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21.09.2005:
   21.09.2005

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REPORT ON THE RESULTS OF THE USE OF THE AMINO ACID COMPOUND PROVIT IN THE TREATMENT OF PERINATAL ENCEPHALOPATHY IN CHILDREN.

(Short summary of 7 reports of specialized medical institutions)
1997

Provit has been used for 20 days at the Neonate Pathology Department of the Moscow N.F. Filatov Municipal Children's Hospital No. 13 (Head Neonatologist of the Moscow Public Health Committee: Asst. Prof. D.N. Degtyarev, Cand. Sc. /Med./), their gestation age being under 34 weeks, the birth weight being not less than 1,500 g; the evaluation by the Apgar score was 5 points in the first minute of life; artificial lung ventilation (ALV) was performed for no longer than 24 hours. The preparation was administered in a 2-cycle course of 10 days each with a 5-day interval. Somatic pathology was mostly represented by pneumonia, aspiration syndrome and hyperbilirubinemia. Neurologic manifestations were characterized by the syndrome of the functional activity depression of the central nervous system in combination with hypotonia, increased nervous and reflex excitability and convulsions. Similar criteria were used to select a reference group. By the end of the first obser

In the neonatology department of the Pediatrics Research Institute of the Academy of Medical Sciences of Russia (Prof. G.V. Yatsyk, M.D.; Prof. K.A. Semyonova, M.D.) the preparation Provit was administered to 20 infants. The course of treatment included 3 courses of 10 days each with a 5-day interval. Its effectiveness was evaluated by a daily recording of the neurologic status under neurosonographic control. The gestation of the basic and reference groups of infants ranged from 30 to 40 weeks, the birth weight being 1,230 g to 4,350 g. The observation period covered 8 months. The infants' age by the beginning of the first course of treatment varied between 6 days and 6 months and 17 days. According to the observation results, a more rapid positive dynamics of clinical symptoms was registered. Thus, the sucking reflex was restored 3 times as fast as that of the reference group; the support reaction was 2 times as fast; muscular tension disturbances were recorded more seldom at the clos

Provit was given to 20 newborn infants at the Maternity Home and the Municipal Hospital No. 1 in the town of Pyt-Jah (neuropathologist: V.V. Sergeyev). A significant improvement of the neurologic status was noted following the first week of treatment. Diminished tremor was observed in 62% of infants, normalized muscular tonicity was recorded in 64% of babies and regurgitation ceased in 75% of cases. A manifest positive dynamics in the test group was registered over a 3-month period. All the babies were vaccinated at the age of 3-4.5 months. One infant developed psychomotor retardation.

Twenty-two infants (or 8% of the total number of children who received rehabilitation care due to posthypoxic encephalopathy) received Provit at the rehabilitation unit of the Orenburg-based Children's Diagnosis-Rehabilitation Center under the Public Health Ministry of RF (Head of the Rehabilitation Psychoneurology Department: I.I. Tupikova). The patients were given 2 Provit treatment cycles of 10 days each with a 5-day interval between the cycles. Effectiveness was assessed by the data obtained during neurologic examination and cranial ultrasonography. Provit was taken in by babies aged 1-3 months with a various degree of prematurity. Fifty-seven percent of babies had a syndrome of increased nervous and reflex excitability; 38% had a syndrome of motor disorders; a hypertensive-hydrocephalic syndrome was found in 5%. Following two 10-day cycles, cystic changes and pseudocysts disappeared in 70% of infants; a decrease in echogenic phenomenon and in enlarged occipital horns was identifi

In the Newborn Pathology Department of the city of Vladivostok (M.A. Ilyina, I.N. Korolyov, M.N. Kalinkina), Provit was taken in by 23 babies (a reference group comprising 20 babies). The infants weight ranged from 900 to 3,750 g. Prior to treatment, the condition of all infants was assessed as grave. Following the completion of three 10-day cycles, reflexes of the newborn were fully recovered. A retarded formation of motor functions was recorded in the follow-up history of 3 babies aged 3 months (versus 9 babies in the reference group).

In the Functional Medicine Center "Manus" of the city of Vladivostok (Managing Director of "Manus Ltd.": T.N. Chernyshova), Provit was prescribed to 20 babies aged from 27 days to 6 months. Neurologic manifestations of the central nervous system pathology were in the form of disturbed tonus, high convulsive potential of the brain, hypertensive-hydrocephalic syndrome, retarded formation of motor functions. Following 2 months after commencement of treatment, normalization of the neurologic status of the babies that received Provit was recorded, whereas neurologic deficiency was found in an average of 28% of the reference group infants.

In the Regional Clinical-Diagnosis Center of the city of Ryazan (Prof. N.V. Dmitrieva, M.D.; RCDC Head Physician: I.R. Filimonova; neuropahtologist: E.I. Nesterova), 28 children received Provit (the reference group consisting of 20 infants). Six months later, during a follow-up examination, a positive effect was recorded in 89% of the babies that were given Provit and in 50% of the reference group infants who were administered standard treatment. During a check of 9-month old infants, normalization of neurologic symptoms was registered in 96.5% of cases, whereas a retarded formation of motor functions was recorded in 25% of the reference group children.

In the Children's Polyclinic No. 100 in the Central District of Moscow (Asst. Prof. S.S. Zhilina, Cand Sc. /Med./; Head Physician of the Polyclinic: A.Ya. Kral) 51 infant with perinatal encephalopathy were administered Provit, the observation time covering 1 year. A proven elimination of neurologic deficiency was recorded in the test group. Dynamic regression of neurologic symptomatology is presented in charts attached.

CONCLUSION

Thus, the introduction of the food additive Provit into the comprehensive therapeutic treatment of children with hypoxic-ischemic encephalopathy contributes to a more rapid elimination of neurologic deficiency, a more rapid recovery of the motor activity in mature and premature infants with central nervous system perinatal impairment and to a normalization of the muscular tonus. Recovery of infants' reactions to visual and auditory stimulation, normalization, duration of attention concentration and emotional background was recorded. Provit does not produce any shifts or side effects in other organs and systems.

The preparation is recommended for general use.


 
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