Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies.

Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open-label, single-arm study of IVIG in immunoglobulin (Ig)-naïve or IVIG pre-treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double-blind, randomized study including an open-label, single-arm IVIG phase in IVIG pre-treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre-treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was -1.0 (interquartile range -2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA-approved IVIG for CIDP, in a population of mainly pre-treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Aggressive behavior as a rare side effect of subthalamic stimulation in Parkinson's disease.

Although deep brain stimulation (DBS) has a well-established position in the treatment of Parkinson's disease (PD), it may be accompanied by different side effects including behavioral changes. We present a patient with advanced PD after bilateral stimulation of the subthalamic nucleus (STN) who developed attacks of aggressive behavior. The patient with a 12 year history of PD underwent the procedure of DBS with one-stage bilateral stereotactic approach using the Leksel G stereotactic frame. For STN identification microrecording technique was applied (5 microelectrodes). Four weeks after surgery STN stimulation was switched on. With increasing the amplitude of stimulation on the right (active contacts 1 and 2) the patient experienced transient episodes of aggression. Change of stimulation mode led to withdrawal of all side effects. We hypothesize that aggression episodes in the patient were caused by stimulation of limbic circuit probable within STN although we cannot exclude simultaneous stimulation of neighboring structures. Aggression episodes are rare side effect of STN-DBS, nevertheless they may be expected in more posteromedial placement of the electrode within STN. The presented case extends the evidence for non-motor functions of STN and highlights its role as an integrating structure within the basal ganglia system.

[Evaluation of the effectiveness of add-on therapy with tiagabine and evaluation of cognitive functions after application of this therapy in patients with drug-resistant focal epilepsy - an observational study (GABI-EPI)]. / Ocena skutecznosci terapii dodanej tiagabina oraz ocena funkcji poznawczych po zastosowaniu tej terapii u pacjentów z ogniskowa padaczka lekoodporna - badanie obserwacyjne (GABI-EPI).

OBJECTIVE: To assess the efficacy of add-on therapy with tiagabine and cognitive functions in patients with drug-resistant focal epilepsy, when used in everyday clinical practice. MATERIALS AND METHODS: The total number of 437 patients with drug-resistant epilepsy with focal seizures were observed; 436 patients were treated with tiagabine as add-on therapy at a dose of 5-50 mg per day. During the study a number visits were secheduled: Visit V0 - upon enrolment of tiagabine-treated patients into the observational study, visit V1 - four weeks after reaching the initial dose of tiagabine, visit V2 - four weeks after reaching the target dose of tiagabine. The type and number of epileptic seizures, antiepileptic therapy used, concomitant treatment and adverse events were analysed. Analyses were performed using McNemar's, Wilcoxon's, Mann-Whitney's and Fisher's tests. The patients'cognitive functions were assessed using the MM SE scale. RESULTS: The mean observation time was 90 days. Men accounted for 48.3% of the study population and their average age was 41,5±14,0 and women accounted for 51.7% and their average age was 43.4±13.9. About 80% of the patients received valproic acid or carbamazepine before administration of tiagabine. Other most commonly used drugs included acetylsalicylic acid and ramipril. In the group of 185 patients who used drugs inducing liver enzymes before administration of tiagabine, 13% received a dose below 30 mg of tiagabine and 87% above 30 mg. In the group of patients treated with drugs which do not induce liver enzymes, 91.6% received tiagabine in a dose below 30 mg and 8.4% in a dose above 30 mg. The percentage of patients experiencing epileptic seizures was reduced from 72.2% between visits V0-V1 to 58.7% between visits V1-V2 (p<0.001). A decrease in the population of patients who experienced seizures and a reduction of the number of seizures were observed in all age groups. In the youngest age group, the number of seizures since the last visit went down from 5.4 to 3.7 (the average difference amounted to 1.7), in the 40-59 years age group, the number of seizures went down from 4.0 to 3.1 (the average difference amounted to 0.9) and in patients above the age of 60, from 3.0 to 2.1 (the average difference amounted to 0.9) (p<0.001; p=0.001 and p<0.001, respectively). Adverse events occurred in 4 (i.e. 0.9%) patients, dizziness being the most common. The Mini Mental State Examination (MM SE) was performed in 25% of patients. Cognitive functions did not deteriorate. The average MM SE score corresponded to a mild level of cognitive impairment. CONCLUSIONS: Tiagabine is a well tolerated drug providing effective control of focal seizures and in a sub-population of 25% patients whose cognitive functions were evaluated using MM SE, no significant adverse effect of the drug on such functions was observed.

Disappearance of white matter lesions on MRI and clinical recovery after initiating antiretroviral therapy in a case of HIV infection presenting as spastic paraparesis.

We present a case of a 30-year-old Polish female who presented with increasing for about 2 years spastic paraparesis and urinary incontinence. She denied any risky sexual behaviors, drug abuse, there was no history of surgery or blood transfusions. MRI of the brain showed diffuse, hyperintensive in T2, poorly defined lesions in the white matter. About 3 months later paraparesis increased and control MRI showed progression of previously described lesions. She was then diagnosed with HIV infection. There was a suspicion of progressive multifocal leucoencephalopathy (PML) or vacuolar myelopathy in the course of HIV infection. Antiretroviral treatment was initiated leading, together with rehabilitation, to a progressive improvement of symptoms. Pathological lesions on brain MRI completely disappeared. In conclusion, HIV test should be done in every patient with neurological signs of unknown cause.

Efficacy and safety of Privigen(®) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study).

This prospective, multicenter, single-arm, open-label Phase III study aimed to evaluate the efficacy and safety of Privigen(®) (10% liquid human intravenous immunoglobulin [IVIG], stabilized with L-proline) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients received one induction dose of Privigen (2 g/kg body weight [bw]) and up to seven maintenance doses (1 g/kg bw) at 3-week intervals. The primary efficacy endpoint was the responder rate at completion, defined as improvement of ≥1 point on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale. The preset success criterion was the responder rate being ≥35%. Of the 31 screened patients, 28 patients were enrolled including 13 (46.4%) IVIG-pretreated patients. The overall responder rate at completion was 60.7% (95% confidence interval [CI]: 42.41%-76.43%). IVIG-pretreated patients demonstrated a higher responder rate than IVIG-naïve patients (76.9% vs. 46.7%). The median (25%-75% quantile) INCAT score improved from 3.5 (3.0-4.5) points at baseline to 2.5 (1.0-3.0) points at completion, as did the mean (standard deviation [SD]) maximum grip strength (66.7 [37.24] kPa vs. 80.9 [31.06] kPa) and the median Medical Research Council sum score (67.0 [61.5-72.0] points vs. 75.5 [71.5-79.5] points). Of 108 adverse events (AEs; 0.417 AEs per infusion), 95 AEs (88.0%) were mild or moderate in intensity and resolved by the end of study. Two serious AEs of hemolysis were reported that resolved after discontinuation of treatment. Thus, Privigen provided efficacious and well-tolerated induction and maintenance treatment in patients with CIDP.

Neurofilament heavy chain and heat shock protein 70 as markers of seizure-related brain injury.

PURPOSE: Status epilepticus (SE) has deleterious effects on brain tissue, but whether brief recurrent seizures may also damage neurons represents a matter of controversy. Therefore, it remains a central area of epilepsy research to identify individuals at risk where disease progression can be potentially prevented. Biomarkers may serve as tools for such identification. Thus the present study aimed at analyzing the levels of heat shock protein 70 (HSP-70, also designated as HSPA1A) and neurofilament heavy chain protein (NfH(SMI35) ) in cerebrospinal fluid (CSF) of patients with seizures of different severity. METHODS: Forty-one patients were included, of whom 20 patients had a single generalized tonic-clonic seizure (GTCS) episode (SS), 11 had repetitive GTCS (RS), and 10 experienced convulsive SE. The control group consisted of 18 subjects. HSP-70 levels were measured using a conventional enzyme-linked immunosorbent assay (ELISA), whereas the NfH(SMI35) protein levels were detected by an electrochemiluminescence (ECL) immunoassay. KEY FINDINGS: Patients with SE (p < 0.001) and RS (p < 0.05) had significantly higher NfH(SMI35) levels than controls, and SE was associated with increased concentrations when compared with SS (p < 0.001). NfH(SMI35) levels in SS did not differ from controls. Patients with SE had significantly raised HSP-70 levels compared to RS (p < 0.05), SS (p < 0.05), and controls (p < 0.001). SS and RS did not differ from each or from controls. Levels of NfH(SMI35) and HSP-70 showed a significant correlation (r = 0.34; p = 0.007) in the group of all study subjects, which was not apparent when controls and patients with seizures were considered separately. The correlation between NfH(SMI35) and HSP-70 tended to be inverse in patients with SE, but it did not reach statistical significance (r = -0.3; p > 0.05). SIGNIFICANCE: Studying biochemical markers as additional quantitative tools for the measurement of neuronal damage (especially subclinical), complementary to available techniques of imaging, and clinical assessment might prove useful for identifying patients at risk of accumulating neuronal injury resulting from uncontrolled seizures. NfH(SMI35) and HSP-70 are of potential value as sensitive and specific biomarkers of seizure-related pathologic events. Future longitudinal studies are needed to monitor such patients by correlating biochemical, neuroimaging, and clinical methods of assessment.

Bilateral paramedian thalamic infarction with hypothalamic dysfunction.

Unilateral thalamic lesions cause transient or permanent behavioral, sensory and oculomotor disturbances; bilateral lesions of thalamus result in more severe and longer lasting symptoms. We present an atypical case of bilateral paramedian thalamic infarct with concomitant hypothalamic dysfunction. The only risk factor of ischaemic stroke found in the patient was a short lasting episode of atrial fibrillation. Bilateral paramedian thalamic infarcts may result from occlusion of one paramedian thalamic artery, which arises from the posterior cerebral artery, either with separated or with a common trunk, thus supplying the thalamus bilaterally. Independently of anatomical variants of thalamus blood supply, the most probable cause of infarct in our patient was unilateral or bilateral occlusion of the posterior cerebral artery by cardioembolism, probably in the course of basilar artery occlusion. Hypothalamic dysfunction may accompany thalamic infarcts; thus hypothalamo-pituitary function should be routinely assessed in bithalamic infarcts.

Analysis of ventricular late potentials in signal-averaged ECG of people with epilepsy.

PURPOSE: There has been growing interest in cardiac disturbances in epilepsy patients and their etiologic role in the context of sudden death. Ventricular late potentials (VLPs) recorded on signal-averaged electrocardiography (SAECG) reflects delayed ventricular depolarization and identifies the structural or functional substrate for the ventricular tachycardia in the reentry mechanism. Therefore, abnormal SAECG poses the potential of identifying patients at increased risk of malignant ventricular arrhythmias and sudden cardiac death. The aim of this exploratory study was to screen epilepsy patients who were treated with established doses of antiepileptic drugs (AEDs) on the presence of VLPs. METHODS: Forty-five consecutive patients with the diagnosis of epilepsy and 19 healthy volunteers, aged younger than 46 years, participated in the study. Exclusion criteria included symptoms or signs of diseases other than epilepsy, in particular relating to heart disease or medication influencing the cardiovascular system, as well as seizure reported by patients that occurred <3 days before the ECG examination. The electrocardiogram was recorded according to the standard protocol. The seizure frequency was calculated based on the available data of epileptic events within the preceding 3 months. Disease duration was estimated by determining the time from the first reported seizure to the present. KEY FINDINGS: There were 22 patients (48%) in the epilepsy group and only one patient (5%) in the control group fulfilling the criteria for VLP (p = 0.0005). Subsequently, epilepsy patients were divided into two subgroups according to VLP presence. Patients with VLP had longer disease duration (p = 0.03) compared to those without VLP. Similarly, patients with VLP more frequently had refractory epilepsy (p = 0.03) and had higher monthly seizure frequency (p = 0.02). Analysis of the proportions of generalized seizures (GS) and focal seizures (FS) showed a tendency for higher number of generalized tonic-clonic seizures in the VLP group, but this did not reach statistical significance (p = 0.06). VLP patients tended to be more often on polytherapy (defined as more than one AED per patient) (p = 0.07) as compared to epilepsy patients without VLP. However, if the numbers of AEDs per patients among the subgroups were compared, patients with VLP were treated with more AEDs than patients without VLP (p = 0.01). The study was not sufficiently powered to pinpoint any particular drug or AED combination to influence the appearance of VLP in epileptic patients. In particular, there was no difference in valproate or carbamazepine exposure, considering the percentage of patients exposed or the total daily dose administered. SIGNIFICANCE: Epilepsy patients more frequently display abnormal SAECGs with VLPs as compared to the control population, and their presence correlates with the disease duration, uncontrolled seizures, and polytherapy. Further longitudinal studies are needed in order to stratify the risk of life-threatening ventricular events in epilepsy patients with VLPs.

Validation analysis of the Polish version of the Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL).

BACKGROUND AND PURPOSE: The aim of this study was to perform a validation analysis of the Polish adaptation of the Multiple Sclerosis International Quality of Life Questionnaire, MusiQoL. MATERIAL AND METHODS: Validation analysis included the translation of the original English version into Polish according to translation principles and the analysis of convergent validity, internal reliability and reproducibility of the Polish version of MusiQoL. The study included 150 randomly chosen patients (109 women and 41 men) with definite multiple sclerosis (MS) diagnosed according to McDonald criteria. Mean age of patients was 41 ± 10 years and mean disease duration was 11.7 ± 7.2 years. The patients completed the examined MusiQoL, the Functional Assessment of Multiple Sclerosis (FAMS) and the Multiple Sclerosis Impact Scale (MSIS-29). Data regarding sociodemographic status and MS history were collected. The disability of the patients was assessed according to the Expanded Disability Status Scale (EDSS). The examination was repeated after 28 ± 4 days. RESULTS: The internal reliability, convergent validity and reproducibility of MusiQoL were satisfactory. The dimensions of the scale exhibited high internal consistency (Cronbach's alpha from 0.67 to 0.90). The MusiQoL correlated with FAMS (positive correlations), EDSS and MSIS-29 (negatively). CONCLUSIONS: Psychometric-statistical analysis showed that the Polish version of MusiQoL is a valuable measure to examine the health-related quality of life of Polish MS patients.

[Efficacy and tolerability of dose-escalation with generic gabapentin--a multicenter, non-interventional study]. / Skutecznosc i bezpieczenstwo zwiekszania dawek generycznej gabapentyny--wieloosrodkowe badanie nieinterwencyjne.

The aim of this study was to determine the efficacy and tolerability of 1800-2400 mg/day of generic gabapentin (Gabapentin Teva) as add-on treatment for refractory partial - onset epilepsy. This was a multicenter, open-label, dose-escalation study of patients with refractory epilepsy (median age of 45.5 years [41-50; 25-75% percentile range], male 45.6%, female 47.8%). The inclusion criteria were insufficient partial-onset epilepsy control, defined as at least 1 seizure per month, while on adjunctive therapy with gabapentin used on daily doses below 1200 mg. The baseline seizure number was assessed over 3 months of observation in patients being on stable doses of their AED therapy and those subjects who met the inclusion criteria were enrolled into the study by their neurologist (Visit 0). Subsequently, patients were seen, and their data were evaluated at Visit I i.e. after the target dose of 1800 mg per day was achieved (mean duration of 3.6 [0.1-28.3] weeks) and 4 weeks later at Visit II, after the target dose up to 2400 mg per day. Primary efficacy was assessed by seizure frequency (number/month). Tolerability was assessed by adverse events and clinical evaluations. All the study periods were completed by 916 patients. A substantially lower median seizure frequency was observed at all gabapentin dosing periods (visit I - 2.0 [0-40] seizures per month and visit II - 1.0 [0-13] seizures per month; median and range) compared with the baseline period (3.0 [1-20] seizures per month) (Wilcoxon test p<0.001). In addition, the gradual increase of GBP dose led to raising proportion of patients rendered seizure free (Visit I - 1.1% and Visit II - 28.5%) compared with the baseline period 0.0% (McNemar test p<0.001). The dose escalation with GBP was well tolerated by the majority of patients. The most common adverse events during visit II were somnolence (2.8%) and dizziness (1.8%). In conclusion, gabapentin dose escalation to a dose range of 1800-2400 mg/d over 8 [1-32] week period proved to be an effective and well tolerated in patients with insufficient seizure control on lower doses with partial-onset epilepsy.

[Processes of free radical lipid peroxidation with a particular regard to the role of paraoxonase-1 in the pathogenesis of multiple sclerosis]. / Procesy wolnorodnikowej peroksydacji lipidów ze szczególnym uwzglednieniem roli paraoksonazy-1 w patogenezie stwardnienia rozsianego.

Oxidative stress is an imbalance between free radicals production and antioxidant defences. Reactive oxygen species (ROS) and reactive nitrogen species (RNS) can attact and demage a variety of critical biological molecules, including lipids, essential cellular proteins and DNA and may be exert in pathogenesis of many disorders. Products of lipid peroxidation can be easily reliably detected in biological fluids and tissues, yielding sensitive and specific signals of lipid peroxidation occurred in vivo. Those products are: isoprostanes (isoP) dimalonealdehyde (MDA), 4-hydroxynonenal (4-HNE). Paraoxonase-1 (PON-1) play a key role in defence of lipid peroxidation. PON-1 is an serum enzyme bound up with high density lipoproteins (HDL). The aim of this work is to discuss the role of oxidative stress in the pathogenesis of multiple sclerosis.

Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study.

Cladribine is currently registered as a 10-milligram tablet formulation with a fixed cumulative dosage of 3.5 mg/kg over 2 years. It is important to investigate if an increased dosage may lead to further clinical stability with preserved safety. This study used an off-label subcutaneous (s.c.) formulation of cladribine and compared outcomes (Expanded Disability Status Scale (EDSS) scores and disease progression) between 52 relapsing multiple sclerosis (RMS) patients receiving different s.c. dosing regimens with up to 20 years of follow-up. The study group received induction therapy with s.c. cladribine (1.8 mg/kg cumulative dose; consistent with 3.5 mg/kg of cladribine tablets). Patients were subsequently offered maintenance therapy (repeated courses of 0.3 mg/kg s.c. cladribine during 5-20-year follow-up). Forty-one patients received an increased cumulative dose (higher than the induction dose of 1.8 mg/kg); 11 received the standard induction dose. Risk of progression on the EDSS correlated with lower cumulative dose (p < 0.05) and more advanced disability at treatment initiation (p < 0.05) as assessed by EDSS change between year 1 and years 5 and 10 as the last follow-up. Maintenance treatment was safe and well-tolerated, based on limited source data. Subcutaneous cladribine with increased cumulative maintenance dosage was associated with disease stability and favorable safety over a prolonged period of follow-up (up to 20 years) in RMS patients.

Immunomodulatory effects of vitamin D on monocyte-derived dendritic cells in multiple sclerosis.

In order to evaluate the effects of vitamin D3 on monocyte-derived dendritic cells (DCs) of relapsing-remitting multiple sclerosis patients, DCs differentiation and maturation were evaluated in vitro based on surface phenotypic changes. The expression of CD14, CD83, CD1a, CD80, CD86, CD206 and C209 was analysed by fluorescence-activated cell sorting. The results reveal that vitamin D3 inhibits both the differentiation and maturation of DCs. Moreover, inhibits the secretion of IL 23/12p40 and increases the secretion of CCL2. The data suggest that one of the mechanisms of the beneficial action of vitamin D3 in multiple sclerosis may be associated with its influence on DCs.

Selected aspects of the epidemiology of multiple sclerosis in Poland - a multicentre pilot study.

BACKGROUND AND PURPOSE: The aim was to conduct a pilot study of selected epidemiological aspects of multiple sclerosis (MS) in Poland. MATERIAL AND METHODS: Cross-sectional data were collected in 21 centres providing MS treatment. The demographic profile of the patients, medical history of MS, disability status, comorbidity, and diagnostic and treatment modalities were analysed. RESULTS: Data on 3581 patients were obtained, including 2494 women (69.6%) and 1030 men (28.8%) - sex ratio 2.4 : 1. The mean age was 40.7 ± 11.9 years. Monofocal onset was reported in 80.8% of cases - the most frequently reported location of lesions was supratentorial (36.1%), followed by optic nerves (26.5%) and spinal cord (20.1%). The mean disease duration was 10.2 ± 8.8 years (range 0.04-53 years), and the mean time from the first symptoms to MS diagnosis was 2.6 years. Relapsing-remitting MS was reported in 70.5% of patients, secondary progressive in 16.8%, primary progressive in 8.4%, and 'benign MS' in 2.5%. The mean EDSS score was 3.3 ± 2.2 (range 0-9.5). The family history of MS was positive in 6.4% of cases. Comorbidity mainly applied to the musculoskeletal system (6.5%), the urinary system (5.8%) and psychiatric disturbances (5.5%). Brain magnetic resonance studies were available in 96.3% of the patients, evoked potentials in 54%, and cerebrospinal fluid testing in 63.1% - of whom only 41.2% were tested for oligoclonal bands, with 84% of samples being positive. Immunomodulatory drugs were used in 842 patients (24%), predominantly interferon beta (81%) and glatiramer (13%). Mitoxantrone was the most commonly used immunosuppressant. CONCLUSIONS: This project is the first countrywide large-scale MS survey, covering approximately 18% of patients, according to our estimates. The results identify the clinical condition of the patients, as well as diagnostic and treatment modalities.

Decreased cerebrospinal fluid hypocretin-1 (orexin A) in patients after repetitive generalized tonic-clonic seizures.

The effects of seizures on the hypocretin/orexin system have not yet been investigated in epileptic patients. The present study aimed to assay hypocretin-1 in the cerebrospinal fluid (CSF) of patients after generalized tonic-clonic (GTC) seizures. Study groups consisted of 21 patients after GTC seizures and 19 controls. Diagnostic lumbar puncture was performed in control and epileptic patients within 48 h after the GTC seizures. Hypocretin-1 levels were measured in unextracted CSF samples, using a standardized commercial radioimmunoassay. There was a significant overall difference in median CSF hypocretin-1 concentrations between controls and patients with GTC patients (p < 0.001). The lowest concentrations were noted in a subgroup of patients with repetitive GTC seizures (RS) compared to those with a single GTC seizure (SS) (p > 0.05) or controls (p < 0.001). The current results suggest that the hypocretin-1 system deficiency contributes to the complex pathophysiology of repetitive GTC seizures and status epilepticus (SE) and could be associated with typical somnolence after seizure attacks.

Serum bilirubin and uric acid levels as the bad prognostic factors in the ischemic stroke.

Bilirubin (Bil) and uric acid (UA) are the endogenous antioxidant compounds possibly involved in the pathogenesis of ischemic stroke (IS). Our goal was to find the relationship between serum Bil and UA levels with clinical presentation and outcomes of patients suffering from IS. Forty-three patients (mean age: 71.9 years, +/- 12.1; women: 48.8%) with confirmed IS were enrolled. Stroke severity was assessed by the National Institutes of Health Stroke Scale (NIHSS) after 1, 3, 5, and 10 days and functional disability was assessed three months after stroke onset using the Barthel Index (BI). Serum Bil and UA levels were measured 1, 3, 5, and 10 days after stroke. The difference between NIHSS scores from days 1 and 10 (improvement ratio) inversely correlated with the average UA serum level (r = -0.48, p < .01) but not with the average Bil level. Negative correlations were observed between the BI measured three months after stroke compared to the average Bil serum level (r = -0.5, p < .01). However, no relationship between BI and UA level was observed. Our results indicated that Bil and UA levels are poor prognostic factors for ischemic stroke.

[Fatigue in multiple sclerosis]. / Zespól zmeczenia w stwardnieniu rozsianym.

Fatigue is one of the most common symptoms of multiple sclerosis (MS) and is associated with reduced quality of life. The fatigue syndrome is characterized by uncontrollable apathy, exhaustion, fatigability and lack of energy. The mechanisms underlying fatigue in MS are still poorly understood but studies suggest that immune and neuroendocrine factors may play a causative role in the development of fatigue. The first step in management of MS-related fatigue is identifying and eliminating any secondary causes (adverse effects of drugs, infections, sleep disorders, metabolic diseases). As the fatigue syndrome in patients with MS cannot be evaluated objectively in the routine clinical setting, a number of scales have been developed. The Fatigue Severity Scale is a general scale. Additional scales that have been tested in MS include the Fatigue Impact Scale. Therapy of fatigue syndrome consists of modafinil, amantadine, pemoline and non-pharmacological management.

[Validation analysis of selected psychometric features of Polish version of Modified Fatigue Impact Scale--preliminary findings]. / Analiza walidacyjna wybranych aspektów psychometrycznych polskiej wersji Zmodyfikowanej Skali Wplywu Zmeczenia (Modified Fatigue Impact Scale) - wyniki wstepne.

BACKGROUND AND PURPOSE: Fatigue is one of the most frequent and most disabling symptoms in multiple sclerosis (MS), disturbing patients' daily life. The Modified Fatigue Impact Scale (MFIS) is composed of 21 items; it evaluates the impact of fatigue on three dimensions of quality of life of patients with multiple sclerosis: physical, cognitive and psychosocial. MFIS is easy and quick to perform. The patient scores between 0 and 84 points - the higher the score, the stronger the impact of fatigue on the patient's quality of life. MATERIAL AND METHODS: One hundred and twenty-two patients with clinically definite MS, according to McDonald criteria, were qualified for the study. All patients had neurological examination and their disability was assessed according to the Expanded Disability Status Scale (EDSS). Patients were asked to complete the MFIS, the Polish version of the generic scale SF-36, and a sociodemographic questionnaire. Clinical data related to the course of the disease and exacerbation of particular symptoms were collected by using a special questionnaire with the participation of a neurologist. Reliability analysis was done by estimating internal consistency of the scale using Cronbach's coefficient alpha. The theoretical validity was assessed by analysing correlations between MFIS scores and SF-36 and EDSS scores as well as convergent validity. RESULTS: MFIS scale and its subscales correlate with Vitality and Mental Health in the highest degree. According to the strongest correlations between MFIS subscales, Physical Subscale correlates with generic subscales connected with physical functioning, Cognitive Subscale correlates with Mental Health and Psychosocial Subscale with Vitality and Social Functioning. CONCLUSIONS: Both the reliability and validity of MFIS are satisfactory; the scale seems to be a valuable tool to evaluate the impact of fatigue on quality of life of patients with MS.