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Groprinosin

Groprinosin (inosine pranobex) is an immunostimulant with a direct antiviral effect, due to the ability of the active component of the drug to interact with the ribosomes of infected cells, and indirectly, associated with an increase in the synthesis of the endogenous immune protein interferon. Thanks to such a multifaceted mechanism of action, Groprinosin helps the body effectively fight viral infections. It is able to stimulate the formation of NK cells - the so-called. natural killer cells that immediately begin to fight viruses. Its therapeutic range covers influenza viruses, parainfluenza viruses, respiratory syncytial virus, adenoviruses, etc. The use of Groprinosin at the initial stage of the disease (optimally in the first hours) can stop the further progression of the viral infection. If the infection has already developed, then the drug can significantly alleviate its clinical manifestations and hasten the moment of recovery, making the prognosis more favorable. A wide range of antiviral activity and a powerful immunostimulating effect minimize the risk of relapse, reducing the chances of catching an acute respiratory infection during a period of epidemic trouble. At the same time, the drug not only treats, but also prevents infection, making the body more resistant to the penetration of viral agents. Groprinosin is effective not only against viruses that cause acute respiratory infections: it is also used for herpesvirus infections, which is especially important in the autumn-winter period, when, having only gotten rid of one infection, we are forced to start fighting herpes on the lips. The use of Groprinosin as part of the combined treatment of herpes infection speeds up the healing of surfaces affected by the virus, reduces the likelihood of the formation of new blisters and erosive manifestations, and minimizes the risk of relapse.

With timely initiation of treatment, the period of the active phase of the disease is shortened and the severity of its course is reduced. The active component of the drug is quickly and completely absorbed in the digestive tract, which ensures its high bioavailability. Inosine and its metabolic products are excreted from the body through urine. The half-life of the drug is 50 minutes. The optimal time to take it is after a meal. The frequency of administration is 3-4 times a day. Elderly patients take the drug on a general basis: no dose adjustment is required. Groprinosin can be used in pediatric practice after the patient reaches three years of age. The effectiveness of the drug in acute infection is much higher if treatment is started immediately after the first signs of the disease appear. Extraction of the active component of Groprinosin from the body occurs in the form of uric acid, therefore, with prolonged use of the drug, it is recommended to monitor the level of uric acid in the blood and urine at certain intervals (the same applies to cases of simultaneous administration of drugs that increase the concentration of uric acid with Groprinosin). Given the active metabolism of the drug in the liver, it is necessary to exercise special caution when using it in people suffering from liver pathologies. During a medication course using Groprinosin, the patient may experience drowsiness and slight dizziness. When used together with immunosuppressants, the immunostimulating effect may be suppressed.

Indications for use

— Influenza and acute respiratory viral infections.

— Infections caused by herpes simplex virus types 1, 2, 3 and 4: genital and labial herpes, herpetic keratitis, herpes zoster, chicken pox, infectious mononucleosis caused by the Epstein-Barr virus.

— Cytomegalovirus infection.

- Severe measles.

— Human papillomavirus infection: papillomas of the larynx and vocal cords (fibrous type), genital human papillomavirus infections in men and women, warts.

— Subacute sclerosing panencephalitis.

— Molluscum contagiosum.

special instructions

Inosine pranobex, like other antiviral agents, is most effective for acute viral infections if treatment is started at an early stage of the disease (the first day). After 2 weeks of using inosine pranobex, the concentration of uric acid in the blood serum and urine should be monitored. Also, with long-term use, it is recommended to periodically monitor the concentration of uric acid in the blood serum and urine.

Patients with significantly increased concentrations of uric acid in the body can simultaneously take medications that lower their concentrations. It is necessary to monitor the concentration of uric acid in the blood serum when prescribing the drug simultaneously with drugs that increase the concentration of uric acid or drugs that impair renal function.

With long-term use (after four weeks of use), it is advisable to monitor liver and kidney function every month (transaminase activity, creatinine level, uric acid in blood serum). Inosine pranobex should be used with caution in patients with acute liver failure, since the drug is metabolized in the liver.

Impact on the ability to drive vehicles and machinery

The effect of inosine pranobex on psychomotor functions of the body and the ability to drive vehicles and moving mechanisms has not been studied. When using the drug, the possibility of dizziness and drowsiness should be taken into account.

Contraindications

— Hypersensitivity to inosine pranobex and other components of the drug.

- Gout.

- Urolithiasis disease.

- Arrhythmias.

— Chronic renal failure.

— Children under 3 years of age (body weight up to 15-20 kg).

— Pregnancy and breastfeeding period.

— Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

Carefully

Caution should be exercised when administered simultaneously with xanthine oxidase inhibitors, diuretics, zidovudine, and in acute liver failure.

Use during pregnancy and breastfeeding

The use of the drug Groprinosin-Richter during pregnancy and breastfeeding is contraindicated, since the safety of use has not been established.

Groprinosin®-Richter (Groprinosin-Richter)

Mode of application

Inside after meals. For correct dosing, a measuring syringe is included for taking the drug orally.

Doses

The dose of the drug depends on the patient’s body weight and disease. The daily dose is divided into several parts (3-4), which should be taken at regular intervals throughout the day. The duration of treatment is usually 5-14 days. The drug should be continued for 1-2 days after the symptoms disappear.

The recommended daily dose for adults and elderly patients, as well as children 3 years of age and older (body weight more than 15-20 kg) is 50 mg/kg body weight in 3-4 doses. 1 ml of Groprinosin®-Richter contains 50 mg of inosine pranobex.

For the treatment of severe infections, the dose can be individually increased to 100 mg/kg body weight 4-6 times a day. The maximum daily dose for adults is 3-4 g/day (60-80 ml/day).

For children over 3 years of age, the drug is prescribed in accordance with the table:

Body mass	Single dose when taken 3 times a day	Maximum daily dose
15-20 kg	5-6.5 ml	15-20 ml/day
21-30 kg	7-10 ml	21-30 ml/day
31-10 kg	10-13 ml	31-10 ml/day
41-50 kg	13.5-16.5 ml	41-50 ml/day

The maximum daily dose for children aged 3 years and older is 50 mg/kg/day.

Duration of treatment

Acute infections

: Duration of treatment in adults and children is usually from 5 to 14 days. Treatment should be continued until the clinical symptoms disappear and for another 1-2 days after the symptoms disappear. If necessary, the duration of treatment can be increased individually under the supervision of a physician.

Chronic recurrent infections:

in adults and children, treatment must be continued in several courses of 5-10 days with an interval of 8 days. During maintenance therapy, the dose can be reduced to 500-1000 mg per day (10-20 ml/day) for 30 days.

Herpetic infections

: treatment continues for 5-10 days until the symptoms of the disease disappear. To reduce the number of relapses during the asymptomatic period, the drug is prescribed 500 mg 2 times a day (20 ml/day) for 30 days.

Human papillomavirus infections:

as monotherapy, the drug is prescribed for 14-28 days for adults at a dose of 1000 mg 3 times a day (60 ml/day), for children - 250 mg per 5 kg of body weight (1 ml/kg/day) 3-4 times a day .

Recurrent genital warts:

as monotherapy or in combination with surgical treatment, the drug is prescribed for adults at a dose of 1000 mg 3 times a day (60 ml/day), for children - at a dose of 250 mg per 5 kg of body weight (1 ml/kg/day) in 3-4 reception. 3 courses are carried out for 14-28 days with an interval of 1 month.

Cervical dysplasia associated with human papillomavirus:

2-3 courses of 1000 mg 3 times a day (60 ml/day) for 10 days with an interval of 10-14 days.

Special patient groups

Use in elderly patients:

There is no need for dose adjustment; the drug is used in the same way as in middle-aged patients. It should be taken into account that in elderly patients, increases in the concentration of uric acid in the blood serum and urine are more common than in middle-aged patients.

Patients with renal and liver failure

: During treatment with Groprinosin®-Richter, uric acid levels in the blood serum and urine should be monitored every 2 weeks. Monitoring the activity of liver enzymes is recommended every 4 weeks during long courses of treatment with the drug.

The incidence of cervical cancer (CC) in Russia continues to remain one of the first places and has increased over the past ten years from 15.1 to 17.3 per 100,000 population [6]. The age peak of incidence falls at the age of 45-55 years, although there is a rapid increase in the incidence of cervical cancer among women under 30 years of age. Studies by domestic and foreign authors [1, 4, 9] indicate the importance of the human papillomavirus in the development of cancer and dysplastic processes in the cervix.

The main feature of human papillomavirus infection (HPV infection) is considered to be its wide distribution among adolescents and young women, mainly under 25 years of age [2]. Low sexual culture of the population, frequent changes of sexual partners, non-use of condoms, bad habits (smoking, substance abuse, alcoholism) increase the risk of developing HPV infection, which contributes to an increase in the number of inflammatory diseases of the genital tract, reproductive dysfunction, miscarriage and intrauterine infection of the fetus, and also the formation of cervical intraepithelial neoplasia of the cervix. At the same time, it has been noted that adolescents and young women experience faster spontaneous clearance (elimination) of HPV and regression of existing HPV-associated pathology compared to women of a later age. According to the observations of S.I. Rogovskaya and V.N. Prilepskaya [5], at the age of 18-25 years this period increases to 1.5-2 years in every second patient. Most researchers note a significant diversity of types of papillomaviruses. The most commonly detected virus is type 16, followed by type 18. These viruses account for about 50% of the total number of HPV infections. The human papillomavirus can have a productive (with the formation of condylomas and papillomas) and non-productive effects on the epithelium. The result of non-productive action is intraepithelial lesions such as cervical intraepithelial neoplasia and cancer [2, 8].

The most vulnerable area for the effects of the virus is the transformation zone - the area where columnar epithelium is replaced by flat epithelium. Perhaps the tropism of HPV to cells undergoing metaplasia is associated with their increased sensitivity to viral infection [7, 8], therefore the presence of complicated ectopia and other diseases against the background of a viral infection is an aggravating circumstance for the development of cervical cancer.

The variety of types of viruses, the ability to cause both productive and non-productive effects on the epithelium, the formation of various pathological processes on the cervix and external genitalia, the combination of viruses with other infectious agents require a differentiated approach to conservative treatment and selective assessment of the need for invasive techniques.

The effectiveness of therapy largely depends on the choice of treatment method, the use of immunocorrective therapy and the advisability of combined treatment using destructive effects on the cervix. Most researchers emphasize the failure of local destruction methods, note frequent relapses of HPV infection against the background of immunodeficiency, and justify the feasibility of immunotherapy [1, 5].

V.N. Prilepskaya and S.I. Rogovskaya [2, 3, 5] propose combined destructive treatment of papillomavirus lesions of the cervix while taking immunotherapy drugs that reduce the activity of the virus and increase immunity. Reasonable immunocorrection increases the effectiveness of therapy and reduces the likelihood of relapse.

The most widely used are interferons and their inducers, immunomodulators. These drugs stimulate nonspecific immunity, enhance the production of interleukins, increasing the synthesis of antibodies, and stimulate the chemotactic and phagocytic activity of monocytes, macrophages and polymorphonuclear cells.

Currently, there is a large selection of drugs - immune activators. The antiviral drug Groprinosin (manufactured by Gedeon Richter, Hungary) contains an active substance - inosine pranobex, which suppresses the replication of DNA and RNA viruses by binding to the cell ribosome and changing its stereochemical structure. In addition to the antiviral effect, the drug also has immunomodulatory properties due to the inosine complex, which increases its availability to lymphocytes; stimulates biochemical processes in macrophages, increases the production of interleukins, increases the synthesis of antibodies, enhances the proliferation of T-lymphocytes, including T-helpers, natural killer cells.

The purpose of this study is to study the effectiveness of monotherapy and combination treatment (the etiotropic drug groprinosin and radio wave destruction) in patients with cervical pathology due to HPV infection.

Material and methods

A total of 56 patients aged from 18 to 29 years (mean age 23.4±0.2 years) with histologically confirmed subclinical forms of PVI and CIN I (which is interpreted in modern literature as low-grade squamous intraepithelial lesion - LSIL) were examined.

All women underwent a comprehensive examination, including a medical history, general and gynecological examination, extended colposcopy, bacterioscopy of Gram-stained vaginal smears, typing using polymerase chain reaction (PCR), and cytological examination of scrapings from the cervix.

In 39 (69.6%) patients, menarche was observed before 14 years of age, in 16 (28.6%) after 14 years of age, and in every third, menarche was observed later. The majority of women - 41 (73.2%) - had a regular menstrual cycle; every fifth had irregular periods (opso- or hyperpolymenorrhea). The average age at the onset of sexual activity, the number and frequency of changing sexual partners were assessed. The analysis showed that the average age at the onset of sexual activity was 15.9±0.1 years. Only every third patient had a permanent sexual partner, every fourth had polygamous sexual relationships (more than 5 partners).

When studying the somatic history, it was found that chronic tonsillitis and other foci of infection of the nasopharynx occurred in 17 (30.3%) patients, diseases of the gastrointestinal tract - in 15 (26.8%), vegetative-vascular dystonia - in 19 (33). ,9%). The index of somatic diseases was 1.2 per 1 patient. A study of the history of childhood infections showed that every second woman had chickenpox, every third had measles rubella; respiratory viral infections were present in 29 (51.8%) patients. A high infectious index of more than 1.5 per patient indicates possible changes in immune status.

Of particular interest was the study of the gynecological history, which revealed that the inflammatory processes of the external and internal genital organs amounted to more than 85%. Despite the young age of the subjects, 3 (5.3%) had acute endometritis, 16 (28.6%) had an inflammatory process of the uterine appendages, and 43 (76.8%) had vulvovaginitis. All episodes of inflammatory diseases were previously treated.

A gynecological examination revealed 100% pathology of the cervix (complicated ectopia, cervicitis, leukoplakia, etc.). Determination of sexually transmitted infections using PCR and bacterioscopy made it possible to establish not only different typings of HPV infection, but also multifactorial causes of inflammatory changes in the cervix. Bacterial vaginosis was detected in 32 (57.1%), Mycoplasma hominis

in 16 (28.6%), and
Ureaplasma urealyticum
- in 22 (39.3%), herpes virus - in 9 (16.1%), opportunistic flora in high concentrations was determined in 24 (42.9%) women.
Fungi of the genus Candida
were identified in every third - in 17 (30.4%), chlamydia - in 8 (14.3%), trichomonas were identified in 2 (3.6%).

It should be emphasized that in 100% of women, the examination results demonstrated the presence of mixed infections, i.e. combinations of HPV with other infectious agents. The combination of HPV with one infection occurred in only 5 (8.9%), with two infectious factors was noted in 31 (55.4%) patients, with three or more infectious agents - in 20 (35.7%) subjects. There were 3.6 types of pathogens per patient.

Most often, human papillomavirus type 16, 18 was detected, which was detected in 93.9%; HPV types 31, 33 and HPV types 6, 11 were found in 14.3 and 17.9%, respectively.

All patients underwent simple and extended colposcopy before and after treatment. At the initial stage of the examination, various colposcopic pictures were revealed: a low-atypical transformation zone in the form of leukoplakia, acetowhite epithelium, iodine-negative zones, mosaic, puncture in various combinations with each other and signs of focal and diffuse chronic cervicitis.

Cytological examination of scrapings from the cervix revealed type I cytogram in 26.8% of those examined, type II in 73.2%. A high percentage of infection and the presence of an inflammatory cytogram significantly increase the risk of developing cervical intraepithelial neoplasia.

All patients were divided into a main group (n=36), where combined treatment was used using groprinosin and radio wave destruction, and a control group (n=20), where only local mono-destruction of LSIL lesions was carried out after a course of etiotropic treatment.

After verification of the infection, specific therapy for the underlying infectious disease was carried out. Etiotropic therapy was based on European recommendations for the treatment of STIs and did not differ in the two groups of patients. Antibacterial drugs were used, for candidiasis - antifungal drugs, for bacterial vaginosis - correction of microbiocenosis according to general therapeutic regimens.

Radio wave destruction was carried out, as a rule, immediately after menstruation - on the 5-8th day of the menstrual cycle. After anti-inflammatory treatment in the main group, groprinosin was prescribed 2 tablets (1000 mg) 3 times a day for 5 days 7-10 days before destruction of the lesions, and then two more courses of 2 tablets (1000 mg) 3 times a day for for 5 days with a break between courses of 1 month.

The effectiveness of treatment was assessed after 3 months and six months.

Results and discussion

Our data indicate that the effectiveness of combination treatment using groprinosin was higher and amounted to 86.1%, while with monodestruction it was 65%. It is important that recurrence of human papillomavirus infection by the 6th month of observation was detected in 5.6 and 25% of women in the main and control groups, respectively. Symptoms of the inflammatory process on the cervix were observed only with relapse of HPV infection. In addition, with a comprehensive treatment regimen, a higher frequency of HPV clearance after 6 months was revealed (66.7 and 45% in the main and control groups, respectively) and better epithelization. Treatment failures in almost 35% of patients in the main group can be explained by the fact that local destruction of foci of subclinical manifestations of PVI against the background of chronic cervicitis allows one to act only on the area of the epithelium where the clinical manifestation of the infection occurred, while reservoirs of HPV or other pathogens remain in the surrounding tissues latent state, which may be the basis for further relapse of cervicitis and persistent infection. Adequate immunotherapy promotes more complete elimination of pathogens and complete epithelization of the cervix, which reduces the frequency of relapses and increases the effectiveness of therapy for HPV-associated cervical diseases.

In addition to clinical efficacy, the tolerability of groprinosin was assessed. It was found that 3 (5.4%) patients experienced mild malaise and nausea, which were relieved on the 2nd day of taking the drug and did not require its discontinuation. No other side effects or allergic reactions were noted.

conclusions

1. Most patients with papillomavirus infection had a burdened somatic and gynecological history.

2. Human papillomavirus infection is often combined with other opportunistic diseases (bacterial vaginosis, the presence of Mycoplasma hominis

and
Ureaplasma urealyticum
and candidiasis) and STIs, which together account for more than 90% of all other pathogens.

3. Groprinosin is a highly effective drug for the treatment of HPV infection in diseases of the cervix.

4. When using groprinosin in combination with radio wave therapy, the effectiveness reaches 86.1% when monitored after six months, despite pronounced initial morphological changes in the cervix.

5. Considering the high effectiveness of the drug, good tolerability and absence of side effects, groprinosin can be used in the treatment of HPV-associated cervical diseases in women.

pharmachologic effect

Inosine pranobex - a synthetic derivative of purine, is a complex containing inosine and N, N-dimethylamino-2-propanol in a molar ratio of 1:3.

It has immunostimulating activity and nonspecific antiviral effect. The effectiveness of the complex is determined by the presence of inosine; the second component increases its availability to lymphocytes.

Restores the functions of lymphocytes in conditions of immunosuppression, increases blastogenesis in the monocyte population, stimulates the expression of membrane receptors on the surface of T-helper cells, prevents a decrease in the activity of lymphocytes under the influence of glucocorticosteroids, and normalizes the inclusion of thymidine in them. Inosine pranobex stimulates the activity of T-lymphocytes and natural killer cells, the functions of I-suppressors and T-helpers, increases the production of immunoglobulin G (IgG), interferon-gamma, interleukins IL-1 and IL-2, reduces the formation of anti-inflammatory cytokines IL-4 and IL-10. potentiates the chemotaxis of neutrophils, monocytes and macrophages.

The drug exhibits antiviral activity in vivo against herpes simplex virus, cytomegalovirus, measles virus, human T-cell lymphoma virus (type III), polioviruses, influenza A and B viruses, ECHO virus (human enterocytopathogenic virus), encephalomyocarditis and equine encephalitis viruses . The mechanism of the antiviral action of inosine pranobex is associated with inhibition of viral RNA and dihydropteroate synthetase, which is involved in the replication of some viruses, enhances the synthesis of lymphocyte mRNA suppressed by viruses, which is accompanied by a decrease in the synthesis of viral RNA and translation of viral proteins, increases the production of alpha and gamma interferons by lymphocytes with antiviral properties. When administered in combination, it enhances the effect of interferon-alpha, acyclovir and zidovudine.