Use of the drug Semax 0,1% in the early rehabilitation period of ischemic stroke
T. J. Zayats, AA Potapov, VV Rudnev, IV Lobanova
"The Kremlin medicine. Clinical Gazette" є 2, 2001
48 patients with ischemic stroke, mild to moderate severity, which in the recovery period after stroke applied a new domestic preparation "Semax 0,1%. Semax relates to regulatory peptides, characteristic of these bioactive substances is a high efficiency and absence of negative consequences. In small doses, it is an endogenous regulator of the functions of the CNS, in large doses of 250-300 mg / kg has antihypoxia and neurotrophic effects. After a Kousa treatment all patients had positive dynamics according to neurological status, EEG, CT, as well as REG and UZDG. No side effects were noted.
The problem of treating patients with ischemic stroke remains one of the most pressing and difficult years in modern neuroscience. To work back no more than 20% of stroke patients, and 1 / 3 of cases stroke is composed of people of working age [W]. According to the World Health Organization, stroke is the leading cause of disability of the surviving patients. Currently around the world with disabilities due to stroke are approximately 30 million people. Disability is not only dramatically reduces the quality of life for the patients themselves, but also a heavy burden on their families and caregivers for them. For example, the Framingham study showed that after stroke, 31% of patients in need of outside help, 20% need for walking sticks and other devices that facilitate the movement, 71% of patients 7 years after stroke observed speech disorders.
Stroke patients require care in hospital (15%) or intensive home care (30%), and many (60%) have difficulties in social rehabilitation .
Modern methods of rehabilitation of these patients are characterized by limited efficacy and many patients need to end the life of their own. Necessary to search for new treatments and approaches to the rehabilitation of stroke patients, help to reduce disability, to make them self-service persons and the return to near-normal lifestyle. Moreover, that the stroke "younger" and often affects people of working age, which significantly increases the indirect costs of the state for treatment.
When creating new drugs, researchers are increasingly turning to the possible use of the internal, intrinsic regulators of the human body. These compounds include so-called regulatory peptides. At present peptides represent one of the most studied class of biologically active substances. A characteristic feature of the peptides are highly effective in small doses, quick onset of effect and no adverse effects .
As a result of long research and many experiments under the leadership of acad. IP Ashmarin scientists from the Institute of Molecular Genetics, Academy of Sciences and Moscow State University. MV Lomonosov Moscow State University as a drug has been developed "Semax 0,1%. "Semax 0,1% - the first domestic nootropics undiminishing type of a group of endogenous regulators of central nervous system functions - neuropeptide, is a synthetic analogue of a fragment of ACTH 4.10 an amino acid sequence Met-Glu-His-Phe-Pro-Gly-Pro. By 1990, "Semax 0.1%" was provided by the rules set of verification tests on the harmlessness and was allowed Farmkomitetom for research on human volunteers, and then for the first phase of clinical trials. In 1993, he was approved for widespread use as therapeutic and preventive nootropic drugs. Since the beginning of 1991 are held all over the expanding clinical effectiveness studies "Semax 0,1%" in pathological conditions associated with impaired cerebral blood flow and the various intellectual and mental disorders of the CNS, the Institute of Neurology, the Department of Psychiatry and Neurosurgery, Military Medical Academy and the Center autonomic pathology Sechenov. IM Sechenov .
In very small doses (3-30 mg / kg) is an endogenous regulator semax function of the CNS, has a strong neuroprotective effect, increases the adaptive capacity of the brain and in large doses (150-300 mg / kg) has angioprotektivnoe, antihypoxia and neurotrophic effects. Semax has directed neurotrophic and neyromoduliruyuschim actions to ensure its influence on the manifestation of focal stroke. When endonasal administration of drugs through 4 min penetrates the blood-brain barrier, its half-life in the body is a few minutes, and the therapeutic effect after a single dose - 20 to 24 hours.
Are the most effective daily dose of 12 mg in patients with moderate stroke and 18 mg - severe stroke at 5 and 10-day course of treatment (respectively to 6 and 9 mg 2 times a day in one drop of standard solution containing 0.05 mg active substance) [W]. In a rehabilitation treatment doses are 2,5-5 mg / day for 5-10 days, as a stimulant of mental health semax applied at a dose of 0.2 mg (0.2 ml) intranasally 1 per day.
We examined 48 patients who have a treatment applied semax early recovery period of moderate severity and lung ischemic stroke (27 women, of whom 14 were aged 40-60 years and 13 - over 60 years, 21 males, 8 of which were aged 40-60 years and 13 older than 60 years). Hemispheric strokes suffered 26 patients, the stem - 22. The control group comprised 20 people, who in the early recovery period of ischemic stroke was carried out as a unified complex therapy, including disease, antiplatelet drugs, exercise therapy, physiotherapy, acupuncture without the inclusion of neuroprotective drugs.
Patients with ischemic stroke on the background of the treatment was administered semax dose of 3 mg / day (5 drops in each nostril every 2 hours 6 times a day) for 10 days. Comparative analysis was carried out before and after treatment. All the patients were conducted comprehensive general somatic, clinical neurological examination, electroencephalography, rheoencephalography, ehoentsefaloskopiya, Supersonic soundings Doppler P-300, visit an ophthalmologist, a psychologist before and after application of Semax, CT of the brain (CT in the dynamics conducted in 39 patients), the patients whose recovery of neurological deficits occurred in full (9 persons), CT in the dynamics was undertaken.
All patients with ischemic stroke after the treatment noted positive dynamics of neurological status in the form of extinction and significant reduction of headaches, the vast majority of patients (36 patients) - to reduce mnemonic disorders, increased RAM, a regression of neurological deficit.
All patients with mild stroke (22 people) a stable regression focal symptoms passed much faster than in the control group, on average a factor of 2. Of these, 9 patients (all previously suffered hemispheric stroke) rehabilitation of motor disorders occurred in full.
Patients who previously had a stroke of moderate severity, also noted a positive impact Semax to restore lost functions. In 19 patients stated a good functional recovery (significant reduction in severity of hemiparesis with hemispheric stroke and decrease dizziness, regression of the bulbar syndrome in stem stroke), 7 patients had minimal improvement in the neurological and neuropsychological aspects.
According to the observed decrease in the severity of EEG changes in bioelectrical activity of the brain dysfunction of brainstem structures, reducing power slow-wave activity. Less than a clear positive trend can be traced according to REG, Echo ES and UZDG. According to the CT of the brain as a positive trend in reducing the source of ischemic stroke was observed in all patients with stroke in the carotid (in the control group, CT, performed in similar terms, revealed a positive trend only half of the patients) and 10 patients with stem stroke, without dynamics - in 12 patients (control group, positive dynamics was observed in one tenth of patients).
Thus, the inclusion Semax in complex therapy of early recovery period of ischemic stroke had a positive effect in 100% of patients with mild ischemic stroke (22 persons), 73% of patients with stroke of moderate severity (19 patients), minimal positive effect was noted in 27 % (7 people). And a good positive trend was observed in all patients after hemispheric stroke in 68% (15) of patients with ischemic stroke stem localization, and in 32% (7) are satisfied or equivocal result. None of the patients there were no adverse side effects or negative dynamics.
1. Ashmarin IP, Nezavibatko VN et al, Journal of Higher Nervous Activity. - 1997. - T. 47. - є 2. - S. 420-430.
2. Ashmarin IP. Kamensky AA, Shelekhov SL / / Reports of USSR Academy of Sciences. - 1978. - T. 240. - є 5. - 1245 sec.
3. Bulletin of practical neurology. - 1999. - є 5.
4. Gusev EI, Skvortsova VI, Myasoedov NF et al, Journal of Neurology and Psychiatry. - 1997. - є 6. - S. 26-34.
5. Gusev EI, Skvortsova VI Medical card patients. - M., 1990. - S. 1-44.
6. Gusev EI, Skvortsova VI, Nasonov VL and other cerebrovascular diseases. - Saint-Petersburg, 1998.
7. "Stroke. A Practical Guide for management of patients. " - Saint-Petersburg: Polytechnics, 1998.
8. "Vascular diseases of the nervous system / edited by Academician of AMS USSR EV Schmidt. - M.: Medicine, 1975.
9. Shmyrev VI, Biryulya EN / / Doctors. - 1999. - є 10 - P. 20-22.
10. Shmyrev VI, Mironov NV / / Clinical Journal. - 1999. - є 1.
11. Shmyrev VI, Mironov NV, Shestakova, AG et al Proceedings of the Conference of the UC MC RF President Administration. - M., 1998.
12. Allain H., Decombre R., Sajag V. et al. / / Stroke. - 1991. - Vol. 1, є 1. - S. 83-92.
13. Shemberg P. / / Neurology. - 1991. - Vol. 41. - P. 1867-1873.
14. H. Potaman VN, Alfeeva LY et al. / / Peptides. - 1993. - Vol. 14. - P. 491-495.