Description
Reaferon-EC is the first domestic interferon drug - recombinant interferon alpha-2.
Absolutely identical to human leukocyte interferon. Reaferon-EC has pronounced antiviral and immunomodulatory activity. Therefore, Reaferon-EC finds its main application in the treatment of dangerous infectious diseases, one of them is hepatitis. Reaferon-EC is especially effective and often has no alternatives in complex therapy, as well as in monotherapy for acute and chronic hepatitis of various etiologies, because the basis of most treatment regimens for viral hepatitis is interferon.
As a result of studies, it was revealed that in 45% of patients with hepatitis B who received treatment with recombinant interferon alpha-2, the hepatitis B virus was not detected at the end of treatment.
Treatment of hepatitis usually takes 6-12 months.
Clinical effectiveness of the drug Reaferon-ES-Lipint in the treatment of influenza and ARVI
As an advertisement
Influenza and other acute respiratory diseases remain the most widespread infections. Influenza viruses affect various organs and systems and cause severe hypertoxic forms in 5% of patients. Mortality among hospitalized patients is 0.5–2.5%. Pneumonia, complicating influenza and ARVI, is reported in 2–17% of all patients with influenza and in 15–46% of hospitalized patients [5].
Violations of various parts of the immune system and nonspecific resistance contribute to the severe course of influenza [4, 5]. Great importance in the pathogenesis of influenza and acute respiratory viral diseases (ARVI) is attached to the development of a state of interferon deficiency [4]. Interferons (IFN-α/β and γ) are cytokines that regulate cell differentiation, growth and reproduction, therefore they are among the most important homeostatic agents and factors of nonspecific resistance of the body. The antiviral effect is expressed in IFN-α/β, and the immunoregulatory and antiproliferative effects are characteristic of IFN-γ [4].
The antiviral effect of interferon α-2b manifests itself during the period of virus reproduction through active inclusion in the metabolic processes of cells. Interferon, interacting with specific receptors on the surface of cells, initiates a number of intracellular changes, including the synthesis of specific cytokines and enzymes (2-5-adenylate synthetases and protein kinases), the action of which inhibits the formation of viral protein and viral ribonucleic acid in the cell.
The immunomodulatory effect of interferon α-2b is manifested in an increase in the phagocytic activity of macrophages, an increase in the specific cytotoxic effect of lymphocytes on target cells, a change in the quantitative and qualitative composition of secreted cytokines, a change in the functional activity of immunocompetent cells, a change in the production and secretion of intracellular proteins.
The purpose of this work was to evaluate the clinical effectiveness of Reaferon-ES-Lipint in the treatment of patients with influenza and ARVI.
Reaferon-EC-Lipint is a domestic preparation of recombinant human interferon α-2b in liposomal form. The drug has antiviral and immunomodulatory activity. Liposomes, unlike polymer drug delivery systems, are completely biodegradable and biocompatible, protect protein from the acidic contents of the stomach, ensure complete and rapid absorption through the intestine and long-term circulation of IFN in the blood with further induction of endogenous IFN. The drug Reaferon-ES-Lipint is easy to dose, available for use, and safe [1, 3].
Materials and research methods
Under observation were 45 patients of both sexes, aged 18–50 years, with symptoms of influenza and ARVI. In addition to the general clinical examination, immunofluorescence examination of smears of secretion from the lower nasal passages, serological and x-ray examination of patients were carried out. The results obtained were statistically processed.
Patients of the main group (n = 30) in addition to basic therapy received 500 thousand IU of the drug Reaferon-EC-Lipint orally twice a day for 3 days. Patients in the control group (n = 15) received only basic therapy drugs (Antigrippin, multivitamins, expectorants). The effectiveness of Reaferon-ES-Lipint was taken into account according to the following criteria: duration and intensity of the temperature reaction, duration of infectious intoxication (headache and muscle pain, malaise, weakness, loss of appetite), dynamics of the development of catarrhal symptoms (cough, runny nose, sore throat), frequency of complications .
Results and discussion
A comprehensive laboratory examination showed that in 35 patients the disease was caused by influenza A (H3N2) and A (H1N1) viruses, in 10 cases of acute respiratory viral infection of various etiologies.
A clinical marker of the severity of infection is the severity of febrile reactions. With uncomplicated influenza among those taking Reaferon-EC-Lipint, 70% of patients had a body temperature that did not exceed 38.5 °C, which indicates a mild course of the disease, and only 10 people (30%) had a moderate course of influenza with a body temperature above 38. 6 °C. In the control group, against the background of basic therapy, 51.5% of patients had a fever above 38.6–39.0 °C, thus, in more than half of the patients in the control group the disease was moderate. The duration of fever in 81.8% of patients in the main group who received Reaferon-ES-Lipint did not exceed 2–3 days; with basic therapy, in 54.5% of patients the fever lasted 4–5 days. The inclusion of the drug Reaferon-EC-Lipint in the basic therapy regimen made it possible to reduce the severity and duration of the febrile period.
While taking Reaferon-ES-Lipint, symptoms of infectious intoxication in the form of headache, malaise, and weakness were relieved on average 1.2 days faster than in the control group (p < 0.05).
At the time of inclusion in the study, mucous, mucopurulent nasal discharge was recorded in 100% of patients in the main and control groups. This symptom resolved in a shorter period of time (0.5 days less) in patients of the main group than in the control group; the differences were not significant (p > 0.05). The cough symptom was recorded in the main group for 4.2 ± 0.25 days, which was significantly shorter by 1.5 days than in the comparison group - 5.7 ± 0.2 (p < 0.05). The symptom complex of tracheobronchitis (cough, voice changes, hard breathing, wheezing) was recorded in 5 patients of the main group and 4 control groups. The average duration of symptoms was 1 day shorter in patients of the main group (3.5 ± 0.25 days) than in the control group (4.5 ± 0.3 days) (p < 0.05).
Thus, while taking Reaferon-ES-Lipint, patients experienced catarrhal symptoms faster (on average 3.5–4.2 days); in the control group, these symptoms manifested themselves longer (4.5–5.7 days, p < 0 .05).
The overall average duration of one case of uncomplicated influenza when taking the drug Reaferon-ES-Lipinta was 1 day shorter (p < 0.05).
During the period of active observation, the development of complications was recorded in 13.3% of the main group and 33.3% of the control group (nosebleeds in 6 patients, pneumonia in 3 patients). The incidence of complicated influenza and acute respiratory viral infections was 2.5 times lower compared to the group of patients who received only basic therapy (p < 0.001).
Thus, the use of the drug Reaferon-EC-Lipint in patients with moderate forms of influenza and other acute respiratory viral infections led to a statistically significant decrease in the duration of objective signs of the syndrome of general infectious intoxication, productive cough and a decrease in the incidence of complications. The drug was well tolerated, the organoleptic qualities of the drug were satisfactory, and no adverse drug reactions were recorded.
The high clinical efficacy and safety of the drug Reaferon-ES-Lipint as part of complex therapy for influenza and other acute respiratory viral infections has been shown by other researchers [6]. The drug was successfully used for emergency prevention of influenza and other acute respiratory viral infections in children and adults during influenza epidemics or seasonal increases in morbidity [2, 3]. Our studies allow us to recommend the drug Reaferon-ES-Lipint for the treatment of acute respiratory infections.
conclusions
The inclusion of the drug Reaferon-ES-Lipint in the basic treatment regimen for influenza and ARVI improves the clinical effectiveness of treatment.
Literature
- Bazhutin N. B., Zolin V. V., Kolokoltsov A. A., Targonsky S. N. Prospects for the use of liposomal drugs in medical practice // Terra medica. 2003. No. 3 (31). pp. 3–6.
- Erofeeva M.K., Maksakova V.L., Kolyvanova I.L. et al. Reaferon-ES-Lipint as a means of emergency prevention of influenza-like viral diseases // Cytokines and inflammation. 2004. T. 2. No. 4. P. 44–47.
- Erofeeva M.K., Maksakova V.L., Pozdnyakova M.G., Kolyvanova I.L. Possibility of using liposomal alpha-2b interferon for the prevention of influenza and other acute respiratory viral infections // Issues of modern pediatrics. 2007. T. 6. No. 1. P. 42–46.
- Ershov F. I., Kiselev O. I. Interferons and their inducers (from molecules to drugs). M., 2005. 368 p.
- Isakov V. A. Clinical and pathogenetic aspects of severe influenza // Allergol. and immunol.//2002. Vol. 3, No. 1, pp. 136–144.
- Lobzin Yu. V., Lvov N. I., Kolokoltsov A. A. Clinical effectiveness of the drug “Reaferon-ES-Lipint liposomal” in the complex therapy of patients with influenza and other acute respiratory diseases when administered orally/Reaferon-ES-Lipint. Collection of articles and theses. Koltsovo, 2003. pp. 3–11.
V. A. Isakov*, Doctor of Medical Sciences, Professor V. Ya. Sergeeva* T. E. Efimova* I. V. Kabolova* S. N. Targonsky** O. N. Mukhina** M. G. Sharypova* *, 1
* Medical LLC, Veliky Novgorod ** Vector-Medica CJSC, Novosibirsk
1 Contact information
Pharmacological action
Antiviral, immunomodulatory, antitumor, antiproliferative agent.
Prevents viral infection of cells, changes the properties of the cell membrane, prevents adhesion and penetration of the virus into the cell. Initiates the synthesis of a number of specific enzymes, disrupts the synthesis of viral RNA and viral proteins in the cell. Changes the cytoskeleton of the cell membrane, metabolism, preventing the proliferation of tumor (especially) cells. It has a modulating effect on the synthesis of some oncogenes, leading to normalization of neoplastic cell transformation and inhibition of tumor growth. Stimulates the process of antigen presentation to immunocompetent cells, modulates the activity of killer cells involved in antiviral immunity. When administered intramuscularly, the rate of absorption from the injection site is uneven. The time to reach maximum concentration in plasma is 4-8 hours. 70% of the administered dose is distributed in the systemic circulation. Half-life is 4-12 hours. It is excreted mainly by the kidneys by glomerular filtration.
Reaferon EC-LIPINT lyophilisate for children, bottles 250 thousand IU No. 5
A country
Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Interferon alpha-2
Compound
Recombinant human interferon alpha.
pharmachologic effect
Pharmacological action - antiviral, immunomodulatory, antitumor, antiproliferative. Prevents viral infection of cells, changes the properties of the cell membrane, prevents adhesion and penetration of the virus into the cell. Initiates the synthesis of a number of specific enzymes, disrupts the synthesis of viral RNA and viral proteins in the cell. Changes the cytoskeleton of the cell membrane, metabolism, preventing the proliferation of tumor (especially) cells. It has a modulating effect on the synthesis of some oncogenes, leading to normalization of neoplastic cell transformation and inhibition of tumor growth. Stimulates the process of antigen presentation to immunocompetent cells, modulates the activity of killer cells involved in antiviral immunity. When administered intramuscularly, the rate of absorption from the injection site is uneven. The time to reach maximum concentration in plasma is 4-8 hours. 70% of the administered dose is distributed in the systemic circulation. Half-life is 4-12 hours. It is excreted mainly by the kidneys by glomerular filtration.
Indications for use
Hairy cell leukemia, chronic myeloid leukemia, viral hepatitis B, active viral hepatitis C, primary (essential) and secondary thrombocytosis, transitional form of chronic granulocytic leukemia and myelofibrosis, multiple myeloma, kidney cancer; AIDS-related Kaposi's sarcoma, mycosis fungoides, reticulosarcoma, multiple sclerosis, prevention and treatment of influenza and acute respiratory viral infection.
Interaction
Disturbs the metabolism of cimetidine, phenytoin, warfarin, theophylline, diazepam, propranolol.
Side effect
Lethargy, fever, chills, loss of appetite, muscle pain, headache, joint pain, sweating, nausea, vomiting, changes in taste, dry mouth, weight loss, diarrhea, abdominal pain, constipation, flatulence, increased peristalsis, heartburn, liver dysfunction, hepatitis, dizziness, visual disturbances, ischemic retinopathy, depression, drowsiness, impaired consciousness, nervousness, sleep disturbance, allergic skin reactions (rash, itching).
Contraindications
Hypersensitivity, severe heart disease (including a history), acute myocardial infarction, severe dysfunction of the liver, kidneys or hematopoietic system, epilepsy and/or other disorders of the central nervous system; chronic hepatitis against the background of decompensated cirrhosis of the liver; chronic hepatitis in patients receiving or recently receiving immunosuppressant therapy (with the exception of short-term pre-treatment with steroids). Restrictions on use: Pregnancy, breastfeeding (breastfeeding should be stopped), childhood.
Overdose
No information available.
special instructions
Combinations with drugs acting on the central nervous system and immunosuppressants should be avoided. Throughout the course, it is necessary to monitor the content of blood cells and liver function. To mitigate side effects (flu-like symptoms), simultaneous administration of paracetamol is recommended.
Dispensing conditions in pharmacies
On prescription
Indications for use
- Hairy cell leukemia,
- chronic myeloid leukemia,
- viral hepatitis B,
- viral active hepatitis C,
- primary (essential) and secondary thrombocytosis,
- transitional form of chronic granulocytic leukemia and myelofibrosis,
- multiple myeloma,
- kidney cancer;
- AIDS-related Kaposi's sarcoma,
- mycosis fungoides,
- reticulosarcoma,
- multiple sclerosis,
- prevention and treatment of influenza and acute respiratory viral infection.
Contraindications for use
- Hypersensitivity,
- severe heart disease (including a history), acute myocardial infarction
- severe dysfunction of the liver, kidneys or hematopoietic system,
- epilepsy and/or other disorders of the central nervous system;
- chronic hepatitis against the background of decompensated cirrhosis of the liver;
- chronic hepatitis in patients receiving or recently receiving immunosuppressant therapy (with the exception of short-term pre-treatment with steroids).
Restrictions on use: Pregnancy, breastfeeding (breastfeeding should be stopped), childhood.
Directions for use and doses
Intramuscularly, subcutaneously.
Hairy cell leukemia - initial dose of 3 million IU per day for 16-24 weeks, maintenance treatment - 3 million IU 3 times a week.
Cutaneous T-cell lymphoma - days 1-3 - 3 million IU per day, days 4-6 - 9 million IU per day, days 7-84 - 18 million IU per day; maintenance treatment - maximum tolerated dose (no more than 18 million IU) 3 times a week.
Kaposi's sarcoma against the background of AIDS - initial dose of 3 million IU per day in the first 3 days, 4-6 days - 9 million IU per day, 7-9 days - 18 million IU per day, if tolerated, the dose is increased to 36 million IU within 10-84 days; maintenance treatment - the maximum tolerated dose (but not more than 36 million IU) 3 times a week.
Renal cell cancer - 36 million IU per day with monotherapy or 18 million IU 3 times a week in combination with vinblastine. The dose is increased gradually according to the scheme, starting with 3 million IU over 84 days.
Melanoma - 18 million IU 3 times a week for 8-12 weeks. Chronic myeloid leukemia and thrombocytosis in chronic myeloid leukemia - days 1-3 - 3 million IU per day, days 4-6 - 6 million IU per day, days 7-84 - 9 million IU per day, course - 8-12 weeks.
Thrombocytosis in myeloproliferative diseases, except for chronic myeloid leukemia - days 1-3 - 3 million IU per day, days 4-30 - 6 million IU per day.
Chronic active hepatitis B - 4.5 million IU 3 times a week for 6 months.
Chronic hepatitis C - initial dose of 6 million IU 3 times a week for 3 months; maintenance dose - 3 million IU 3 times a week for another 3 months.
For primary and secondary thrombocytosis, 2 million IU per day is prescribed at the beginning of treatment, 5 days a week for 4-5 weeks. If the platelet count does not decrease after 2 weeks, the dose is increased to 3 million IU per day; if there is no effect by the end of the third week, the dose is increased to 6 million IU per day.
For initial thrombocytopenia (less than 15 G/l), the initial dose is 0.5 million IU.
During the transition phase of chronic granulocytic leukemia and myelofibrosis, 1-3 million IU per day is prescribed according to the regimen; for multiple myeloma, 1 million IU every other day in combination with cytostatics and corticosteroids for at least 2 months.
Reaferon-ES-Lipint
Reaferon-ES-Lipint (active component - interferon-alpha-2b) is a domestic immunobiological drug with antiviral and immunomodulatory effects. It is a freeze-dried human recombinant interferon alpha-2b, enclosed in liposomes. This is a highly purified sterile protein, “composed” of 165 amino acids and has universal activity. The antiviral effect of Reaferon-EC-lipint is based on its ability to influence the synthesis of DNA, RNA and proteins, the immunomodulatory effect is based on an interferon-induced increase in the activity of macrophages and an increase in the selective effect of cytotoxic T-lymphocytes on target cells. These properties of the drug predetermine the possibility of its use in the treatment of viral diseases, including acute respiratory viral infections. Reaferon-ES-lipint is available in the form of a lyophilisate for the preparation of a suspension for oral administration. The suspension is prepared immediately before use: to do this, the contents of the bottle are dissolved in a few milliliters of distilled or boiled water at room temperature. Vigorous shaking for 2-3 minutes results in a homogeneous, ready-to-use suspension. In the acute form of hepatitis B, Reaferon-EC-lipint is taken half an hour before meals, 1 million IU 2 times a day for 10 days (adults and children over 7 years old), 500 thousand IU 1 time a day for 10 days (children from 3 to 7 years old). Depending on the results of control biochemical blood tests, the duration of the drug course can be increased until complete clinical recovery. For the chronic form of hepatitis B, the drug is taken 1 million IU 2 times a day for 10 days, and then 1 time a day for 1 month (adults and children over 7 years old), 500 thousand IU 2 times a day for 10 days, and then - 1 time per day for 1 month (children from 3 to 7 years). As part of specific immunotherapy, Reaferon-EC-lipint is taken in the morning half an hour after breakfast: for allergic rhinoconjunctivitis - 500 thousand.
ME once a day for 10 days at the rate of 5 million ME per course of treatment; for atopic bronchial asthma - 500 thousand IU 1 time per day for the first 10 days, and then every other day for 20 days. The total duration of the medication course is 30 days. To prevent influenza and ARVI, the drug is taken half an hour before meals, 500 thousand IU twice a week for 30 days during epidemic troubles (adults and children under 15 years of age); 250 thousand ME twice a week for 30 days during epidemic troubles (children from 3 to 15 years). When treating influenza and ARVI, 500 thousand IU 2 times a day for 3 days (adults and children over 15 years old), 250 thousand IU 2 times a day for 3 days (children from 3 to 15 years old). For complex treatment of genitourinary tract infections, adults take 500 thousand ME twice a day for 10 days. When using Reaferon-ES-lipint in the doses recommended in the instructions, the drug practically does not cause unwanted side effects. However, it must be taken into account that recombinant interferon in some cases (for example, in individuals with individual intolerance) can provoke flu-like symptoms. It is necessary to avoid co-administration of Reaferon-EC-lipint with drugs that suppress the central nervous system, as well as immunosuppressants (including systemic glucocorticosteroids). During treatment you should refrain from drinking alcohol. The drug can inhibit the activity of isoenzymes of the cytochrome P450 system, thus affecting the metabolism of warfarin, diazepam, dipyridamole, propranolol, theophylline, phenytoin, cimetidine and some cytostatics.
In conclusion, it would be appropriate to present the results of a study on the effectiveness of Reaferon-EC-lipint in the treatment of urogenital chlamydia in women, conducted at the Siberian State Medical University. In patients taking the drug, a more than twofold increase in antibody titer was noted, which indicates the high effectiveness of immunomodulatory therapy.
