[Kagocel in the therapy of influenza and acute respiratory viral infections: Data analysis and systematization from the results of preclinical and clinical trials]. / Kagotsel v terapii grippa i ostrykh respiratornykh virusnykh infektsii: analiz i sistematizatsiia dannykh po rezul'tatam doklinicheskikh i klinicheskikh issledovanii.

The article provides the summarized data of clinical trials evaluating the efficacy and safety of kagocel used to prevent and treat influenza and acute respiratory viral infections of different etiologies. The results of numerous preclinical and clinical trials suggest that the kagocel substance is highly safe and that it is appropriate to use the drug for the treatment and prevention of influenza and acute respiratory viral infections of another etiology.

[Comparative efficacy of etiotropic therapy of patients with HBeAg-positive chronic hepatitis B (by the data of the international comparative placebo-controlled study)].

Comparative placebo-controlled study entrolled 647 patients with verified diagnosis of chronic virus hepatitis B (HBeAg+), not previously subjected to antiviral therapy (with nucleotide analogues or interferons). The drug under the investigation was cycloferon, an earlier interferon inductor. The antiviral combination therapy of the main group patients (323 subjects) included the use of cycloferon + lamivudine for 48 weeks and the therapy of the control group patients (324 subjects) included the use of lamivudine + placebo for 48 weeks. The cycloferon and lamividine combination antiviral therapy was shown preferable vs. the lamivudine + placebo therapy by biochemical remission, virusological response, seroconversion by HBeAg by the 48th week of the treatment and HBsAg clearance. The conbination therapy provided lower frequency of the relapses within 24 weeks of the observation. The higher efficacy of the antiviral combination therapy was evident of the impact of the antiviral activity of cycloferon itself and its immunomodulating and interferon-inducing activity on elimination of the virus-infected hepatocytes. The use of the 48-week course of the antiviral combination therapy is advisable as the prime treatment in the management of patients with HBeAg-positive chronic hepatitis not previously treated with nucleoside analogues and as a variant of therapy for lamivudine-refractory patients.

[Efficacy of antiviral agents in the treatment of Crimean hemorrhagic fever].

The study aimed at estimating the pharmacotherapeutic efficacy of medications possessed of antiviral activity, such as ribavirin, cycloferon solution and tablets, in 410 patients with Crimean hemorrhagic fever: The early beginning of therapy (days 1-4 after the onset of the disease) with these drugs reduced the number of severe cases and manifestations of hemorrhagic syndrome. The duration of the disease decreased, the occurrence of intoxication syndrome reduced to a minimum, hemorrhagic rash rapidly disappeared, and the frequency of complications decreased. Adverse events were documented in 5.2% of the patients (n = 15); most of them developed on day 2 after using the drugs, their duration did not exceed 2.2 days. There were no cases of drug withdrawal.

[Modified therapy of herpetic infection].

The study demonstrates a higher pharmacotherapeutic and economic efficacy of an alternative treatment modality for genital herpes using cycloferon, an inducer of endogenous interferons, compared with acyclovir. Clinical remission due to suppression of virus replication occurred in 72.3 and 73.5% of the cases within 6 months after the treatment with cycloferon and cycloferon + acyclovir respectively. Acyclovir alone prevented reactivation of the disease only in 128% of the patients. The cost/effectiveness ratio in patients given combined therapy was 27.95 compared with 12.9 in case of monotherapy with acyclovir which suggests economic feasibility of the use of cycloferon as the drug of choice for the management of genital herpes. The efficacy of therapy was identical in patients with and without deletion of the GSTM1 gene encoding glutathione-S-transferase which suggests the possibility to effectively use cycloferon in genetically heterogeneous patients.

[Immunomodulators in combined therapy of patients with chronic hepatitis].

The efficacy of the use of triple schemes in combined therapy of chronic virus hepatitis was estimated and its safety was monitored. The problems of therapy of mixed hepatitis in drug addicts are discussed. Immunotropic agents, increasing the efficacy of the standard therapy of chronic affections of the liver, are suggested to be used as the third remedy in the combined therapy.

[Cycloferon in emergency prophylaxis of respiratory viral infections and influenza].

Medicinal products for the treatment and prevention of influenza and acute respiratory infection (ARI) are listed. Clinical symptoms of ARI in the period of enhanced morbidity during 2009-2010 are described. Different forms of control of viral infections are discussed. Clinical and epidemiological efficacy of cyclopheron for the treatment of ARI and influenza in organized groups of population is assessed.

[The use of cycloferon in the combined treatment of tuberculosis patients infected with HIV and viral hepatitis].

The study was designed to evaluate efficiency of 8-week treatment of 86 patients with tuberculosis and concomitant mild hepatitis B using cycloferon tablets. This therapy had beneficial effect on the symptoms of intoxication syndrome and respiratory manifestations of tuberculosis; in addition, it improved hemograms. By the end of the treatment the frequency of sputum abacillation was 4.9 times and positive X-ray dynamics (cavity closure) 2.2 times higher than in control. Therapy positively influenced hepatic function assessed from activity of cytolitic enzymes and bilirubin level; also, it improved serum levels of total protein.

[Reamberin for pathogenetic therapy of acute and chronic viral diseases of the liver].

The study including 427 patients with acute and chronic viral hepatitis was designed to assess results of clinical and laboratory diagnostics of hepatic problems and the state of thiosulfide antioxidative system. It was shown that infusion of succinate-containing preparation reamberin (400 ml/day for 10 days) took less time to eliminate clinical manifestation of the disease (dispeptic and asthenovegetative syndromes) than conventional therapy. Simultaneously the levels of biochemical markers of hepatic cytolysis and cholestasis significantly decreased while serum antioxidative potential recovered. The normal size of the liver was achieved 3.4 times more frequently than in control. No side effects or adverse reactions other than listed in the instruction for use of reamberin occurred. The preparation had to be withdrawn only in one patient.

[Combined cycloferon treatment of tuberculosis in patients infected with HIV].

Outcome of treatment of 102 patients co-infected with HIV and tuberculosis hospitalized at Second Municipal Tuberculosis Hospital (St. Petersburg) is analyzed. The median period of follow up was 8 weeks. In order to select the optimum treatment scheme, all patients were divided into three groups (I-III). Group I (51 patients) received, in addition to antituberculosis medications, cycloferon 600 mg tablets on alternate days. Group II (16 patients) received alpha and gamma interferons (Interal injection, 3 MU and Ingaron injection, 500,000 on alternate days) in combination with antituberculosis medications. Control group III (35 patients) received antituberculosis treatment plus placebo. Assessment of the outcome of TB treatment upon 8 weeks of follow up showed a remarkable improvement of clinical and immunological conditions in the patients who received interferons and cycloferon.

[Pathogenetically substantiated therapy of patients with virus hepatitis C, quality of life, and the disease outcome risk (clinical survey)].

The aspects of virus hepatitis C immunopathogenesis are discussed. The main attention is paid to higher production of Th1 cytokines providing active protection of the host from HCV. The up-to-date approaches to the therapy of chronic hepatitis C, described in the literature and the original ones, including the triple therapy with immunomodulators of various mechanisms of action, i.e. cycloferon (injections and tablets), galavit and derinat are presented. The comparative efficacy of the therapy is estimated. Cycloferon is shown to be the drug of choice in the treatment of patients with virus hepatitis addicted to narcotics. The clinical and laboratory efficacy of the metabolic hepatoprotector remaxol with antioxidant activity is described. Its high effictivity and satisfactory tolerability (side effects requiring discontinuation of the drug use were recorded only in 0.3% of the cases), as well as the minimal risk of no biochemical remission after its use allow to conseder remaxol as a highly efficient metabolic hepatoprotector for pathogenetic therapy of chronic hepatitis.

[Influence of environmental and industrial immunotoxic hazards on clinical course of HIV-infection].

The authors assessed peculiarities of effects caused by the most prevalent environmental pollutants (polychlorinated biphenyls, polycyclic aromatic hydrocarbons, lead, mercury) extensively accumulated in human body on clinical course of HIV-infection.

[Use of immunomodulators in the therapy of chronic hepatitis C: improving standard approach].

Results of a comparative study of the standard and an improved (triple) antiviral therapy in a group of 86 patients with chronic viral hepatitis C (1b genotype) with a period of infection up to five years are presented. The standard therapy consisted in the administration of concentrated alpha-interferon (Interal, Russia) and synthetic nucleozide ribavirin, while the improved (triple) therapy additionally included the administration of the interferon inducer cycloferon. The effectiveness of treatment using the improved scheme increased by 8.8%, the number of adverse drug reactions decreased more than three times, and morphological improvement was observed in 69.4-87.8% of patients. Modification of the standard treatment of hepatitis C improves the quality of life of hepatitis C patients.

[Hepatoprotective activity of remaxol in patients with chronic hepatic disorders].

This milticentre randomized clinical study of the efficiency of remaxol infusion solution (hepatoprotective medicine for chronic liver dysfunction) included 494 patients with chronic hepatitis B and C. 294 of them staying in 7 clinics were given remaxol and 200 ones received placebo. Randomization was achieved by the envelope method. A detailed description of clinical and laboratory characteristics of the diseases is presented. Effects of remaxol vs placebo on the functional activity of affected liver are discussed. Results of laboratory and clinical analysis indicate that mechanism of remaxol action is based on hepatoprotective, antioxidative, and anticholestatic activities of the drug.

[Chemotherapy of chronic viral hepatitis B: randomized multicenter investigation results].

During treatment of patients with chronic hepatitis B the best therapeutic effect was obtained with the inclusion in the scheme of antiviral therapy cycloferon. Complete stable remission was achieved in 54.1% of patients in combination cycloferon with lamivudin, but the appointment of alpha-interferon with cycloferon provided remission 44.1% of patients resistant to treatment with lamivudin. Therapy of chronic hepatitis B with cycloferon can reduce the frequency and severity of side effects, prevents the development of resistance to lamivudin and the emergence of mutant viruses.

[Cycloferon efficacy of therapy of chronic hepatitis B (results of randomized multicentre study)].

The best therapeutic effect in the treatment of patients with chronic hepatitis B was observed with the use of cycloferon in the scheme of the antiviral therapy. The combination of cycloferon with lamivudine provided complete stable remission in 54.1% of the patients, whereas the use of a-interferon in combination with cycloferon provided remission in 44.1% of the lamivudine-resistant patients. The use of cycloferon in the therapy of chronic hepatitis B made it possible to lower the frequency and manifestation level of the side effects and prevented the lamivudine resistance development and generation of the virus mutants.

[Efficiency of using cycloferon as part of combined therapy for chronic hepatitis C (a review of multicenter clinical trials)].

The results of a study of the efficiency of treatment in patients with chronic hepatitis C conducted in a complex of multicenter clinical trials of the impact of various antiviral therapy regimens including the interferon genesis inductor cycloferon are reviewed. Four hundred and seventy-eight patients with hepatitis C virus infection were followed up. The study has demonstrated that the incorporation of cycloferon into the standard treatment regimen, which is manifested by the effect of drug synergism, by producing antiviral, immunomodulating, and antifibrotic effects, is a promising pharmacotherapy for chronic hepatitis C. This treatment is economically sound, reduces the incidence and degree of adverse reactions and increases the quality of life in the patients.

[Cycloferon efficacy in viral and bacterial diseases of children (clinical review)].

The authors' findings and literature data on the pharmacotherapeut efficacy of cycloferon, an interferon inductor (immunomodulators) are described. The drug effect in the treatment of various socially significant children' diseases, including acute respiratory tract viral infection, bronchial asthma, allergic conditions with infection protection disturbances, mycoplasmic infection, bronchopulmonary complications of acute respiratory tract viral infection with low intensity of free radical oxidation is indicated. The use of cycloferon at the background of vaccination was shown to provide inhibition of the autoimmune processes causing postvaccinal complications in frequently ill children. The results of the use of cycloferon in the treatment of gastrointestinal tract and intestinal infections of both the viral and bacterial genesis are discussed. Cycferon is recommended to be used for correction of the intestine dysbiosis (the microflora level came to normal in 95% of the children). The use of the drug in surgical pathology and in particular in appendicular peritonitis for decreasing the postoperative complications and correction of the immune disturbances due to chronic viral hepatitis C and B in children under the complex therapy is described. The cycloferon safety and efficacy were confirmed by the postmarketing randomized trials.

[Cycloferon, as an agent in the therapy and urgent prophylaxis of influenza and acute respiratory tract viral infection (multicentre randomized controlled comparative study)].

Data on the study of the efficacy of the tablets of cycloferon, an early inductor of types 1 and 2 interferon, in the treatment of influenza and acute respiratory tract viral infections in adults are presented. The study enrolled 522 patients with moderate influenza of type A (H1N1) verified in 61% of the patients and type A (H3N2) verified in 7.5% of the cases. The patients were randomized with the envelope procedure. In the patients treated with cycloferon the intensity and period of the fever were stopped earlier and averaged from 1.8 to 3 days vs. 5 days in the reference group (symptomatic therapy). The improvement signs in the general state of the patients treated with cycloferon were noted on the 2nd day. The influenza complication as pneumonia was recorded in 2.2% of the patients treated with cycloferon, whereas in the patients under the symptomatic therapy the complications as bronchitis, pneumonia, angina were stated in 21.4% of the cases. For urgent prophylaxis of the influenza and respiratory tract viral infections (epidemiologic study) a group of 3717 subjects randomized with the table of random numbers was observed. 2080 patients were treated with cycloferon and 1637 patients were under the symptomatic therapy. The results were evaluated by the efficacy index and the protection estimate (T. A. Semenenko, 1991). The total efficacy index and the protection estimate in all the patients of the group were 4.9 and 79.8% respectively. The complicated forms of the disease were recorded in 1.5% of the patients treated with cycloferon and in 10.5 and 11.3% of the patients not treated with cycloferon.

[Immunomodulators in the "gold standard" of the chronic viral hepatitis C therapy].

The best therapeutic effect in the treatment of patients with chronic virus hepatitis C was observed with the use of cycloferon included into the standard antiviral therapy with alpha-interferon and ribavirine. The 18-month observation revealed an increase of the biochemical and antiviral responses to 41.0 and 30.7% respectively. The use of cycloferon provided a decrease in the frequency and manifestation of the side effects. The therapy with the use of cycloferon had a favourable effect on the indices of the quality of life of the patients: by the majority of the scales of the questionnaires it was appraised maximum (from 85 to 96 points).

[Molecular-epidemiologic characteristic of hepatitis A outbreak among workers of food stores network].

Investigation of hepatitis A (HA) outbreak developed in 2005 among workers of food stores networkwas performed using conventional epidemiologic diagnostics as well as methods of molecular epidemiology. In 14 of 15 ill persons, using polymerase chain reaction, HAV RNA was detected by PCR in serum obtained on 2 - 25 day of illness (mean - 9.3 days). In 10 cases it was possible to determine nucleotide sequence of VP1/VP2 region of HAV genome and perform phylogenetic analysis of obtained isolates. It was determined that all isolates belonged to subgenotype IA, had high degree of homology and grouped in one cluster. These findings demonstrate their descendance from one source of infection, which, with high degree of probability, was the cook who made salads from fresh vegetables. HAV strain, which caused this epidemic outbreak circulates in Saint Petersburg for a long time and was already detected in 2004. Importance of vaccination against HA for persons working in manufacturing and distribution of food and use of molecular epidemiologic methods of surveillance for this infection is underlined.