良性原发性眼睑痉挛中眶隔前与睑板前肉毒杆菌毒素注射的并发症：一项随机对照试验

Complications of Preseptal Versus Pretarsal Botulinum Toxin Injection in Benign Essential Blepharospasm: A Randomized Controlled Trial.

作者信息

Sanguandikul Lalita, Apinyawasisuk Supanut, Jariyakosol Supharat, Hirunwiwatkul Parima, Chongpison Yuda

机构信息

From the Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Ophthalmology Department, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

出版信息

Am J Ophthalmol. 2021 Dec;232:9-16. doi: 10.1016/j.ajo.2021.04.029. Epub 2021 May 7.

DOI:10.1016/j.ajo.2021.04.029

PMID:33965414

Abstract

PURPOSE

The purpose of this study was to compare ocular complications and efficacy of preseptal (PST) versus those of pretarsal (PTS) botulinum toxin type A (BoNT-A) therapy in cases of benign essential blepharospasm (BEB).

DESIGN

Randomized clinical trial.

METHODS

Setting: university hospital.

PATIENTS

24 participants with BEB were enrolled from August 2019 to June 2020. All patients and the outcome evaluator were masked to the injection allocation.

INTERVENTIONS

for each participant, 1 eye was randomized to receive PST BoNT-A injection, and the fellow eye received PTS BoNT-A injection of the same amount from a single investigator. At baseline, 1, and 3 months after the injection, we collected the symptoms of tearing, lagophthalmos, ptosis, and diplopia and measured margin-to-reflex distance (MRD) 1 and 2 (mm), degree of lagophthalmos (mm), presence of ectropion, entropion, limitation of ocular motility, tear film breakup time (second), Schirmer's test (mm) , ocular surface staining scores (Oxford's scheme), and Jankovic rating scale of both eyes separately. Main outcome measurements were complications of the injection.

RESULTS

There were statistically significant higher rates of self-reported lagophthalmos in PTS (n = 12; 52.17%) than in PST (n = 7; 30.43%) BoNT-A injections (P = .024) and significantly higher estimated measurements of lagophthalmos in PTS (0.59 mm; 95% confidence interval [CI]: 0.44-0.72) than in PST (0.26 mm; 95% CI: 0.12-0.40) injection at 1 month using an interaction model (Bonferroni-corrected P = .001). No significant differences in the efficacy and other complication outcomes between the injection locations were observed.

CONCLUSIONS

PTS BoNT-A injection had a higher rate of lagophthalmos than PST BoNT-A injection for BEB.

摘要

目的

本研究旨在比较睑前（PST）与睑板前（PTS）A型肉毒杆菌毒素（BoNT-A）治疗在良性特发性眼睑痉挛（BEB）患者中的眼部并发症及疗效。

设计

随机临床试验。

方法

地点：大学医院。

患者

2019年8月至2020年6月招募了24例BEB患者。所有患者及结果评估者均对注射分配情况不知情。

干预措施

对每位参与者，一只眼睛随机接受睑前BoNT-A注射，另一只眼睛由同一位研究者注射等量的睑板前BoNT-A。在基线、注射后1个月和3个月时，我们分别收集流泪、兔眼、上睑下垂和复视症状，并测量双眼的边缘至反射距离（MRD）1和2（mm）、兔眼程度（mm）、睑外翻、睑内翻、眼球运动受限情况、泪膜破裂时间（秒）、泪液分泌试验（mm）、眼表染色评分（牛津方案）以及扬科维奇评分量表。主要结局指标为注射并发症。

结果

PTS（n = 12；52.17%）注射BoNT-A后自我报告的兔眼发生率在统计学上显著高于PST（n = 7；30.43%）注射（P = 0.024），并且在1个月时，使用交互模型（经邦费罗尼校正的P = 0.001），PTS注射的兔眼估计测量值（0.59 mm；95%置信区间[CI]：0.44 - 0.72）显著高于PST注射（0.26 mm；95% CI：0.12 - 0.40）。在注射部位之间，未观察到疗效及其他并发症结果的显著差异。