17 research outputs found
Specifics of motivation of volunteers participating in in a clinical trial of the COVID-19 vaccine
Background. The pandemic coronavirus infection has contributed to the development of effective preventive methods to slow the spread of the virus. Mass vaccination is the only way to protect oneself from infection. The development of drugs, including vaccines, involves clinical trials (CT). The problem of conducting a CT is recruiting the necessary number of volunteers. Goal: to identify specifics of motivation of patients participating in the clinical trial of COVID-19 vaccines, as it is a very important medical and sociological issue requiring more detailed study. Materials and Methods. The results of an anonymous questionnaire survey of volunteers participating in the “EpiVacCorona” vaccine CT are presented. Overall, 203 questionnaires were analyzed, containing 19 questions answered by the residents of Kaliningrad, aged 20 to 84 years. At the stage of completion of participation in the clinical trial, information was obtained about the respondent’s attitudes to the trial, the main factors of motivation or demotivation to participate, the degree of their trust in the trial. Results. Information disseminated through the employer was an effective way to organize patient recruitment for the vaccine CT; the effectiveness of using the media was quite low. The positives of participation in the CT for volunteers were ethical considerations. Negatives for participants were the risks associated with adverse reactions or receiving a placebo. Relatives had the greatest influence on the volunteers’ decision to participate in the CT, and medical professionals, media personalities, and scientists had less influence. Conclusion. The results will help to improve patient recruitment, patient awareness of the CT, and the benefits to medicine and society. Motivating and demotivating factors will improve patient recruitment
XPS Study of Ion Irradiated and Unirradiated UO2 Thin Films.
XPS determination of the oxygen coefficient kO = 2 + x and ionic (U(4+), U(5+), and U(6+)) composition of oxides UO2+x formed on the surfaces of differently oriented (hkl) planes of thin UO2 films on LSAT (Al10La3O51Sr14Ta7) and YSZ (yttria-stabilized zirconia) substrates was performed. The U 4f and O 1s core-electron peak intensities as well as the U 5f relative intensity before and after the (129)Xe(23+) and (238)U(31+) irradiations were employed. It was found that the presence of uranium dioxide film in air results in formation of oxide UO2+x on the surface with mean oxygen coefficients kO in the range 2.07-2.11 on LSAT and 2.17-2.23 on YSZ substrates. These oxygen coefficients depend on the substrate and weakly on the crystallographic orientation. On the basis of the spectral parameters it was established that uranium dioxide films AP2,3 on the LSAT substrates have the smallest kO values, and from the XRD and EBSD results it follows that these samples have a regular monocrystalline structure. The XRD and EBSD results indicate that samples AP5-7 on the YSZ substrates have monocrystalline structure; however, they have the highest kO values. The observed difference in the kO values was probably caused by the different nature of the substrates: the YSZ substrates provide 6.4% compressive strain, whereas (001) LSAT substrates result only in 0.03% tensile strain in the UO2 films. (129)Xe(23+) irradiation (92 MeV, 4.8 × 10(15) ions/cm(2)) of uranium dioxide films on the LSAT substrates was shown to destroy both long-range ordering and uranium close environment, which results in an increase of uranium oxidation state and regrouping of oxygen ions in uranium close environment. (238)U(31+) (110 MeV, 5 × 10(10), 5 × 10(11), 5 × 10(12) ions/cm(2)) irradiations of uranium dioxide films on the YSZ substrates were shown to form the lattice damage only with partial destruction of the long-range ordering.The irradiation experiment was performed at the Grand Accelé rateur National d ́ ’Ions Lourds (GANIL) Caen, France, and supported by the French Network EMIR. The support in planning and execution of the experiment by the CIMAPCIRIL and the GANIL staff, especially I. Monnet, C. Grygiel, T. Madi, and F. Durantel, is much appreciated. The work was supported by RFBR grant no. 16-03-00914-a and partially supported by M.V. Lomonosov Moscow State University Program of Development. A.J.P. acknowledges funding from the UK EPSRC (grant EP/I036400/1) and Radioactive Waste Management Ltd. (formerly the Radioactive Waste Management Directorate of the UK Nuclear Decommissioning Authority, contract NPO004411A-EPS02), a maintenance
grant from the Russian Foundation for Basic Research (projects 13-03-90916) and CSAR bursary. Thanks are given to A.M. Adamska, G.I. Lampronti, V.A. Lebedev, P.G. Martin, L. Payne, and A.A. Shiryaev for their help in characterization of the samples
Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection? - Results of a randomized controlled pilot trial
Antibiotic resistance of pathogens causing uncomplicated urinary tract infections in Russian Federation
Introduction. The choice of antibiotic for the treatment of uncomplicated urinary tract infections (UTI) is mainly carried out empirically. At the same time, it should correspond to local data on the sensitivity of uropathogens to antibacterial drugs. If the level of uropathogen resistance in the region is more than 10-20% to any antibiotic, its use should be limited to empirical therapy.Purpose of research. Identify the structure of pathogens of uncomplicated UTIs and determine the dynamics of their sensitivity to the most commonly used antibacterial drugs.Materials and methods. This article presents a summary data of Russian multicenter epidemiological on the etiology of uncomplicated UTIs and the resistance of pathogens to antibiotics. The study are included female outpatients meeting the following criteria: 1) non-pregnant women over 18; 2) the presence of lower UTIs (acute or exacerbation of chronic cystitis); 3) uropathogen isolation > 103 CFU/ml with a positive test results for the presence of leukocytes in the urine and >105 CFU/ml for any test results for the presence of leukocytes in the urine.Results. The most frequent uropathogen causing uncomplicated UTI is E. coli, which is excreted in 72.4% - 90.6% of patients. Cephalosporins of the third generation (cefixime), Nitrofurantoin, Fosfomycin have a high microbiological activity against E. coli, the frequency of resistant strains to them is 0%, 0-1.9% and 0%, respectively. The persistently high resistance of E. coli strains is determined to Ampicillin (33.1% - 41.5%) and Co-trimoxazole (19.3% - 26.2%). For non-fluorinated and fluorinated quinolones, there is a tendency to increase the proportion of resistant strains during the study period.Conclusions. High generation Cephalosporins (cefixime), Nitrofurantoin, Fosfomycin have high activity against uropathogens сausing uncomplicated UTI. Ampicillin and Co-trimoxazole cannot be considered the drugs of choice for the treatment of uncomplicated UTI according to currently established criteria
Efficacy and safety of Ergoferon versus oseltamivir in adult outpatients with seasonal influenza virus infection: a multicenter, open-label, randomized trial
Objectives Ergoferon is an antiviral complex drug containing released-active forms of antibodies to interferon gamma, CD4, and histamine. Its efficacy and safety in the treatment of acute respiratory viral infections has been reported previously. The aim of this study was to compare Ergoferon with oseltamivir. Methods A multicenter, open-label, randomized controlled trial of patients aged 18 to 65 years, who had tested positive for influenza A or B antigens, was performed. A total of 156 patients were enrolled as the intention-to-treat population; these patients were assigned randomly to receive either Ergoferon or oseltamivir (n = 78 in each group). Results The percentage of patients achieving a normal body temperature (≤37.0°С) following 5 days of treatment did not differ significantly between the groups. The mean duration of fever in the Ergoferon and oseltamivir groups was 2.1 ± 1.5 days and 2.3 ± 1.6 days, respectively (p = 0.01). The average time to the resolution of influenza symptoms was approximately 3 days, with no significant between-group difference. Total quality of life scores were similar in the two groups following 5 days of drug administration. The incidence of adverse events did not differ significantly between the groups, nor were there any serious adverse events. Conclusions Ergoferon and oseltamivir were equally effective and safe in adult outpatients with seasonal influenza A or B virus infection. Clinical trial registration: ClinicalTrials.gov identifier NCT01804946 © 2016 The Author(s
EPIDEMIOLOGY OF UNCOMPLICATED OUTPATIENT URINARY TRACT INFECTIONS IN THE RUSSIAN FEDERATION
Introduction. Urinary tract infections (UTIs) are one of the most common bacterial infections of practical interest to specialists in different areas. The most common form of UTI is acute uncomplicated cystitis (AUC). To date, there is a limited number of studies devoted to the study of this problem in the Russian Federation.Purpose of research. The aim of this study was to assess the prevalence and clinical features of communitybased UTI in Russia.Materials and methods. The study was conducted in two stages, the first stage was completed in 2005- 2006, the second stage – in 2017, the method of questionnaire was used. During the first stage, young women were surveyed in organized groups (Universities and Colleges) using a paper traditional questionnaire in 20 cities of the Russian Federation, the Republic of Belarus and Kazakhstan. The second stage of the research was carried out using the technology of online surveys. Information about the online questionnaire was shared at specialized events in which mainly young people of 18-25 years participated – lectures at Universities, youth events, social networks, etc. During the second stage of the study, 20 cities of the Russian Federation were covered.Results. At the first stage of the study, 660 women were interviewed, the average age was 20.9 ± 1.6 (median - 18.0) years. At least one episode of dysuria was reported by 19.0% ± 1.5% of the respondents, with 22.9% of the respondents having recurrent cystitis. In the second stage of the study, 525 respondents were interviewed, the average age was 21.1 ± 1.8 years. The occurrence of at least one episode of dysuria during the life о21.1% ± 1.7 of the respondents, while 28.5% of ± 2.0 of the respondents reported the development of 3 or more episodes of the dysuria over the last 12 months.The median duration of cystitis symptoms was 2 days in both the first and second stages of the study. Most often, symptoms of dysuria persisted 1-3 days (64.1%), 4-5 days (23.0%) or 5-7 days (9.5%). The most correlated with the development of cystitis were family history (OR - 2.26-2.42), sexual activity and use of spermicides (OR – 1.69 and 2.43). From 40% to 50.9% of respondents in the case of dysuria do not seek medical care. When reached a medical care, most often consulted a doctor urologist (15.8% - 22.3%), gynecologist (16.7% - 17.7%), rarely a therapist (8.8 – 11.4) or other specialties (1.3% - 14.8%). No pharmacological treatments were used and 20.1% - 23.1% of the respondents, herbal medicine – 24.0% - 23.9%. Antibiotics, spasmolytic drugs and NSAIDs were the most commonly used. Over the past 12 years, there have been significant changes in the structure of antibiotics used in cystitis – the frequency of use of ampicillin, amoxicillin, co-trimoxazole, gentamicin has clearly decreased. On the contrary, increased frequency of use of phosphomycin, norfloxacin, levofloxacin.Conclusions. According to the survey of young women, 19.1%-21.1% of respondents report the occurrence of symptoms of AUC. 22.9% - 28.5% of women report the development of 3 or more episodes of dysuria during the year. Usually clinical symptoms persist for 2 days (median), the duration of dysuria in the range of 1-3 days reported 64.1% - 70.9% of patients. The risk of AUC correlated with the activity of sexual life, family history of UTI, spermicides using – OR – 1.69, 2.42 and 2.43, respectively. 40.3-50.9% patients with AUC did not seek medical care, the main method of treatment of cystitis in an outpatient setting is the use of antibiotics.Disclosure: The study did not have sponsorship. The authors have declared no conflicts of interest
LOW DOSAGE ACETYLSALICYLIC ACID: A VARIETY OF FORMULATIONS
The most prevalent formulation of the low-dosage (ld) acetylsalicylic acid (ASA) for prevention purposes is the gut soluble pill — 80,6% of the ldASA registered in pharmacy market. Formulations of ldASA mostly presented as ASA monodrugs (84,4%), containing only ASA as active substance, predominantly as 100 mg dosage. Amount of ASA of 81 mg has become widespread only in North America, that is related to nonmetric measurement system. Combinational ldASA with non-soluble antacide (magnesium hydroxide) are not broadly used throughout the world — 1,6% of all pharmacy market registered labels, and mostly in use in the regions of former USSR
COMPARISON OF ENTERIC-COATED ASPIRIN TABLETS BY DIFFERENT PRODUCERS: DISSOLUTION TEST RESULTS
Prospects for Raman spectroscopy in cardiology
Raman spectroscopy (RS) is a promising diagnostic method with high informative value and sensitivity. In addition, it is non-destructive and minimally invasive, and also requires minimal sample preparation, which opens up wide prospects for in vitro and in vivo use. There are some perspectives for this method in future cardiology practice. RS may allow to identify previously studied markers of cardiovascular disease, as well as to search for new ones. It is a sensitive method for the detection and biochemical assessment of early-stage atherosclerotic lesions and can be used in vivo. Of great interest is the possibility of using the RS to control the amount of eluted substance from drug-eluting stents to assess clinical efficacy. Study of platelet membranes using the RS technique revealed structural changes in patients with hypertension. This method makes it possible to assess myocardial viability in the border zone after myocardial infarction, and the obtained results correlate with the intraoperative data. More details about the prospects of using the RS will be described in the review