Репозиторий Университета

© 2019 The Authors Background: Retigabine is an antiepileptic drug developed for the adjunctive treatment of adults with epilepsy and partial-onset seizures (POS). Following its approval in 2011, reports of ophthalmological/dermatological pigmentation/discoloration led to a restriction of the indication in 2013, and in 2017, retigabine was voluntarily withdrawn from the market because of its limited usage. Here, data are reported from four open-label extension studies focusing on long-term safety with particular emphasis on ophthalmological and dermatological events. Methods: Studies 113413 (NCT01336621), 114873 (NCT01777139), 115097 (NCT00310388), and 115098 (NCT00310375) were multicenter, open-label extension studies of retigabine (300–1200 mg/day) for the adjunctive treatment of adults with POS. Safety assessments included monitoring treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). When new safety issues were identified, protocols were amended to include additional on-treatment safety evaluations, including ophthalmological and dermatological examinations. Patients who had abnormal retinal pigmentation, unexplained vision change, pigmentation of nonretinal ocular tissue, or abnormal discoloration of skin, lips, nails, and/or mucosa at the end of the treatment phase were asked to enter a safety follow-up continuation phase comprising 6-monthly ophthalmological/dermatological assessments. Results: The safety population (patients receiving ≥ 1 dose of retigabine in the open-label phase) comprised 98, 30, 376, and 181 patients for studies 113413, 114873, 115097, and 115098, respectively. Mean (standard deviation) treatment exposure ranged from 529 (424) to 1129 (999) days. In total, 68%–96% and 4%–27% of patients across the studies experienced TEAEs and TE SAEs, respectively. There were seven on-treatment deaths and two after discontinuation. Overall, 14%–73% of patients had an on-treatment eye examination, of whom 8/53, 4/22, 17/54, and 14/36 had abnormal retinal pigmentation and 15/53, 7/22, 15/54, and 11/36 had nonretinal ocular pigmentation in studies 113413, 114873, 115097, and 115098, respectively. Four patients had confirmed acquired vitelliform maculopathy. In patients with unresolved events at discontinuation and ≥ 1 posttreatment follow-up, retinal pigmentation resolved completely in 1/3, 0/3, 0/10, and 1/7 patients and nonretinal ocular pigmentation in 1/4, 0/3, 8/10, and 4/6 patients, respectively. Overall, 12%–83% of patients had an on-treatment dermatological examination, of whom 11/58, 0/25, 23/46, and 23/37 had any-tissue discoloration, respectively. In patients with unresolved events at discontinuation and ≥ 1 posttreatment follow-up, discoloration of skin, lips, nails, and/or mucosa resolved completely in 2/3, 0/0, 7/13, and 1/11 patients, respectively. Conclusions: The safety profile of retigabine in adults with POS across four open-label studies was generally consistent with data from previous placebo-controlled studies. Discoloration of various tissues occurred in a proportion of patients treated with retigabine and resolved completely in a small number of these patients following treatment discontinuation. In addition, comprehensive eye examination identified a new adverse reaction of acquired vitelliform maculopathy in a limited number of patients.

© 2019 Elsevier Inc. Objective: To evaluate the pathologic response, safety, and feasibility of nephrectomy following receipt of immune checkpoint inhibition (ICI) for renal cell carcinoma (RCC). Methods: Patients who underwent nephrectomy for RCC after exposure to nivolumab monotherapy or combination ipilimumab/nivolumab were reviewed. Primary surgical outcomes included operative time (OT), estimated blood loss (EBL), length of stay (LOS), readmission rates, and complication rates. Pathologic response in the primary and metastatic sites constituted secondary outcomes. Results: Eleven nephrectomies (10 radical, 1 partial) were performed in 10 patients after ICI with median postoperative follow-up 180 days. Six patients received 1 to 4 cycles of ipilimumab/nivolumab, while 5 received 2 to 12 infusions of nivolumab preoperatively. Five surgeries were performed laparoscopically, and 4 patients underwent concomitant thrombectomy. One patient exhibited complete response (pT0) to ICI, and 3/4 patients who underwent metastasectomy for hepatic, pulmonary, or adrenal lesions exhibited no detectable malignancy in any of the metastases resected. No patients experienced any major intraoperative complications, and all surgical margins were negative. Median OT, EBL, and LOS were 180 minutes, 100 ml, and 4 days, respectively. Four patients experienced a complication, including 3 that were addressed with interventional radiology procedures. One patient died of progressive disease >3 months after surgery, and 1 patient succumbed to pulmonary embolism complicated by sepsis. No complications or readmissions were noted in 6 patients. Conclusion: Nephrectomy following ICI for RCC is safe and technically feasible with favorable surgical outcomes and pathologic response. Timing of the nephrectomy relative to checkpoint dosing did not seem to impact outcome. Biopsies of lesions responding radiographically to ICI may warrant attention prior to surgical excision.

© 2019, MDPI AG. All rights reserved. Tuberculosis is known to be the biggest global health problem, causing the most deaths by a single infectious agent. Vaccine-development efforts are extremely important. This paper represents the results of the first-in-human trial of recombinant subunit tuberculosis vaccine GamTBvac in a Phase I study. GamTBvac is a new BCG booster candidate vaccine containing dextran-binding domain modified Ag85a and ESAT6-CFP10 MTB antigens and CpG ODN adjuvant, formulated with dextrans. Safety and immunogenicity of GamTBvac were estimated in an open-label clinical trial on 60 Mycobacterium tuberculosis uninfected (MTB-uninfected) volunteers previously-vaccinated with Bacillus Calmette—Guérin vaccine (BCG). The candidate vaccine had an acceptable safety profile and was well-tolerated. Three different vaccine doses with a double-immunization scheme were assessed for immunogenicity and induced a significant increase in IFN-γ in-house IGRA response and IgG ELISA analysis. Among them, the half dose vaccine group (containing DBD-ESAT6-CFP10, 12.5 μg; DBD-Ag85a, 12.5 μg; CpG (ODN 2216), 75 μg; DEAE-Dextran 500 kDa, 250 μg; and Dextran 500 kDa, 5 mg) provided high, early and stable in time immune response specific to both protein antigen fusions and is proposed for the further studies.

© 2019, Pediatria Ltd. All rights reserved. Objective of the research: To study the effect of different temperature conditions and shelf life of expressed mother and donor breast milk (BM) on its microbiological safety. Materials and methods: N open prospective study was performed, which included 120 lactating women. BM samples were microbiologically evaluated under various storage conditions. Seeding of biological material was performed by a semi-quantitative method. Species identification of the obtained microorganisms was performed using a MALDI-TOF-MS Biotyper MicroFlex mass spectrometer and a VITEK bacteriological analyzer. Results: In 66% of women, samples of expressed BM showed an increase (103–105 CFU/ml) of conditionally pathogenic bacteria (CPB) with a predominance of S. epidermidis (55%). None of the samples of the expressed BM stored for 3 hours at room temperature (t° + 23°C) during the day in the refrigerator (t° + 4–6°C) and for 1 month in the freezer (t ° –18°C), the growth of CPB was not recorded. However, a decrease in the growth of bacteria total number was revealed, including S. epidermidis, when storing expressed milk for 24 hours at t° + 4–6°С and for 1 month at t° –18°С. It was found that BM pasteurization leads to a significant decrease in the number of CPB. The study revealed no increase in the total number of bacteria during storage of donor milk at t° –18°C for both 1 and 3 months.

© 2019, Pleiades Publishing, Inc. Abstract: Genetic engineering is considered as background for crop protection against pest damage by adding new genes inside the grains. Rice, like other cereals is included in gene engineering experiments. The questions about possible gene transfer related to food safety appear. It is important to find any additional genes or fragments in animal tissues after consumption of genetically modified (GM) food. Therefore, in this study, the remaining of CryIA(b) gene and P35 were assessed in the liver of rats fed with GM rice. This work presents an experimental study with the intervention of GM rice feeding by Sprague Dawley rats. Overall, 20 male and 20 female SD rats were fed by pellets made by GM rice in 50% of needed carbohydrate for 90 days. Then, sampling was done from rats liver. DNA extraction was done based on the protocol. The quality and quantity of the extracted DNA was done by agarose gel electrophoresis and spectrophotometry, respectively. Detection of GM genes residues, including CryIA(b), P35, and T35 was done by Polymerase Chain Reaction using specific primer pairs. The results were analyzed by agarose gel electrophoresis alongside with 50 bp DNA ladder. The results were compared with the ones in control groups with feeding by standard pellet of non-modified rice. All amplification tests were done in triplicates. Analysis of the amplification of P35, CryIA(b) and T35 showed no residues inside the liver tissue. The results showed no significant difference in the presence of transgenic gene of cryIA(b), T35, and P35 in the liver tissue between the control and experiment groups. Therefore, this study rejects the possibility of gene settle of GM rice gene residues in liver tissue of the animal model studied.

© 2018, Springer Science+Business Media, LLC, part of Springer Nature.  The polypeptide analgesic compounds APCH3 (a TRPV1 receptor inhibitor) and PT1 (a P 2 X 3 receptor inhibitor) were shown not to act on the cardiovascular system or respiratory system when given either as single or multiple doses in mice. The low molecular weight compound sevanol (an ASIC3 receptor inhibitor) had no effect on the cardiovascular system, but prolonged use for 14 days affected measures of the respiratory system, significantly increasing respiratory rate and peak expiratory flow rate.

© 2018 IEEE. Modern laser technologies have a wide range of scientific, commercial, medical and other applications. In medicine, lasers are used both for diagnostic, therapeutic, and surgical purposes. Safety of laser radiation in assisted reproductive technologies is discussed in the paper. Efficiency of using femtosecond (fs) laser pulses to perform noncontact embryo biopsy as well as laser-assisted hatching is shown. First results on femtosecond laser marking on the surface of embryo outer shell for individual embryo tagging are also presented. Question of safety of THz radiation for living objects (starting at the cellular level and ending with the organism in whole) is still a matter of controversy and requires further study. Experimental study of high-power THz pulses effect on living 2D cell culture is presented. MSC cells are exposed to multiple (from 80 to 100) THz pulses with intensities up to 1 MV/cm. No short-term damage effects are observed during first hours post cell irradiation.

© 2017, Springer Science+Business Media, LLC, part of Springer Nature. We need to take into complex assessment a set of influencing factors of drinking water safety. This raises the task of developing an integrated methodology assessing the safety of drinking water that reaches the consumers. For the integrated assessment of the safety of drinking water, the method of clustering was chosen, namely, the neural network method of Kohonen self-organizing maps. Zones were separated by the method of cluster neural network analysis. The zones are characterized by different content of metal cations in drinking water, levels of carcinogenic and non-carcinogenic risk to the health of the child population, and the probability of the receipt of metal cations with potable water to consumers.

© 2018, © International Headache Society 2018. Background: Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods: In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. Primary endpoint was change in monthly migraine days. Secondary endpoints were ≥50% reduction in monthly migraine days, change in acute migraine-specific medication treatment days, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary. All endpoints assessed change from baseline at month 3. Results: Patients receiving erenumab experienced −2.9 days change in monthly migraine days, compared with −1.8 days for placebo, least-squares mean (95% CI) treatment difference of −1.0 (−1.6, −0.5) (p < 0.001). A ≥ 50% reduction in monthly migraine days was achieved by 39.7% (erenumab) and 29.5% (placebo) of patients (OR:1.59 (95% CI: 1.12, 2.27) (p = 0.010). Migraine-specific medication treatment days were reduced by −1.2 (erenumab) and −0.6 (placebo) days, a treatment difference of −0.6 (−1.0, −0.2) (p = 0.002). The ≥5-point reduction rates in Migraine Physical Function Impact Diary – Physical Impairment were 33.0% and 27.1% (OR:1.33 (0.92, 1.90) (p = 0.13) and in Migraine Physical Function Impact Diary – Everyday Activities were 40.4% and 35.8% (OR:1.22 (0.87, 1.71) (p = 0.26). Safety and adverse event profiles of erenumab were similar to placebo. Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions: As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration: ClinicalTrials.gov, NCT02483585.

© 2018 The Author(s) Published by S. Karger AG, Basel. Background: The most common functional gastrointestinal disorders (FGID) are functional dyspepsia (FD) and irritable bowel syndrome (IBS), with a prevalence in the general population of 15-20% (FD) and 10% (IBS), respectively. The complexity of pathophysiologic mechanisms and limitations in therapeutic options make the management of FD and IBS patients a challenge in routine clinical practice. Summary: Syndromes classified as FGID frequently overlap, and coexist with gastroesophageal reflux disease (GERD). Patients with overlapping symptoms are more likely to seek medical care. The challenge for routine clinical practice is to find the best approach for treatment of multiple symptoms. STW 5, a combination of 9 herbal extracts, was shown to have multi-target effects: it normalizes the disturbed gastrointestinal motility, alleviates hypersensitivity, inhibits inflammation, suppresses gastric hypersecretion, and modulates the microbiota. Controlled randomized studies proved STW 5 to be efficacious both in FD and IBS, with control over the full spectrum of upper and lower gastrointestinal symptoms. STW 5 reduced concomitant heartburn in FD patients. STW 5 was well tolerated in the examined populations, independent of concomitant diseases and concomitant medication. Key Messages: The clinical use of the herbal preparation STW 5 in FD and IBS is evidence-based. STW 5 is an example for the concept of multi-target therapy. It offers treatment opportunities in routine clinical practice with high prevalence of overlap of FGID and concomitant GERD. Considering that FD and IBS are typically chronic and recurrent conditions, the clinically observed good tolerability and safety of STW 5 is an advantage.

© 2018 by the authors; licensee Modestum Ltd., UK. Objective: Prolongation of the QT interval in patients with coronary heart disease (CAD) is a risk factor of polymorphic ventricular tachycardia (PVT) and as consequence, the sudden death. Drug-drug interactions (DDI) on metabolic rate involving cytochrome P-450 (CYP) is the one of the major cause of Long QT Syndrome (LQTS). The aim of the present study was to improve the safety of combined pharmacotherapy when using drugs that affect the QT interval. Method and Results: Medication occurrence of potential dangerous combination of medicines that are affected on QT interval duration in patients with CAD are researched (outpatient medical records (patient history) analysis). Clinical relevance of DDI, which are associated with changes in CYP enzyme activity, categorized by drugs.com Medication Guide. Finding potential dangerous combination of medicines that are affected on QT interval duration were administered to patients with CAD in 3.6% cases in outpatient clinical practice. The most often prescribed combination of drugs is amiodarone and torasemide (13.3% evidence of all concomitant administration that are leading to QT prolongation). The potential mechanism of Amiodarone and Torasemide interaction on metabolic rate that are leading to QT prolongation are competitive substrates CYP 2C8 and a result of inhibited CYP 2C9 by amiodarone. Conclusion: Ability to predict the prolongation of the QT interval caused by DDI on metabolic rate make possible to improve the safety concomitant administration to patients with CAD.

© 2018 Stolichnaya Izdatelskaya Kompaniya. В последние годы наблюдается очевидная тенденция увеличения в популяции числа пожилых больных. Эти пациенты в большинстве случаев страдают несколькими коморбидными заболеваниями, что значительно утяжеляет прогноз и усложняет тактику ведения. Представлен клинический случай пожилой пациентки, длительное время страдающей сахарным диабетом 2 типа, получающей инсулинотерапию, нахо- дящейся на программном гемодиализе из-за терминальной хронической почечной недостаточности, а также имеющей постоянную форму фибрилляции предсердий. Пациентка была госпитализирована в ГКБ №1 им Н.И. Пирогова по поводу острого повторного инфаркта миокарда. Проведено экстренное чрескожное коронарное вмешательство, стентирование инфаркт-зависимой артерии стентом с лекарст- венным покрытием. Послеоперационный период осложнился развитием острой кровопотери на фоне кровотечения из верхних отделов желудочно-кишечного тракта, тяжелой анемии сочетанного генеза (постгеморрагической, нефрогенной), что потребовало от врачей принятия нестандартных решений по выбору антитромботической терапии. Данный клинический случай иллюстрирует сложности ведения пожилых полиморбидных пациентов в реальной клинической практике, и спорные вопросы, возникающие при назначении им антитромботической терапии, особенно, после развившегося кровотечения. Рекомендательные документы не могут дать ответ на все вопросы, которые ставит перед врачом повседневная практика. В каждом конкретном случае возобновление антитромботической терапии и ее оптимальный выбор для пожилого полиморбидного пациента с развившимся кровотечением является предметом дискуссии, и представляет для лечащего врача настоящий вызов.

© 2018, Stolichnaya Izdatelskaya Kompaniya. The aim of the review is presenting the possibilities and perspectives of the third generation of thienopyridine P2Y12 receptor inhibitor prasugrel in the treatment of patients with acute coronary syndrome (ACS). The main pathogenetic stage of ACS is intracoronary thrombosis, which develops on the surface of a damaged atherosclerotic plaque. The use of acetylsalicylic acid with addition of the second antiplatelet agent, so-called dual antiplatelet therapy, is a standard component in the treatment of any type of ACS, regardless of reperfusion and the selected treatment strategy. Due to some limitations in the use of clopidogrel as the second component of dual antiplatelet therapy, the possibility of prasugrel or ticagrelor usage should be considered in patients with ACS with percutaneous coronary intervention (PCI). Prasugrel therapy is associated with better clinical outcomes as compared with clopidogrel therapy in moderate or high-risk patients who undergo PCI. Because of higher bleeding risk and the lack of clinical benefits in special subgroups of patients, prasugrel must not be used in patients with a stroke or transient ischemic attack in the past. If, after a thorough individual benefit-risk assessment a decision is in favor of prescribing prasugrel to the patient older than 75 years or with a small body weight the maintenance dose of prasugrel is to be reduced by half. Real clinical practice data has shown that with following these recommendations prasugrel demonstrates optimal efficacy, safety, and even more significant impact on the prognosis than this in clinical trials. Prasugrel is able to reduce significantly the incidence of cardiovascular events such as cardiovascular death, myocardial infarction and stroke in patients with ACS who undergo PCI.

© Saint Petersburg Pasteur Institute. All rights reserved. The review is devoted to the analysis of pertussis incidence of children in the age group of 5-7, as well as strategies of DTP immunization with the help of the drugs in foreign countries. Mass vaccination against pertussis began in the middle of the 20th century, which contributed to a reduction in incidence and mortality rate from this infection. However, in the last decade, there has been an opposite tendency of increasing incidence of patients among children under school age, school age and adults. Atypical forms of the disease and complications due to ARVI, respiratory mycoplasmosis and cytomegalovirus infections are described in the review. Various strategies for the use of whole-cell and acellular pertussis vaccines as part of DTP drugs are described, as well as the epidemiological effect of introducing an additional booster dose of vaccine to children under school age. The expediency of revaccination of children aged 6-7 in Russia is argued, which can help to reduce the overall incidence of pertussis. The research materials related to the study of the properties of acellular anti-pertussis vaccine, such as immunogenicity and safety in comparison with whole-cell vaccine, are analyzed. The main drugs and their composition, which are used to vaccinate children against pertussis, are described in the review. It is assumed, that the increase in the incidence among children and teenagers, with the appearance of atypical forms of pertussis, is associated with a number of factors, such as the spread of new genotypes of Bordetella pertussis bacterium, emerged from mutations, as well as short duration of immunity after vaccination with acellular drugs, in comparison with whole-cell, and the use of more modern methods of detecting the pathogen. The mechanisms of the immune response due to different types of pertussis vaccines are also reviewed. It is concluded, that revaccination of children aged 6-7 with an additional fifth dose of an acellular vaccine against pertussis, as part of the DTaP instead of the Td drug, which is regulated in the National Calendar of preventive vaccinations, will have a favorable effect on the epidemic situation with pertussis infection in Russia.

© 2018 Izdatel'stvo Meditsina. All rights reserved. This review summarizes the state-of-the-art in the problem of assessment of the safety of domperidone - a prokinetic and anti-emetic drug belonging to those most widely used in clinical practice. Special attention is devoted to the potential cardiotoxicity of domperidone, mechanisms of adverse effects development, and risk factors. For reducing the risk of development of dose-dependent side effects, new drugs have been created and used so as to maintain the active agent concentration in the blood plasma within the therapeutic range. Another method of increasing the efficacy and safety of domperidone treatment is based on the potentiation effect. An example is the use of domperidone in a fixed combination with omeprazole (Omez-DSR), in which a the prokinetic is present in a modified release form, which ensures uniform delivery of the acting agent into blood flow (without drug concentration +AJM-peaks+AJQ-related to increased risk of dose-dependent adverse drug reactions.

Glycosaminoglycan-peptide complex (GPC) (Rumalon®) is an injectable slow-release anti-inflammatory agent (SRIA) that has complex anti-inflammatory and metabolic effects. GPC has been successfully used in the treatment of osteoarthritis (OA) for several decades. The agent now returns again to Russian clinical practice. Objective: to evaluate the efficacy and tolerability of GPC in patients with knee OA, in whom other SRIAs have been previously ineffective. Subjects and methods. A study group consisted of 104 patients (92.3% women) (mean age, 63.2±8.5 years; body mass index (BMI), 28.5±5.4 kg/m2) with severe joint pain (?40 mm on a 100-mm visual analogue scale (VAS)) and/or the need to regularly use nonsteroidal anti-inflammatory drugs (NSAIDs). All the patients received oral SRIAs in the last 6 months and had no improvement. At baseline, VAS pain intensity was 59.4±13.1 mm; the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain was 227.3±90.8; WOMAC stiffness, 97.9±42.1; WOMAC function, 769.2±326.1; total WOMAC scores, 1095.1±426.6. GPC was used by the standard scheme: 25 intramuscular injections every other day per treatment cycle; the results of treatment were assessed at 8 and 12 weeks by VAS and WOMAC pain scores, needs for NSAIDs, satisfaction with treatment (measured on a 1- to 5-pont scale where 1 = no improvement or deterioration and 5 = the best result). Results and discussion. At 8 and 12 weeks, VAS pain scores decreased by 30.1±18.3% and 36.9±16.9%, respectively; the reductions in WOMAC pain scores were 29.8±16.3 and 38.2±23.4%; WOMAC stiffness scores, 29.2±15.4 and 31.6±17.4%; WOMAC function scores, 27.7±14.7 and 30.6±18.4%; and total WOMAC scores, 27.2±13.5 and 33.6±18.0%. The changes in pain intensity and WOMAC scores were statistically significant in both followup periods (p<0.001). The majority of patients rated their treatment result as good or excellent: 70.2% at 8 weeks and 75.9% at 12 weeks. 31.7% of the patients completely stopped taking NSAIDs at 12 weeks. Two patients were noted to have adverse reactions (pain at the injection site and allergic skin reaction) that did not require treatment discontinuation and completely resolved without consequences after completion of a GPC treatment cycle. Conclusion. GPC is an effective and safe agent for the treatment for OA, as well as in patients with severe OA and inefficiency of oral SRIAs.

© Pushkareva M.V., Shevyreva M.P., Goncharuk N.N., May I.V., Andrishunas A.M., 2018. The article contains information on hazardous chemical wastes, reasons that cause their occurrence and accumulation in the environment as well as issues related to accumulation of persistent organic pollutants (POPs) in the environmental objects. The authors outline specific features of POPs and their possible influence on the environment and a human body; they also dwell on priority activities accomplished in the RF in relation to POPs after Stockholm Convention on Persistent Organic Pollution was ratified. Provisions of international law in the sphere of providing chemical safety are being consolidated now and operating bodies of Basel, Rotterdam, and Stockholm Conventions interact with each other in order to fix concentrations for chemicals which are persistent organic pollutants and to determine their low contents in wastes. The European Union countries and Canada have submitted their proposals on concentrations of 21 various chemicals in wastes for consideration by all the concerned parties. Scientific validity of the proposed concentrations has been analyzed; the analysis results are given in the article. Given the hazards caused by chemicals wastes that contain POPs for people and the environment, the authors suppose that additional research should be performed on substantiation of POPs safe concentrations in wastes. Taking into account national security and common provisions of international laws related to solving global, national, and regional tasks, the authors note that it is necessary to update legislation on state regulation in the sphere of providing chemical safety; they also give grounds and outline conceptual approaches to creation of the Federal Law "On chemical safety". The article gives a basic idea of this law; its purpose; an object of its regulation; people or economic entities whose activities are subject to its force; a place this law, when passed, is going to have in the RF federal legislation and a system of international agreements that are ratified by the RF. It should be noted that when the Federal Law "On chemical safety" is adopted, it will allow to reduce negative effects produced by hazardous chemical wastes on population and the environment and will have both medical and social-economic outcomes.

© 2018 Ima-Press Publishing House. All Rights Reserved. In 2015, the experts from various medical associations of Russia elaborated the clinical guidelines "Rational use of nonsteroidal anti-inflammatory drugs (NSAIDs) in clinical practice". These guidelines were drawn up to improve the use of NSAIDs, our country's most popular agents to treat pain in acute and chronic diseases. The main purpose of this paper was to reduce the frequency of potentially dangerous class-specific adverse events (AE) that may arise from the use of NSAIDs. To do this, the authors proposed a NSAID choice algorithm based on the assessment of risk factors for AE, the individual characteristics of various representatives of this drug group, and the possibility of prevention of AE. Since then, new data on the efficacy and safety of NSAIDs have been obtained. This has necessitated the revision and addition of a number of provisions in the 2015 guidelines. It seems that the new version of the guidelines, which has been drawn up based on the analysis of a large number of clinical and epidemiological studies, their meta-analysis, by taking into account the clinical experience and opinion of the world's leading experts, presents more fully the main aspects of the use of NSAIDs in real clinical practice. The guidelines are intended for physicians of all specialties.