Servicio de Oftalmología, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.
Servicio de Oftalmología, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.
Arch Soc Esp Oftalmol (Engl Ed). 2022 Oct;97(10):549-557. doi: 10.1016/j.oftale.2022.06.011. Epub 2022 Jul 22.
To compare the efficacy of botulinum toxin A (BoNTA) injection into the lacrimal gland versus lateral tarsal strip (LTS) for functional epiphora.
Randomized clinical trial. Sequential, parallel, non-blinded study design. Patients aged 18 years or older with functional epiphora and a minimum score of 3 in Munk Scale (MS) were randomized to BoNTA or LTS group. Changes in Munk scale, Schirmer test (ST) and quality of life (QoL) were assessed at week 6 and during follow-up until week 30. The mean time without epiphora and the adverse events (AE) were recorded.
The final analysis included 25 patients, 12 (21 eyes) assigned to BoNTA (5U/0.05 mL) and 13 (20 eyes) to LTS. At 6 weeks there was an improvement in the MS in BoNTA versus LTS group (-2.48 vs -1.55, P = .0152) and at 12 weeks (-2.68 vs -1.69, P = .0267). A significant decrease was noted in the ST at week 2, 12 and 30 with BoNTA. The QoL improved after both interventions without statistical significance. The mean duration of effectiveness in BoNTA group was 26.2 weeks (range 7.7-36.6) and in LTS group was 24.8 weeks (range 6.7-37.6), P = .937. The main AE were temporary eyelid ptosis in 25% (3/12) of the BoNTA group and surgical scar discomfort in 23% (3/13) of the LTS groups, P = .722. No AE were classified as severe.
BoNTA injection into the lacrimal gland is a safe and effective treatment for functional epiphora, with a greater decrease in MS at 6 and 12 weeks compared with LTS.
比较肉毒杆菌毒素 A（BoNTA）注射到泪腺与外侧睑板条（LTS）治疗功能性溢泪的疗效。
随机临床试验。顺序、平行、非盲研究设计。年龄在 18 岁或以上，有功能性溢泪，Munk 量表（MS）评分至少为 3 的患者被随机分为 BoNTA 或 LTS 组。在第 6 周和第 30 周的随访期间，评估 Munk 量表、泪液分泌试验（ST）和生活质量（QoL）的变化。记录无溢泪的平均时间和不良反应（AE）。
最终分析包括 25 例患者，12 例（21 只眼）接受 BoNTA（5U/0.05ml），13 例（20 只眼）接受 LTS。在第 6 周，BoNTA 组的 MS 评分较 LTS 组改善（-2.48 对-1.55，P=0.0152），在第 12 周改善（-2.68 对-1.69，P=0.0267）。BoNTA 治疗后 2 周、12 周和 30 周 ST 显著下降。两种干预措施后 QoL 均有改善，但无统计学意义。BoNTA 组的有效持续时间平均为 26.2 周（7.7-36.6 周），LTS 组为 24.8 周（6.7-37.6 周），P=0.937。主要的不良反应是 BoNTA 组 25%（3/12）出现暂时性眼睑下垂，LTS 组 23%（3/13）出现手术疤痕不适，P=0.722。没有不良反应被归类为严重。
BoNTA 注射到泪腺是治疗功能性溢泪的一种安全有效的方法，与 LTS 相比，6 周和 12 周时 MS 下降更明显。
