Method of treating secondary immunodeficiency in children in post-operative period in case of severe craniocerebral injury, combined with injuries of musculo-sckeletal system

FIELD: medicine.

SUBSTANCE: for treatment of traumatological and neurosurgical diseases ceruloplasmin is included in treatment scheme. Single daily introduced dose is 6-8 mg/kg, depending on child's age, per 200 ml of 0.9% of sodium chloride solution. Medication is introduced by intravenous drip at rate 20-25 drops a minute for not less than 12 days.

EFFECT: efficient treatment of secondary immunodeficiency with minimal side effects of ceruloplasmin treatment.

1 ex

 

The present invention relates to medicine, namely to Pediatrics, and can be used in the practice of the treatment of trauma and neurosurgical diseases in children for the treatment of secondary immunodeficiency.

Severe traumatic brain injury, combined with injuries of the musculoskeletal system, leads to the simultaneous loss of a significant volume of circulating blood in the body is disturbed transport of iron, activates the processes of lipid peroxidation, altered neuropeptide regulation of the immune response and, as a consequence, is formed immunosuppression (1; 2; 3). According to our observations in patients after 48 hours from the moment of injuries occur most expressed human immune protection.

Important in the regulation of the immune status is tissue and serum enzyme ceruloplasmin (CP), which is involved in oxidative reactions with antioxidant and immunomodulatory properties(4; 5; 6; 7; 8; 9).

Despite the fact that at the present time, we have accumulated rich clinical experience in the diagnosis and treatment of secondary immunodeficiency, are not well developed corrective actions for this condition. The clinicians have difficulties with supervision of children with severe traumatic brain and concomitant injuries, when encountered in the postoperative p is the period of secondary immune deficiency significantly affects the results of the treatment. Often immunodeficiency States are saved in children even after several months from the time of the injury, which requires additional monitoring of physicians outpatient network and is the cause of re-hospitalization and additional rehabilitation measures.

Currently, the most common method of correction of immunodeficiency, including children, is therapy of drugs on the basis of human immunoglobulins. The transfusion of human immunoglobulin does not always occur without attaching severe side effects. These include: vomiting, headache, chills and fever, changes in neurological status until aseptic meningitis (15).

For the prototype of the present invention, the selected correction method of secondary immunodeficiency in children, including the introduction of drugs, namely Pentaglobin (drug acting which is a human immunoglobulin) (15). The method consists in the fact that this drug was administered to 3-5 ml/kg of body weight intravenously for 10 hours over 3 days, but the high cost of Pentaglobin and technical complexity of its production (not done in Russia) do not allow at present widely to implement it in practical medicine, which led to the search for the new ways of treatment of secondary immunodeficiency in children in particular with severe traumatic brain injury, combined with injuries of the musculoskeletal system.

The task of the invention is given: the development of a method of treatment of secondary immunodeficiency in children with the use of drugs that are highly efficient correction of secondary immunodeficiency at low cost and at the same time characterized by technical simplicity of production.

This object is achieved in that in claim 1 of the claims as drugs used ceruloplasmin, which is administered in a daily dose of 6-8 mg/kg of body weight, depending on age and body weight of the child, in 200 ml of 0.9% solution of sodium chloride intravenous infusion at a rate of 20 drops per minute for 12 days.

Ceruloplasmin is a multifunctional glycoprotein α2-globulin fraction of blood serum, which belongs to the class of metallothionen blue oxidase (10). For the first time in its pure form this enzyme was obtained in 1948 Holmberg. It is established that a small amount of ceruloplasmin is synthesized in the brain tissue (11). In the absence of ceruloplasmin in the Central nervous system decreases the number of dopaminergic neurons, is the accumulation of iron, activating the processes of free radical peroxide Oka the population (12; 13). The authors emphasize that the antioxidant effect of drugs on the basis of ceruloplasmin may be used in the correction of various neurological and neurosurgical pathology.

The main functions of ceruloplasmin in the body is to transport copper, mobilization of serum iron for blood formation, antioxidant activity and inhibition of lipid peroxidation, involved in acute phase reactions, regulation of the level of biogenic amines in the brain. From 1961 initiated clinical application of ceruloplasmin in adults background mutilating surgeries for tumors in the treatment of traumatic and posthemorrhagic shock, radiation sickness, burns, septic pathology (14).

In the present invention first shown the principal possibility of application of ceruloplasmin in children for the treatment of secondary deficits induced severe damage. Previously ceruloplasmin in the treatment of neurosurgical diseases were not applied. A special study of the authors of this application showed the possibility of using this drug in the practice of the treatment of children of different ages from 7 to 18 liters in the postoperative period with severe traumatic brain injury, combined with injuries of the musculoskeletal system. Developed conditions (the eskers, circuit, method of administration), subject to which the application of ceruloplasmin in children causes no side effects at high clinical results of the correction of secondary immunodeficiency. In particular, the authors of this application for the first time found that, in practice, child with severe concomitant injuries are the most effective: 1) single daily dose of 6-8 mg/kg based on body weight and age of the child (in accordance with our clinical observations a dose of less than 6 mg/kg did not provide the necessary clinical effect, and higher than 8 mg/kg a dangerous allergic reactions in the form of increase of body temperature up to subfebrile figures); 2) intravenously at a rate of 20-25 drops per minute as, according to our clinical observations, the increase in the rate of infusion above 25 drops per minute resulted in 5 patients to cephalgia on the background of a sharp increase intracranial pressure (earlier in practice, treatment of ceruloplasmin in adults was used intravenous speeds 30-36 drops per minute, and in patent No. 2268745 from 27.01.2006 "Method of prevention and / or treatment of anemia in children (options)" we suggest the introduction of ceruloplasmin at 40 drops per minute); 3) the use of isotonic sodium chloride (in adult practice is used as isot the technical solution of sodium chloride, and 5% glucose solution), because the use of infusion of ceruloplasmin in children with the use of 5% glucose caused by our observations, the increase in body temperature to 38° (3 patients). The use of isotonic R-RA sodium chloride justified us patent No. 2268745 from 27.01.2006 "Method of prevention and / or treatment of anemia in children (options)".

Developed and substantiated scheme is the introduction of ceruloplasmin in children for the treatment of secondary immunodeficiency after severe head injury.

Thus it is shown that for the treatment of secondary immunosuppression ceruloplasmin children must be entered for at least 12 days after injury and surgery. This is justified as follows: we studied the different schemes under the control of the results of the analysis of indicators of cellular immunity in blood plasma and obtained the following results: introduction within 5-7 days after injury and (or) operation is not enough (the effect is worse than 12 days prior to surgery); introduction after surgery for more than 12 days did not give further rise effect, i.e. after the operation optimally 12 days of injections). The treatment is not less than 12 injections can provide optimal immune-stimulating effect.

The authors of the application as a result of clinical studies have established that on the 2nd day after injury patients formiruet the Xia pronounced immunosuppression, which later becomes the cause of many complications and significantly worsens the prognosis.

The proposed method is as follows:

1. For the treatment of children of secondary immunodeficiency in the postoperative period with severe traumatic brain injury, combined with injuries of the musculoskeletal system, take a vial liofilizirovannogo ceruloplasmin, containing 100 mg, throw the preparation of 5 ml of 0.9% sodium chloride solution until complete dissolution of the powder and a solution pale blue color. This solution is dissolved in 200 ml of 0.9% sodium chloride solution and injected intravenously at a rate of 20-25 drops per minute. Daily dose is calculated from 6-8 mg/kg depending on age and body weight of the child. The drug is administered for at least 12 days after the injury and surgery.

An example of a specific implementation of the method is given in the form of extracts from the history.

Statement of the case history No. 10386 for 2003

Patient PV, 12 HP, Diagnosis: Severe concomitant traumatic brain injury. Brain contusion 1 degree open comminuted fracture of both bones of the left forearm in the bottom third with displacement of bone fragments, usilenno-laceration of the lower third of the left forearm with the rupture of the tendons of the flexors and extensors of the wrist, usilenno-wanye wounds of both elbow joints, right parieto-occipital region.

The boy came after autotray 22.08.03 in serious condition, state of consciousness - deep stunned, disturbed severe pain due to a significant traumatic injuries, wounds were badly contaminated with gasoline and earth, it was noted bleeding.

When admission alone made the CBC-Hb 80 g/l, er 2,9 center of 0.82, a hematocrit of 21%. Among biochemical parameters - about. protein 74,2 g/l, albumin was 59.9%, α1-globulins of 4.4%, α2-globulins of 11.4% (above the norm), β-globulins 8,3, γ-globulins of 16.0%. 24.08.03 performed studies of cellular and humoral immunity: CD3 (total T cells) 32% (average 72±7), CD4 (T-helper) 27% (average 39±5), CD8 (T-suppressor) 15% (average 23±4), CD20 (b-lymphocytes) 13% (norm 11-16), HLA-DR (activated T cells) 11% (average 14±7), CD16 (natural killer cells) 10% (average 12±6), immunoregulatory index of 1.8 (rate of 1.05 and 2.1), IgG 23,5 g/l (normal 12,1±2,61), IgA 2,13 g/l (normal range of 1.46±0,38), IgM 1.5 g/l (normal 1,04±0,46). Thus, the patient noted a pronounced secondary cell immunodeficiency and increased levels of IgG, which is an adverse prognostic sign in terms of the formation of purulent-septic complications.

After surgical interventions on the reposition of bone fragments, and the rehabilitation of infected wounds, antibiotic therapy and in Usinas programs boy received infusions of ceruloplasmin liofilizirovannogo for injection at a dose of 8 mg/kg in 200 ml of 0.9% solution of sodium chloride daily for 12 days at a rate of 20 drops per minute.

By the 12th day of treatment the patient's condition improved significantly, disappeared headaches, muscle pain, appetite, purulent discharge from the wound was not observed secondary healing. In General, the analysis of blood HB 112 g/l, er 3,5, CTC 0,96. Cellular immunity total T cells (CD3) 74%, T-help./inductors (CD4) 44%, T-cytotox. cells (CD8) 31%, b-cells (CD20) 6%, (HLA-DR) Asset. CL 15%, (CD16) natures. killers 12%, immunore. index of 1.4 (all indicators of cellular immune defense within limits), IgG of 12.6 g/l, IgA 1.88 g/l, IgM 1.5 g/L.

Thus, the inclusion in the complex therapy of the drug, "Ceruloplasmin liofilizirovanny for injection" has greatly improved the treatment outcome of the patient.

In the clinic of pediatric surgery GOU VPO "Nigga" on the basis of the neurosurgical Department of the state institution "the CLINIC" the treatment of immunodeficiency in 15 patients with severe traumatic injuries in age from 7 to 18 years old (all boys). Among these, 2 were closed craniocerebral injury with brain injury 2nd degree and epidural hematoma, 2 - brain injury 2nd degree with a depressed fracture and compression of brain structures, 9 - brain contusion 1-3-th degree in combination with fractures of long tubular bones. 2 patients were treated over a compression-comminuted fractures of the spine dysfunction of pelvic organs. Patients received the intravenous infusion of the drug within 12 days from the time of admission to hospital and surgical scheme 1 proposed method.

Analysis of cellular immunity in children after 48 hours from the time of injury revealed signs of immunosuppression: the percentage of total T-lymphocytes (CD3) was reduced in 2 times, T-helper cells (CD4) - by 35.3%, b-lymphocytes (CD20) by 19%. Over the next 12 days in hospital patients received infusions of ceruloplasmin in the above mentioned doses. The laboratory analysis of blood for 10-12 days of treatment revealed significant differences in children treated with the introduction of ceruloplasmin and the control group (15 patients). When using ceruloplasmin percentage concentration of total T-lymphocytes (CD3) increased 1.7 times, and T-helper cells (CD4) - 28%. At the same time, the analysis immunograms children in the control group showed a further deepening of secondary immunodeficiency: a decrease in the total T-lymphocytes (CD3) 2.3 times, T-helper cells (CD4) 1.6 times, T-killer cells (CD8) in 1,4 times, b-lymphocytes (CD20) to 1.27 times. Clinically the patients of the main group were less pronounced manifestations of cerebral symptoms (nausea and vomiting), there was no purulent complications, quickly restored the function of the pelvic organs. On the contrary, in 3 children in the control group appeared purulent-septic complications (furunculosis, destructive pneumonia, abscess of the abdominal wall).

Thus, the use of ceruloplasmin in children according to the variant of the proposed method is allowed to obtain a high clinical results. When this reached delivered in the present invention task: ceruloplasmin is a tool that has a low cost (645 rubles), unlike Pentaglobin used in the method prototype (more than 10000 rubles), also unlike Pentaglobin ceruloplasmin is characterized by the technical ease of manufacturing. This result is achieved in that the raw material used alcoholic precipitate IY-1 in blood plasma, after receiving the homogenate conduct heat denaturation of protein impurities, conduct sorption homogenate using DEAE-Sephadex, washed sorbent from unbound proteins elute ceruloplasmin, precipitated impurities with chloroform, and ethanol precipitated the desired product ethyl alcohol, dissolve the target residue, conduct sterilizing filtration, pasteurization, filling and freeze drying of ceruloplasmin.

The introduction stage of pasteurization can improve virological safety of the drug.

Literature

1. Andreev, A.A., Kartavenko V.I. Golikov, P.P., Davydov BV, Nikolaev POSTGRADUATE Dynamics components of lipid peroxidation and antioxidant system in patients with severe concomitant injuries. // Questions of medical chemistry. - 1998. - T, No. 5. - C-494.

2. Kolesnikov I.S., Lytkin M.I., Pleshakov V.T. Autotransfused blood and its components in hir is rgii. - L.: Medicine, 1979. - 216 C.

3. Gordon M.S. Managing anemia in the cancer patient: old problems, future solutions. // The Oncologist. - 2002. - V.7. - P.331-341.

4. Katsunuma H. Clinical experience with ceruloplasmin on aplastic anemia. // Jap. J. Clin. Med. - 1961. - V 19. - P.424.

5. Arimori S. Treatment of aplastic anemia, with special reference to ceruloplasmin. // Jap. J. Clin. .. Med. - 1966. - V.43. - P.1897.

6. Here I.V., Black, VA, NICHOLAS Berlin, Sanin O.L., Baraboi, VA, staroselskoe IV, Korobko V.B. have been, Kamyanets L.Y., Yaremenko L.Y. Application of ceruloplasmin in combination with adjuvant chemotherapy in cancer of the stomach. // Medical business. - 1991. No. 3. - P.24-27.

7. Zakirova A.N., Zakirova A.D. the Influence of antioxidants on lipid peroxidation, blood rheology and for angina. // Health Bashkortostan. - 1999. No. 2. - P.67-70.

8. Vasiliev V.B. have been, Kachurin A.M., Rocco R.P., Beltramini M Spectral studies of the active site of ceruloplasmin deleting and restoring him of copper ions. // Biochemistry. - 1996. - T, No. 2. - S-307.

9. Seshadri V., P.L. Fox, C.K. Mukhopadhyay Dual role of insuline in transcriptional regulation of the acute phase reactant ceruloplasmin // J. Biol. Chem. - 2002. - V.277. - P.27903-27911.

10. Kalinin NM immunity Disorders with recurrent furunculosis. // The cytokines and inflammation. - 2003. - Vol.2, No. 1. - P.41-44.

11. B.N. Patel, David S. A novel glycosylphosphatidylinositol-dialog form of ceruloplasmin in expressed by mammalian astrocytes. // J. Biol. Chem. - 1997. - V.272. - P.20185-20190.

12. B.N. Patel, R.J. Dunn, Jeong S.Y., Zhu Q., Julien J.-P., David S. Ceruloplasmin regulates iron levels in the CNS and prevents free radical injury. //J. Neurosci. - 2002. - V.22. - P.6578-6586.

13. Ponka P. Hereditary causes of disturbed iron homeostasis in the central nervous system. // Ann. N. Y. Acad. Sci. - 2004. - V.1012. - P.267-281.

14. Adelia NV, Osipova N.A., Nemtsov ER, Sergeeva T. New opportunities for the prevention and correction of postoperative septic complications and multiple organ failure in Oncology. Anestesiol. and reanimate., 1997, No. 3, p.36-41.

15. Register of medicines of Russia radar encyclopedia of medicine. - 14th edition / CH. edit Glaskowsky. - M.: radar-2006, 2005. - s-625.

Treatment of secondary immunodeficiency in children with severe traumatic brain injury, combined with injuries of the musculoskeletal system, which includes the introduction of medications, characterized in that as the medications used ceruloplasmin, which is administered in a daily dose of 6-8 mg/kg of body weight, depending on the age of the child, in 200 ml of 0.9%sodium chloride intravenous infusion at a rate of 20-25 drops per minute for at least 12 days.



 

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