[The results of Russian multicenter open-label observational study of the efficacy and safety of мelaxen (melatonin) for the treatment of disordered sleep in patients with chronic cerebral ischemia].

The results of the multicenter open-label observational study of the efficacy and safety of the Melaxen (melatonin) for the treatment of disordered sleep in patients with chronic cerebral ischemia are presented. 2062 patients were studied with the use of subjective psychometric scales: subjective sleep characteristics scale, sleep apnea screening questionnaire, Epworth sleepiness scale, hospital anxiety and depression scale. Mean age of patients was 55.7±9.0 years, there were 74.1% females and 25.9% males. Melaxen was given in dosage of 3 mg. before sleep for 24 days. The use of Melaxen leads to the increase of subjective sleep quality by the subjective sleep characteristics scale from 19.7±3.1 points to и 22.7±3.4 points on day 14 and 22.7±3.4 on day 24 (differences are significant at p<0.0001). There was the decrease of the relative number of patients with frequent night awakenings, prolonged sleep latency, short night sleep, poor quality of morning awakening and multiple bothering dreams. Authors conclude that the use of Melaxen in dosage of 3 mg before sleep is effective and safe insomnia treatment in patients with chronic cerebral ischemia.

[Neurophysiological, neurochemical, autonomous and chronobiological basics of sleep medicine].

The review discusses various mechanisms of the rapidly growing problem of Sleep Medicine. The "Sleep-wakefulness" cycle is a continuum of different functional states and the diseases that these states might prompt to manifest themselves in various ways. In these cases, we must say that change produces the conditions of disease manifestation rather than the disease itself. The paper describes the dynamics of the autonomous parameters during sleep, emphasizes the role and importance of chronobiological aspects of the "sleep-wakefulness" cycle. The holographic principle of the operation I sleep cycle is described which persists even in the cerebral stroke. From the standpoint of neurochemistry, modern hypnotics and drugs of the nearest future can be divided into 2 groups: proS (pro sleep)--for sleeping, and antiW (anti-wakefulness)--vs. wakefulness.

[Clinical experience in using agomelatin (valdoxan) in the neurological practice].

The author presents the own clinical experience of the use of agomelatin (valdoxan) in the complex treatment of patients with ischemic stroke, migraine, fibromyalgia and during "drug holidays" after the withdrawal of benzodiazepines. In all cases of comorbid neurological diseases and clinically diagnosed insomnia and depression, valdoxan demonstrated its efficacy and safety.

[A multicenter program on assessment of efficacy and safety of a new therapeutic scheme for patients with chronic cerebrovascular insufficiency].

An assessment of the complex multicenter prospective non-comparative program aimed at studying of efficacy and safety of a new scheme of therapy with cavinton in patients with chronic cerebrovascular insufficiency has been conducted. One hundred and forty-nine patients (46 male, 113 female), aged from 35 to 65 years, have been examined. The treatment started from intravenous infusions of the drug during 7 days as follows: 20, 30, 40, 50, 50, 50 and 50 mg of cavinton solution diluted in 500 ml of physiologic solution with the following peroral taking of cavinton forte in dose 10 mg 3 times daily during 11 weeks. Efficacy of drug was primarily assessed with MMSE and then by SF-36 and CGIC-PGIC. There were significant differences in scores on MMSE and SF-36 before and after treatment and on CGIC-PGIC on the 8th and 90th days of the study. The parenteral and peroral use of cavinton is well-tolerated and has a favorable safety profile.

[Use of omaron in patients with post-stroke cognitive disorders].

Efficacy of omaron (a combination of piracetam 400 mg and cinnarizin 25 mg) has been studied 3 months after stroke in 90 post-stroke patients. Forty-five patients receiving the basic therapy (antihypertensive and antithrombotic drugs, statins) have been included in the control group and 45 patients of the main group received in addition omaron (1 pill 3 times daily during 2 months). Intensity of neurologic disturbances, degree of disability, cognitive functions assessed by neuropsychological tests (the Mini-Mental State Examination, the Frontal Assessment battery, the Five words test, the Clock drawing test, the Schulte test) and emotional state (the Centre for Epidemiologic Studies Depression scale, the Spilberger scale) have been measured. During the period of the study, none of the patients had stroke or myocardial infarction. The improvement of indices of neurological status, decrease of disability degree and normalization of arterial pressure were found in both groups after 2 months of treatment. The significant improvement (p<0,05) of performance on tests for neurocognitive functions and parameters of emotional state was noted in patients treated with omaron compared to those of the control group. The good tolerability of omaron, absence of serious side-effect in combination with other drugs used for prevention of secondary stroke were reported.

[The use of andante in the therapy of insomnia].

Thirty patients with psychophysiological insomnia (mean age 46,2+/-9,8 years) have been examined. All patients received 10 mg andante (zaleplone) in the evening 15 minutes before going to sleep during 7 days. A comparative assessment was conducted on the 1st and 7th days using a questionnaire for assessment of subjective sleep characteristics, the Obstructive Sleep Apnea Questionnaire, the Epworth Sleepiness scale, the Hospital Anxiety and Depression scale and the Beck Depression Inventory. Polysomnographic recording of night sleep was conducted in 15 patients. A significant decrease of anxiety and depression on the Hospital Anxiety and Depression scale and the Beck Depression Inventory (p<0,05) was found to the 7th day. After the treatment, the mean value on the questionnaire for assessment of subjective sleep characteristics increased by 63,6% from baseline and reached the normal level (p<0,05). Patients with initial pathological changes of the hypnogram had the following improvements: the significant increase of duration and percentage of stage 4 and delta sleep; decrease of falling asleep time, fast sleep latency period and awakenings during sleep; sleep quality index had reached the normal level (p<0,05) in 66% of cases. Forty percents of patients rated the efficacy of therapy as "very good", 34% as "good" and 13% as "moderate". No side-effects of andante were reported.

[Migraine and "sleep-wake" cycle].

The results of the comparative analysis of patients with migraine attacks developing in the waking period (AP) and night sleep period are presented. Patients with sleep-related migraine (SM) had higher levels of depression and anxiety, marked autonomic dysfunction and stable sleep disturbances that resulted in significant maladaptation of these patients in the between-attacks period and low quality of life. Depression plays a role in the transformation of AP to SM and formation of stable sleep disturbances in the between-attacks period in patients with SM. It is suggested that common serotoninergic mechanisms involved in migraine attack may contribute to formation of "sleep-wake" cycle and depression development. The principles of optimal therapy of such patients are formulated.

[Sleep-related breathing disturbances in motor neuron disease].

Presented are the results of the study of respiratory parameters, together with standard polysomnography, in 18 patients with motor neuron disease (13 males, 5 females, mean age 61,5 +/- 10,6 years). AHI =10 epis./h was found in 10 (56%) cases. Other 4 patients demonstrated a low level (less 94%) of average blood saturation during sleep. The highest number of obstructive episodes was observed in patients with progressive bulbar palsy and amyotrophic lateral sclerosis (ALS) with bulbar signs. The lowest level of nighttime saturation was registered in patients with ALS without bulbar signs. Mean saturation (less than 94%) was associated with more pronounced limb muscle weakness, rapid disease progression and worse survival.

[Influence of ivadal and depakene chrono on sleep structure in patients with epilepsy]. / Vliianie ivadala i depakina khrono na strukturu sna u bol'nykh épilepsiei.

Because of strong association between epilepsy mechanisms and sleep disturbances, the latter may deteriorate the disease course and the patient's quality of life. Thirty eight patients with epilepsy (19 men and 19 women, mean age 25.6 +/- 11.4 years, age at onset 19.1 +/- 13.3 years, the disease duration 7.2 +/- 6.9 years) have been examined. The control group included 10 healthy individuals. The comparative group comprised 17 patients with physiological insomnia. All the patients had sleep disturbances of different level and were given hypnotic drug ivadal, which was compared to anticonvulsant depakine chrono, directly influencing GABA-ergic brain system. After sleep corrections, positive clinical and electroencephalographic trends in epileptic patients were detected. Comparing to depakine chrono, ivadal was suggested to up-regulate GABA-ergic brain systems during sleep due to rehabilitation of physiological brain characteristics.

[Specific features of the structure of sleep and personality under the conditions of chronic emotional stress and methods of improving the adaptive abilities of man]. / Osobennosti struktury sna i lichnosti v usloviiakh khronicheskogo émotsional'nogo stressa i metody povysheniia adaptivnykh vozmozhnostei cheloveka.

The results of a complex psychophysiological study of human sleep in the chronic stress condition are described. 20 patients with complaints of night sleep disturbances in the chronic stress condition and 10 healthy controls were examined by polysomnography. Profound changes of the quantitative and qualitative sleep parameters, mainly, related with the slow sleep phase, sleep delta characteristics and adaptive wakefulness mechanisms. The study demonstrated the effectiveness of improving the human adaptive parameters in the chronic stress conditions by using the drug and drugless therapy methods.

[Sleep and sedation: clinical and electrophysiological parallels]. / Son i sedatsiia: kliniko-élektrofiziologicheskie paralleli.

Clinical and electrophysiological studies were performed in 10 volunteers and 45 patients with Classes I and II, as stated by the American Society of Anesthesiologists, to evaluate consciousness during sedation. Prior studies on volunteers showed that there was a clear correlation between N-REM sleep and SEF in 90% of cases. Based on these findings, the authors propose a modified suppressed consciousness scale whose rating was adjusted to the levels of N-REM sleep. Irrespective of the type and technique of sedation (infusion of thiopental and propofol; PCS, midazolam), changes in the levels of drug-depressed consciousness were found to be the same.

[Sleep stages after psychoemotional exposure: individuality-dependent changes]. / Stadii sna posle psikhoémotsional'nykh vozdeistvii: individual'nost' izmenenii.

Sleep stages were studied in healthy subjects with the aid of a battery of tests involving questionnaires, psycho-tests, motor tests, polysomnography, and cardiomonitoring. An induced psychoemotional tension was shown to change the 1st sleep stage, to decrease percentage of the 2nd stage of the slow-wave sleep, to redistribute the delta-sleep, and to suppress the REM sleep mechanism. The cerebro-visceral function of increasing the heart rate and its variability in night sleep was also affected. Patterns of the sleep structure changes depended on personality characteristics of the subjects. Thereupon, individual programs should be used in studies of psychoemotional stress effects upon the sleep pattern.

[Migraine: dynamics of psychophysiologic pattern]. / Migren': dinamika psikhofiziologicheskogo patterna.

85 patients with migraine without aura and 20 healthy individuals were examined between the attacks, before the attack, during and after it (1-2 days). The examination included clinical-neurological analysis; psychological Spilberger's and Beck's tests, scale of alexithymia and complex algesic questionnaire; recording of the conditional negative wave; determination of nociceptive flexor reflex; recording of trigeminal evoked potentials; spectral analysis of the heart's rhythms; polysomnographic study. Psychophysiologic pattern characteristic for all the patients was established. Psychological and neurophysiological parameters changed synchronously in the periods before the attack, during and after it. Before the migraineous attack a specific pathologic integration increased and presented maximally (the activity of antinociceptive system weakens anxiety increased, tension of catecholaminergic systems grew, hyperactivity in trigeninal sphere elevated, tolerance to the pain decreased). A clear tendency to the reversibility of these changes was observed after an attack. A dynamics revealed in the psychophysiological pattern could serve as a predictor of a migraineous attack and open some perspectives for prophylaxis of the algesic attack.