Langguth, B*
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OBJECTIVE: Subjective tinnitus is a frequent symptom characterized by perception of sound in the absence of a corresponding external stimulus. Although many people learn to live with tinnitus, some find it severely debilitating. Why tinnitus is debilitating in some patients, but not in others, is still incompletely understood. We aimed to assess the influence of different aspects of psychological distress on perceived tinnitus severity. METHODS: Three hundred seventeen patients diagnosed with chronic subjective tinnitus at two university clinics completed the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ) and the Symptom Check List-90-Revised. The influence of the different dimensions of psychological distress on perceived tinnitus severity was statistically evaluated. RESULTS: Both THI and TQ scores were significantly influenced by gender, site and the dimension "depression". In addition, TQ scores were significantly influenced by age and "somatization," whereas "hostility" had an impact on THI scores only. CONCLUSION: Psychological aspects as well as sociodemographic variables had a significant influence on both TQ scores. However, our results indicate, that these scales reflect emotional distress of tinnitus sufferers differently. This should be taken into consideration in the use of these scales as screening tools for assessment of tinnitus handicap.
- MeSH
- deprese psychologie MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- nepřátelství MeSH
- průzkumy a dotazníky MeSH
- psychický stres psychologie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- somatoformní poruchy psychologie MeSH
- stupeň závažnosti nemoci MeSH
- tinnitus psychologie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
PURPOSE: The purpose of this phase 3 study was to evaluate the efficacy, pharmacokinetics (PK), and safety of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) in patients with primary immunodeficiency (PI). METHODS: Immunoglobulin treatment-experienced subjects with PI received 52 weeks of IGSC 20% given weekly at the same dose as the subject's previous IgG regimen (DAF 1:1); the minimum dose was 100 mg/kg/week. The primary endpoint was serious bacterial infections (SBIs [null vs alternative hypothesis: SBI rate per person per year ≥ 1 vs < 1]). IgG subclasses and specific pathogen antibody levels were also measured. RESULTS: Sixty-one subjects (19 children [≤ 12 years], 10 adolescents [> 12-16 years], and 32 adults) were enrolled. The rate of SBIs per person per year was 0.017. The 1-sided 99% upper confidence limit was 0.036 (< 1), and the null hypothesis was rejected. The rate of hospitalization due to infection per person per year was 0.017 (2-sided 95% confidence interval: 0.008-0.033) overall. The mean trough total IgG concentrations were comparable to the previous IgG replacement regimen. The average of the individual mean trough ratios (IGSC 20%:previous regimen) was 1.078 (range: 0.83-1.54). The average steady-state mean trough IgG concentrations were 947.64 and 891.37 mg/dL, respectively. Seven subjects had serious treatment-emergent adverse events (TEAEs); none was drug-related. The rate of all TEAEs, including local infusion site reactions, during 3045 IGSC 20% infusions was 0.135. Most TEAEs were mild or moderate. CONCLUSIONS: IGSC 20% demonstrated efficacy and good safety and tolerability in subjects with PI.
- MeSH
- dítě MeSH
- dospělí MeSH
- imunoglobulin G terapeutické užití MeSH
- imunologické faktory terapeutické užití MeSH
- intravenózní imunoglobuliny MeSH
- lidé MeSH
- mladiství MeSH
- subkutánní infuze MeSH
- syndromy imunologické nedostatečnosti * diagnóza farmakoterapie MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé MeSH
- mladiství MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
Background: Schizophrenia is a severe and often difficult to treat psychiatric illness. In many patients, negative symptoms dominate the clinical picture. Meta-analysis has suggested moderate, but significant effects of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) on these symptoms. For treatment of depression a much shorter protocol - intermittent theta burst stimulation (iTBS) - has shown to be non-inferior to conventional high-frequency rTMS. This randomized, sham-controlled, rater-blinded clinical trial assesses the effects of conventional HF-rTMS as well as of iTBS of the left dorsolateral prefrontal cortex in comparison with sham. Methods: The study will be conducted at two psychiatric university hospitals in Germany and at two in the Czech Republic. Assuming an effect size of 0.64 to be detected with a power of 80%, the calculated sample size is 90 patients. Primary outcome will be the difference in the Scale for the Assessment of Negative Symptoms (SANS) score between each active arm and the sham arm at end of treatment.In addition, the trial investigates effects on depressive symptoms, cognitive performance and cigarette smoking. Recording magnetic resonance imaging (MRI) and electroencephalography (EEG) data will serve to assess whether treatment success can be predicted by neural markers and is related to specific neurobiological changes. Discussion: This is a clinical trial directly comparing 10 Hz-rTMS and iTBS in a sham-controlled manner in treating negative symptoms of schizophrenia. If successful, this would present an interesting treatment option for a chronic and severe condition that can be applied at most psychiatric hospitals and only takes up a few minutes per day. Trial registration number: This trial has been registered at clinicaltrials.gov, Identifier: NCT04318977. Data dissemination: Results from the trial shall be published in peer-reviewed journals and presented at meetings and conferences.
- Publikační typ
- časopisecké články MeSH
Chronický tinnitus je běžná porucha vyskytující se s prevalencí vyšší než 8 % v populaci starší 50 let, je velmi obtížně léčitelná a narušuje plnohodnotný život postiženého jedince. Tinnitus bývá poměrně často spojen s hluchotou a zdá se, že může být výsledkem patologických neuroplastických procesů v mozkové kůře. Neurozobrazovací studie ukazují na zvýšenou aktivitu v primárním sluchovém kortexu. Transkraniální magnetická stimulace (TMS) je nová a neinvazivní metoda, využívající elektromagnetických principů. TMS je schopna modulovat excitabilitu povrchových vrstev mozkové kůry. Stimulační efekt se šíří i do funkčně spojených vzdálených oblastí mozku. TMS byla již úspěšně užívána u jiných poruch spojených se zvýšenou aktivitou mozkové kůry. Bylo dokázáno, že nízkofrekvenční repetitivní transkraniální magnetická stimulace (rTMS) může být efektivní v terapii poruch provázených změnou excitability mozkové kůry, jako jsou auditivní halucinace. Současné teoretické podklady a první klinické studie nasvědčují tomu, že TMS by mohla mít v léčbě chronického tinnitu dobrý léčebný potenciál. Zřejmá je zde nutnost dalšího výzkumu s větším množstvím pacientů, jak v oblasti klinické, tak v doplnění neurobiologického základu změn vyvolaných TMS.
Chronic tinnitus is a frequent and often severely disabling disorder with a prevalence of over 8 % in subjects over 50 years. Tinnitus disrupts the full-value life of the patient and it is difficult to treat . The disorder is frequently associated with hearing loss and may be the result of neuroplastic alterations within the brain. Neuroimaging studies demonstrate increased activity within the central auditory system. TMS is a non-invasive method uses electromagnetic principles. TMS allows to modulate the excitability within superficial cortical areas. Stimulation effects can propagate also to functionally connected remote brain areas. It has been successfully employed in the treatment of other conditions associated with increased activity of the cerebral cortex. Applied as low frequency rTMS it has been proven to be effective for the treatment of disorders which are associated with focal hyperexcitability such as auditory hallucinations. There is a good theoretical basis and increasing research evidence suggesting a potential of TMS for the treatment of tinnitus. Further studies with large sample sizes and additional assessment of neurobiological effects are needed. Within this paper we discuss the potential for TMS as a therapy of tinnitus.
