The purpose of this prospective study was to test whether intratympanic application of dexamethasone/hyaluronic acid improves hearing outcome in patients with pantonal idiopathic sudden sensorineural hearing loss (ISSHL), in patients with sudden deafness or sudden profound SHL and in patients with predominant high-frequency ISSHL who are refractory to intravenous steroid and vasoactive therapy. The study took place in an academic tertiary referral hospital involving 21 patients with pantonal ISSHL, 10 patients with sudden deafness or sudden profound SHL and 9 patients with a high-frequency ISSHL. Intratympanic dexamethasone/hyaluronic acid was administered in the affected ear. Hearing was evaluated by means of standard pure-tone audiometry. The differences between pure-tone hearing thresholds by air conduction before intravenous therapy and before the beginning of the intratympanic therapy, as well as before and after intratympanic therapy, were calculated. Statistical analysis was performed by means of the Wilcoxon's test for paired samples. Intratympanic injection of dexamethasone/hyaluronic acid results in a significant global (pantonal) improvement in hearing in patients with pantonal ISSHL. It also effects improvement in hearing at selected frequencies (namely at 1.5 and 3 kHz) in patients with a predominant high-frequency ISSHL and at selected frequencies (namely at 0.5, 0.75 and 1 kHz) in patients with sudden deafness or sudden profound SHL. Neither systemic nor local side effects were observed. Intratympanic administration of dexamethasone/hyaluronic acid provides a safe and efficacious therapeutic option for the treatment of patients with pantonal and high-frequency ISSHL who don't respond to intravenous steroid and vasoactive therapy.
Intratympanic combined dexamethasone/hyaluronic acid application provides a reliable and safe therapeutic option for improvement of hearing in patients with isolated low-frequency idiopathic sudden sensorineural hearing loss or sensorineural hearing loss resulting from Ménière's disease who have failed intravenous steroid and vasoactive treatments.
The objective of this study is to test whether there is a difference between the polysomnographic (PSG) values of Apnea-hypopnea index (AHI), minimal oxygen saturation (SpO(2)), oxygen desaturation index (ODI) and arousal index recorded on two consecutive nights (so-called "first night effect") in patients with sleep-disordered breathing (SDB) and concomitant upper airway pathology. Retrospective case-control study of polysomnographical recordings of 130 patients (112 males, 18 females, age range 23-80 years) with SDB and upper airway pathology who were tested on two consecutive nights in a hospital sleep laboratory was conducted. Only patients with upper airway pathology without other medical conditions causing SDB were included. AHI, minimal SpO(2), ODI and arousal index values of the first night were compared to those of the second night using Wilcoxon's test. There were no significant statistical differences between AHI, SpO(2), ODI and arousal index values (P = 0.130, P = 0.640, P = 0.052, and P = 0.692, respectively) between the two nights. However, 15% of the patients showed significant variability in the AHI between the two recordings and in 6% of the patients, a diagnosis of severe OSA (AHI > 10/h) would have been missed if only one night of sleep study had been performed. In general, one night of sleep study is sufficient to lead to a clear diagnosis of severe OSA in patients with sleep-disordered breathing and upper airway pathology but may still not diagnose 6% of the patients with severe OSA. Additionally, 15% of the patients showed a significant variability in the AHI between the two nights.
The aim of the study was to test whether a correlation between the Epworth Sleepiness Scale (ESS) and respiratory sleep parameters recorded by polysomnography (PSG) in patients with sleep-related breathing disorders and upper airway pathology exists. The PSG records of 130 patients (average age 52.6 +/- 10.7 years) with upper airway pathology suspected of having obstructive sleep apnea (OSA) have been retrospectively evaluated. Upper airway pathology included deviation of the nasal septum, inferior nasal turbinate hypertrophy, soft palate webbing, elongated uvula, tonsillar hypertrophy, macroglossia, hypertrophy of the tongue base, unfavorable palate position relative to the tongue base. To test for a possible correlation in this patient population between ESS score and arithmetic values of AHI, SPO(2), ODI and Arousal Index, the Spearman's correlation coefficient was calculated. No correlation between ESS and AHI, minimal SpO(2) and ODI was proven and only a weak positive correlation between Arousal Index and ESS was found in this particular patient population. We concluded that in patients with upper airway pathology, it is not possible to predict solely on the basis of the ESS score the existence of OSA or of other disturbances in Arousal Index, minimal SpO(2) and ODI. Nevertheless, historical data evaluated by questionnaires, such as the ESS provide for additional information combined with the clinical findings to select patients who are candidates for further detailed sleep studies.
The risk of a radiological or nuclear public health emergency is a major growing concern of the U.S. government. To address a potential incident and ensure that the government is prepared to respond to any subsequent civilian or military casualties, the U.S. Department of Health and Human Services and the Department of Defense have been charged with the development of medical countermeasures (MCMs) to treat the acute and delayed injuries that can result from radiation exposure. Because of the limited budgets in research and development and the high costs associated with bring promising approaches from the bench through advanced product development activities, and ultimately, to regulatory approval, the U.S. government places a priority on repurposing products for which there already exists relevant safety and other important information concerning their use in humans. Generating human data can be a costly and time-consuming process; therefore, the U.S. government has interest in drugs for which such relevant information has been established (e.g., products for another indication), and in determining if they could be repurposed for use as MCMs to treat radiation injuries as well as chemical and biological insults. To explore these possibilities, the National Institute of Allergy and Infectious Diseases (NIAID) convened a workshop including U.S. government, industry and academic subject matter experts, to discuss the challenges and benefits of repurposing products for a radiation indication. Topics covered included a discussion of U.S. government efforts (e.g. funding, stockpiling and making products available for study), as well unique regulatory and other challenges faced when repurposing patent protected or generic drugs. Other discussions involved lessons learned from industry on repurposing pre-license, pipeline products within drug development portfolios. This report reviews the information presented, as well as an overview of discussions from the meeting.
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