1.The Effects of Increased Intra-Abdominal Pressure on Bacterial Translocation.
Coskun POLAT ; Orhan Cem AKTEPE ; Gokhan AKBULUT ; Sezgin YILMAZ ; Yuksel ARIKAN ; Osman Nuri DILEK ; Ozcan GOKCE
Yonsei Medical Journal 2003;44(2):259-264
In this study, we investigated the effect of different values of intra-abdominal pressure on bacterial translocation. Twenty-four Wistar-Albino rats were divided into four groups. The animals belonging to the Control group were not subjected to any increased intra-abdominal pressure. In groups I, II and III, an intra-abdominal pressure of 14, 20, and 25 mmHg, respectively, was established by carbon dioxide pneumoperitoneum for a period of 60 minutes. Four hours after the pneumoperitoneum, all animals were sacrificed to evaluate the degree of bacterial translocation at this time. Liver, spleen and mesenteric lymph nodes were excised under sterile conditions. Bacterial growth was assessed using standard bacteriological techniques and compared statistically. The Kruskal-Wallis and Mann-Whitney U tests were used for the statistical analysis. Different amounts of bacterial growth were found in all of the animals subjected to increased intra-abdominal pressure, except for the controls. Bacterial translocation was detected at an intra-abdominal pressure of 14 mmHg but this finding was not statistically significant (p > 0.05). There was a significant increase in bacterial growth in animals subjected to an intra- abdominal pressure of 20 mmHg or above (p < 0.001). As a result, we found that bacterial translocation started when the intra-abdominal pressure reached a level of 14 mmHg. Patients should be closely monitored for septic complication risks following laparoscopic procedures in which the intra-abdominal pressure exceeds 20 mmHg.
Abdomen
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Animals
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*Bacterial Translocation
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Carbon Dioxide
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Laparoscopy/*adverse effects
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Pneumoperitoneum, Artificial/adverse effects
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Pressure
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Rats
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Rats, Wistar
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Splanchnic Circulation
2.Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial.
Nagamu INOUE ; Kiyonori KOBAYASHI ; Makoto NAGANUMA ; Fumihito HIRAI ; Morio OZAWA ; Dilek ARIKAN ; Bidan HUANG ; Anne M ROBINSON ; Roopal B THAKKAR ; Toshifumi HIBI
Intestinal Research 2017;15(3):395-401
BACKGROUND/AIMS: Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671). METHODS: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments. RESULTS: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively. CONCLUSIONS: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.
Adalimumab*
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Biological Products
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Endoscopy
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Humans
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Incidence
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Ulcer