1. elektronické vydání 1 online zdroj (440 stran)
Po více než 10 letech vychází úspěšná základní publikace v oboru. Kniha sumarizuje problematiku všech segmentů oboru otorinolaryngologie a foniatrie. Zabývá se vyšetřovacími metodami, diagnostikou a terapií chorob, pozornost je rovněž věnována prevenci onemocnění a rehabilitaci.
- Klíčová slova
- Oftalmologie, ORL,
- MeSH
- otorinolaryngologické nemoci MeSH
- otorinolaryngologie trendy MeSH
- poruchy hlasu patologie MeSH
- poruchy řeči patologie MeSH
- poruchy sluchu patologie MeSH
- NLK Obory
- otorinolaryngologie
BACKGROUND AND OBJECTIVE: Vertigo derived from peripheral vestibular disorders is quite frequently encountered in daily clinical practice and can be a severely disabling symptom associated with substantial impairment of health-related quality of life for the affected patients. Betahistine, a structural analogue of histamine and presumably the most widely prescribed anti-vertigo drug worldwide, has previously been shown to be an effective and safe treatment for these patients. The objective of the present study was to evaluate whether the fixed combination of cinnarizine and dimenhydrinate (Arlevert®) is non-inferior and thus a potentially useful alternative to betahistine dihydrochloride in the treatment of patients suffering from peripheral vestibular vertigo. METHODS: In this prospective, multicenter, double-blind, randomized, non-inferiority clinical trial, outpatients from 8 ENT clinics in Austria, Bulgaria, the Czech Republic and Russia were randomly assigned to receive three times daily one tablet of either the fixed combination cinnarizine 20 mg/dimenhydrinate 40 mg or betahistine dihydrochloride 16 mg for 4 weeks. Primary endpoint was the reduction of the mean vertigo score (MVS), a validated 12-item composite score defined as the mean of 6 vertigo symptoms (dystasia and walking unsteadiness, staggering, rotary sensation, tendency to fall, lift sensation, blackout) and 6 trigger factors for vertigo (change of position, bowing, getting up, driving by car/train, head movements, eye movement), after 4 weeks of therapy, as judged by the patient on a 5-point visual analogue scale (VAS). The non-inferiority margin was set to 0.3. Secondary outcomes included the patient's and investigator's judgment of global efficacy, the patient's rating of impairment of daily activities, and safety/tolerability of the treatments. RESULTS: Three hundred and six patients (mean age 53.5 years, approximately 60% female) were enrolled and randomized to the fixed combination cinnarizine/dimenhydrinate (n = 152) or betahistine (n = 154) groups; 297 patients completed the study and 294 (146 and 148, respectively) were valid for the per-protocol analysis, which was used for the non-inferiority analysis. Treatment with cinnarizine/dimenhydrinate led to a stronger reduction of the MVS [least squares mean (LSM)] after 4-week therapy (primary endpoint) in comparison to betahistine (0.395 vs 0.488; difference: - 0.093, 95% CI - 0.180; - 0.007, p = 0.035); since the upper limit of the two-sided 95% confidence interval was not only below the non-inferiority margin of 0.3, but also entirely below 0, superiority of the fixed combination could be demonstrated. The combination preparation was also more effective after 1 week of therapy and received more favorable patient's ratings on overall efficacy and impairment of daily activities. Both treatments were very well tolerated. Only 12 patients (3.92%) reported 13 non-serious adverse events; 2 cinnarizine/dimenhydrinate-treated patients discontinued the study prematurely due to adverse events as compared to 5 betahistine-treated patients. CONCLUSION: The fixed combination of cinnarizine 20 mg and dimenhydrinate 40 mg was found to be not only non-inferior, but superior to betahistine 16 mg in the improvement of peripheral vestibular vertigo. Furthermore, taking into account a good and slightly favorable safety profile, the present study provides evidence that the fixed-combination preparation is a potent and even superior alternative to betahistine in the treatment of vertigo related to peripheral vestibular disorders. STUDY REGISTRATION: EudraCT No. 2011-004025-27.
- MeSH
- betahistin škodlivé účinky terapeutické užití MeSH
- cinarizin škodlivé účinky terapeutické užití MeSH
- dimenhydrinát škodlivé účinky terapeutické užití MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- fixní kombinace léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- prospektivní studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- vertigo farmakoterapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Background Ginkgo biloba extract EGb 761® and pentoxifylline are frequently prescribed for the treatment of tinnitus. Objective To compare the treatment effects of Ginkgo biloba extract EGb 761R and pentoxifylline. Setting The study was performed at Department of Otorhinolaryngology of University Hospital Královské Vinohrady and 3rd Medical Faculty, Charles University in Prague. Method Patients with sub-chronic or chronic tinnitus were enrolled in double-blind trial and randomized to receive 120 mg EGb 761® or 600 mg pentoxifylline, each twice a day and in double-dummy fashion over a 12-week period. Main outcome measure changes in 11-Point Box Scales for tinnitus loudness and annoyance, the abridged Tinnitus Questionnaire (Mini-TQ), the Hospital Anxiety and Depression Scale (HADS), and the Sheehan Disability Scale (SDS). Results Full analysis set for efficacy analysis comprised 197 patients (EGb 761®, 99; pentoxifylline 98). For both treatment groups, significant improvements were observed in the Mini-TQ, the 11-Point Box Scales for tinnitus loudness and annoyance, the HADS anxiety score and the SDS. There was no relevant difference with regard to tinnitus-related outcomes between the two treatment groups. 20 adverse events were documented in EGb 761® group and 36 adverse events were reported for pentoxifylline group. No serious adverse event was reported during the study. Conclusion EGb 761® and pentoxifylline were similarly effective in reducing the loudness and annoyance of tinnitus as well as overall suffering of the patients. The incidence of adverse events was lower in the EGb 761® group.
- MeSH
- chronická nemoc MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- lidé středního věku MeSH
- lidé MeSH
- pentoxifylin škodlivé účinky terapeutické užití MeSH
- psychiatrické posuzovací škály MeSH
- rostlinné extrakty škodlivé účinky terapeutické užití MeSH
- senioři MeSH
- tinnitus farmakoterapie patofyziologie psychologie MeSH
- vazodilatancia škodlivé účinky terapeutické užití 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
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Česká republika MeSH
- MeSH
- Ginkgo biloba * MeSH
- kardiovaskulární nemoci farmakoterapie prevence a kontrola terapie MeSH
- kognitivní poruchy prevence a kontrola terapie MeSH
- lidé MeSH
- metabolické nemoci patofyziologie prevence a kontrola MeSH
- muskuloskeletální systém patofyziologie MeSH
- nežádoucí účinky léčiv prevence a kontrola MeSH
- nootropní látky aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- oční nemoci diagnóza patofyziologie terapie MeSH
- otologické chirurgické výkony metody využití MeSH
- randomizované kontrolované studie jako téma MeSH
- rehabilitace metody MeSH
- senioři MeSH
- statistika jako téma MeSH
- vertigo diagnóza klasifikace terapie MeSH
- vestibulární nemoci * diagnóza patofyziologie terapie MeSH
- závrať * diagnóza etiologie terapie MeSH
- Check Tag
- lidé MeSH
- senioři MeSH
- Publikační typ
- přehledy MeSH
- MeSH
- hluchota genetika vrozené MeSH
- labyrintitida diagnóza terapie MeSH
- lidé MeSH
- nedoslýchavost diagnóza klasifikace MeSH
- nemoci vnitřního ucha diagnóza patologie terapie MeSH
- poruchy sluchu diagnóza etiologie chemicky indukované MeSH
- vestibulární nemoci chemicky indukované virologie MeSH
- vestibulární schwannom diagnostické zobrazování terapie MeSH
- vnitřní ucho abnormality patologie zranění MeSH
- Check Tag
- lidé MeSH
2., doplněné a aktualizované vydání xxii, 418 stran : ilustrace (převážně barevné) ; 25 cm
Kniha sumarizuje problematiku všech segmentů oboru otorinolaryngologie a foniatrie. Zabývá se vyšetřovacími metodami, diagnostikou a terapií chorob, pozornost je rovněž věnována prevenci onemocnění a rehabilitaci. Nakladatelská anotace. Kráceno
- MeSH
- otorinolaryngologické nemoci MeSH
- otorinolaryngologie trendy MeSH
- poruchy hlasu patologie MeSH
- poruchy řeči patologie MeSH
- poruchy sluchu patologie MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- otorinolaryngologie
- NLK Publikační typ
- kolektivní monografie