Department of Ophthalmology, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan, Republic of China.
J Glaucoma. 2010 Oct-Nov;19(8):546-50. doi: 10.1097/IJG.0b013e3181ca76a9.
To assess the efficacy and safety of botulinum toxin type A (BoNT-A) injection in patients suffering from intractable periorbital pain after acute angle closure glaucoma (AACG).
In this prospective randomized intervention study, 19 patients suffering from periorbital pain after an AACG attack were injected with BoNT-A or placebo for pain relief. Patients were assessed on days 1, 2, 7, 14, 30, 60, and 90. The main outcomes were mean change of visual analog rating scale (VARS) and index scores measured through a quality-of-life questionnaire (EQ-5D), and changes in the visual analog scale (VAS), all of which were assessed at each visit. A secondary outcome was the frequency and nature of adverse events and the number of patients who withdrew from the study as a result.
In the treatment group (n=10), the mean index score of EQ-5D and VAS changed significantly from the placebo group (by 0.299 and 2.61, respectively) from day 2 (P<0.01). The VARS of EQ-5D also disclosed significant changes from day 2 (17, P<0.01). In addition, efficacy was maintained mainly between days 2 and 60 but declined slightly by day 90. The most frequently reported treatment-related adverse events in the treatment and placebo groups were local tenderness (21%), subcutaneous hemorrhage (10.5%), and conjunctivitis (10.5%). No severe adverse events were reported during the study or follow-up period.
BoNT-A is effective and well tolerated for the treatment of periorbital pain after an AACG attack. Its effects may be maintained for 3 months.
评估 A 型肉毒毒素（BoNT-A）注射治疗急性闭角型青光眼（AACG）后难治性眶周疼痛患者的疗效和安全性。
在这项前瞻性随机干预研究中，19 名 AACG 发作后出现眶周疼痛的患者接受 BoNT-A 或安慰剂注射以缓解疼痛。患者在第 1、2、7、14、30、60 和 90 天进行评估。主要结局为视觉模拟评分量表（VARS）和生活质量问卷（EQ-5D）指数评分的平均变化，以及视觉模拟量表（VAS）的变化，所有这些均在每次就诊时进行评估。次要结局为不良事件的频率和性质以及因不良事件而退出研究的患者人数。
在治疗组（n=10）中，EQ-5D 和 VAS 的平均指数评分从第 2 天开始（分别为 0.299 和 2.61）与安慰剂组相比显著变化（P<0.01）。EQ-5D 的 VARS 也从第 2 天开始发生显著变化（17，P<0.01）。此外，疗效主要在第 2 天至第 60 天维持，但在第 90 天略有下降。治疗组和安慰剂组最常报告的与治疗相关的不良事件是局部压痛（21%）、皮下出血（10.5%）和结膜炎（10.5%）。在研究或随访期间未报告严重不良事件。
BoNT-A 治疗 AACG 后眶周疼痛有效且耐受良好。其疗效可能维持 3 个月。
