Introduction Surgical treatment of the forefoot deformities using corrective osteotomies can be associated with local reactions, manifested by postoperative swelling and pain. The factors can impact the timing and quality of early patient rehabilitation. The search for safe and effective means to relieve postoperative swelling and pain is essential in modern traumatology and orthopedics. The escin lysinate solution with angioprotective, anti-edematous, and analgesic effects, is considered as a pathogenetically substantiated approach. The objective was to compare the efficacy and safety of escin lysinate used to reduce postoperative swelling and pain in patients after corrective osteotomies of the foot and the standard therapy and therapy supplemented with a short course of systemic glucocorticosteroids. Material and methods A prospective randomized study included 30 patients (18–70 years) who underwent SCARF osteotomy of the first metatarsal bone, AKIN osteotomy, and/or Weil osteotomy. Patients were divided into three groups (10 individuals each) who underwent standard therapy (control); standard therapy + escin lysinate; standard therapy + dexamethasone. The severity of swelling of the limb, pain assessed with the visual analog scale (VAS), the need for nonsteroidal anti-inflammatory drugs (NSAIDs), the level of C-reactive protein, and the safety of therapy were dynamically evaluated. Results The pain significantly reduced in the first three postoperative days in the escin lysinate group as compared to the control group with a reduced need for NSAIDs. A greater edema regression was observed at the metatarsal level at six weeks. Dynamics in pain was noted in the dexamethasone group at a short term with a less need for NSAIDs. No adverse reactions or clinically significant changes in laboratory parameters were recorded. Discussion Postoperative edema was more evident in the foot as compared to other anatomical sites due to limited soft tissue volume and slow venous and lymphatic outflow from the distal extremities. In this context, medications that reduce vascular and tissue permeability play a role. Aescin lysinate was shown to demonstrate efficacy in neurosurgery and otolaryngology with the use being associated with reduceed edema and inflammation. In orthopedics and traumatology, the drug demonstrated angioprotective and analgesic potential in lower extremity injuries. Unlike systemic glucocorticosteroids such as dexamethasone having a pronounced but short-term anti-inflammatory effect and being associated with the risk of hyperglycemia, infections and bone loss, escin lysinate has a safety profile and can be considered as a pathogenetically justified agent for the control of postoperative inflammation and edema. Conclusion A comparative evaluation of the adjuvant use of escin lysinate, standard therapy, and therapy supplemented with a short course of systemic glucocorticosteroids after corrective foot osteotomies demonstrated earlier pain relief and accelerated edema resolution with no risk of adverse reactions with escin lysinate. The drug can be considered an effective and safe addition to standard therapy, providing a more favorable early postoperative effect.
Introduction Phage therapy is a promising approach to addressing the problem of antibiotic resistance in orthopedic infection pathogens. Staphylococci are the leading etiotropic agents of implant-associated infections, with 15 % of S. aureus strains being methicillin-resistant (MRSA). Bacteriophage preparations are available on the Russian pharmaceutical market, and the concentration of phages active against the microbial agent influences their effectiveness. The objective was to compare the activity of commercial bacteriophage kits against methicillin-resistant Staphylococcus aureus isolated from patients with orthopedic infections. Material and methods Clinical strains of S. aureus (n = 25), consecutively isolated from patient biomaterial in 2025 were examined. Identification was performed using MALDI-TOF MS, and antibiotic susceptibility assessed according to EUCAST v.15. Phage lytic activity was evaluated using meat-peptone agar and a five-point scale with the strain sensitivity to a specific drug determined as sensitive, weakly sensitive, or resistant. Statistical analysis was performed using IBM SPSS Statistics v.26. Results The S. aureus strains included in the study were resistant to cefoxitin. Of the MRSA strains tested, the majority (76 %) were sensitive to PBP 1. A larger number of strains (60%) were classified as "weakly sensitive" to PBP 3. There were less variations in "non-susceptible" cultures, with only one strain demonstrating resistance to the three bacteriophage preparations. A comparative analysis of antistaphylococcal drugs from various manufacturers revealed differences in the activity against clinical MRSA isolates. There were 84 % isolates being sensitive to PBP 4 and 36 % to PBP 5. One isolate was resistant to the phages tested. Discussion The differences in the activity of commercial phages could be associated with the composition of the resulting preparations, which had lower affinity for strains isolated from patients in other regions. Given the wide geographical distribution of patients with orthopedic infections hospitalized in federal centers, the ability to choose bacteriophages from a wide range of commercial kits available on the market increases the likelihood of their successful use. Conclusion Commercial drugs presented on the Russian market were characterized by different lytic activity against clinical strains of MRSA, with Pyophag® and Staphylophag® exhibiting greater activity.
The clinical guidelines describe modern approaches to the prevention, diagnosis, and treatment of infections associated with orthopedic implants. The clinical guidelines are intended for physicians of various specialties providing medical care to relevant patients: orthopedic and trauma surgeons, anesthesiologists and critical care physicians, clinical pharmacologists, healthcare administrators, as well as medical students, residents, and postgraduates. This publication presents the key provisions of the clinical guidelines, the full text of which can be found on the website cr.minzdrav.gov.ru.
Introduction Treatment of patients with orthopedic infection includes a combination of the optimal surgical debridement and adequate antibacterial therapy. Gram-negative bacteria are encountered in 13–28 % of orthopedic infections, and A. baumannii, K. pneumoniae, P. aeruginosa are significant bacteria notorious for its high and intrinsic antibiotic resistance and can be associated with worse outcomes. The objective was to substantiate the choice of drug for targeted empirical and etiotropic antibacterial therapy based on the analysis of antibiotic resistance in leading gram-negative bacteria (A. baumannii, K. pneumoniae, P. aeruginosa) isolated from patients with orthopedic infection. Material and methods Antibiotic sensitivity of leading Gram(–) microorganisms isolated from patients with orthopedic infection was retrospectively examined between 01.01.2011 and 31.12.2022. The average frequency of isolated resistant strains was examined and resistance trends of leading Gram(–) pathogens to various antimicrobialbacterial drugs (fluoroquinolones, co-trimoxazole, cephalosporins, carbapenems, monobactams, aminoglycosides, fosfomycin, colistin) determined. Results Over a 12-year period, statistically significant trends were revealed towards an increase in the proportion of A. baumannii strains resistant to ciprofloxacin (p = 0.024) and levofloxacin (p = 0.012), and P. aeruginosa (p = 0.018) and K. pneumoniae (p = 0.018) strains resistant to ciprofloxacin. The predicted proportion of A. baumannii strains resistant to fluoroquinolones tends to 100 %. There was a significant increase in A. baumannii and P. aeruginosa strains resistant to cefoperazone+[sulbactam] (p = 0.027 and p = 0.010, respectively), K. pneumoniae strains resistant to meropenem and imipenem (p = 0.037 and p = 0.003, respectively), and P. aeruginosa strains resistant to imipenem (p = 0.001). No statistically significant trends were found for the remaining antibiotics; drug resistance of the pathogens remained stable or had a wave-like course over the 12-year period. Cefoperazone + [sulbactam] was the optimal drug active against Gram(–) bacteria. Discussion There is an authoritative list of antimicrobiall drugs active against A. baumannii, K. pneumoniae, P. aeruginosa strains, mainly containing drugs for parenteral administration. The list is limited to one or two groups for resistant strains, and there are no drugs available in oral form. This causes difficulties in the infection control and a high rate of relapses. The negative dynamics in increasing antibiotic resistance of leading Gram(–) pathogens to fluoroquinolones, cephalosporins and carbapenems is a global problem necessitating the use of reserve antibiotics. Conclusion Protected cephalosporin is more practical for targeted empirical initial antimicrobial therapy due to the lower risk of selected resistant strains. Fluoroquinolones and carbapenems can be used with the sensitivity known. Polymyxin B and fosfomycin should be considered as reserve drugs for the treatment of infections caused by strains resistant to other AB, and prescribed as part of combination therapy. Aminoglycosides and unprotected cephalosporins can be an alternative due to the pharmacokinetic characteristics and high level of resistance when more active drugs cannot be administered.
Introduction Staphylococcus aureus is a leading pathogen causing osteoarticular infections. Panton – Valentine leukocidin (PVL) is considered one of the key of virulence factors with its role being poorly explored in orthopedic infections. The objective was to evaluate the occurrence of the PVL gene in S. aureus strains, the effect on laboratory markers of inflammation and on the course of the infectious process in orthopedic patients. Material and methods A retrospective analysis of 130 S. aureus strains isolated from 100 patients was performed. The presence of the lukS-PV and lukF-PV genes was determined using PCR. Laboratory parameters (CRP, ESR, leukocytes, neutrophils, and procalcitonin) and long-term treatment outcomes were assessed. Results PVL was detected in 15 % of strains S. aureus. No statistically significant effect of PVL on the levels of routine inflammatory markers was found. A key finding was that the presence of the PVL gene was associated with an increased risk of adverse outcome. Discussion The findings can be associated with debates on the clinical significance of PVL. Despite a significant impact on outcome The absence of significant differences in systemic inflammatory markers suggests that the negative effect of PVL is rather mediated by other mechanisms than by global inflammation activation measured by routine tests. These include direct cytotoxic tissue damage, impaired immune cell function, and the emergence of specific immunological processes. The association identified between PVL and the MRSA phenotype is consistent with the global epidemiological picture, where this toxin is a marker of hypervirulent community-acquired strains. Conclusion The presence of PVL is a significant risk factor for a poor outcome of orthopedic infection suggesting the need for its detection for risk stratification and optimization of patient management strategy. Conclusion The presence of PVL is a significant risk factor for an unfavorable outcome of orthopedic infection, which indicates the need for its detection for risk stratification and optimization of patient management tactics.
The aim of the study - to substantiate the choice of a drug for empirical antibacterial therapy based on the analysis of antimicrobial resistance dynamics in leading Gram(+) bacteria isolated from patients with orthopedic infection from 2011 to 2022. Methods. We performed a retrospective study of data on the antimicrobial susceptibility in leading Gram(+) bacteria isolated from patients who were treated from 01.01.2022 to 31.12.2022. Based on the data obtained, we investigated the dynamics and determined the prognosis of resistance in leading Gram(+) pathogens. This article analyzes 5 groups of antibiotics active against Gram(+) microorganisms: fluoroquinolones, sulfonamides, tetracyclines, lincosamides, fosfomycin. Results. More than 75% of MRSA strains and more than 50% of MRSE strains demonstrated resistance to fluoroquinolones. Methicillin-sensitive strains have a lower resistance profile; the proportion of moxifloxacin-resistant MSSA during the entire follow-up period was 2.3%, MSSE - 14.7%. The proportion of ciprofloxacin-resistant E. faecalis strains decreased during the 12-year follow-up from 61.3% in 2011 to 40.4% in 2022. Over the 12-year follow-up period, our center has seen a decrease in the proportion of Staphylococcus spp. strains resistant to co-trimoxazole. At the same time, the drug is more active against S. aureus and methicillin-sensitive strains than against S. epidermidis and MR strains, respectively. The local monitoring data in our center demonstrate the activity of fosfomycin against more than 90% of staphylococci. In general, the average proportion of MRSA strains resistant to this drug was 5.8%, MRSE - 7.7%, and MSSE - 7%. The proportion of clindamycin-resistant MSSA increased from 1.5 to 12% and averaged 4.4%. At the same time, the incidence of clindamycinresistant MRSA varied between 39-60% with a tendency to decrease to 48% by the end of the follow-up period. Conclusions. None of the broad-spectrum antibiotics can be recommended for use in the initial empirical therapy of orthopedic infection. Fluoroquinolones and co-trimoxazole are active against 30-33%, tetracyclines - against 39% (mainly due to the continued activity of minocycline and tigecycline), clindamycin - against 64% of gram-positive pathogens. Fosfomycin remains active against about 90% of staphylococci. However, to date, there are no criteria for assessing the sensitivity of enterococci to it, and therefore the sensitivity of enterococci to fosfomycin has not been determined.
Real-word data obtained using medical devices differ from the use of drugs. When using medical devices, the effectiveness is usually not in doubt, and the issues of biocompatibility, safety, and long-term use come to the fore. This article presents a translation of the clinical guidelines of the People’s Republic of China on planning and conducting studies on the use of medical devices in real-world clinical practice, as well as statistical processing of the information obtained in an abbreviated form.
This review describes the basics of protein biosynthesis and RNA interference processes, discusses the useful and unique properties of siRNA therapy, its advantages and disadvantages in comparison with other gene silencing methods, provides a brief overview of technical advances and modifications of siRNA therapy, and characterizes siRNA-registered drugs and agents at different stages of clinical trials.
Objective: to perform pharmacoeconomic analysis of the feasibility of using topical bacterial lysate in the form of nasal spray (IRS®19) for the treatment and prevention of upper respiratory tract infections in pediatric population in comparison with other drugs registered in Russia, belonging to the class of topical interferons. Material and methods. Based on the Rosstat data and information from open sources, the population of patients with acute respiratory infections (ARI) was calculated. Considering the Russian clinical recommendations “Acute respiratory viral infection (ARVI)” and “Acute tonsillitis and pharyngitis (acute tonsillopharyngitis)”, the direct medical costs of providing medical care to specialized patients were determined. Direct costs on the part of parents included all costs for purchasing medicines for basic or concomitant therapy. Direct costs on the part of the healthcare system and the state included the costs of providing medical care at the outpatient stage. Direct non-medical costs included payments for disability leaves, indirect costs – lost gross domestic product (GDP) due to absence from work. Results. The total costs of the healthcare system and the state for 1 AVI patient are 42,472 rubles in case of uncomplicated course and 70,649 rubles in case of complicated course. In case of IRS®19 application from the first day of the disease, it is possible to reduce its duration by more than two-fold. Thus, the costs of medical care amount to 2,078 rubles. Payments for disability leaves by the Social Fund of Russia will amount to 2,287 rubles, and the lost GDP – 9,148 rubles (total costs 13,513 rubles). Conclusion. For the first time in Russian economic conditions, the use of IRS®19 for ARI treatment and prevention in children was evaluated. IRS®19 application from the first symptoms of the disease allows refusing the use of topical interferons, reduces the duration of symptoms and the need for prescription of antitussives, vasoconstrictors, and antibiotics.
Background. The number of surgeries on the musculoskeletal system is increasing every year. Along with the increasing access to orthopedic care, the number of patients with orthopedic infection, the etiological agents of which can be from various taxonomic groups, is also increasing. Staphylococcus aureus and different types of coagulase-negative staphylococci (CoNS), including S. epidermidis and S. lugdunensis, together are the causative agents in 70% of cases. Aim of the study — to analyze the dynamics of the microbial spectrum isolated from patients of the septic surgery department for the period from 2011 to 2022. Methods. We performed a retrospective analysis of the microbial spectrum isolated from patients who were treated in the septic surgery department from January 1, 2011 to December 31, 2022. The leading pathogens were microorganisms whose share in the spectrum exceeded 3.5%. Of the isolated pathogens, 48.8% were the only etiological agents, and microbial associations were detected in 51.2% of the isolated pathogens. Results. A total of 10,327 bacteria strains were identified over the 12-year period. The leading microorganisms causing orthopedic infection were Staphylococcus spp., Enterococcus spp., Propionibacterium spp., Pseudomonas aeruginosa, Corynebacterium spp., Streptococcus spp., Klebsiella spp. and Acinetobacter spp. In the dynamics of isolated pathogens during the analyzed period, several trends were determined: a decrease in the shares of S. aureus, Enterococcus spp., P. aeruginosa, Acinetobacter spp. and an increase in the shares of CoNS and Corynebacterium spp. Conclusion. During 12 years, in the microbial spectrum of orthopedic infection in patients of the septic surgery department of our Center, Gram-positive bacteria, in the majority representatives of the genus Staphylococcus, prevailed. At the same time, a significant decrease in the share of S. aureus strains and an increase in the frequency of isolation of various species of CoNS were registered. A significant decrease in the number of non-fermenting Gram-negative bacteria was also revealed.
Background. The outcome of complex treatment of implant-associated infection (IAI) depends on various factors, but one of the most important is the etiology of the inflammatory process. Treatment of orthopedic infection caused by Gram-negative microorganisms in general and representatives of the family Enterobacteriaceae in particular causes many difficulties, one of which is the rapid growth of antibiotic resistance. Aim of the study - to evaluate the factors affecting the course and prognosis of implant-associated infection caused by Klebsiella spp. Methods. We performed a retrospective analysis of case histories of 85 patients who underwent treatment of IAI caused by Klebsiella spp. in the clinical departments of the center from January 1, 2017 to December 31, 2021. According to the results of the telephone survey, the patients were divided into 2 main groups depending on the outcome of the 2-year follow-up period determined in accordance with the Delphi criteria. Results. It was found that the prognosis was significantly worsened by the number of sanitizing surgical interventions in the anamnesis (p = 0.022), the need for sanitizing intervention in the early postoperative period (p<0.001) and the presence of Klebsiella spp. growth in postoperative culture tests (p = 0.002), hypoalbuminemia on 7-14 days after the surgery (p = 0.008). The administration of trimethoprim-sulfamethoxazole for the outpatient treament stage significantly improved the outcome (p = 0.038), which is most likely due to a high proportion of polymicrobial associations - 69.5%. Conclusions. There is a statistically significant direct relationship between the probability of an unfavorable treatment outcome of patients with IAI caused by Klebsiella spp. and the number of sanitizing surgical interventions in the anamnesis, low serum albumin (g/l) on 7-14 days after the operation, revision intervention in the early postoperative period, positive growth of Klebsiella spp. in postoperative culture tests. The probability of a favorable outcome was increased by the prescription of trimethoprim-sulfamethoxazole for oral administration at the outpatient stage.
Objective: pharmacoeconomic analysis of the feasibility of using topical bacterial lysate Imudon® for the treatment and prevention of acute upper respiratory tract infections in the pediatric population in comparison with other medicines belonging to the class of topical antiseptics.Material and methods. For the population calculated on the basis of Rosstat data, taking into account the Russian clinical recommendations "Acute respiratory viral infection (ARVI)" and "Acute tonsillitis and pharyngitis (acute tonsillopharyngitis)", the direct medical costs of medical care were determined. The cost of basic therapy of 1 case of acute respiratory infection (ARI) with symptoms of pharyngitis was calculated for two variants of clinical course: favorable (when ARI proceeds without complications and the patient does not need to be prescribed antibacterial drugs), and unfavorable (when confirmed bacterial infection joins and antibiotics are required). The indirect costs of child care are associated with lost gross domestic product (GDP). In estimating the GDP shortfall, it was assumed that the parent does not contribute to the country’s GDP during the entire childcare period.Results. GDP per capita for 2022 amounted to 2853.13 rubles per day. Thus, with a favorable course of the disease, indirect costs will be 19,972 rubles, and with an unfavorable course – 39,944 rubles. The total costs of the healthcare system and the state for 1 ARI patient are 32,192 rubles in case of favorable course and 71,644 rubles in case of unfavorable course. Imudon® administration allows reducing direct costs of parents for purchase of medicines for treatment of 1 ARI case by 23.6% compared to the therapeutic strategy associated with the use of local antiseptics.Conclusion. For the first time in Russian economic conditions, the use of Imudon® for the treatment and prevention of acute upper respiratory tract infections in children was evaluated. Its use from the first ARI symptoms allows refusing the use of local antiseptics, shortens the duration of the disease symptoms, and reduces the need for antibiotics, i.e. is feasibleable compared to local antiseptics.
Purpose: Dabigatran is usually prescribed in recommended doses without monitoring of the blood coagulation for the prevention of venous thromboembolism after joint arthroplasty. ABCB1 is a key gene in the metabolism of dabigatran etexilate. Its allele variants are likely to play a pivotal role in the occurrence of hemorrhagic complications. Methods: The prospective study included 127 patients with primary knee osteoarthritis undergoing total knee arthroplasty. Patients with anemia and coagulation disorders, elevated transaminase and creatinine levels as well as already receiving anticoagulant and antiplatelet therapy were excluded from the study. The association of ABCB1 gene polymorphisms rs1128503, rs2032582, rs4148738 with anemia as the outcome of dabigatran therapy was evaluated by single-nucleotide polymorphism analysis with a real-time polymerase chain reaction assay and laboratory blood tests. The beta regression model was used to predict the effect of polymorphisms on the studied laboratory markers. The probability of the type 1 error (p) was less than 0.05 was considered statistically significant. BenjaminiHochberg was used to correct for significance levels in multiple hypothesis tests. All calculations were performed using Rprogramming language v3.6.3. Results: For all polymorphisms there was no association with the level of platelets, protein, creatinine, alanine transaminase, prothrombin, international normalized ratio, activated partial thromboplastin time and fibrinogen. Carriers of rs1128503 (TT) had a significant decrease of hematocrit (p = 0.001), red blood count and hemoglobin (p = 0.015) while receiving dabigatran therapy during the postoperative period compared to the CC, CT. Carriers of rs2032582 (TT) had a significant decrease of hematocrit (p = 0.001), red blood count and hemoglobin (p = 0.006) while receiving dabigatran therapy during the postoperative period compared to the GG, GT phenotypes. These differences were not observed in carriers of rs4148738. Conclusion: It might be necessary to reconsider thromboprophylaxis with dabigatran in carriers of rs1128503 (TT) or rs2032582 (TT) polymorphisms in favor of other new oral anticoagulants. The long-term implication of these findings would be the reduction of bleeding complications after total joint arthroplasty.
This article provides a brief overview of the key aspects of planning, conducting, and reporting NICE clinical practice data collection and analysis studies, as well as general information about the sources of real-world data (RWD) and their use in NICE management decision-making algorithms. The difficulties of finding and using RWD are described, as well as methods for overcoming them, brief NICE recommendations for assessing the suitability of data and an algorithm for conducting quantitative studies to collect evidence from RWD are given.
Relevance. Diseases of the cardiovascular system remain one of the main causes of death worldwide. The incidence of cardiovascular and circulatory diseases increased by one third between 1990 and 2010. The prevalence of atrial fibrillation (AF) ranges from 2.5–3.5% in the general population of patients to 9–17% in individuals aged 80 years and older. The aim of the study is to analyze the costs of the Russian healthcare system for various types of treatment of atrial fibrillation. Materials and methods . The assessment of the present economic burden of AF included an assessment of such direct costs as inpatient treatment, outpatient visits, treatment in a day hospital, medical support, treatment of complications of AF. Results. The socio-economic burden of AF in the Russian Federation for 2022 without surgical treatment amounted to 196.44 billion rubles per year, compared to 2010 and 2018, costs increased by 77% and 73%, respectively.
Background. Stenotrophomonas maltophilia (S. maltophilia) is a gram-negative non-fermenting bacillus and is a rare pathogen of orthopedic infection. Due to the relatively low virulence of S. maltophilia, many clinicians are still faced with the question of whether this bacterial species is simply a colonizing agent or the true cause of infection. Aim of the study to raise the awareness of practitioners about S. maltophilia as a rare pathogen of orthopedic infection. Methods. A retrospective analysis was performed concerning the frequency of S. maltophilia isolation from patients treated at the Vreden Center for periprosthetic infection and/or osteomyelitis from January 1, 2009 to October 31, 2022. The literature search by keywords was carried out in the PubMed/MEDLINE, Scopus, eLIBRARY, and Cyberleninka databases. The search retrieved 587 articles published in Russian or English over the period from 2012 to November 2022. Results. During the study period, 9 cases of orthopedic monoinfection with S. maltophilia were identified in 9 patients aged 36 to 83 years. At the time of admission, no leukocytosis was detected in patients, and only 2 of 9 patients had elevated C-reactive protein level. S. maltophilia is naturally resistant to many broad-spectrum antibiotics. Co-trimoxazole is considered the drug of choice for the treatment of S. maltophilia infection. The limited choice of drugs for targeted therapy, the presence of multiple determinants of antibiotic resistance, the existence of microbial associations and patient risks including implantation, chronic nature of infection, elderly age, as well as the presence of significant concomitant somatic pathology can lead to the ineffectiveness of the ongoing treatment of infections caused by S. maltophilia. Our experience shows that in the case of sensitivity of S. maltophilia strain to co-trimoxazole it is possible to prescribe this drug for a long course as monotherapy, provided that the radical surgical treatment of the focus is performed.
About 10 years ago, the FDA launched an initiative to expand the role of patients in informing regulators and sponsors about the most serious consequences of the disease and the main treatment goals that can lead to desired medical outcomes. This initiative has grown into four guidance that aim.
Aim. To conduct a pharmacoeconomic analysis of the use of the drug Eliquis® (apixaban), belonging to direct oral anticoagulants (DOACs), for the treatment and prevention of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), including in patients suffering from cancer disease compared with other anticoagulants. Materials and Methods. The economic assessment was made from the standpoint of the healthcare of the Russian Federation. Comparative evaluation of the effectiveness of DOACs was carried out on the basis of the combined rate of the incidence of VTE and death from VTE, as well as death from any cause. Safety assessment — based on the rate of major bleeding (MB) and clinically significant non-severe bleeding (CSNSB). The evaluation was performed on the basis of data obtained in the course of previously performed meta-analyses, the results of which were published. The total cost of patient management for each of the compared alternative treatment tactics was estimated by calculating the cost of a course of drug therapy, as well as the cost of managing adverse events in the study horizon, which was 12 months. The conclusion about the most preferred alternative was made on the basis of data on the relationship between the effectiveness and cost of treating the patient. Results. Apixaban compared with dabigatran and rivaroxaban was associated with a lower risk of developing MB and CSNSB. In addition, in patients taking apixaban, there was a trend towards a decrease in the risk of death from any cause compared with patients who used dabigatran and rivaroxaban, which did not reach statistical significance, which in turn led to the choice of the method of pharmacoeconomic analysis — “cost minimization”. It has been established that the use of apixaban is characterized by the lowest costs, the cost of managing one patient amounted to 59 271,89 rubles per year, which is 28,8 % and 27,2 % lower than similar costs for treatment regimens with the original drugs dabigatran and rivaroxaban, respectively. The difference in costs was due to both the cost of treating complications (1362.8 rubles vs. 2536.3 rubles vs. 3170.9 rubles for apixaban, rivaroxaban and dabigatran, respectively), and the cost of treatment and prophylaxis of DOACs (31 514,20 RUB vs 46 434,8 RUB vs 46 790,6 RUB, respectively). Similar results were achieved in the group of patients suffering from oncological diseases, as DOACs also allowed to reduce costs by 4–5 times compared with the use of LMWH. Conclusion. Among the original DOACs and traditional LMWH therapies, the apixaban regimen has the best cost-effectiveness ratio and is the most preferred alternative in terms of pharmacoeconomic analysis.
Aim . To compare the effectiveness of direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (AF) for preventing stroke and systemic thromboembolism (embolism in the vessels of the systemic circulation, systemic embolism) in terms of pharmacoeconomic indicators. Materials and Methods . The economic assessment was carried out from the standpoint of the healthcare system of the Russian Federation. We used published data on the clinical efficacy and safety of DOACs, which were obtained earlier in clinical trials. The efficacy of therapy was assessed by the incidence of ischemic stroke (IS) of systemic embolism (SE), while the safety was assessed by the incidence of major bleeding (MB) and clinically signifi cant minor bleeding (CSNMB). The total cost of patient management for each alternative treatment option included both the cost of drug therapy and the cost of managing adverse events over a study horizon of 12 months. The conclusion about the most preferred alternative was made on the basis of the ratio of effectiveness and cost of treating the patient. Results . The use of apixaban to prevent IS or SE in patients with AF was accompanied by a decrease in the incidence of their development (HR 0.80, 95 % CI 0.73–0.89; HR 0.72, 95 % CI 0.60–0.85 — compared with rivaroxaban and dabigatran, respectively), as well as a decrease in the frequency of MB compared with other DOACs (HR 0.55, 95 % CI 0.53–0.59; HR 0.78, 95 % CI 0.70–0.87 — compared with rivaroxaban and dabigatran, respectively). Since apixaban was more effective and safer than rivaroxaban and dabigatran, a cost-effectiveness approach was applied in this study. The least expensive treatment regimen included apixaban, the direct cost was 33,263 roubles per patient. The advantage was achieved both due to the lower of therapy with apixaban (29.6–34.0 % lower than other DOACs) and the minimum cost of managing the adverse events: for MB and CSNMB, it was reduced by 20.7 % compared to dabigatran and by 44.7 % compared to rivaroxaban; for stroke/SE, it was reduced by 25.9 % and 20.6 %, respectively. Conclusion . In patients with AF, apixaban was more cost-effective compared with rivaroxaban or dabigatran for preventing IS and SE, as it led to higher clinical efficacy and safety while requiring less healthcare system costs.
Introduction Mycobacterium abscessus species belongs to the group of non-tuberculosis mycobacteria responsible for chronic infections in people with weakened immunity. M. abscessus exist in various ecological niches and are able to colonize artificial surfaces, including medical and surgical instruments/ devices. Due tothe low incidence of M. abscessus as a causative agent of orthopedic infection, a rare clinical case of periprosthetic infection caused by M.abscessus would interest practitioners.The aim is to present a clinical case of periprosthetic infection caused by M. abscessus.Materials and methods From the medical records and discharge documents, it was known that female patient X. underwent total hip replacement at her residence hospital. Signs of acute infection of the postoperative wound appeared in the early postoperative period.Results Three months later, the patient was hospitalized in a specialized institution with a diagnosis of chronic deep periprosthetic infection. During the examination, the mycobacterial etiology of the process was established. During two hospitalizations, the patient underwent 4 consecutive revision surgeries (including muscle plastic surgery and installation of an antimicrobial spacer) and massive parenteral antibiotic therapy for 8 months, including at the outpatient stage, using at least 3 antibacterial agents. After 4 years, the patient does not complain of the infectious process. Postoperative scar is 45 cm. The residual shortening of the right lower limb of 3 cm was compensated by orthopedic shoes.Discussion Treatment of infection caused by M. abscessus is challenging due to the natural resistance of the pathogen to a wide range of antibacterial drugs. The literature describes separate cases of orthopedic infections caused by this pathogen. All authors agree that the key to successful treatment is a combination of radical surgical debridement and antibacterial therapy using at least three antimicrobial drugs.Conclusion A rare clinical case of periprosthetic infection caused by Mycobacterium abscessus after primary hip replacement is presented. This infectious agent is a rare pathogen, for which there is no proven therapeutic algorithm. Long-term aggressive antibiotic therapy in combination with stage-by-stage surgical treatment was successful.