title: Evaluation of OK-432 Injection Therapy as Possible Primary Treatment of Intraoral Ranula.
abstract: OBJECTIVE
  A ranula is a pseudocyst caused by mucous extravasation from the sublingual gland. Recently, a sclerosing agent, OK-432 (picibanil), has been reported to be highly effective for treating lymphangioma and cervical cystic lesions. The present study assessed the effectiveness of OK-432 injection therapy for intraoral ranula to clarify whether it can be used as the primary treatment.
  
  
  METHODS
  The present study was a retrospective clinical study of patients with intraoral ranula who received OK-432 injection therapy from 2005 to 2015. The ranula size was measured on computed tomography or magnetic resonance imaging studies. We dissolved 1 Klinische Einheit (KE) unit of OK-432 powder in normal saline equal to the aspiration volume. The primary endpoint was the treatment results. The secondary endpoints were the relation between the treatment results and the lesion length and aspiration volume.
  
  
  RESULTS
  A total of 23 patients received OK-432 injection therapy for an intraoral ranula. The mean lesion size was 19.96 mm. The mean aspiration volume was 2.14 mL. The number of injections was 1 to 4 (mean 1.70). The treatment results were complete regression (CR) in 18 (78.2%), partial regression (PR) in 3 (13.0%), and no response (NR) in 2 (8%) patients after the last injection. The overall efficacy rate was 91.2% (21 of 23). No serious complications were observed. The lesion length and aspiration volume of the CR group was 17.38 mm and 1.40 mL, respectively. The lesion length and aspiration volume of the PR/NR group was 29.20 mm and 4.80 mL, respectively. The PR/NR group lesions were significantly larger than the CR group lesions.
  
  
  CONCLUSIONS
  OK-432 injection therapy for intraoral ranula is safe and effective compared with other surgical therapies. This therapy could potentially become a primary treatment of intraoral ranula.
authors.affiliation: Instructor, Department of Oral and Maxillofacial Surgery, Tokyo Medical University, Tokyo, Japan. Electronic address: mk-oms@tokyo-med.ac.jp.
authors.forename: Michihide
authors.initials: M
authors.lastname: Kono
authors.affiliation: Associate Professor, Department of Oral and Maxillofacial Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Satomi
authors.affiliation: Lecturer, Department of Oral and Maxillofacial Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Harutsugi
authors.initials: H
authors.lastname: Abukawa
authors.affiliation: Instructor, Department of Oral and Maxillofacial Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: On
authors.initials: O
authors.lastname: Hasegawa
authors.affiliation: Lecturer, Department of Oral and Maxillofacial Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Watanabe
authors.affiliation: Professor and Chair, Department of Oral and Maxillofacial Surgery, Tokyo Medical University, Tokyo, Japan.
authors.forename: Daichi
authors.initials: D
authors.lastname: Chikazu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D005260:Female; D006801:Humans; D007267:Injections; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010844:Picibanil / Q000008:administration & dosage / Q000627:therapeutic use*; D011900:Ranula / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D012189:Retrospective Studies; D014057:Tomography, X-Ray Computed; D055815:Young Adult
chemical_list: D010844:Picibanil