Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Medical Unit Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden.
Acta Otolaryngol. 2021 May;141(5):531-536. doi: 10.1080/00016489.2021.1889660. Epub 2021 Mar 27.
Ranula is a rare benign cystic lesion in the floor of the mouth, which can herniate through the mylohyoid muscle and become a plunging ranula. Treatment for ranulas is currently surgical excision of the sublingual gland. Sclerotherapy with OK-432 is a well-established treatment of lymphatic malformations, but not yet thoroughly evaluated on ranulas. Objectives: To evaluate sclerotherapy of ranulas with OK-432 in a randomized double-blinded trial.
20 patients with plunging or intraoral ranula were randomized to two double-blinded injections with OK-432 or saline. Effect on the ranula and evaluation of symptoms and QOL were investigated.
Treatment response differed significantly between OK-432 and placebo, = .041(student's T-test). All patients with intraoral ranulas had a complete response, but only 1/4 of the patients with plunging ranula. The inflammatory reaction after injection with OK-432 caused a mild to moderate impact on QOL. No serious complications were observed.
This study suggests that sclerotherapy with OK-432 in ranula is a very effective treatment for intraoral ranulas, but possibly less useful in plunging ranulas.
This is a limited study, but we believe that sclerotherapy with OK-432 should be recommended as primary treatment at least for intraoral ranulas.
舌下腺囊肿是一种罕见的口腔底部良性囊性病变，可通过颏舌肌疝出形成潜突性舌下腺囊肿。目前治疗舌下腺囊肿的方法是手术切除舌下腺。OK-432 硬化疗法是一种成熟的治疗淋巴管畸形的方法，但尚未对舌下腺囊肿进行彻底评估。目的：通过随机双盲试验评估 OK-432 治疗舌下腺囊肿的效果。
20 例潜突性或口内型舌下腺囊肿患者随机分为两组，分别接受 OK-432 或生理盐水的双盲注射。观察对舌下腺囊肿的影响以及症状和生活质量的评估。
OK-432 与安慰剂的治疗反应有显著差异，P=.041（学生 t 检验）。所有口内型舌下腺囊肿患者均有完全缓解，但只有 1/4 的潜突性舌下腺囊肿患者有缓解。OK-432 注射后的炎症反应对生活质量有轻度至中度影响。未观察到严重并发症。
本研究表明，OK-432 硬化疗法治疗舌下腺囊肿对口内型舌下腺囊肿非常有效，但对潜突性舌下腺囊肿可能效果较差。
这是一项有限的研究，但我们认为 OK-432 硬化疗法至少应推荐作为口内型舌下腺囊肿的首选治疗方法。
