Фармакоэпидемиологический анализ антимикробной терапии ожоговой травмы в реальной клинической практике

Aim: to conduct a pharmacoepidemiological analysis of antimicrobial therapy of burn injury in the hospital settings. Materials and methods. The study was based on medical records of patients with burn injuries hospitalized in the Volga University Hospital (Nizhny Novgorod) in 2018. DDD (Defined Daily Dose) analysis was used to evaluate the actual drug consumption based on the defined daily dose; DU90% (Drug Utilization 90%) analysis allowed us to assess the consumption of drugs based on their representation in the total number of defined daily doses; the “cost of illness” and ABC analyses were also used. Results and discussion. For antimicrobial agents of interest, the NDDD (Number of DDD) per year, and the NDDD/100 bed-days were determined. Among these antimicrobial agents (AMA), the largest number of prescriptions was noted for vancomycin (18.06% of treatment courses and 92.86% of patients); amikacin (15.28% of treatments and 78.57% of patients); tigecycline (13.89% and 71.43%, respectively); cefoperazone / sulbactam (12.50% and 64.29%) and co-trimoxazole (12.50% and 64.29%). The NDDD/100 bed-days value for vancomycin was 100.73, followed by amikacin and co-trimoxazole: 86.85 and 71.93 NDDD/100 bed days, respectively. Other antimicrobial agents had significantly lower consumption rates. A group containing 90% of NDDD of antimicrobial agents used for burn injury included: vancomycin – 22.30% of total consumption; аmikacin – 19.23%; co-trimoxazole – 15.93%; cefoperazone / sulbactam – 10.72%; tigecycline – 10.54%; cefepime – 6.47%; levofloxacin – 3.04%. These agents accounted for 83.33% of all drug dose prescriptions. The costs of one DDD in segments DU10% and DU90% amounted to 1976.80 rubles and 1282.58 rubles, respectively. In group A, 80% of costs were for tigecycline – 41.98%; vancomycin – 19.06%; cefoperazone / sulbactam – 6.98%; cefepime – 6.82%. The average costs of treatments with AMA from group A were 15112.45 rubles, from group B – 24082.86 rubles, and from group C – 3498.58 rubles.Implications. The AMAs most commonly used in the treatment of burn injury are vancomycin, amikacin, tigecycline, cefoperazone / sulbactam and co-trimoxazole. The use of vancomycin, tigecycline, cefoperazone / sulbactam and co-trimoxazole is associated with the highest costs of AMA therapy. In the overall spending structure, the cost of amikacin therapy represents an insignificant part (i.e., group C according to the ABC analysis). Notably, amikacin is prescribed more often than other drugs because of its high efficacy in the hospital settings and its low price. We found that more expensive AMA (ertapenem, polymyxin B, linezolid, piperacillin / tazobactam) were used when the starting regimen of antimicrobial therapy produced no adequate clinical effect. Conclusion. This pharmacoepidemiological analysis made it possible to take a broader look at the cost of AMA consumed by the patients and not only those purchased by the hospital. The results provide for a rational approach to the selection of AMA names and doses. Цель – проведение фармакоэпидемиологического анализа антимикробной терапии ожоговой травмы в условиях реальной клинической практики стационара. Материалы и методы. Материалами для исследования послужили данные медицинских карт пациентов с ожоговой травмой, госпитализированных во взрослое ожоговое отделение Университетской клиники ФГБОУ ВО «ПИМУ» Минздрава России в 2018 г. В качестве методов исследования использовались DDD-анализ (англ. – Defined Daily Dose – установленная суточная доза) – анализ фактического потребления лекарственных препаратов на основе установленной суточной дозы и DU90%-анализ (англ. – Drug Utilization 90%) – анализ потребления лекарственных препаратов на основе их доли в общем числе установленных суточных доз, анализ стоимости болезни, АВС-анализ. Результаты и их обсуждение. Были определены NDDD (англ. – number of DDD – количество установленных суточных доз) в год для антимикробных препаратов, количество установленных суточных доз лекарственного препарата на 100 койко-дней (NDDD/100 кой-ко-дней). Наибольшее количество назначений антимикробных препаратов (АМП) сопряжено с использованием ванкомицина (18,06% от общего количества курсов, 92,86% от общего количества пролеченных больных); амикацина (15,28% от общего количества курсов, 78,57% от общего количества пролеченных больных); тигециклина (13,89% от общего количества курсов, 71,43% от общего количества пролеченных больных); цефоперазона/сульбактама (12,50% от общего количества курсов, 64,29% от общего количества пролеченных больных) и ко-тримоксазол (12,50% от общего количества курсов, 64,29% от общего количества пролеченных больных). Доля потребления ванкомицина составила 100,73 NDDD/100 койко-дней, далее следуют амикацин и ко-тримоксазол, 86,85 и 71,93 NDDD/100 койко-дней соответственно. У других антимикробных препаратов уровень потребления был значительно ниже. В группу, составляющую 90% всех потребляемых NDDD антимикробных препаратов при ожоговой травме, вошли: ванкомицин – 22,30% в общей структуре потребления; амикацин – 19,23%; ко-тримоксазол – 15,93%; цефоперазон/сульбактам – 10,72%; тигециклин – 10,54%; цефепим – 6,47%; левофлоксацин – 3,04%. Эти лекарственные препараты составляют 83,33% в реальной структуре назначения. Показатели стоимости одной DDD в сегменте DU10% и DU90% составили 1976,80 руб. и 1282,58 руб. соответственно. 80% затрат (группа А) составляют затраты на тигециклин – 41,98%; ванкомицин – 19,06%; цефоперазон/сульбактам – 6,98%; цефепим – 6,82%. Средняя стоимость курсов АМП, входящих в группу А, составила 15112,45 руб., входящих в группу В – 24082,86 руб., входящих в группу С – 3498,58 руб.Выводы. Наиболее используемыми АМП в терапии ожоговой травмы являются ванкомицин, амикацин, тигециклин, цефопера зон/сульбактам и ко-тримоксазол. С ванкомицином, тигециклином, цефоперазон/сульбактамом и ко-тримоксазолом связаны наибольшие затраты в структуре затрат на АМТ. Затраты на курсы амикацина в общей структуре затрат на АМТ составляют незначительную часть (группа С по результатам АВС-анализа) при высокой частоте применения, что может быть связано как с высокой чувствительностью возбудителей инфекции в стационаре к данному АМП, так и со случаями частого потребления ввиду низкой стоимости. Установлено использование более дорогостоящих курсов АМП (эртапенем, полимиксин В, линезолид, пиперациллин/тазобактам) в случаях отсутствия должного клинического эффекта от стартовой схемы антимикробной терапии. Заключение. Фармакоэпидемиологический анализ позволил шире взглянуть на систему затрат на АМП не с точки зрения закупаемых в стационаре ЛП, а с точки зрения потребления, что позволяет произвести комплексную оценку рациональности назначения АМП и правильности их дозирования. 

Clinical features of post-COVID-19 period. Results of the international register “Dynamic analysis of comorbidities in SARS-CoV-2 survivors (AKTIV SARS-CoV-2)”. Data from 6-month follow-up

Aim. To study the clinical course specifics of coronavirus disease 2019 (COVID-19) and comorbid conditions in COVID-19 survivors 3, 6, 12 months after recovery in the Eurasian region according to the AKTIV register. Material and methods.The AKTIV register was created at the initiative of the Eurasian Association of Therapists. The AKTIV register is divided into 2 parts: AKTIV 1 and AKTIV 2. The AKTIV 1 register currently includes 6300 patients, while in AKTIV 2 — 2770. Patients diagnosed with COVID-19 receiving in- and outpatient treatment have been anonymously included on the registry. The following 7 countries participated in the register: Russian Federation, Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic, Republic of Moldova, Republic of Uzbekistan. This closed multicenter register with two nonoverlapping branches (in- and outpatient branch) provides 6 visits: 3 in-person visits during the acute period and 3 telephone calls after 3, 6, 12 months. Subject recruitment lasted from June 29, 2020 to October 29, 2020. Register will end on October 29, 2022. A total of 9 fragmentary analyzes of the registry data are planned. This fragment of the study presents the results of the post-hospitalization period in COVID-19 survivors after 3 and 6 months. Results. According to the AKTIV register, patients after COVID-19 are characterized by long-term persistent symptoms and frequent seeking for unscheduled medical care, including rehospitalizations. The most common causes of unplanned medical care are uncontrolled hypertension (HTN) and chronic coronary artery disease (CAD) and/or decompensated type 2 diabetes (T2D). During 3- and 6-month follow-up after hospitalization, 5,6% and 6,4% of patients were diagnosed with other diseases, which were more often presented by HTN, T2D, and CAD. The mortality rate of patients in the post-hospitalization period was 1,9% in the first 3 months and 0,2% for 4-6 months. The highest mortality rate was observed in the first 3 months in the group of patients with class II-IV heart failure, as well as in patients with cardiovascular diseases and cancer. In the pattern of death causes in the post-hospitalization period, following cardiovascular causes prevailed (31,8%): acute coronary syndrome, stroke, acute heart failure. Conclusion. According to the AKTIV register, the health status of patients after COVID-19 in a serious challenge for healthcare system, which requires planning adequate health system capacity to provide care to patients with COVID-19 in both acute and post-hospitalization period

Pharmacoepidemiological analysis of antimicrobial therapy for burn injury in the hospital settings

Aim: to conduct a pharmacoepidemiological analysis of antimicrobial therapy of burn injury in the hospital settings. Materials and methods. The study was based on medical records of patients with burn injuries hospitalized in the Volga University Hospital (Nizhny Novgorod) in 2018. DDD (Defined Daily Dose) analysis was used to evaluate the actual drug consumption based on the defined daily dose; DU90% (Drug Utilization 90%) analysis allowed us to assess the consumption of drugs based on their representation in the total number of defined daily doses; the “cost of illness” and ABC analyses were also used. Results and discussion. For antimicrobial agents of interest, the NDDD (Number of DDD) per year, and the NDDD/100 bed-days were determined. Among these antimicrobial agents (AMA), the largest number of prescriptions was noted for vancomycin (18.06% of treatment courses and 92.86% of patients); amikacin (15.28% of treatments and 78.57% of patients); tigecycline (13.89% and 71.43%, respectively); cefoperazone / sulbactam (12.50% and 64.29%) and co-trimoxazole (12.50% and 64.29%). The NDDD/100 bed-days value for vancomycin was 100.73, followed by amikacin and co-trimoxazole: 86.85 and 71.93 NDDD/100 bed days, respectively. Other antimicrobial agents had significantly lower consumption rates. A group containing 90% of NDDD of antimicrobial agents used for burn injury included: vancomycin – 22.30% of total consumption; аmikacin – 19.23%; co-trimoxazole – 15.93%; cefoperazone / sulbactam – 10.72%; tigecycline – 10.54%; cefepime – 6.47%; levofloxacin – 3.04%. These agents accounted for 83.33% of all drug dose prescriptions. The costs of one DDD in segments DU10% and DU90% amounted to 1976.80 rubles and 1282.58 rubles, respectively. In group A, 80% of costs were for tigecycline – 41.98%; vancomycin – 19.06%; cefoperazone / sulbactam – 6.98%; cefepime – 6.82%. The average costs of treatments with AMA from group A were 15112.45 rubles, from group B – 24082.86 rubles, and from group C – 3498.58 rubles.Implications. The AMAs most commonly used in the treatment of burn injury are vancomycin, amikacin, tigecycline, cefoperazone / sulbactam and co-trimoxazole. The use of vancomycin, tigecycline, cefoperazone / sulbactam and co-trimoxazole is associated with the highest costs of AMA therapy. In the overall spending structure, the cost of amikacin therapy represents an insignificant part (i.e., group C according to the ABC analysis). Notably, amikacin is prescribed more often than other drugs because of its high efficacy in the hospital settings and its low price. We found that more expensive AMA (ertapenem, polymyxin B, linezolid, piperacillin / tazobactam) were used when the starting regimen of antimicrobial therapy produced no adequate clinical effect. Conclusion. This pharmacoepidemiological analysis made it possible to take a broader look at the cost of AMA consumed by the patients and not only those purchased by the hospital. The results provide for a rational approach to the selection of AMA names and doses

Clinical features of post-COVID period. Results of an International Register "Dynamics Analysis of Comorbidities in SARS-CoV-2 Survivors (ACTIV SARS-CoV-2)" (12-month follow-up)

Aim. To investigate on post-COVID period in patients of the Eurasian region.Material and methods. A total of 9364 consecutively hospitalized patients were included in ACTIV registry. Enrollment of patients began on June 29, 2020, and was completed on March 30, 2021, corresponding to the first and second waves of the pandemic. Demographic, clinical, and laboratory data, computed tomography (CT) results, information about inhospital clinical course and complications of COVID-19 during hospitalization were extracted from electronic health records using a standardized data collection form. The design included follow-up telephone interviews with a standard questionnaire at 3, 6, and 12 months to examine the course of post-COVID period.Results. According to ACTIV register, 63% of patients after COVID-19 had new adverse symptoms or exacerbations of the existing symptoms lasting for up to 1 year. After hospital discharge, 79,8% of patients sought unscheduled medical attention in the first 3 months, 79,1% at 4-6 months, and 64,8% at 7-12 months. Readmission rate was 11,8% in the first 3 months, 10,9% at 4-6 months, and 10,1% at 7-12 months. The most common reasons for unscheduled treatment in the first 3 months were uncontrolled hypertension, decompensated type 2 diabetes, destabilization of coronary artery disease, gastrointestinal disease, AF episodes, exacerbation of asthma and chronic obstructive pulmonary disease, decompensated heart failure (HF). The 12-month mortality of COVID-19 survivors after the discharge was 3,08%. Multivariate analysis showed that independent risk factors for fatal outcome were age (direct correlation), the levels of hemoglobin (inverse correlation), oxygen saturation (inverse correlation), and aspartate aminotransferase (direct correlation), as well as class III-IV HF, prior stroke, cancer, inhospital acute kidney injury. Based on these identified risk factors, a nomogram was constructed to determine the 3-month mortality risk after discharge.Conclusion. Analysis of ACTIV register showed that end of the acute phase of COVID-19 does not imply a complete recovery

Lipid profile in hospitalized patients with COVID-19 depending on the outcome of its acute phase: data from the international registry "Dynamics analysis of comorbidities in SARS-CoV-2 infection survivors"

Aim. To study the lipid profile in hospitalized patients with coronavirus disease 2019 (COVID-19) depending on the outcome of its acute phase according to the AKTIV international registry.Material and methods. The AKTIV registry included men and women over 18 years of age with a diagnosis of COVID-19, who were treated in a hospital. A total of 9364 patients were included in the registry, of which 623 patients were analyzed for levels of total cholesterol, low-density lipoprotein cholesterol (LDL-C) and triglycerides on days 1-2 of hospitalization. The level of high-density lipoprotein cholesterol (HDL-C) was calculated using the Friedewald equation.Results. We found that a decrease in LDL-C level was significantly associated with an unfavorable prognosis for hospitalized patients with COVID-19. This pattern persisted in both univariate and multivariate analyses. LDL-C levels in the final multivariate model had a significant relationship with the prognosis (an increase in the death risk by 1,7 times with a decrease per 1 mmol/l). In addition, we found that the survival of patients with an indicator level of <2,45 mmol/l is significantly worse than in patients with an LDL-C level ≥2,45 mmol/l. All patients with high LDL-C ((≥4,9 mmol/l) survived, while among patients with low LDL-C (<2,45 mmol/l. All patients with high LDL-C ((≥4,9 mmol/l) survived, while among patients with low LDL-C (<1,4 mmol/l), mortality was 13,04%, which was significantly higher than in patients with LDL-C ≥1,4 mmol/l (6,32%, p=0,047).Conclusion. A decrease in LDL-C in the acute period is significantly associated with an unfavorable prognosis for hospitalized patients with COVID-19. Determination of LDL-C can be included in the examination program for patients with COVID-19. However, the predictive value of this parameter requires further study in prospective clinical studies