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The aim of the study was to evaluate the efficacy and safety of an RNA double-stranded sodium salt drug, a lyophilisate for a solution preparation for an intramuscular and subcutaneous administration, as a means of post-exposure COVID-19 prophylaxis in comparison with placebo.Material and methods. A double-blind, placebo-controlled, multicenter, randomized phase III clinical trial was conducted to evaluate the efficacy and safety of a double-stranded sodium salt RNA drug (RADAMIN®VIRO), a lyophilisate for preparing a solution for intramuscular and subcutaneous administration as a means of post-exposure prophylaxis of COVID-19. The study was conducted in 10 research centers in the Russian Federation from May 31, 2022 to January 17, 2023. The study included men and women aged ≥18 years who cohabitate with a person with a documented COVID-19 diagnosis and do not have symptoms characteristic of COVID-19. At the randomization stage, the subjects were assigned to one of two groups: group 1 (n=400) received a study drug RADAMIN®VIRO 5 mg (1 vial) intramuscularly once a day; group 2 (n=400) received placebo 1 vial intramuscularly once a day. The total duration of the study for each subject was no more than 30 days.Results. By day 10-11, in the double-stranded sodium salt RNA preparation group, the proportion of the subjects with confirmed COVID-19 and at least 1 symptom characteristic of COVID-19 was 5.76% (23/399), and in the placebo group – 11. 03% (44/399). The difference in proportions between the study drug and placebo groups was 0.0526 (5.26%), the 95% confidence interval (CI) for the difference in proportions between the groups was -95% CI [0.0123;0.0937]). More than 94% of single-dose subjects did not become infected with COVID-19 with any symptoms during the 11 days of the follow-up. As a result of a comparative analysis, it was shown that the infection frequency in the study drug group was statistically significantly (almost twice) less than in the comparison group, which indicates a high efficiency and expediency of using the double-stranded sodium salt RNA preparation as a means of the post-exposure COVID-19 prophylaxis.Conclusion. Thus, regardless of the vaccination availability, the effectiveness and feasibility of using the study double-stranded sodium salt RNA preparation as a means of the post-exposure COVID-19 prophylaxis was demonstrated not only in medical institutions (outpatient clinics and hospitals), but also in caregivers and/or the persons in contact with COVID-19 patients. The situation was the same in the organizations and enterprises in case of evolution of a mass infection threat and the availability of appropriate medical personnels.

Aim: to analyze current approaches to H. pylori eradication therapy in adults and present the materials of Experts Council held on December 9, 2022 in Moscow.General statements. H. pylori infection is the main etiological factor of gastritis, peptic ulcer, and gastric cancer. Eradication of H. pylori is recognized as a necessary measure to reduce the incidence of these diseases. The approaches to selecting an eradication regimen should be optimized to take into account epidemiological trends and achieve better treatment outcomes. The updated Maastricht VI Consensus Report presents the means to overcome the difficulties in selecting an approach to the treatment of H. pylori infection. However, eradication therapy remains challenging due to adverse events (primarily antibiotic-associated diarrhea), poor treatment tolerance and patient compliance. Eradication therapy can be optimized by supplementing treatment regimens with strain-specific probiotics that reduce adverse events, improve patient compliance and eradication rates, such as Saccharomyces boulardii CNCM I-745 strain with established efficacy.Conclusion. The inclusion of certain probiotics in eradication regimens improves treatment tolerance, reduces the risk of adverse events, improves patient compliance and eradication rates.

Aim: bring to the attention of practitioners indications for anti-Helicobacter therapy, methods and procedure for diagnostics and eradication therapy of Н. pylori infection.Key points. Chronic gastritis caused by Н. pylori infection, including asymptomatic persons, may be considered as an indication for eradication therapy of Н. pylori as etiological therapy and opportunistic screening for gastric cancer prevention. Indications, for obligatory anti-Helicobacter therapy include peptic ulcer, gastric MALT lymphoma, early gastric cancer (EGC) with endoscopic resection. H. pylori primary diagnostics methods include 13C-urea breath test, H. pylori stool antigen lab test, rapid urease test and serological method. The serological method cannot be used after anti-Helicobacter therapy.In Russia H. pylori strains' resistance to clarithromycin does not exceed 15 % in most regional studies. The first line therapy for Н. pylori infection eradication is the standard triple therapy including a proton pump inhibitor (PPI), clarithromycin and amoxicillin, enhanced with bismuthate tripotassium dicitrate. A classic four-component therapy based on bismuthate tripotassium dicitrate or quadrotherapy without bismuth drug products which includes PPI, amoxicillin, clarithromycin and metronidazole, may be used as alternative to the first line eradication therapy. The standard triple therapy may be prescribed for 14 days only in those regions, where it has been proven to be effective. Quadrotherapy with bismuthate tripotassium dicitrate is also used as main second line therapy in case of standard triple therapy, bismuth enhanced standard triple therapy or combined therapy failure. Another second line therapy includes PPI, levofloxacin and amoxicillin, to which a bismuth-containing drug product may be added. The third line therapy is selected individually based on previously used treatment settings.Conclusion. In each case of H. pylori infection the decision for eradication therapy should be made, which is especially relevant as eradication of H. pylori has been recognized as an effective measure for the prevention of gastric cancer.

Community-acquired pneumonia is one of the most common acute infectious diseases that has a significant share in the structure of mortality from respiratory diseases. It is extremely important to select rational antibiotic therapy which ensures optimal clinical efficacy, improved outcome, reduced rate of antibiotic resistance selection, and minimization of side effects.Methods. The target audience of these clinical recommendations are therapists, general practitioners, pulmonologists, anesthesiologist-resuscitators, and clinical pharmacologists. Each thesis-recommendation about diagnostic and therapeutic procedures has been scored according to the scale of classes of recommendations from 1 to 5 and A, B, C scale of the levels of evidence. The clinical recommendations also contain comments and explanations to these theses, algorithms for the diagnosis and treatment, and reference materials on the use of antibacterial drugs and microbiological (culture) tests.Conclusion. The presented clinical guidelines cover current information about the etiology, clinical manifestations, diagnosis and treatment tactics for community-acquired pneumonia. The presented clinical guidelines have been approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation in 2021.

The problem of microbial antibiotic resistance and investigation of its underlying mechanisms is of paramount importance for all fields of clinical medicine, including oncology. The aim of the study was to examine the mechanisms of antibiotic resistance for major pathogens causing purulent-inflammatory complications in cancer patients. Materials and methods . In 2012—2015 there was conducted a prospective examination of 184 cancer patients, including 67 patients at the Department of Surgery no. 1 and 117 patients at the Intensive Care Unit of the Krasnoyarsk Regional Clinical Oncology Center named after A.I. Kryzhanovsky. For this, we collected bronchoalveolar lavage fluid, wound discharge and investigated the material by using bacteriological method, as well as MALDI-TOF. Antibiotic sensitivity was studied as follows: disco-diffusion, double disc method, carbapenem inactivation method, staphylococcal sensitivity — by screening method, PCR, E-test method, and serial dilutions in Muller-Hinton broth. Genotyping and antibiotic resistance mechanisms study were performed by using PCR, M-PCR, and sequencing. The WHONET program (WHO) was used, with significance level set at p < 0.05. Results . Microbiological examination of bronchoalveolar lavage fluid and wound discharge samples allowed to uncover prevalent associations of multi-resistant (MDR) and extremely resistant pathogens (XDR). The microflora of the lower respiratory tract and in the wound secretion in cancer patients were found to be dominated by non-fermenting Gram-negative bacteria reaching up to 44.5% and 48%, respectively; as well as order Enterobacteriales found in 24% and 34.9%, respectively; Gram-positive bacteria — 24% and 17.1%, respectively. Imipenem- and/or meropenem-resistant P. aeruginosa and A. baumannii, K. pneumoniae strains, were assessed for MBL production phenotypically, as well as the genes of the most common VIM, IMP types, whereas A. baumannii — for OXA-23, OXA-40, and OXA-58; and K. pneumoniae — for OXA-48. 20 strains and 16 strains of P. aeruginosa and A. baumannii , respectively, were studied by PCR. It was found that A. baumannii strains formed no MBL, but 56.3% of A. baumannii isolates (9 strains) produced OXA-23 and OXA-40 carbapenemases. Among P. aeruginosa strains there were three of them which possessed VIM (15.0%), whereas the remaining strains formed no MBL, but were resistant to carbapenems being associated with other resistance mechanisms, e.g. efflux, decreased permeability of cell wall etc. Among 6 isolates of K. pneumoniae , 1 strain produced OXA-48. In cancer patients, the percentage of methicillin-resistant strains among all members of the genus Staphylococcus was 48.9% (4 strains belonged to MRSA). PVL- MRSA strains belonged to the clones ST239/spa3(t037)/SCCmecIIIA /tst,sek,seq + (75%) and ST8/ spa1(t008)/SCCmecIVc /sea + (25%). MRSA ST239 showed multiple antibiotic resistance: to aminoglycosides ( aacA-aphD, aadD genes were detected), linkcosamides/macrolides (the ermA gene was detected), fluoroquinolones (mutations in the GyrA gene — Ser84Leu; in GrlA - Ser80Phe), rifampicin (MIC more than 128 gg/ml; mutations in the rpoB gene are His481Asn, Ile527Met), sulfamethoxazole, tetracycline ( tetM gene), and chloramphenicol (66.7% of isolates, the cat gene encoding chloramphenicol acetyl transferase was detected); but sensitive to vancomycin (MIC 1.0 gg/ ml), linezolid in 100% of cases. MRSA ST8 are resistant to aminoglycosides ( aacA-aphD, aadD genes), lincosamides/macrolides ( ermC gene), tetracyclines ( tetK gene), chloramphenicol ( cat gene); and 100% sensitive to fluoroquinolones, rifampicin (MIC 0.006 gg/ml), sulfamethaxazole, vancomycin (MIC 1.0 gg/ml), daptomycin (MIC 0.094 gg/ml), linezolid (MIC 0.75 gg/ml). Conclusion . Thus, it was found that members of the order Enterobacteriales, A. baumannii, P. aeruginosa and MRSA retain high resistance to a large number of antibacterial drugs of almost all classes. These data should be taken into account while choosing proper antibiotic therapy, as well as controlling spread of nosocomial infections caused by multiresistant microorganisms.

Purpose of the study – to evaluate the antibacterial activity and biological compatibility of alloy coatings based on two-dimensionally ordered linear chain carbon (TDOLCC).Materials and Methods. Coatings based on TDOLCC were synthesized using alloying additions like nitrogen (TDOLCC+N) and silver (TDOLCC+Ag) on the surfaces of titanium plates and polystyrene plates by the ion-stimulated carbon condensation in a vacuum. The authors examined the superficial bactericidal activity of the coatings and its resistance to mechanical effects. Coated plates were evaluated in respect of rate of microbial biofilms formation by clinical isolates with multiple and extreme antibiotic resistance. Specimens were colored with crystal violet solution to visualize the biofilms. Cytotoxic effect of coatings was evaluated in respect of primary culture of fibroblasts and keratinocyte cell line HaCaT.Results. The authors observed pronounced superficial bactericidal effect of TDOLCC+Ag coating in respect of microorganisms of several taxonomic groups independently of their resistance to antibacterial drugs. TDOLCC+Ag coating proved capable to completely prevent microbial biofilm formation by antibiotic resistant clinical isolates of S. aureus and P. aeruginosa. Silvercontaining coating demonstrated mechanical resistance and preservation of close to baseline level of superficial bactericidal activity even after lengthy abrasion treatment. TDOLCC based coatings did not cause any cytotoxic effects. Structure of monolayers formed in cavities coated by TDOLCC+N and TDOLCC+Ag was indistinguishable from the monolayers in cavities of control plates.

Aim.To prove that diagnostic algorithm based on additional measurement of serum C-reactive protein (CRP) for administration of systemic antibacterial therapy (ABT) to patients with suspected community-acquired pneumonia (CAP) and concomitant chronic heart failure (CHF) does not influence outcomes of disease.Materials and methods.This open, single-center, randomized, prospective, noninferiority study included 160 adult patients with documented functional class II–IV CHF who had been admitted with a preliminary diagnosis of non-severe CAP. Patients were randomized at 1:1 to two groups; group 1 – with additional measurement of CRP (n=80) and group 2 – with the use of routine diagnostic methods (n=80). In group 1, systemic ABT was administered only when serum CRP was >28.5 mg / l (threshold level of the biomarker calculated at the previous stage of the study); group 2 received a standard treatment. Noninferiority test result for both algorithms was evaluated by the number of patients with clinical success on days 12–14 (primary endpoint). Non-inferiority margin was δ=–13.5 %. In addition secondary endpoints (early clinical response on days 3–5; early in-hospital adverse events (development of complications; admission to intensive care unit (ICU); death), death, recurrent CAP or CHF worsening with readmission at 28 day; mortality at 90 and 180 days) were estimated. Standard statistical tools were used for all intergroup comparisons.Results:76 patients of each group reached the primary endpoint. Systemic ABT was administered to 51 (67.1 %) patients in group 1 and 76 (100 %) patients in group 2 (p0.05) regarding all endpoints: clinical success, 70 (92.1 %) vs. 69 (90.8 %), Δ=1.3 % (one-sided 97.5 % CI: – 8.25 % for non-inferiority margin δ=–13.5 %); early clinical response, 66 (86.8 %) vs. 68 (89.5 %); admission to ICU, 1 (1.3 %) vs. 1 (1.3 %); development of complications, 20 (26.3 %) vs. 22 (28.9 %); readmission, 5 (6.6 %) vs. 6 (7.9 %); in-hospital mortality, 2 (2.6 %) vs. 1 (1.3 %), mortality at 28 day, 3 (3.9 %) vs. 2 (2.6 %), at 90 day, 5 (6.6 %) vs. 4 (5.3 %), at 180 day, 8 (10.5 %) vs. 9 (11.8 %) cases, respectively.Conclusion:additional measurement of serum CRP in patients with CHF and suspected non-severe CAP was able to reduce rate of systemic ABT administration without outcomes and prognosis worsening.

Mycoplasma genitalium is one of the obligate pathogens that cause sexually transmitted diseases. To detect this pathogen in routine practice, only molecular genetic methods are used that are also used to identify the resistance of MGE to antibiotics. The first-line drugs for the treatment of diseases caused by MGE, are tetracycline and macrolides. In recent years, many countries have increasingly recorded cases of unsuccessful therapy macrolides. Mutations that confer antibiotic resistance to macrolides for Mycoplasm genitalium are concentrated in nucleotide positions 2058 and 2059 in region V of the 23S rRNA gene. Unknown status of macrolide resistance M. genitalium can lead to the development of a persistent infection. We describe the first reported cases of clinical josamycin treatment failure from patient with ure - thritis. The reason for antibiotic resistance was a mutation in the 23S rRNA of MGE as a nucleotide substitution in position A2058G.

To study in vitro activity of antimicrobials against clinical isolates from patients with community-acquired urinary tract infections (UTIs) in different regions of Russia, Belarus and Kazakhstan in 2017-2018.A total of 1260 isolates collectedin the Russian Federation, Belarus and Kazakhstanas a part of the international multicenter prospective epidemiological study of the dynamics of antimicrobial resistance of uropathogens causing community-acquired urinary tract infections in different subsets of patients ("DARMIS-2018") were included in the analysis. 1124 strains represented the Enterobacterales order. Uropathogenswere isolated from children and adults of both sexes of all age groups with acute (and recurrences of chronic) community-acquired UTIs including pregnant women with asymptomatic bacteriuriain 34 centers of 26 cities of Russia, Kazakhstan and Belarus in 2017-2018.Enterobacterales jointly comprised a total of 89,2% of all isolated bacterial pathogens (88,9% in the adult subset; 89,3% in the subset of pregnant women and 91,4% in the subset of children and adolescents under 18). The most prevalent species were Escherichia coli (69,4% in the adult subset; 73,6% in the subset of pregnant women and 77,1% in the subset of children and adolescents under 18) and Klebsiella pneumoniae (11,5% in the subset of adults; 10,4% in the subset of pregnant women and 7,1% in the subset of children and adolescents under 18 years of age). The maximum activity against E. coli among oral drugs demonstrated fosfomycin (97,9% in the adult subset; 95,9% in the subset of pregnant women and 99,1% in the subset of children and adolescents under 18) and nitrofurantoin (97,9% in adult subset; 100% in the subset of pregnant women and 96,3% in the subset of children and adolescents under 18). Out of the parenteral drugs meropenem (out of carbapenems) and amikacin showed the highest activity (99,5% and 97,7% in the adult subset; 99,5% and 99,1% in the subset of pregnant women; 100% and 97,2% in the subset of children and adolescents under 18 years of age, respectively). Ampicillin, amoxicillin/clavulanic acid and trimethoprim/sulfamethoxazole demonstrated the lowest in vitro activity against Escherichia coli (less than 80% for everypatient subset). The susceptibility of E. colito ciprofloxacin was 60,4% in the adult subset; 80,0% in the subset of pregnant women and 80,6% in the subset of children and adolescents under 18. The rate of production of extended spectrum beta-lactamases among E. coli isolates based on the results of phenotypic tests was 21,9%.Results of this study indicate the increase of resistance of community-acquired isolates of Enterobacterales and in particular E. coli to the most of antimicrobials in Russia, Belarus and Kazakhstan.

The results of the systemic antimicrobials (AM) consumption and expenditures assessment in the departments of surgery of multi-profile hospitals in different regions of the Russian Federation and the Republic of Belarus in 2009-2010 based on retrospective collection and analysis of the data from the hospital expenditure notes using ATC/DDD methodology are presented. The average AM consumption and expenditure rates in the above mentioned departments varied from 24.9 DDD/100 bed-days to 61.7 DDD/100 bed-days depending on the department profile, with beta-lactams (cephalosporins and penicillins) share in the consumption being as high as 70-90%, followed by fluoroquinolones and aminoglycosides. Only 55-70% of the consumed AM belonged to the drugs of choice, whereas the improper AM consumption and expenditure rates amounted up to 10-18%. The study outputs can be used for the budget allocation and AM distribution improvement in the departments of surgery, as well as for the development and efficacy control of the local antimicrobial stewardship programs.

To investigate the actual practice of antibacterial therapy of sexually-transmitted bacterial diseases (STD) in adult patients at the various regions of the Russian Federation as well as to evaluate the concordance of the antibacterial therapy with national standards, a multicenter retrospective analytical trial was carried out. Investigational data of 1250 subjects (61% males, 39% females, the mean age of 28.8 ± 9.2) with early types of Lues (n = 341), uncomplicated urogenital gonococcal infection (n = 309), candidiasis (n = 310), mycoplasmosis (n = 137) and ureaplasma infection (n = 153), being treated at prevention and treatment facilities of 10 cities of Russia from January to December 2007 were analysed. 1567 prescriptions for the treatment of the underlying disease were registered, among which 1352 (86.2%) prescriptions regarded antibacterial agents. The therapy of early forms of Lues most frequently included benzathine benzylpenicillin (38.4%), procaine penicillin (28.3%), ceftriaxone (26.9%), and benzylpenicillin (5.5%); therapy of uncomplicated urogenital gonococcal infection included: ceftriaxone (57.5%), spectinomycin (9.3%), doxycycline (7.2%), and azithromycin (5.1%); urogenital chlamydial infections: azithromycin (28.2%), doxycycline (22.2%), clarithromycin (14.9%), josamycin (11.1%), and ofloxacin (7.9%); urogenital mycoplasmal and ureaplasmal infections: doxycycline (32.4 and 31.3%), josamycin (21.4 and 21.3%), azithromycin (15.2 and 11.3%), clarithromycin (14.5 and 11.3%), levofloxacin (4.1 and 6.9%). Frequency of administration of ther drugs was less then 5% for each one. The study has demonstrated a high variability of choice of antibacterial agents by physicians along with an evident tendency to exceeding the total doses during the course therapy. The prescribed therapy was conforming with national recommendations in 71.8% of the subjects, while the total treatment doses were consistent with recommended doses in 24% of patients only, that indicates a necessity to change the established practice of bacterial STD therapy in Russia.

Amoxicillin/clavulanic acid (ACA) is one of the drugs of choice for treatment of lower respiratory tract infections (LRTI) in adults. One of the serious disadvantages of ACA is relatively high rate of gastrointestinal adverse events (AE). A new form of ACA, which is dispersable tablets Solutab, could potentially reduce the rate of AE because of more rapid and predictable absorption of clavulanic acid from intestine and improve clinical outcomes due to higher adherence to treatment. This trial was aimed to compare AE rate and clinical efficacy of the new dispersable ACA form Solutab with those of traditional ACA tabs in adult patients with non-severe LRTI. The treatment regimen comprised 500/125 mg t.i.d. during 5 to12 days. This was an open, prospective randomized trial performed at 4 clinical centres. Adults with clinically and radiologically detected non-severe community-acquired pneumonia or I or II types COPD exacerbations with purulent sputum received dispersable ACA tablets (the 1st group) or traditional coated tabs of ACA (the 2nd group) in a random proportion of 1 : 1. Clinical efficacy was evaluated with clinical signs, physical symptoms, additional laboratory and instrumental testing. The safety was assessed based on the patient's complaints and results of physical and laboratory examination in visits 2 (Day 3 or 4), 3 (Day 5 to 12), and 4 (Day 30 to 40 after taking the first dose of the drug). The trial involved 200 patients, the mean age, 32.7 ± 18.7 and 33.3 ± 18.6 yrs in the 1st and the 2nd groups, respectively. The groups were similar for history, severity, and clinical course of the disease. Clinical efficacy was 96.9 % in both groups in visit 3, 95.9 % and 96.9 % in the 1st and the 2nd group, respectively, in visit 4. The mean duration of antibacterial therapy was 7.1 ± 1.5 days in the 1st group and 7.2 ± 1.4 days in the 2nd group. AE were reported in 15 % and 31 % of the patients, respectively (p = 0.01). Gastrointestinal AE predominated in both the groups but the rate of diarrhea was lower in patients receiving dispersable ACA: 6 % vs. 17 % in the 2nd group (p = 0.027). Therefore, the new dispersable drug form of ACA has better safety profile in adult patients with non-severe LRTI compared to traditional ACA that was demonstrated by reduction in the AE, mainly diarrhea, rate. Both drug forms showed equally high clinical efficacy.

An immunochromatographic strip (ICS) test was developed for the detection of diphtheria toxin by using an equine polyclonal antibody as the capture antibody and colloidal gold-labeled monoclonal antibodies specific for fragment A of the diphtheria toxin molecule as the detection antibody. The ICS test has been fully optimized for the detection of toxin from bacterial cultures; the limit of detection was approximately 0.5 ng of diphtheria toxin per ml within 10 min. In a comparative study with 915 pure clinical isolates of Corynebacterium spp., the results of the ICS test were in complete agreement with those of the conventional Elek test. The ICS test was also evaluated for its ability to detect toxigenicity from clinical specimens (throat swabs) in two field studies conducted within areas of the former USSR where diphtheria is epidemic. Eight hundred fifty throat swabs were examined by conventional culture and by use of directly inoculated broth cultures for the ICS test. The results showed 99% concordance (848 of 850 specimens), and the sensitivity and specificity of the ICS test were 98% (95% confidence interval, 91 to 99%) and 99% (95% confidence interval, 99 to 100%), respectively.

To assess an incidence rate of surgical site infections (SSI) after open appendectomy and effectiveness of combined preventive measures (CPM).This study was performed at three surgical departments of Smolensk hospitals. A total of 150 consecutive patients (50 at each department) hospitalized since January 2012 were included into the retrospective observation (period I). In order to perform prospective evaluation of CPM, a total of 66 consecutive patients (randomized 1:1) hospitalized since December 2012 (period II) were followed up at each of the departments. Antibiotic prophylaxis (AP) with IV amoxicillin/clavulanate (1.2 g) was planned for all patients from period II. The study group (group 1) included patients with surgical wound closure with triclosan-coated polyglactin 910 and additionally with a skin 2-octylcyanoacrylate-based adhesive. The control group (group 2) included patients with surgical wound closure with non-triclosan-coated polyglactin 910. Each patient from the period II was assigned to an "Individual SSI Prevention Package" (IPP), which included an antibiotic, sutures, skin adhesive (only in a package for CPM) and label "AP" for patients' medical records. Patients' medical records were reviewed by one expert. Exclusion criteria were: age14 years; transition to midline laparotomy; drainage of the abdominal cavity through the surgical wound; simultaneous interventions; secondary appendicitis; refusal to use of sutures from the IPP. In order to determine signs of SSI presence/absence within 30 days after surgery, attempts to contact with patients by phone were made. The data obtained was recorded into case report forms and then entered into the study database.A total of 322 patients were included into the final analysis (mean age: 34.8±17.1 years). The mean length of hospital stay was 8.2±2.5 days. The mean duration of hospital stay with or without SSI was 7.9±1.8 and 14.2±4.0 days, respectively (p0.001). The AP during the periods I and II was performed in 56.1% (83/148) and 97.7% (170/174) of patients, respectively (p0.00001). Cephalosporins I-IV were the most frequently used antibiotics during the period I (85.6%). During the period II, amoxicillin/clavulanate from IPP was used in 98.2% of patients. Percentage of IV antibiotic administration in different time periods was 57.3% and 98.2%, respectively (p0.0001); frequency of the first administration before skin incision was 53.6% and 97.1%, respectively (p0.0001). The telephone contact with patient was successful in 74.8% (both periods), 56.8% (period I) and 90.2% (period II) of cases, respectively. SSI was recorded only once per patient with the following priority: SSI was documented in the patient's medical record; patient developed SSI that was not documented (in the expert's opinion) in the patient's medical record; SSI signs were determined during the telephone contact or reported by the patient. The incidence of SSI in both study periods, period I and period II was 14.9%, 15.5% and 14.4%, respectively (p0.05 for all comparisons). In the patient subgroup with successful telephone contact, the incidence of SSI in both study periods, period I and period II was 17.4%, 21.4% and 15.3%, respectively; the incidence of SSI in group 1 and group 2 of the period II was 12.0% and 18.9%, respectively (p0.05 for all comparisons).SSI after an open appendectomy remains an important problem. In order to determine a true incidence of SSI, it is necessary to improve the national nosocomial infection surveillance system. The CMP used in the study have showed a trend to significant SSI risk reduction and may be recommended to maximize patient protection. Further large studies are needed to confirm effectiveness of the proposed CMP.Цель работы. Определить актуальность инфекций области хирургического вмешательства (ИОХВ) после аппендэктомии с лапаротомным доступом по Волковичу-Дьяконову на современном этапе и оценить эффективность комплексного подхода к профилактике их развития. Материал и методы. Проведено многоцентровое проспективное рандомизированное слепое исследование в трех хирургических отделениях (центрах) стационаров Смоленска, в которых в наблюдение были включены первые 50 пациентов, госпитализированных последовательно с 01.01.12 по 30.11.12 (I период). Истории болезни (ИБ) пациентов были запрошены в архиве и подвергнуты ретроспективной оценке одним экспертом. Для проспективной оценки эффективности комплексного подхода к профилактике ИОХВ в наблюдение были включены пациенты, последовательно поступавшие с 01.12.12 (II период) в те же хирургические отделения. В каждом центре были включены по 66 пациентов, которые предварительно были рандомизированы на равные группы по 33 человека. Всем пациентам планировалось проведение профилактики ИОХВ амоксициллином/клавуланатом, т.е. 'стандартизированной' антибактериальной профилактики (АБП), под которой понимали ограничение выбора антибиотика при хирургических вмешательствах одного вида в обычных условиях одним препаратом в отличие от 'рутинной' практики АБП без какой-либо регламентации (на усмотрение врача). Анализируемую (1-ю) группу с комплексным подходом к профилактике ИОХВ составили пациенты, которым операционная рана была ушита шовным материалом полиглактином 910, импрегнированным триклозаном и дополнительно закрыта кожным клеем на основе 2-октилцианоакрилата, а контрольную (2-ю) - без триклозана. В наблюдение были включены 198 пациентов (по 99 в каждой группе). Для каждого пациента были приготовлены 'индивидуальные пакеты профилактики ИОХВ', включавшие помимо антибиотика, шовного материала и клея (последний - только в пакетах для комплексной профилактики) еще и 'стикер АБП' - наклейку в ИБ о факте проведения процедуры. ИБ пациентов II периода были подвергнуты анализу одним экспертом. При указании в ИБ контактных телефонов пациентов обоих периодов была предпринята попытка их телефонного опроса в целях установления факта развития/отсутствия ИОХВ после выписки в сроки до 30 дней с момента оперативного вмешательства. Критериями исключения из окончательного анализа являлись следующие условия: возраст менее 14 лет, конверсия (переход на срединную лапаротомию); выполнение дренирования брюшной полости через операционную рану; симультанные вмешательства; вторичный аппендицит; полный отказ от использования шовного материала из индивидуального пакета профилактики ИОХВ'. Все полученные в результате исследования сведения были внесены в индивидуальные регистрационные карты (ИРК) с последующим переносом информации в единую электронную базу данных методом двойного ввода. Результаты. В окончательный анализ были включены 322 пациента - 158 (49,0%) женщин и 164 (50,9%) мужчины, средний возраст которых составил 34,8±17,1 года. Средняя длительность госпитализации составила 8,2±2,5 сут. Длительность госпитализации пациентов без и с ИОХВ составила в среднем 7,9±1,8 и 14,2±4,0 сут соответственно (р0,001). Частота проведения АБП в I и II периодах исследования составила 56,1% (83/148) и 97,7% (170/174) соответственно (р0,00001). В ИБ 98,9% (90/91) пациентов 1-й группы II периода и 92,8% (77/83) пациентов 2-й группы II периода присутствовал стикер АБП о проведении процедуры. Наиболее часто для профилактики ИОХВ в I периоде использовались цефалоспорины I-IV поколений, общая доля которых составила 85,6% (83/97). Во II периоде исследования в 98,2% (167/170) случаев использовали амоксициллин/клавуланат из индивидуального пакета профилактики ИОХВ. Почти половину всех случаев в I периоде составили случаи в/м введения антибиотика, в/в введение отмечено в 57,3% (55/96). Во II периоде подавляющее большинство случаев было представлено в/в введением препарата - 98,2% (167/170), р0,0001. В I и II периодах первое введение препарата до разреза (предоперационная АБП) отмечено у 53,6% (44/82) и 97,1% (165/170) пациентов соответственно (р0,0001). За оба временных периода исследования ИОХВ в ИБ документирована у 3,7% (12/322) пациентов и недокументирована, по мнению эксперта, еще у 2,5% (8/322) пациентов. Таким образом, частота развития 'суммарной ИОХВ' на госпитальном этапе составила 6,2% (20/322). Доля пациентов, с которыми был осуществлен телефонный контакт в оба периода исследования, составила 74,8% (241/322), 56,8% (84/148) и 90,2% (157/174) соответственно. Частота 'заявленной ИОХВ', развившейся на госпитальном этапе и после выписки у пациентов в I и II периодах составила 10,1% (15/148) и 12,1% (21/174) соответственно (р0,05). Абсолютное большинство пациентов 86,1% (31/36) с 'заявленной ИОХВ' обращались по этому поводу за медицинской помощью после выписки из стационара. Регистрация 'общей ИОХВ' происходило только один раз для одного пациента со следующим приоритетом: ИОХВ диагностирована и документирована на госпитальном этапе, ИОХВ не документирована, заявленная ИОХВ. Таким образом, частота развития общей ИОХВ у всех пациентов в оба временных периода исследования, I и II периодах составила 14,9% (48/322), 15,5% (23/148) и 14,4% (25/174) соответственно. Частота развития общей ИОХВ в 1-й и 2-й группах II периода составила 11,0% (10/91) и 18,1% (15/83) соответственно. Различия не являлись статистически значимыми для всех пар сравнений (р0,05). При оценке субпопуляции пациентов, с которыми был осуществлен телефонный контакт, частота общей ИОХВ в оба временных периода исследования, I и II периодах 17,4% (42/241), 21,4% (18/84) и 15,3% (24/157) соответственно. Частота развития общей ИОХВ в 1-й и 2-й группах II периода в субпопуляции составила 12,0% (10/83) и 18,9% (14/74) соответственно, р0,05 для всех пар сравнения. Выводы. ИОХВ после традиционной аппендэктомии остаются актуальной проблемой современной хирургии. Для определения истинной частоты развития ИОХВ необходимо совершенствовать национальную систему регистрации нозокомиальных инфекций. Комплексный подход к профилактике ИОХВ с использованием 'индивидуального пакета профилактики ИОХВ' продемонстрировал тенденцию к значительному снижению риска развития таких осложнений в сравнении со стандартизированной АБП и рутинной практикой АБП, что позволяет рекомендовать его для максимального повышения противоинфекционной защиты пациентов. Для достоверного подтверждения этого факта необходимы дальнейшие, более масштабные исследования.

A rise in efficacy of the treatment of acute infection affecting the lower urinary tract (LUTI) and prolongation of recurrence-free interval in chronic LUTI can be achieved only by an optimal antibacterial treatment. The study was made of 987 community-acquired strains of uropathogens from the patients living in 20 cities of the Russian Federation, Belarus and Kazakhstan (of them, 903 strains were from Russia). Enterobacteriaceae comprised 83.5%. E. coli infection of LUTI was found in 63.5% patients. The incidence of this infection was about the same both in uncomplicated and complicated cases (64.6 and 62.1%, respectively). Most active oral drugs against E.coli were phosphomycin (98.4%), furasidin (95.7%), nitrofurantoin (94.1%) and oralcefalosporins of the third generation (ceftibuten and cefixim). As to Enterobacteriaceae, only phosphomycin had activity against these bacteria above 90%, i.e. 91.5%. Furasidin and nitrofurantoin activity was 86.3 and 76.8%, respectively. From parenteral drugs, most active against E. coli were carbapenems (ertapenem, meropenem, imipenem. Strains resistant to them were not isolated. High in vitro activity was demonstrated also by cefoperason/sulbactam (97.4%), piperacillin/tasobactam (95.7%), cefalosporins of the third/fourth generation and amikacin (98.9%). Carbapenems were also highly active against Enterobacteroaceae. Empiric treatment of uncomplicated urinary infection should be performed with medicines which are not used for other indications.