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A型肉毒毒素注射联合或不联合透明质酸钠治疗婴幼儿内斜视的短期疗效-前瞻性干预研究。

Short-term outcome of botulinum neurotoxin A injection with or without sodium hyaluronate in the treatment of infantile esotropia-a prospective interventional study.

机构信息

Department of Ophthalmology, King George's Medical University, Lucknow, Uttar Pradesh, India.

出版信息

Indian J Ophthalmol. 2020 Aug;68(8):1600-1603. doi: 10.4103/ijo.IJO_1552_19.

Abstract

PURPOSE

To compare the short-term outcome of botulinum neurotoxin A (BoNT-A) with or without sodium hyaluronate in the treatment of infantile esotropia (IE).

METHODS

In this tertiary care hospital-based prospective, interventional, non-randomized study on infants with IE below one year of age, 25 cases were enrolled in the sodium hyaluronate (SH) group to receive 2.5 U BoNT-A injection combined with SH in each medial rectus muscle (MR). Thirty patients were enrolled in the control group to receive 2.5 U BoNT-A injection with normal saline in each MR. The change in mean primary ocular deviation (POD) and complications were assessed at 2 weeks, 1 month, 3 months, and 6 months post injection. Mann-Whitney U test was used for non-parametric unpaired data. Chi-square test and Fisher's exact test were used to test for the strength of the association between the two categorical variables.

RESULTS

Satisfactory ocular alignment was achieved in 76% in SH group and 73% in the control group (P value = 0.80). While the change in mean POD was comparable (29.2 prism diopters [PD] vs 29.3 PD; P value = 0.65), the complication rates were significantly lesser in SH (16% vs 33.3%; P value = 0.14).

CONCLUSION

BoNT-A combined with SH is equally effective with lesser complications as compared to botulinum toxin alone in the treatment of IE.

摘要

目的

比较玻璃酸钠(SH)联合肉毒毒素 A(BoNT-A)与单独使用 BoNT-A 治疗婴幼儿内斜视(IE)的短期疗效。

方法

这是一项在一家三级医院进行的前瞻性、干预性、非随机研究,纳入年龄在 1 岁以下的 IE 婴儿。25 例患者纳入 SH 组,每侧内直肌注射 2.5 U 的 BoNT-A 联合 SH;30 例患者纳入对照组,每侧内直肌注射 2.5 U 的 BoNT-A 联合生理盐水。在注射后 2 周、1 个月、3 个月和 6 个月,评估平均第一眼位偏斜度(POD)的变化和并发症。非参数配对数据采用 Mann-Whitney U 检验。卡方检验和 Fisher 确切概率法用于检验两个分类变量之间的关联强度。

结果

SH 组的眼位矫正满意度为 76%,对照组为 73%(P 值=0.80)。平均 POD 的变化相似(29.2 棱镜度[PD] vs 29.3 PD;P 值=0.65),但 SH 组的并发症发生率显著较低(16% vs 33.3%;P 值=0.14)。

结论

与单独使用 BoNT-A 相比,BoNT-A 联合 SH 治疗 IE 的疗效相当,但并发症较少。

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