05 >0.05 <0.05 >0.05 >0.05
表3 重复注射的患儿治疗前后斜视度的变化情况(PD)
编号 复发时间(个月) 斜视度
复发 注射前 注射后3个月 注射后6个月
1 6 -30.0 -30.0 -10.0 -30.0
2 6 -30.0 -27.5 -5.0 -30.0
3 6 -30.0 -30.0 -8.0 -30.0
4 6 -25.0 -40.0 0.0 -25.0
5 3 -35.0 -47.5 -35.0  
6 6 -25.0 -37.5 -5.0 -25.0
7 6 -30.0 -47.5 -5.0 -30.0
8 6 -22.5 -27.5 -7.5 -22.5
9 3 +20.0 +40.0 +20.0  
10 3 -30.0 -40.0 -30.0  
11 6 -25.0 -47.5 -10.0 -25.0
12 6 -25.0 -40.0 0.0 -25.0
13 6 -27.5 -35.0 0.0 -27.5
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