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Journal of Investigative Surgery : the... Feb 2017Purpose/aim: Modified radical mastectomy is the standard surgery for breast cancer in developing countries. However, seroma formation regarded as the most frequent... (Comparative Study)
Comparative Study Randomized Controlled Trial
UNLABELLED
Purpose/aim: Modified radical mastectomy is the standard surgery for breast cancer in developing countries. However, seroma formation regarded as the most frequent postoperative complication limits the therapeutic benefit of mastectomy and axillary surgery. The purpose of this study was to evaluate the efficacy of OK-432 in reducing seroma formation after axillary dissection.
METHODS
This prospective cohort study included 80 patients with advanced breast cancer who underwent modified radical mastectomy. Patients were randomized into two groups, which differed with the OK-432 administration. N = 40 patients per group were treated with either OK-432 plus closed suction drainage or drainage-only.
RESULT
In comparison with the drainage-only group, we found that patients in the OK-432 group had a lower drainage volume (p = .030) and a shorter duration of axillary drainage (p < .01). Besides, the use of OK-432 could reduce the incidence of seroma formation (p < .01) and the volume of seroma (p = .040). There were also significant differences in reducing the chance of evacuative punctures (p = .036) and the healing time (p < .01) between control and OK-432 group.
CONCLUSION
OK-432 not only shortened the suction drainage duration, but also significantly reduced seroma formation as well as the needs for aspiration punctures after modified radical mastectomy.
Topics: Adult; Axilla; Biological Products; Breast Neoplasms; Female; Humans; Incidence; Lymph Node Excision; Lymph Nodes; Mastectomy, Modified Radical; Middle Aged; Picibanil; Postoperative Complications; Prospective Studies; Seroma; Suction; Time Factors
PubMed: 27431576
DOI: 10.1080/08941939.2016.1204386 -
Pediatric Surgery International Dec 2005This study includes all the children treated with OK-432 for lymphangioma at our institute. Twenty-nine children treated between 1999 and 2003 are reported for the first...
This study includes all the children treated with OK-432 for lymphangioma at our institute. Twenty-nine children treated between 1999 and 2003 are reported for the first time: twelve cases regressed completely, eight cases regressed more than 50% and seven remained unchanged; two cases were lost at follow-up. The outcome was related to the size of the cysts, the larger ones having a better prognosis. The adverse reactions are discussed and the methods of treatment are described in detail. Fifteen children, treated before 1999 and already reported, are reviewed after a long-term follow-up. Four had a recurrence: one regressed spontaneously and three needed further treatment. The other 11 had no complaints. Even considering the risk of recurrence, OK-432 therapy remains our first line therapy for lymphangiomas, avoiding surgery in most cases.
Topics: Antineoplastic Agents; Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Lymphangioma, Cystic; Magnetic Resonance Imaging; Male; Neoplasm Recurrence, Local; Picibanil; Remission Induction; Remission, Spontaneous
PubMed: 16249902
DOI: 10.1007/s00383-005-1564-9 -
Acta Paediatrica (Oslo, Norway : 1992) Aug 2019We assessed the long-term health-related quality of life (HRQoL) of children who received sclerotherapy for lymphatic malformations. This treatment involved injecting...
Long-term health-related quality of life in children with lymphatic malformations treated with sclerotherapy generally matched age-appropriate standardised population norms.
AIM
We assessed the long-term health-related quality of life (HRQoL) of children who received sclerotherapy for lymphatic malformations. This treatment involved injecting drugs into the blood vessels to make them shrink.
METHODS
Our cross-sectional study retrospectively reviewed patients who received OK-432 sclerotherapy injections at Karolinska University Hospital, Stockholm, Sweden, from 1998 to 2013. We studied 49 patients (63% female) aged 8-18 at least five years after their first injection. HRQoL was assessed with the KIDSCREEN-52 questionnaire and a study-specific questionnaire addressed disease consequences and patient satisfaction. We determined associations between HRQoL and disease and treatment and the patient's sex.
RESULTS
Overall HRQoL paralleled age-appropriate norms in the general population, but some subgroups had lower levels. Regression-based estimates showed that larger numbers of injections were negatively associated with HRQoL in the dimensions autonomy, parent relations and home life, financial resources and school environment (p = 0.01-0.03). Malformations in the head and neck area were negative predictors across dimensions and were strongest for psychological well-being (p = 0.009), parent relations and home life (p = 0.017) and school environment (p = 0.006).
CONCLUSION
Despite generally positive outcomes, multiple injections and malformations in the head and neck were associated with impaired HRQoL.
Topics: Adolescent; Antineoplastic Agents; Child; Cross-Sectional Studies; Female; Humans; Lymphatic Abnormalities; Male; Picibanil; Quality of Life; Retrospective Studies; Sclerotherapy
PubMed: 30556934
DOI: 10.1111/apa.14700 -
The Laryngoscope Jan 2009To determine the efficacy and safety of the immunostimulant OK-432 (Picibanil) as a treatment option in the management of children with cervicofacial lymphatic... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To determine the efficacy and safety of the immunostimulant OK-432 (Picibanil) as a treatment option in the management of children with cervicofacial lymphatic malformations.
STUDY DESIGN
A prospective, randomized, multi-institutional phase II clinical trial at 27 U.S. academic medical centers.
METHODS
182 patients with lymphatic malformations (LM) were enrolled between January 1998 and November 2004. Of the 151 patients with complete case report forms, 117 patients were randomized into immediate or delayed treatment groups; 34 patients were nonrandomized and assigned to the open-label group. Treatment consisted of a four-dose intralesional injection series of OK-432 at eight-week intervals. Patients randomized into the delayed treatment group served as observational controls for spontaneous regression. Response to therapy was measured radiographically by quantitating change in lesion size and graded as complete (90%-100%), substantial (60%-89%), intermediate (20%-59%), or none (<20%).
RESULTS
Of 117 patients randomized with intent-to-treat, 68% demonstrated a complete or substantial response to OK-432 immunotherapy. Response data for macrocystic LM were higher, with a complete or substantial response in 94% of patients; 63% of patients with mixed macrocystic-microcystic LM responded to treatment; no patients with microcystic LM responded to treatment. Spontaneous resolution occurred in less than 2% of patients. Median follow-up of 2.9 years demonstrated a 9% recurrence rate. Major adverse effects related to therapy occurred in 11 patients. As compared to historical surgical data on LM, OK-432 immunotherapy is more effective (P < .001) and has a lower morbidity (P < .001).
CONCLUSIONS
OK-432 immunotherapy is an effective, safe, and simple treatment option for the management of macrocystic cervicofacial LM.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00010452.
Topics: Academic Medical Centers; Adolescent; Adult; Aged; Antineoplastic Agents; Child; Child, Preschool; Female; Humans; Immunotherapy; Infant; Lymphatic Abnormalities; Male; Middle Aged; Picibanil; Prospective Studies; Safety; Treatment Outcome; United States
PubMed: 19117316
DOI: 10.1002/lary.20041 -
Brazilian Journal of Otorhinolaryngology 2020
Topics: Airway Obstruction; Head and Neck Neoplasms; Humans; Infant; Lymphangioma; Male; Picibanil; Sclerosing Solutions; Sclerotherapy; Tracheostomy; Treatment Outcome
PubMed: 27297957
DOI: 10.1016/j.bjorl.2016.04.016 -
Foot & Ankle International Feb 2009We devised a method of sclerotherapy using OK432. The present study comprised a retrospective followup of sclerotherapy outcomes.
BACKGROUND
We devised a method of sclerotherapy using OK432. The present study comprised a retrospective followup of sclerotherapy outcomes.
MATERIALS AND METHODS
Eighteen feet in 18 consecutive patients (seven men, 11 women; mean age, 55 years) were treated with sclerotherapy. Previous surgery had been performed one to four times for seven feet. After aspirating the contents of the ganglion cysts, 0.2 to 0.3 ml of suspension of OK432 (lyophilized strep pyogenes) was injected. The volume of fluid aspirated was from 0.2 to 2.5 ml, with an average of 0.9 ml. Mean duration of followup was 3 years 6 months. Clinical evaluation was performed using the AOFAS hallux scale.
RESULTS
All ganglion cysts disappeared after sclerotherapy. However, recurrences were observed in eight feet. Mean duration until recurrence was 13 months. Sclerotherapy was again performed for all patients with recurrence. Re-recurrence occurred in three feet. A third sclerotherapy was performed for all three patients. All ganglion cysts had disappeared by final followup. Mean AOFAS score improved from 75 points before therapy to 95 points at followup. Six patients had complications with local redness and pain for 1 to 6 days after injection.
CONCLUSION
Sclerotherapy using OK432 is a minimally invasive treatment of symptomatic ganglion cysts of the hallux. Recurrence is common but complications are infrequent and self-limited.
Topics: Adult; Aged; Aged, 80 and over; Cysts; Foot Diseases; Hallux; Humans; Middle Aged; Picibanil; Recurrence; Retrospective Studies; Sclerotherapy
PubMed: 19254507
DOI: 10.3113/FAI-2009-0128 -
Nihon Geka Gakkai Zasshi Apr 1983Intratumoral administration of a large dose of OK-432 has two antitumor functions; a direct cytotoxic effect and an indirect effect through the host reticuloendotherial...
Intratumoral administration of a large dose of OK-432 has two antitumor functions; a direct cytotoxic effect and an indirect effect through the host reticuloendotherial functions. It has been pointed out that this method, however, occasionally results in shock. Several investigators have suggested the importance of the use of general anesthesia to avoid such shock. In order to explore the hemodynamic effect of intratumoral injection of OK-432, a simulated experiment (OK-432 or saline intramuscular injection) was carried out utilizing 10 anesthetized and 10 unanesthetized dogs. In addition, hemodynamic alterations during the OK-432 administration were studied in nine patients under neuroleptal anesthesia. In both anesthetized and unanesthetized dogs, OK-432 intramuscular injection resulted in a slight decrease of the mean arterial pressure, left ventricular systolic pressure and cardiac output as compared with those of the saline injected dogs. The hemodynamic alterations, however, were minimal and were thought not to cause severe hemodynamic derangements. Clinical experiences also showed no serious hemodynamic effects by the OK-432 intratumoral injections. It was concluded that the OK-432 intratumoral injection appeared not to induce hemodynamic derangement when applied to euvolemic and hemodynamically stable patients.
Topics: Animals; Biological Products; Blood Pressure; Cardiac Output; Dogs; Hemodynamics; Humans; Injections, Intramuscular; Picibanil; Stomach Neoplasms
PubMed: 6674797
DOI: No ID Found -
Cancer Investigation Feb 2012The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE).
METHODS
A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups.
RESULT
Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p < .05). The median survival time for patients in Group A and Group B were 8.9 and 6.2 months, respectively (p > .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05).
CONCLUSION
In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.
Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Cisplatin; Combined Modality Therapy; Female; Humans; Hyperthermia, Induced; Lung Neoplasms; Male; Middle Aged; Picibanil; Pleural Effusion, Malignant; Prospective Studies; Quality of Life; Survival Analysis
PubMed: 22148972
DOI: 10.3109/07357907.2011.633292 -
European Radiology Dec 2021To review the effectiveness and safety of chemical ablation using ethanol or OK-432 for the treatment of TGDCs (thyroglossal duct cysts). (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To review the effectiveness and safety of chemical ablation using ethanol or OK-432 for the treatment of TGDCs (thyroglossal duct cysts).
METHODS
MEDLINE and EMBASE databases were searched up to May 29, 2020, to identify studies reporting the safety and efficacy of chemical ablation using ethanol or OK-432 for the treatment of TGDCs. The search query consisted of synonyms of thyroglossal duct cysts and ethanol or OK-432 ablation. The pooled success and complication rates were calculated using the inverse variance method to calculate weights, and pooled proportions were determined using the DerSimonian-Laird random-effects method.
RESULTS
Seven original articles including a total of 129 patients were included. The efficacy of chemical ablation was acceptable, with a pooled success rate of 70% (95% CI, 47-86%). The pooled success rate of ethanol ablation was superior to that of OK-432 ablation, although with equivocal statistical significance (84% vs. 51%, p = 0.055). Repeat ethanol ablation achieved a pooled success rate of 47% (95% CI, 24-71%). The chemical ablation procedures were safe, with a pooled major complication rate of 0.9% (95% CI, 0.1-5.8%).
CONCLUSIONS
Chemical ablation using ethanol or OK-432 for the treatment of TGDCs had acceptable success and low complication rates, and repeat treatment after initial failure was also feasible. In addition, it is an inexpensive and simple procedure and could therefore be considered a first-line treatment for TGDCs.
KEY POINTS
• The efficacy of chemical ablation using ethanol or OK-432 was acceptable, with a pooled success rate of 70% (95% CI, 47-86%). The pooled success rate of ethanol ablation was superior to that of OK-432 ablation, although with equivocal statistical significance (84% vs. 51%, p = 0.055). • Repeat ethanol ablation was also feasible, with a pooled success rate of 47% (95% CI, 24-71%). • The chemical ablation procedures were safe, with a pooled major complication rate of 0.9% (95% CI, 0.1-5.8%).
Topics: Ablation Techniques; Ethanol; Humans; Picibanil; Sclerotherapy; Thyroglossal Cyst
PubMed: 34003346
DOI: 10.1007/s00330-021-08033-2 -
Fetal Diagnosis and Therapy 2019The treatment options for fetal chylothorax include thoracocentesis, thoracoamniotic shunting, and pleurodesis using OK-432. Knowledge on the long-term outcomes after...
BACKGROUND
The treatment options for fetal chylothorax include thoracocentesis, thoracoamniotic shunting, and pleurodesis using OK-432. Knowledge on the long-term outcomes after treatment with OK-432 is limited.
OBJECTIVE
The aim of this study was to assess the long-term outcomes of children treated in utero with OK-432.
METHODS
We performed follow-up on pregnancies and children treated in utero with OK-432 between 2003 and 2009 at Copenhagen University Hospital Rigshospitalet for pleural effusions at gestational age (GA) 16+0-21+6 weeks. Anamnestic information, physical examination, pulmonary function test, neuropediatric examination, and intelligence testing using the Wechsler Intelligence Scale were used for evaluation.
RESULTS
Fourteen cases, all chylothorax, were treated with OK-432. None had preterm premature rupture of membranes (PPROM), and the median GA at delivery was 38+5 (24+4-41+5) weeks. Twelve children were eligible for follow-up. The median age at follow-up was 11.4 (7.8-13.8) years. Pulmonary function was normal in all children and the mean full-scale IQ did not differ from that of normal children. Four children had a diagnosed medical condition, attention deficit disorder, or genetic syndrome. The remaining children had normal follow-up.
CONCLUSION
Children treated with OK-432 have comparable survival rates and long-term neurodevelopmental outcomes to those treated with thoracoamniotic shunts. There seems to be a lower risk of procedure-related PPROM.
Topics: Adolescent; Child; Child Development; Chylothorax; Follow-Up Studies; Humans; Picibanil; Pleurodesis; Respiratory Function Tests; Wechsler Scales
PubMed: 30282075
DOI: 10.1159/000489775