INTRODUCTION/AIMS: Prospective, randomized, controlled trials of intravenous immunoglobulin (IVIG) maintenance therapy in myasthenia gravis (MG) are lacking. In this trial, we evaluated the safety and efficacy of caprylate/chromatography-purified IVIG; (IGIV-C) in patients with generalized MG undergoing standard care. METHODS: Sixty-two patients enrolled in this phase 2, multicenter, international, randomized trial (1:1 IGIV-C [2 g/kg loading dose; 1 g/kg every 3 weeks through week 21] or placebo). Efficacy was assessed by changes in Quantitative MG (QMG) score at week 24 versus baseline (primary endpoint) and percentage of patients with clinical improvement in QMG, MG Composite (MGC), and MG-Activities of Daily Living (MG-ADL) scores (secondary endpoints). Safety assessments reported all adverse events (AEs). RESULTS: The change in QMG at 24 weeks was -5.1 for IGIV-C and -3.1 for placebo (p = .187). Seventy percent of patients in the IGIV-C group had improvement in MG-ADL (≥2-point decrease) versus 40.6% in the placebo group (p = .025). Patients showing clinical improvement in QMG and MGC (≥3-point decrease) were 70.0% for IGIV-C versus 59.4% for placebo (p = .442) and 60.0% for IGIV-C versus 53.1% for placebo (p = .610). IGIV-C was well tolerated; serious AEs were similar between arms. Three of four MG exacerbations requiring hospitalizations occurred in the IGIV-C arm with one death. DISCUSSION: Several efficacy parameters showed numerical results greater than those seen in the placebo group. This was a small study and may have been underpowered to see significant differences. Additional studies may be warranted to fully determine the efficacy of IVIG maintenance therapy in MG.
- MeSH
- autoprotilátky krev MeSH
- činnosti denního života MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- imunologické faktory terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- intravenózní imunoglobuliny * terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- lidé středního věku MeSH
- lidé MeSH
- myasthenia gravis * farmakoterapie MeSH
- prospektivní studie MeSH
- receptory cholinergní * imunologie MeSH
- senioři 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
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
BACKGROUND AND OBJECTIVE: Intracerebral hemorrhage (ICH) is a serious medical condition with high mortality. However, factors leading to long-term mortality after ICH are largely unclear. The aim of this community-based study is to assess predictors of long-term mortality after spontaneous ICH. METHODS: We identified all patients admitted with spontaneous ICH to hospitals with a certified stroke unit in Brno, the second largest city in the Czech Republic (CR), in 2011, the year of the Czech Population and Housing Census. We reviewed their medical records for risk factors, radiographic parameters, and measures of post-stroke neurological deficit [National Institutes of Health Stroke Scale (NIHSS)]. Using the dates of death from the Czech National Mortality Register, we calculated mortality at 30 days, six months, one year, and three years after the ICH. Multivariate analysis with forward stepwise logistic regression was performed to determine independent predictors of mortality (p < 0.05). RESULTS: In 2011, 1086 patients with stroke were admitted to the four stroke-certified hospitals in Brno, CR. Of these, 134 had spontaneous ICH, with complete data available in 93 of them entering the final analysis. The mortality at 30 days, 6 months, 1 year, and 3 years post-ICH was 34%, 47%, 51%, and 63%, respectively. The mortality was highest in the first few days post-event, with 50% of patients dying in 255 days and average survival being 884 ± 90 days. Both NIHSS and modified ICH (MICH) score showed to be strong and reliable predictors of short- as well as long-term mortality; the risk of death post-ICH increased with older age and size of ICH. Other risk factors contributing to higher, primarily shorter-term mortality included history of cardiac failure, myocardial infarction, or atrial fibrillation. CONCLUSIONS: In our community-based study, we found that severity of neurological deficit at admission (NIHSS), combined with age and size of ICH, well predicted short- as well as long-term mortality after spontaneous ICH. A history of cardiac failure, myocardial infarction, or atrial fibrillation at presentation were also predictors of mortality, underscoring the need for optimal cardiac management in patients with ICH.
- MeSH
- cerebrální krvácení * mortalita MeSH
- lidé středního věku MeSH
- lidé MeSH
- retrospektivní studie MeSH
- rizikové faktory MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
Neuropatická bolest patří k častým klinickým příznakům onemocnění periferního (mononeuropatie, polyneuropatie) i centrálního nervového systému (míšní léze, stavy po cévních mozkových příhodách apod.). Významně snižuje kvalitu života pacientů, interferuje se spánkem a je často provázena úzkostí a/nebo depresí. Léčba neuropatické bolesti je dominantně založena na farmakoterapii, pro kterou je k dispozici řada preparátů využitelných v monoterapii či v rámci kombinované léčby. K lékům první volby (s průkazem účinnosti na úrovni IA) patří některá antiepileptika a antidepresiva. Z antiepileptik jde především o modulátory alfa-2-delta podjednotky kalciových kanálů, tedy gabapentin a pregabalin. Oba léky byly dlouhodobě považovány za srovnatelně účinné, v posledních 5–7 letech však bylo publikováno několik negativních studií vysoké kvality s pre- gabalinem, zatímco evidence účinku gabapentinu je nadále velmi robustní. Z antiepileptik je pro dosažení analgetického účinku klíčová blokáda zpětného vychytávání noradrenalinu. Využitelné jsou proto především léky ze skupiny inhibitorů zpětného vychytávání serotoninu a noradrenalinu (SNRI, např. duloxetin či venlafaxin) a také tricyklická antidepresiva (TCA, především amitriptylin), zatímco efekt inhibitorů zpětného vychytávání serotoninu (SSRI) v terapii neuropatické bolesti prokázán nebyl. Účinné jsou také opioidy (tramadol, morfin, oxykodon, tapentadol), které jsou využívány jako léky druhé či třetí volby, a to jako monoterapie či add-on terapie k lékům první volby. U pacientů s lokalizovanou neuropatickou bolestí (např. u postherpetické neuralgie) lze využít topicky aplikované preparáty (např. kapsaicin či topicky aplikovaný lidokain), jejichž výhodou je excelentní bezpečnostní profil. Prakticky u všech zmíněných léků je pokračování terapie podmíněno dokumentací jejich účinnosti, např. poklesem intenzity bolesti hodnocené pomocí numerické škály bolesti. Vedle farmakoterapie lze v léčbě neuropatické bolesti využít také postupy nefarmakologické, síla doporučení pro jejich využití (vycházející z evidence jejich účinnosti) je však u většiny těchto postupů daleko nižší než v případě farmakoterapie, obvykle z dů- vodu absence kvalitních a dostatečně velkých studií. Většina používaných neinvazivních nefarmakologických metod má vynikající bezpečnostní profil a jejich použití je obzvláště výhodné u pacientů vyššího věku. U pacientů s periferní neuropatickou bolestí jde především o transkutánní elektrickou nervovou stimulaci (TENS), která vykazuje excelentní bezpečnost a u pacientů s lokalizovanou bolestí je doporučována dokonce jako jedna z metod 1. volby. Účinnost v léčbě neuropatické bolesti i fibromyalgie je prokázána také u vysokofrekvenční repetitivní transkraniální mozkové stimulace (rTMS) kontralaterální primární motorické kůry (M1), případně dalších oblastí mozku. U závažných refrakterních typů neuropatické bolesti je možné využít stimulaci míšní (SCS), případně stimulaci periferního nervu (PENS). Jedná se však již o invazivní metody indikované u malého procenta pacientů s vysokou intenzitou bolesti a nejnižší odpovědí na konvenční terapie. Využitelné jsou také některé psychoterapeutické metody, zejména mindfulness či kognitivně-behaviorální terapie, které lze s výhodou použít zejména jako přídatnou (add-on) terapii na úrovni druhé volby. Ostatní nefarmakologické postupy vykazují v provedených metaanalýzách nekonkluzivní výsledky a jejich užití se dle aktuální úrovně evidence spíše nedoporučuje.
Neuropathic pain is a common clinical symptom of peripheral (mononeuropathy, polyneuropathy) and central nervous systém disorders (spinal cord lesions, post-stroke conditions, etc.). It significantly reduces pa‘ients‘ quality of life, interferes with sleep and is often associated with anxiety and/or depression. The treatment of neuropathic pain is mainly based on pharmacotherapy, for which a number of agents are available for use as monotherapy or in combination therapy. First choice drugs (with evidence of efficacy at the IA level) include some antiepileptics and antidepres- sants. The antiepileptic drugs are mainly alpha-2-delta calcium channel subunit modulators, i.e. gabapentin and pregabalin. Both drugs have long been considered comparably effective, but in the last 5-7 years several negative, high-quality trials have been published with pregabalin, while the evidence for gabapentin remains very robust. Among the antiepileptic drugs, blockade of norepinephrine reuptake is key to achieving analgesia. Therefore, serotonin and noradrenaline reuptake inhibitors (SNRIs) (e.g. duloxetine or venlafaxine) and tricyclic antidepressants (TCAs, especially amitriptyline) are particularly useful, whereas the effect of serotonin reuptake inhibitors (SSRIs) in the treatment of neuropathic pain has not been demonstrated. Opioids (tramadol, morphine, oxycodone, tapentadol) are also effective and are used as second- or third-line drugs, either as monotherapy or as adjunctive therapy to first-line drugs. For patients with localised neuropathic pain (e.g. postherpetic neuralgia), topical agents (e.g. capsaicin or lidocaine) can be used, which have the advantage of an excellent safety profile. For all these agents, continuation of therapy requires documentation of efficacy, e.g. a reduction in pain intensity as assessed by a numerical pain scale. In addition to pharmacotherapy, non-pharmacological treatments can be used to treat neuropathic pain, but the strength of the recommendations for their use (based on evidence of their effectiveness) is much lower than for pharmacotherapy for most of these treatments, usually due to a lack of large, high-quality trials. Most of the non-invasive non-pharmacological methods used have an excellent safety profile and their use is particularly beneficial in older patients. For patients with peripheral neuropathic pain, transcutaneous electrical nerve stimulation (TENS) can be used with excellent safe‘y. It‘s even recommended as a first-line treatment for patients with localised pain. High-frequency repetitive transcranial brain stimulation (rTMS) of the contralateral primary motor cortex or several other brain regions has also been shown to be effective in the treatment of neuropathic pain and fibromyalgia. For refractory forms of neuropathic pain, spinal cord stimulation (SCS) or peripheral nerve stimulation (PENS) can be used, but both are invasive and their use is limited to a small percentage of patients with the most severe pain and least response to conventional therapies. Some psychotherapeutic techniques, particularly mindfulness or cognitive behavioural therapy, may also be used, particularly as second-line adjunctive therapy. Other non-pharmacological treatments have shown inconsistent results in meta-analyses and their use is not recommended based on the current level of evidence.
- MeSH
- akupunkturní terapie MeSH
- analgetika farmakologie klasifikace terapeutické užití MeSH
- antidepresiva aplikace a dávkování farmakologie terapeutické užití MeSH
- antikonvulziva aplikace a dávkování farmakologie terapeutické užití MeSH
- aromaterapie MeSH
- elektrická stimulace metody MeSH
- hyperestezie diagnóza MeSH
- kanabinoidy farmakologie terapeutické užití MeSH
- kombinovaná terapie metody MeSH
- lidé MeSH
- míšní stimulace MeSH
- neuralgie * diagnóza farmakoterapie psychologie terapie MeSH
- parestezie diagnóza MeSH
- periferní nervový systém MeSH
- transkraniální magnetická stimulace MeSH
- všímavost MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy MeSH
Degenerative cervical myelopathy (DCM) represents the final consequence of a series of degenerative changes in the cervical spine, resulting in cervical spinal canal stenosis and mechanical stress on the cervical spinal cord. This process leads to subsequent pathophysiological processes in the spinal cord tissues. The primary mechanism of injury is degenerative compression of the cervical spinal cord, detectable by magnetic resonance imaging (MRI), serving as a hallmark for diagnosing DCM. However, the relative resilience of the cervical spinal cord to mechanical compression leads to clinical-radiological discordance, i.e., some individuals may exhibit MRI findings of DCC without the clinical signs and symptoms of myelopathy. This degenerative compression of the cervical spinal cord without clinical signs of myelopathy, potentially serving as a precursor to the development of DCM, remains a somewhat controversial topic. In this review article, we elaborate on and provide commentary on the terminology, epidemiology, natural course, diagnosis, predictive value, risks, and practical management of this condition-all of which are subjects of ongoing debate.
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
Diagnosing delirium in neurointensive care is difficult because symptoms of delirium, such as inappropriate speech, may be related to aphasia due to primary brain injury. Therefore, validated screening tools are needed. The aim of this study was to compare two Czech versions of already validated screening tools - the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and the Intensive Care Delirium Screening Checklist (ICDSC) - in a cohort of acute stroke patients. We also aimed to assess the pitfalls of delirium detection in the context of non-convulsive status epilepticus (NCSE). We analysed 138 stroke patients admitted to the neurological intensive care unit (ICU) or stroke unit. According to expert judgement, which was used as the gold standard, 38 patients (27.54%) developed delirium. The sensitivity and specificity of the ICDSC were 91.60% and 95.33%, respectively, and the positive and negative predictive values were 76.76% and 98.54%, respectively. Similarly, the sensitivity and specificity of CAM-ICU were 75.63% and 96.74%, respectively, and the positive and negative predictive values were 79.65% and 95.93%, respectively. We did not detect an episode of NCSE mimicking delirium in any of our stroke patients who were judged to be delirious by expert assessment. Our results suggest that the ICDSC may be a more suitable tool for delirium screening than the CAM-ICU in patients with neurological deficit. NCSE as a mimic of delirium seems to be less common in the acute phase of stroke than previously reported.
- Publikační typ
- časopisecké články MeSH
BACKGROUND: In multiple sclerosis (MS), dysphagia is an important and common clinical symptom. Although often overlooked and underdiagnosed, it can have a significant impact on a patient's life, including social integration, and it can lead to malnutrition, aspiration pneumonia, and suffocation, i.e., life-threatening complications. Early detection of dysphagia is essential to prevent these risks. However, the optimal screening method and the inter-relationship between different methods used for dysphagia screening are not clear. The aim of this study was to compare the diagnostic performance of a simple question about swallowing problems, the DYsphagia in MUltiple Sclerosis (DYMUS) swallowing questionnaire, and the Timed Water Swallowing Test (TWST) to detect dysphagia in people with relapsing-remitting MS (RRMS). METHODS: Patients with MS were asked about subjective swallowing difficulties and, regardless of their response, completed the DYMUS questionnaire and underwent the TWST at their routine follow-up visit. Patients with at least one positive screening method were offered an objective assessment of swallowing function using the Fiberoptic Endoscopic Evaluation of Swallowing (FEES). The results were statistically analyzed and correlated with demographic and MS-related parameters. RESULTS: Of the 304 people with RRMS enrolled in the study, 46 (15.1 %) reported having subjective difficulty swallowing when asked a simple question. The DYMUS questionnaire was positive in 59 (19.4 %) of the 304 patients; 51 (16.8 %) had an abnormality on the TWST. A clear correlation (r = 0.351, p < 0.01) was found between the DYMUS and TWST results, but a significant proportion of patients (about half) had an abnormality on only one of these tests. The positivity of at least one of the screening methods used (DYMUS or TWST) had a better chance of identifying a patient with dysphagia than a simple question (p < 0.001). Of the patients with a positive result for difficulty swallowing, 37 underwent FEES, which confirmed dysphagia in 94.6% of this subgroup. Patients with higher Expanded Disability Status Scale (EDSS) scores, female gender, and older age were at higher risk of developing dysphagia. CONCLUSION: The DYMUS questionnaire and TWST had a confirmed potential to identify more patients with dysphagia than a simple question about swallowing problems. However, our study found only a partial overlap between DYMUS and TWST; a combination of these two methods was more sensitive in identifying patients with MS at risk of dysphagia. Furthermore, the screening showed excellent specificity: almost 95 % of the positively screened patients had dysphagia confirmed by objective methods. Age, female gender, and a higher EDSS score appear to be potential risk factors for dysphagia in patients with MS.
- Publikační typ
- abstrakt z konference MeSH
- Publikační typ
- abstrakt z konference MeSH
Špatná kvalita spánku a rozvoj deliria jsou časté komplikace v intenzivní péči. Incidence obou komplikací je vysoká a pohledem medicíny založené na důkazech jsou v obou případech signifikantně prokázané závažné konsekvence. Stran deliria je k dispozici více dat, zatímco u zhoršené kvality spánku je i vzhledem k technickým limitacím monitorace a diagnostiky významný prostor k dalšímu výzkumu. Tento článek shrnuje data, která jsou k dispozici stran epidemiologie a rizikových faktorů snížené kvality spánku i deliria v prostředí intenzivní péče.
Poor quality of sleep and delirium are frequent complications of intensive care. The incidence of both complications is high, and evidence-based medicine has significantly demonstrated serious consequences in both cases. More data are available on delirium. While there is significant room for further research on sleep quality impairment, there are also technical limitations of monitoring and diagnosis. This article summarises known data on the epidemiology and risk factors of decreased quality of sleep and delirium in the intensive care setting.
Monitorace kvality spánku a deliria jsou naprosto zásadní pro poskytování moderní intenzivní péče. Představují však přístrojovou a personální výzvu. Nejen proto, že určité metody monitorace, např. polysomnografie, monitorovaný spánek samy ovlivňují. Ačkoliv existují nové alternativy, polysomnografie zůstává zlatým standardem v diagnostice a výzkumu poruch spánku pro nejlepší validitu získaných dat. Bez monitorace a screeningových metod nelze spolehlivě diagnostikovat delirium a poruchy spánku v intenzivní péči a bez jasně stanovené diagnózy nelze zkoumat dopady deliria a snížené kvality spánku. Tento článek shrnuje jednotlivé možnosti monitorace spánku i deliria, jejich výhody a limitace v prostředí intenzivní péče.
Monitoring sleep quality and delirium are essential in providing modern intensive care. They present both equipment and personnel challenges. Not only because certain monitoring methods, such as polysomnography, affect monitored sleep themselves. Although new alternatives exist, polysomnography remains the gold standard in diagnosing and researching sleep disorders for the validity of the data obtained. Without monitoring and screening methods, delirium and sleep disorders cannot be reliably diagnosed in intensive care. Without a clearly established diagnosis, the outcomes of delirium and reduced sleep quality cannot be investigated. This article summarizes various options for monitoring both sleep and delirium, their advantages and limitations in the critical care setting.
- MeSH
- delirium * diagnóza prevence a kontrola MeSH
- kvalita spánku MeSH
- lidé MeSH
- monitorování fyziologických funkcí klasifikace metody MeSH
- monitory vědomí MeSH
- péče o pacienty v kritickém stavu MeSH
- polysomnografie metody MeSH
- sběr dat metody MeSH
- spánek * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- práce podpořená grantem MeSH
- přehledy MeSH
