[Efficacy and safety of treatment with ampasse: the results of a randomized, double-blind, placebo-controlled trial in patients with chronic cerebrovascular disorders]. / Effektivnost' i bezopasnost' terapii preparatom ampasse: rezul'taty randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo issledovaniya u patsientov s khronicheskim narusheniem mozgovogo krovoobrashcheniya.

OBJECTIVE: To assess the efficacy and safety of the drug ampasse in the treatment of patients with chronic cerebrovascular disorders (CCVD). MATERIALS AND METHODS: A multicenter, randomized, double-blind, placebo-controlled, confirmatory study of the efficacy and safety of ampasse (phase III) was conducted in 124 patients aged 50 to 75 years. The main group (MG) - 62 patients, received the test drug ampasse, solution for intravenous administration, 5 mg/ml, at a dose of 5 ml (25 mg), intravenously bolus slowly, the duration of treatment was 15 days. Control group (CG) - 62 patients, received comparison drug: placebo (0.9% sodium chloride-5 ml). RESULTS: All 124 patients fully completed the procedures and visits, there were no dropouts from the study. The proportion of patients who reached the primary endpoint (an increase in the score by 2 or more points on the MoCA scale) was 83.87% in MG and 22.58% in CG, that is, the efficacy of therapy in MG was 61.29% higher than in CG (p<0.001), and good tolerability of the drug was proved. The secondary endpoint is an increase in quality of life (QOL) on the SF-36 V2 scale on Day 31. In MG, there was a statistically significant improvement in all indicators of QOL compared to the baseline. When assessing the safety spectrum, the proportion of patients who had adverse events was 14.52% in MG and 8.06% in CG (p=0.395). CONCLUSION: Ampasse has a positive effect on cognitive functions and QOL, does not increase the frequency of adverse events in patients with CCVD compared to placebo, does not cause significant side effects, and is well tolerated by patients.

[Evaluation of the effectiveness of ARVI treatment regimen including etiotropic (enisamium iodide) and symptomatic treatment].

AIM: To assess the effectiveness of the use of the antiviral drug enisamium iodide in the complex treatment of acute respiratory viral infections (ARVI) caused by various pathogens in routine clinical practice. MATERIALS AND METHODS: А prospective randomized study included 134 patients who were treated in the epidemic season of influenza and ARVI in 20182019. All patients were examined for the presence of influenza A and B viruses, respiratory syncytial virus, human metapneumovirus, parainfluenza virus, coronaviruses, rhinoviruses, adenoviruses in nasopharyngeal swabs by PCR. Patients of the main group received enisamium iodide along with symptomatic therapy, the control group received only symptomatic therapy. The primary parameter of the effectiveness of therapy was evaluated on the scale of the general severity of the manifestations of ARVI (Total Symptom Score TSS) from the 2nd to the 4th day and by the secondary criteria of effectiveness: assessment of the duration of ARVI, the severity of fever, the proportion of patients with normal body temperature, the duration of the main clinical symptoms of acute respiratory viral infections, the proportion of patients in whom complications requiring antibiotics were noted, the dynamics of interferon status on the 6th day. To conduct a statistical analysis, depending on the efficiency parameter, the ANCOVA method with a fixed group factor and an initial score on the TSS severity scale was used as covariates, a criterion for comparing quantitative indicators in two independent groups. RESULTS: According to the results of the analysis of the primary efficacy parameter, the median (interquartile range) of the average score on the scale of the general severity of ARVI manifestations in the main group was 4.33 (3.675.83), in the comparison group 6.00 (4.677.25; p0.001). The duration of systemic and local manifestations of acute respiratory viral infections was statistically significantly less in the main group (p=0.002 and p=0.019, respectively). Prescription of additional therapy was required in 2 (2.9%) patients of the main group (patients taking enisamium iodide), compared with 8 (11.9%) patients in the control group. Serum levels of interferon  and interferon  on the last day of treatment were statistically significantly higher in patients of the main group compared with the control group (p0.001). Treatment (excellent) was evaluated by 42 (62.7%) patients, while in the control group only 17 (25.8%) patients gave similar ratings. Both patients (p0.001) and doctors (p0.002) rated therapy tolerance better in the study group. CONCLUSION: The results confirmed the safety and effectiveness of enisamium iodide as a treatment for ARVI and influenza. The antiviral, interferonogenic and anti-inflammatory properties of the drug are involved in the formation of an antiviral response and reduce the risk of complications, which makes it possible to reduce the number of symptomatic agents used.

[The practice of using a domestic antiviral drug in the etiotropic therapy of acute respiratory viral infection].

AIM: Evaluation of efficacy, safety, tolerability, and determination of the optimal dose of riamilovir in patients diagnosed with acute respiratory viral infection (ARVI). MATERIALS AND METHODS: The study included 270 patients with uncomplicated ARVI of mild and moderate severity (with a laboratory-confirmed PCR method for the presence of ARVI antigens, absence of influenza virus antigens). Patients were included in the study after signing an informed consent. Patients were randomized into 3 groups in a 1:1:1 ratio of 90 patients in each group. Completed the study in accordance with the Protocol: 267 patients. The study involved patients diagnosed with ARVI. RESULTS: Confirmed the efficacy, safety and tolerability of the drug riamilovir. Adverse drug reactions associated, in the opinion of the doctor, with taking the drug and resulting in discontinuation of the drug, were not noted in this study. CONCLUSION: As a result of clinical study, the effectiveness of both ARVI treatment regimens with drug riamilovir has been shown. There were no differences in the effectiveness and safety of the proposed treatment regimens. Practical use of both treatment regimens is recommended. However, according to the authors, taking the drug 3 times a day is much more convenient for patients, improves the quality of life and adherence to therapy.