A 62-year-old Japanese woman who had developed massive cirrhotic ascites was referred to our hospital for a peritoneovenous shunt implant. However, CT examination revealed an umbilical hernia that had not been observed before the peritoneovenous shunt was implanted. We decided to perform laparoscopic umbilical hernia repair to keep carbon dioxide from flowing backward into the central circulatory system. We first clamped the catheter and set the upper limit of the pneumoperitoneum pressure to 6 mmHg. The central venous pressure was also measured simultaneously. Mesh was then applied over the hernia and fixed by the double-crown technique. Finally, 1000-mL physiological saline was infused into the abdominal cavity while the pneumoperitoneum was slowly released. In this case, we safely performed laparoscopic umbilical hernia repair while making some alterations, specifically catheter clamping, reducing pneumoperitoneum pressure, monitoring central venous pressure, and infusing physiological saline.
Background: Disease progression after Bacillus Calmette-Guerin (BCG) instillation therapy for bladder cancer is not rare. The purpose of this study was to evaluate the outcome of patients treated with BCG for superficial bladder cancer, focusing on the patients who developed invasive disease during followup. The possible mechanism and risk factors for early progression after BCG therapy are discussed. Methods: A total of 25 patients with superficial bladder cancer (pTa, pTl, and/or pTis) were treated with intravesical BCG instillation (80 mg in 80 mL saline) once a week for eight weeks. Four of the 25 patients received maintenance therapy with BCG (once a month for 3 to 10 months). Patients were followed every three months and underwent cystoscopy, biopsy, and urinary cytology at these intervals. Disease progression was defined as invasion to muscle or prostate, or development of metastatic disease. Clinicopathological features of the patients, especially those with progression, were analyzed. Results: Progression was observed in six of the 25 patients (including four of 19 patients with carcinoma in situ and two of five patients treated prophylactically with BCG). The average time to progression was 8.7 months. Four patients died of cancer despite intensive treatment. Two patients are alive: one without evidence of disease after cystectomy and the other with metastatic disease. Conclusions: Proper patient selection, careful follow-up, and immediate aggressive therapy in case of progression were considered to be important factors to obtain satisfactory results with BCG therapy for bladder cancer.
A safety assessment for β-galactosidase derived from Aspergillus oryzae (GODO-FAL) was performed. The test article was a concentrated, purified β-galactosidase diluted in glycerin and water with an activity of 10,000 U/mL. A series of genotoxicology tests including micronucleus assay, chromosome aberration assay, and reverse mutagenesis (Ames) assay confirmed that GODO-FAL was not clastogenic or mutagenic at any of the concentrations used, up to 2000 µg/mL for the chromosome aberration assay and 5000 mg per plate in the Ames assay. GODO-FAL was not toxic in acute, repeated oral toxicity, and sub-chronic toxicity assays in Sprague–Dawley rats at any dose used, up to 2000 mg/kg/day. Based on results from the subchronic toxicology assay, the no observed adverse effects level for GODO-FAL was at least 2000 mg/kg/day.
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