Adv Exp Med Biol
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The regulations for the human use of advanced therapy medical products such as gene and cell therapy products have evolved in accordance with advance of clinical experience, scientific knowledge, and social acceptance to these technologies. In Japan, two laws, the Pharmaceuticals and Medical Devices (PMD) Act and the Act on the Safety of Regenerative Medicine (ASRM), were enacted in November 2014. ⋯ Amendments to accompanying guidelines for these two Acts are currently in preparation. It is expected that the new legislative frameworks will promote the timely development of new products and technologies, to bring safe and effective regenerative medicines to Japanese patients.
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Randomized Controlled Trial Comparative Study
Comparison of Small Bore Catheter Aspiration and Chest Tube Drainage in the Management of Spontaneous Pneumothorax.
Beside standard chest tube drainage other less invasive techniques have been used in the management of patients with an acute episode of spontaneous pneumothorax. The aim of the study was to evaluate the short term effect of spontaneous pneumothorax treatment with small-bore pleural catheter and manual aspiration as compared to large-bore chest tube drainage. Patients with an episode of pneumothorax who required pleural intervention were enrolled in the study and randomly assigned to one of the treatment arms: (1) small-bore pleural catheter (8 Fr) with manual aspiration; (2) standard chest tube drainage (20-24 Fr). ⋯ First line treatment success rates were 64% and 82% in the manual aspiration and chest tube drainage groups, respectively; the difference was insignificant. Median time of treatment with small bore catheter was significantly shorter than conventional chest tube drainage (2.0 vs. 6.0 days; p<0.05). Our results show that treatment of spontaneous pneumothorax with small-bore pleural catheter and manual aspiration might be similarly effective as is chest tube drainage in terms of immediate lung re-expansion.
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In critically ill patients, breathing is impaired and mechanical ventilation, using an endotracheal tube (ET) connected to a ventilator, is necessary. Although mechanical ventilation is a life-saving procedure, it is not without risk. Because of several reasons, a biofilm often forms at the distal end of the ET and this biofilm is a persistent source of bacteria which can infect the lungs, causing ventilator-associated pneumonia (VAP). ⋯ The ESKAPE pathogens play a dominant role in the onset of VAP and these organisms were frequently identified in ET biofilms. Also, antibiotic resistant microorganisms were frequently present in ET biofilms. Members of the normal oral flora were also identified in ET biofilms but it is thought that these organisms initiate ET biofilm formation and are not directly involved in the development of VAP.
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Severe kyphoscoliosis can cause chronic respiratory failure. Noninvasive mechanical ventilation (NIMV) is a new optional treatment for such patients. The aim of this study was to evaluate the effectiveness of average volume-assured pressure support (AVAPS) NIMV in patients with kyphoscoliotic chronic respiratory failure. ⋯ The forced vital capacity also increased after 1 year (1,024±258 ml vs. the baseline 908±267 ml; p<0.05). The NIMV was well tolerated and no patient discontinued the treatment during the observation period. We conclude that AVAPS NIMV is an effective treatment option in kyphoscoliotic patients with chronic respiratory failure, resulting in a prompt and long-term improvement of daytime and nocturnal blood gas exchange.
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Enhanced level of soluble urokinase plasminogen activator receptor (suPAR) level has been associated with activation of the immune system. It may be a novel biomarker for pneumonia severity, yet data on this subject are limited. In the present study we seek to determine the suPAR level in hospitalized children with community-acquired pneumonia (CAP), its correlation with pneumonia severity, and to compare the suPAR level between pneumonia and healthy conditions. ⋯ There was a reverse correlation with sodium concentration and capillary blood saturation. Moreover, the suPAR level was significantly higher in children with a severe course of pneumonia compared with those having non-severe pneumonia (7.79 vs. 6.87 ng/mL; p = 0.006). In conclusion, suPAR elevation is observed in pneumonia and may reflect its severity.