[New medical technologies in cough therapy: results of a double-blind randomized placebo-controlled multicenter clinical trial].

AIM: To study the efficacy and safety of Eladis® in comparison with placebo in patients with non-productive cough. MATERIALS AND METHODS: A phase III clinical trial enrolled 250 patients aged 18-65 years with acute respiratory viral infection with upper respiratory tract involvement or acute bronchitis. Patients were randomized into 2 groups of 125 subjects: group 1 received Eladis® (40 mg tablets), group 2 received a matching placebo. The patients received the study drugs 1 tablet BID for 7-14 days. After the treatment, patients were followed up (day 7±2) to assess the effect of therapy on the frequency of coughing attacks, the frequency and severity of daytime and nocturnal cough, the severity of cough, the duration of clinical cough cure, and the effect on the severity of the main acute respiratory viral infection symptoms. RESULTS AND CONCLUSION: The results of the study demonstrate the overall efficacy and statistically significant superiority of Eladis® over placebo: there were significant differences between the study groups in the proportion of patients who decreased the coughing attack frequency by ≥50% by day 5 (p<0.0001). In addition, the clinical cure of cough in the Eladis® group occurred 2 days earlier: the median time was 6 days, vs 8 days in placebo group. There was a decrease in the frequency of cough attacks and a decrease in its severity by more than 3.5 points by day 5 of treatment. All the effects were associated with high safety of the drug.

[The possibilities of impulse oscillometry in the diagnosis of the lung function disorders after COVID-19].

BACKGROUND: Impulse oscillometry (IOS) is an effort independent method of studying lung mechanics. AIM: To study the diagnostic significance of IOS in assessing lung mechanics after COVID-19. MATERIALS AND METHODS: Spirometry, body plethysmography, diffusion test (DLco), IOS parameters were analyzed in 315 patients (the median age 48 years), the median period from the beginning of COVID-19 to the study was 50 days. Statistical analysis included descriptive statistics, correlation analysis and one-dimensional logistic regression analysis with an assessment of odds ratios. RESULTS: In general group, spirometry and body plethysmography parameters were in normal values, while DLCO was reduced in 61% of patients. Parameters of IOS were analyzed in the general group and between the groups, depending on the value of DLco and total lung capacity (TLC): normal or reduced. In general group, reactance area (AX), hererogeneity of resistance Rrs5-Rrs20, resistance at 5 Hz (Rrs5), reactance at 5 Hz (ΔXrs5) were increased in 29.8%, 17.8%, 6%, 4.8% of patients, respectively, and were statistically significantly higher in the group with reduced TLC, whereas in the group with reduced DLco AX, Rrs5-Rrs20 were statistically significantly higher. Logistic regression analysis showed that patients with Rrs5-Rrs20>0.07 kPa×sec/l or AX>0.32 kPa/l had a 1.99-fold and 2.24-fold increased risk for decrease DLco, respectively, while the risk of decrease in TLC was 2.25-fold (p=0.012) and 3.16-fold (p<0.001) higher, respectively. CONCLUSION: IOS allow to detect both dysfunction of small airways (if AX or Rrs5-Rrs20 are increased) and the risk of restrictive pattern and lung diffusion impairment after COVID-19.

[Efficacy and safety of bacterial lysate OM-85 in the treatment of uncomplicated acute respiratory infections: a double-blind, placebo-controlled, multicenter, randomized trial].

AIM: To evaluate the efficacy and safety of OM-85 in the treatment of uncomplicated acute respiratory infections (ARI) in adults. MATERIALS AND METHODS: A double-blind, placebo-controlled, multicenter, randomized trial included 556 patients (18-60 years old) with mild and moderate ARI and negative results of polymerase chain reaction analysis for SARS-CoV-2 RNA and rapid test for influenza A and B viruses. Patients were randomized into two groups: in the first group (n=278), patients received OM-85 (Broncho-munal®) one capsule 7 mg/day for 10 days, while the second group (n=278) was treated with placebo in the same regimen. The primary endpoint was the dynamics of the severity of symptoms over 3, 5, 7 and 10 days of treatment according to the 21-item Wisconsin Upper Respiratory Symptom Survey (WURSS-21), which was assessed by the area under the curve. Secondary efficacy criteria were the dynamics of the severity of symptoms according to the Common Cold Questionnaire (CCQ), the time to the resolution of symptoms according to WURSS-21 and CCQ, the proportion of patients with body temperature below 37°C on each day of treatment, frequency of the need for systemic antibacterial therapy. RESULTS: The superiority of OM-85 over placebo by primary endpoint was observed on the 5th, 7th and 10th days of treatment. OM-85 efficacy has also been proven by secondary criteria. OM-85 shortened the time until the symptoms of ARI resolved according to the WURSS-21 and CCQ, increased the proportion of patients with body temperature below 37°C by 2-9 days. The time needed to resolve the symptoms of disease in 20% of patients according to WURSS-21 was 7 and 9 days in patients taking OM-85 and placebo, respectively. Bacterial lysate increased the probability of complete disappearance of symptoms according to CCQ by 45.7% compared to placebo. The analysis of the frequency and severity of adverse events, laboratory tests, physical and instrumental examination results during treatment confirmed the good tolerability and safety of OM-85. CONCLUSION: The study confirmed the efficacy and safety of OM-85 in the complex treatment of ARI in adults.

[Evaluation of the efficacy and safety of a complex antiviral drug based on antibodies in the treatment of adult patients with acute respiratory viral infection].

AIM: To evaluate the efficacy and safety of Raphamin, containing technologically processed affinity-purified antibodies to interferon , CD4 receptor, 1 domain of the major histocompatibility complex class II and 2 microglobulin major histocompatibility complex class I in the treatment of acute respiratory viral infection (ARVI), including influenza, in adults. MATERIALS AND METHODS: 240 patients 1870 years old with ARVI were included in a phase III (20192020), randomized, double-blind, placebo-controlled trial. Pregnant women, patients with suspected bacterial infections were excluded from the study. Raphamin/placebo was prescribed for 5 days within 24 hours of the illness onset. Primary endpoint was a time to resolution of ARVI (Polymerase chain reaction PCR-confirmed). Additionally, the severity of ARVI, proportion of patients with ARVI resolution/worsening/complications, frequency of antipyretics prescription, and time to resolution of symptoms of ARVI (including PCR non confirmed) were assessed. RESULTS: The average time to resolution of ARVI (PCR-confirmed) was 4.11.9 [4.01.9] and 5.02.5 [5.02.5] days in the Raphamin/placebo groups (ITT and [PP] analysis, р=0.0155 and [р=0.0114], respectively). The duration of ARVI decreased by 0.892.23 [0.932.25] days. Superiority of Raphamin was shown during therapy period according to the ARVI resolution criterion (р=0.0014 [р=0.0005]). There were no statistically significant difference in the severity of ARVI and frequency of antipyretics prescription. The proportion of patients with worsening/complications was 0 [0]% and 2.5 [2.8]% in the Raphamin and placebo groups, respectively. Favorable safety profile of Raphamin (including the incidence and severity of adverse events) and high compliance were shown. CONCLUSION: Raphamin promotes significant decrease, practically by a day, the duration of ARVI, including influenza.

[Models of clinical and social management of patients with autism spectrum disorders]. / Kliniko-sotsial'nye modeli vedeniya patsientov s rasstroistvami autisticheskogo spektra.

OBJECTIVE: To develop clinical and social models and management routes for patients with autism spectrum disorders (ASD). MATERIAL AND METHODS: A clinical follow-up study was performed for 254 patients, aged 4-17 years (average age 7.3 years), who represented the main forms of ASD. Psychopathological, clinical-follow-up, psychological and statistical methods were used. RESULTS AND CONCLUSION: Five management models for patients with different forms of ASD are described; differentiation of routes for interagency monitoring of patients is proposed. The effectiveness of the integrated use of drug and non-drug therapeutic approaches for the management of patients with ASD in the clinical-age aspect is shown. Timely diagnosis of ASD makes it possible to develop differentiated routes of patient management within the framework of interdepartmental interaction and achieve positive results in the clinical and age aspect.

[On the problem of psychological (psychometric) diagnosis of intelligence in children with developmental disorders]. / Psikhometricheskaia otsenka intellekta u deteĭ s narusheniiami psikhicheskogo razvitiia.

A review includes the following sections corresponded with methods of investigation and groups of patients: Wechsler test for atypical autism and schizophrenia; Psycho Educational Profile (PEP) in endogenous mental pathology, the Kaufman Test of Educational Achievement in children schizophrenia, Edinburgh Picture Test in mental dysontogenesis. The results of the studies in these fields are presented.