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The Science Reports of the Research... Sep 1979
Topics: Animals; Biological Products; Gallium Radioisotopes; Male; Neoplasms, Experimental; Picibanil; Radionuclide Imaging; Rats
PubMed: 515724
DOI: No ID Found -
Otolaryngology--head and Neck Surgery :... Dec 2021The role of sclerotherapy for vascular lesions of the head and neck is well established. However, the efficacy of sclerotherapy for benign cystic lesions of the head and... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The role of sclerotherapy for vascular lesions of the head and neck is well established. However, the efficacy of sclerotherapy for benign cystic lesions of the head and neck is less clear. The objective of this review is to determine the efficacy and safety of sclerotherapy for benign cystic lesions of the head and neck.
DATA SOURCES
PubMed/MEDLINE, Cochrane Library, and Embase.
REVIEW METHODS
The PRISMA guidelines (Preferred Reporting Systems for Systematic Reviews and Meta-analyses) were followed for this systematic review. Studies of patients with benign head and neck cystic masses treated primarily with sclerotherapy were included. Thirty-two studies met criteria for inclusion.
RESULTS
A total of 474 cases of sclerotherapy were reviewed. Agents comprised OK-432, ethanol, doxycycline, tetracycline, and bleomycin. Lesions in the analysis were ranula, thyroglossal duct cyst, branchial cleft cyst, benign lymphoepithelial cyst, parotid cyst, thoracic duct cyst, and unspecified lateral neck cyst. A total of 287 patients (60.5%) had a complete response; 132 (27.9%) had a partial response; and 55 (11.6%) had no response. OK-432 was the most widely utilized agent, with a higher rate of complete response than that of ethanol (62.0% vs 39.4%, = .015). Fifty-three cases (11.2%) required further surgical management. One case of laryngeal edema was reported and managed nonoperatively.
CONCLUSION
Sclerotherapy appears to be a safe and efficacious option for benign cystic lesions if malignancy is reliably excluded. Efficacy rates are comparable to those of sclerotherapy for vascular malformations. The rate of serious complications is low, with 1 incident of airway edema reported in the literature.
Topics: Branchioma; Cysts; Ethanol; Humans; Lymphocele; Neck; Parotid Diseases; Picibanil; Ranula; Sclerotherapy; Thyroglossal Cyst; Vascular Malformations
PubMed: 33755513
DOI: 10.1177/01945998211000448 -
Journal of Pediatric Surgery Jun 1994Intralesional injection of OK-432 was employed to treat 64 lymphangiomas between 1986 and 1992. This was used as primary therapy for 46 lesions (group A), as treatment...
Intralesional injection of OK-432 was employed to treat 64 lymphangiomas between 1986 and 1992. This was used as primary therapy for 46 lesions (group A), as treatment following incomplete surgical removal in 14 (group B), and as therapy after failure of bleomycin in 4 (group C). In group A (n = 46), total shrinkage of the lesion, without serious complications, was noted in 23; there was marked shrinkage in 8, slight shrinkage in 12, and no response in 3. Of the cystic lesions (n = 24), significant shrinkage occurred in 22; of the cavernous lesions (n = 22), only 9 improved after treatment. In groups B (n = 14) and C (n = 4) there was significant clinical improvement occurred in 5 and 2, respectively. No recurrence was noted during follow-up (6 to 87 months). The only side effects were fever lasting 2 to 4 days and a local inflammatory reaction of 3 to 7 days' duration. The local inflammation did not cause any damage to the overlying skin and did not lead to scar formation. These data suggest that intralesional injection of OK-432 is effective treatment for lymphangiomas and should be considered as the primary method of treatment.
Topics: Humans; Injections, Intralesional; Lymphangioma; Picibanil
PubMed: 8078021
DOI: 10.1016/0022-3468(94)90370-0 -
Foot & Ankle International Oct 2013The purpose of this study was to evaluate the clinical outcomes and usefulness of OK-432 (Picibanil) sclerotherapy as a new option in the conservative treatment of...
BACKGROUND
The purpose of this study was to evaluate the clinical outcomes and usefulness of OK-432 (Picibanil) sclerotherapy as a new option in the conservative treatment of patients with malleolar bursitis of the ankle.
METHODS
Retrospectively, we reviewed a total of 20 consecutive patients (20 feet) in whom OK-432 sclerotherapy had been performed between March 2009 and June 2010. After aspiration of fluid in the malleolar bursal sac, 0.05 mg of OK-432 was injected into the malleolar bursal sac. We evaluated the clinical outcomes and side effects at the following time points: 2 weeks, 1 month, 3 months, 6 months, and 1 year after OK-432 sclerotherapy. The responses to the treatment were assessed according to the degree of fluctuation, shrinkage of the bursal sac, and soft tissue swelling.
RESULTS
Complete resolution was observed in 19 patients (95%) after the first or second application of OK-432 sclerotherapy, and a partial response was observed in 1 patient (5%) after a second application of OK-432 sclerotherapy. The physical component scores of SF-36 improved from 70.0 ± 6.8 to 76.5 ± 7.3 at the last follow-up (P = .0002).
CONCLUSION
OK-432 sclerotherapy was a useful procedure for patients not responding to the usual conservative treatment of malleolar bursitis of the ankle.
LEVEL OF EVIDENCE
Level IV, retrospective case series.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Bursitis; Female; Humans; Male; Middle Aged; Picibanil; Sclerotherapy; Ultrasonography; Young Adult
PubMed: 23620499
DOI: 10.1177/1071100713488091 -
International Journal of Radiation... Sep 2020In this study, we hypothesized that systemic antitumor immunity might be enhanced by combining pulsed-wave ultrasound hyperthermia (pUSHT) with OK-432 and that the...
PURPOSE
In this study, we hypothesized that systemic antitumor immunity might be enhanced by combining pulsed-wave ultrasound hyperthermia (pUSHT) with OK-432 and that the induced antitumor immunity could confer protection against tumorigenesis. These hypotheses were tested in bilateral and rechallenged tumor models.
METHODS AND MATERIALS
Bilateral and rechallenged tumor models were applied in the studies. In the bilateral tumor model, BALB/c mice were inoculated in both flanks with CT26-luc tumor cells. The tumors in the right flank were treated with 4 courses of pUSHT with or without OK-432. In the rechallenged tumor model, tumor cells were implanted into the right flank. Once formed, the tumors were treated with pUSHT with OK-432, followed by surgical resection. New tumor cells were then implanted into the contralateral flank. The antitumor response was evaluated via infiltrated immune cells and the severity of necrosis/apoptosis in tumors.
RESULTS
In the bilateral tumor model, the tumor growth rate and growth activity of both treated (100% reduction) and untreated tumors (90.5% reduction) were significantly inhibited with the combination treatment compared with the sham control group, and the systemic antitumor effect was prolonged. The survival rate was significantly enhanced (sham control, 8 days; OK plus pUSHT, >20 days). IFNγ CD4 (treated tumor, 8.6-fold; untreated tumor, 4-fold), IFNγ CD8 (treated tumor, 6.7-fold; untreated tumor, 2.6-fold), and T cell and NK cell (treated tumor, 4-fold; untreated tumor, 2.5-fold) infiltration was increased in the combination group compared with the control group. In the rechallenged tumor model, new tumors failed to form with the combination treatment.
CONCLUSION
This experimental study combining pUSHT and OK-432 explored a new therapeutic strategy for controlling colon cancer metastasis. The results show that the combination treatment may produce an effective antitumor immune response.
Topics: Adjuvants, Immunologic; Animals; Cell Line, Tumor; Cell Proliferation; Combined Modality Therapy; Hyperthermia, Induced; Mice; Picibanil; Ultrasonic Waves
PubMed: 32339644
DOI: 10.1016/j.ijrobp.2020.04.021 -
Otolaryngology--head and Neck Surgery :... Jan 2009Nonsurgical treatments, such as sclerotherapy have been attempted for head and neck lymphagiomas. Of the available sclerosing agents, picibanil has shown satisfactory...
INTRODUCTION
Nonsurgical treatments, such as sclerotherapy have been attempted for head and neck lymphagiomas. Of the available sclerosing agents, picibanil has shown satisfactory short-term treatment results in many studies, but no study has presented long-term treatment results. Accordingly, in the present study, the authors retrospectively reviewed the long-term treatment results of picibanil sclerotherapy.
MATERIALS AND METHODS
Fifty-five lymphangioma patients who underwent picibanil sclerotherapy were enrolled. Data about initial and long-term response, recurrence, and excision rate were collected.
RESULTS
Initial response rates were 83.5 percent and long-term response rates were 76.3 percent.
CONCLUSION
Initial and the long-term response rate were equally good for lymphangioma.
Topics: Adolescent; Adult; Child; Child, Preschool; Female; Follow-Up Studies; Head and Neck Neoplasms; Humans; Infant; Lymphangioma; Male; Picibanil; Retrospective Studies; Sclerosing Solutions; Sclerotherapy
PubMed: 19130974
DOI: 10.1016/j.otohns.2008.10.026 -
Nihon Gan Chiryo Gakkai Shi May 1990The present study was designed to determine the optimal dose and frequency of oral administration of a biological response modifier, OK-432 (Picibanil), which has been... (Clinical Trial)
Clinical Trial Randomized Controlled Trial
The present study was designed to determine the optimal dose and frequency of oral administration of a biological response modifier, OK-432 (Picibanil), which has been used for cancer immunotherapy by injection. Ninety one stomach cancer patients were randomly assigned into 7 groups and were administered a placebo or OK-432 at a dose of 5, 20 or 40KE, once or 3 times a week before operation (5KE X 1/W, 20KE X 1/W, 40KE X 1/W, or X 3/W). Misregistration excluded 3 patients and the data of 88 patients were analysed. There was no significant difference in the background status of the patients in each group. In the 1st report, we already showed that 5KE X 3/W might be the optimal regimen to augment the natural killer (NK) activity of regional lymph node lymphocyte (RNL). In the 2nd report, we searched for the optimal regimen to augment the antitumor immunity of T lymphocytes. The proliferative response of RNL to SuPR (protein derived from OK-432) was augmented in all the groups administered OK-432. The responsiveness of PBL to autologous tumor extract enhanced by IL-2 was augmented by 5KE X 1/W, and that of RNL was augmented by 5KE X 3/W. The killer/suppressor (Leu2+15-/Leu2+15+) ratio in RNL increased in all the groups administered OK-432 especially in 20KE X 3/W group. Oral administration of OK-432 augmented both non-specific and the specific antitumor immunity of PBL as well as RNL, and 5KE X 3/W may be the optimal regimen to augment the antitumor immunity, especially of RNL.
Topics: Administration, Oral; Adult; Aged; Biological Products; Clinical Trials as Topic; Double-Blind Method; Humans; Leukocyte Count; Lymphocyte Activation; Middle Aged; Picibanil; Stomach Neoplasms; T-Lymphocytes
PubMed: 2202770
DOI: No ID Found -
Otolaryngology--head and Neck Surgery :... Jun 2010Intralesional injection therapy with OK-432 was developed as a therapy for operatively difficult lymphangioma (cystic hygroma) and is currently becoming a first-choice...
OBJECTIVES
Intralesional injection therapy with OK-432 was developed as a therapy for operatively difficult lymphangioma (cystic hygroma) and is currently becoming a first-choice treatment for this disease. The aim of this article was to evaluate the outcome and complications of the treatment of patients with auricular hematoma by OK-432 therapy.
STUDY DESIGN
Case series with planned data collection.
SETTING
Yamagata University School of Medicine.
SUBJECTS AND METHODS
We tried this therapy in 21 patients with auricular hematoma between January 2001 and February 2009. We injected OK-432 solution into the lesion with a 27-gauge needle to prevent the leak of the agent out of the hematoma. We performed this treatment on an outpatient basis without hospitalization.
RESULTS
Disappearance or marked reduction of the lesion were observed in all patients who had this therapy, and local scarring and deformity of the auricle did not occur in any patients. As for side effects, local pain at the injection site and fever (37 degrees C-38 degrees C) were observed in a few of the patients who had this therapy, but such problems resolved within a few days.
CONCLUSION
These results may allow us to speculate that intralesional injection therapy with OK-432 is simple, easy, safe, and effective and can be used as a substitute for surgery in the treatment of auricular hematoma.
Topics: Adolescent; Adult; Aged; Antineoplastic Agents; Ear Auricle; Ear Diseases; Female; Hematoma; Humans; Injections, Intralesional; Male; Middle Aged; Picibanil; Prospective Studies; Treatment Outcome; Young Adult
PubMed: 20493359
DOI: 10.1016/j.otohns.2010.03.006 -
Gan To Kagaku Ryoho. Cancer &... Apr 1988Two immunotherapeutic methods were developed as adjuvant therapy for gastrointestinal malignancies, one using oral administration of a streptococcal preparation, OK-432,... (Clinical Trial)
Clinical Trial Review
Two immunotherapeutic methods were developed as adjuvant therapy for gastrointestinal malignancies, one using oral administration of a streptococcal preparation, OK-432, and the other with adoptive immunotherapy (AIT), local transfer of IL2-cultured and autologous lymphocytes, combined with local preadministration of OK-432. Tsuchitani and Nio in our laboratory have revealed experimentally that oral OK-432 stimulates tumor-specific and non-specific immune mechanisms of gut-associated lymphoid tissues and inhibits the growth of some murine syngeneic tumors that were transplanted into cecal patches. The clinical efficacy of oral OK-432 on gastric cancer patients has been examined by a controlled randomized trial involving a total of about 1000 cases. Oral OK-432 (5KE, once a week) was revealed to be significantly effective in curatively resected group but not effective in non-curatively resected group. Ten consecutive patients with peritoneal dissemination of gastric cancer were treated with intraperitoneal OK-432 and AIT. AIT was performed by transferring autologous lymph node-lymphocytes cultured for 13 days with crude IL2 and tumor-extract. The survival of the treated patients was significantly longer (50% survival period exceeded 1 year) than that of historical control (95 cases, 50% survival period was 5 months). These immunotherapeutic methods are expected to be useful for multidisciplinary therapy of gastric cancer by a combination of each method with other therapeutic methods.
Topics: Biological Products; Clinical Trials as Topic; Combined Modality Therapy; Humans; Immunization, Passive; Picibanil; Random Allocation; Stomach Neoplasms
PubMed: 3291771
DOI: No ID Found -
Journal of Oral and Maxillofacial... Feb 2017A 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...
PURPOSE
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.
PATIENTS AND 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.
Topics: Adolescent; Adult; Aged; Child; Female; Humans; Injections; Magnetic Resonance Imaging; Male; Middle Aged; Picibanil; Ranula; Retrospective Studies; Tomography, X-Ray Computed; Young Adult
PubMed: 27639155
DOI: 10.1016/j.joms.2016.08.013