SUMMARYPurpose: Double-blind randomized trial to assess efficacy and tolerability of once-daily extendedrelease levetiracetam (LEV XR) tablets (2 · 500 mg) as add-on therapy in patients (12-70 years old) with partial-onset seizures (POS) refractory to one to three antiepileptic drugs. Methods: After an 8-week prospective baselineperiod, eligible patients were randomized (1:1) to once-daily LEV XR 1,000 mg/day or placebo for 12 weeks. Evaluations included changes from baseline in POS-frequency/week, responders ( ‡50% reduction in POS-frequency/week), seizurefreedom, adverse events, laboratory tests, physical and neurologic examinations, vital signs, body-weight, and 12-lead electrocardiogram. Results: Of 188 patients screened, 158 were randomized (intention-to-treat population): LEV XR (n = 79) or placebo (n = 79). Seventy-one (89.9% %) LEV XR and 72 (91.1% %) placebo patients completed the trial. Median POS-frequency/week reduction was 46.1% % on LEV XR and 33.4% on placebo. Estimated reduction with LEV XR over placebo was 14.4% (p = 0.038). Thirty-four (43%) LEV XR and 23 (29.1% %) placebo patients experienced ‡50% % reduction in POS-frequency/week. Eight (10.1% %) patients receiving LEV XR and one (1.3% %) receiving placebo were free of POS during the 12-week treatment period. Forty-one (53.2% %) LEV XR and 43 (54.4% %) placebo patients reported ‡1 adverse event. Adverse events reported with an incidence >5% % and seen more often with LEV XR than with placebo were somnolence, influenza, irritability, nasopharyngitis, dizziness, and nausea. Discussion: Once-daily LEV XR 1,000 mg was effective and well-tolerated as adjunct therapy in patients with POS. Ten percent of patients randomized to LEV XR experienced freedom from POS. These results support the clinical value of this new LEV XR formulation.

Introduction Chronic pain, which usually occurs after traumatic damage to nerves and plexuses, is an additional burden on the patients’ quality of life, which is already impaired due to motor, sensory and autonomic deficits. The aim is to study and clarify changes in immunological parameters and neurotrophic factors in patients with compression, post-traumatic non-gunshot and gunshot neuropathies and plexopathies. Materials and Methods The study included 93 men aged 21 to 59 years with neuropathy and plexopathy of traumatic and non-traumatic origin, which were divided into 3 groups. Patients underwent clinical and neurological examination starting at onset of clinical manifestations and in the dynamics, electromyography, and ultrasound. Immunological examination was performed from 12 to 24 months starting at onset of the disease. Results Differences between the study groups in the concentration of circulating immune complexes and lymphocytotoxicity, decrease in CD4 + T lymphocytes were statistically significant. In the obtained NBT-test results, which characterize the difference between spontaneous and zymosan-stimulated oxygen-dependent phagocytosis, it was found that the cells oxidized granules of nitroblue tetrazolium dye with different degree of intensity, depending on the regenerative capacity of enzymes. We found an increase in the quantitative content of the beta-NGF 303 [35.2; 504.5] pg/ml in the blood of patients of the group III with post-traumatic gunshot neuropathies and plexopathies accompained by chronic neuropathic pain syndrome at a statistically significant level (Kruskal-Wallis test, p=0.0181). Conclusion The study showed a statistically significant (p<0.05) violations of the regulatory link of immune system in patients with post-traumatic gunshot neuropathies and plexopathies, increased circulating immune complexes level, disorders of oxygen-dependent and oxygen-independent phagocytosis, reduced enzymatic regenerative capacity, significant increase in beta-NGF, Thus, as a result of the study, we found statistically significant (p<0.05) violations of the regulatory link of immune system in patients with post-traumatic gunshot neuropathies and plexopathies, increased circulating immune complexes level, disorders of oxygen-dependent and oxygen-independent phagocytosis, reduced enzymatic regenerative capacity, significant increase in beta-NGF 303 [35.2; 504.5] pg / ml, indicating the ongoing process of chronic inflammation, stimulation of the sympathetic nervous system and sensory fibers, which leads to the maintenance and severity of chronic neuropathic pain even after 12 months or more since the injury with damage to nerves and plexuses of the limbs.

No abstract

No abstract

No abstract