Objective To evaluate the safety and tolerability of repeated intratympanic administration of the gel-formulated NMDA receptor antagonist AM-101 in acute patients with inner ear tinnitus. Study Design Prospective, double-blind, randomized, placebo-controlled study. Setting Sixty-nine secondary and tertiary sites in North America, Europe, and Asia. Subjects and Methods In total, 343 subjects with persistent acute tinnitus after traumatic cochlear injury or otitis media were randomized to receive 3 intratympanic doses of either AM-101 0.87 mg/mL or placebo over 3 to 5 days. They were followed for 84 days. The primary safety end point was the incidence of a clinically meaningful hearing deterioration from baseline to study day 35. Further safety assessments included tympanic membrane closure rates, analysis of adverse events, hematology, blood chemistry, and vital signs. In addition, data were collected on applied anesthetics and injection techniques. Results The treatment was well tolerated, with no intervention-related serious adverse events. The incidence of clinically meaningful hearing deterioration was low, comparable between treatment groups ( P = .82 for the primary safety end point) and not different between treated and untreated ears in unilaterally treated subjects. The rate of treatment and procedure-related adverse events was similar among treatment groups. The tympanic membrane was closed in 92% of subjects within 1 week and in all subjects by study day 84. Blood values and vital signs were inconspicuous. Conclusion Repeated intratympanic injections of AM-101 over a 3- to 5-day period appear to be safe and well tolerated, demonstrating the ability to potentially use this delivery approach over longer time periods.
- MeSH
- akutní nemoc MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- intratympanická injekce MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- proteiny regulující apoptózu aplikace a dávkování škodlivé účinky MeSH
- senioři MeSH
- tinnitus farmakoterapie MeSH
- vnitřní ucho MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: To identify incidence, preoperative features, surgical factors, and postoperative events of incidental parathyroidectomy (IP) during thyroidectomy. STUDY DESIGN: A total of 1068 consecutive patients who underwent thyroidectomy performed by a single surgeon between January 2003 and April 2012 were enrolled in retrospective study with prospectively collected data. SETTING: University hospital. SUBJECTS AND METHODS: To assess the impact of IP on study variables, patients were stratified into 2 study groups: IP group and non-IP group. Univariate and multivariate analyses identified significant correlates of IP. RESULTS: In all, 5.4% patients experienced IP. Significant difference (P < .001) was in incidence of temporary hypocalcemia between IP group (36.2%) and non-IP group (16.8%). Multivariable logistic regression model identified total thyroidectomy (odds ratio 3.937, 95% confidence interval [CI] 1.462-10.601, P = .007) and Graves' disease (odds ratio 2.192, 95% CI 1.157-4.158, P = .016) as risk-adjusted factors associated with IP. Multivariate analysis of repeated measures identified statistically significant difference of repeated total calcium level (P < .001) and ionized calcium level (P = .020) between study groups. CONCLUSION: IP during thyroidectomy might be potential complication. Total thyroidectomy, Graves' disease, longer operation time, and identification 3 and more parathyroid glands seemed to be predictive factors for IP. IP is significantly associated with temporary hypocalcemia, but not with permanent hypoparathyroidism.
- MeSH
- dospělí MeSH
- incidence MeSH
- krční disekce metody MeSH
- lidé středního věku MeSH
- lidé MeSH
- náhodný nález MeSH
- nemoci štítné žlázy chirurgie MeSH
- paratyreoidektomie * MeSH
- pooperační komplikace epidemiologie MeSH
- retrospektivní studie MeSH
- senioři MeSH
- tyreoidektomie * MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
OBJECTIVES: The aim of this study was to compare the effectiveness of 5 power lasers (CO(2), diode, KTP, ErCr:YS66, and ND:YVO4) in laser-assisted uvulopalatoplasty. METHODS: This is a prospective study of 100 patients who were treated for snoring by laser-assisted uvulopalatoplasty with different lasers. RESULTS: The number of days of pain medication use and the time to return to normal diet were used as indicators of recovery from surgery. Median of pain medication use was 9, 7, 7, 5, and 4 days, and the median of the time to return to normal diet was 8, 7, 7, 6, and 4 days in the CO(2), diode, KTP, Nd:YVO4, and ErCrYSGG groups, respectively. CONCLUSIONS: Differences in postoperative recovery were observed. Probands treated with ErCrYSGG laser recovered more quickly than the Nd:YVO4, diode, KTP, and CO(2) groups.
- MeSH
- chrápání chirurgie patofyziologie MeSH
- dospělí MeSH
- laserová terapie přístrojové vybavení MeSH
- lasery pevnolátkové MeSH
- lasery plynové terapeutické užití MeSH
- lasery polovodičové terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- patro měkké fyziologie chirurgie MeSH
- polysomnografie MeSH
- pooperační období MeSH
- prospektivní studie MeSH
- senioři MeSH
- uvula palatina fyziologie chirurgie MeSH
- výsledek terapie MeSH
- zákroky plastické chirurgie metody MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- Publikační typ
- srovnávací studie MeSH
