RESUMEN
BACKGROUND: Fondaparinux is an effective and safe anticoagulant in the treatment of acute coronary syndromes (ACS). However, due to the low representation of obese individuals in clinical trials, the effects of applying the results of this drug to this population remain uncertain. OBJECTIVES: To compare Fondaparinux to Enoxaparin in the treatment of obese patients with ACS. METHODS: This is a retrospective cohort study, including obese individuals (BMI ≥ 30 Kg/m2) admitted with non-ST-segment elevation myocardial infarction (NSTEMI) or unstable angina (UA) and treated with Fondaparinux or Enoxaparin between 2010 and 2020. The Fondaparinux and Enoxaparin groups were compared for their clinical and laboratory characteristics using chi-square and Mann-Whitney tests, as appropriate. The incidence of primary outcomes (death, reinfarction, stroke, major bleeding) was compared between groups. P-value < 0.05 was considered significant for all analyses. RESULTS: A total of 367 obese patients with NSTEMI or UA were included, of whom 258 used Fondaparinux and 109 used Enoxaparin. Mean age was 64 ± 12 years, and 52.9% were male. The prevalence of diabetes, hypertension, dyslipidemia, prior coronary artery disease, prior stroke, and implementation of invasive strategy was similar between groups. The incidence of the primary outcome was 4.7% in the Fondaparinux group and 5.5% in the Enoxaparin group (p = 0.729). There was no difference between groups when analyzing the components of the primary outcome separately. CONCLUSION: In a sample of obese patients with NSTEMI or UA, there was no difference in the occurrence of the composite outcome (death, stroke, reinfarction, major bleeding) between patients who used Fondaparinux or Enoxaparin.
FUNDAMENTO: O fondaparinux é um anticoagulante eficaz e seguro usado no tratamento de síndromes coronarianas agudas (SCAs). No entanto, devido à baixa representatividade de indivíduos obesos em ensaios clínicos, os efeitos de se aplicar os resultados desse medicamento nesta população continuam incertos. OBJETIVOS: Comparar o fondaparinux à enoxaparina no tratamento de obesos com SCA. MÉTODOS: Este é um estudo do tipo coorte retrospectivo, incluindo indivíduos obesos (IMC ≥ 30 Kg/m2) internados com Infarto do Miocárdio sem Elevação do Segmento ST (IAMSSST) ou Angina Instável (AI) e tratados com fondaparinux ou enoxaparina entre 2010 e 2020. Os grupos que receberam fondaparinux e enoxaparina foram comparados quanto suas características clínicas e laboratoriais usando o teste do qui-quadrado e o teste de Mann-Whitney, conforme apropriado. A incidência dos desfechos primários (morte, reinfarto, acidente vascular cerebral, sangramento maior) foi comparada entre os grupos. Um p<0,05 foi considerado estatisticamente significativo em todas as análises. RESULTADOS: Um total de 367 pacientes obesos com IAMSSST ou AI foi incluído, dos quais 258 usaram fondaparinux e 109 usaram enoxaparina. A idade média foi 64 ± 12 anos, 52,9% eram do sexo masculino. A prevalência e diabetes, hipertensão, dislipidemia, doença arterial coronariana prévia, acidente vascular cerebral prévio, e implementação de estratégia invasiva foi similar entre os grupos. A incidência do desfecho primário foi 4,7% no grupo fondaparinux e 5,5% no grupo enoxaparina (p = 0,729). Não houve diferença entre os grupos quando os componentes do desfecho primário foram analisados separadamente. CONCLUSÃO: Em uma amostra de pacientes obesos com IAMSSST ou AI, não houve diferença na ocorrência do desfecho composto (morte, acidente vascular cerebral, reinfarto, sangramento maior) entre os pacientes que utilizaram fondaparinux ou enoxaparina.
Asunto(s)
Síndrome Coronario Agudo , Anticoagulantes , Enoxaparina , Fondaparinux , Obesidad , Humanos , Fondaparinux/uso terapéutico , Enoxaparina/uso terapéutico , Masculino , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Obesidad/complicaciones , Obesidad/tratamiento farmacológico , Síndrome Coronario Agudo/tratamiento farmacológico , Síndrome Coronario Agudo/complicaciones , Anciano , Anticoagulantes/uso terapéutico , Resultado del Tratamiento , Angina Inestable/tratamiento farmacológico , Hemorragia/inducido químicamente , Infarto del Miocardio sin Elevación del ST/tratamiento farmacológicoRESUMEN
OBJECTIVE: To evaluate the clinical impact of an institutional thromboprophylaxis protocol in patients with multisystem inflammatory syndrome in children (MIS-C), who are at increased risk for thromboembolism (TE). STUDY DESIGN: We conducted a single-center retrospective cohort study of children less than 18 years between March 2020 and December 2021. Eligible patients were confirmed with MIS-C and were managed with a standardized multidisciplinary treatment approach that included a thromboprophylaxis protocol to guide and unify clinical practice. For high-risk patients, prophylactic dose enoxaparin (target anti-Factor Xa 0.1-0.3 U/mL) was added. In high-risk patients with TE risk factors persistent at hospital discharge, thromboprophylaxis was prescribed for an additional 30 days. RESULTS: Of 135 patients with MIS-C, 124 (92%) required intensive care unit stay and 64 (47%) required a central venous catheter for a median duration of 5 days (IQR, 4-7). Prophylactic dose enoxaparin was initiated in 116 out of 121 patients (96%) deemed high-risk per our protocol at a median of 1 day after admission [IQR, 0-3] achieving target levels at a median of 1 day [IQR, 1-2]. The median initial anti-Factor Xa level was 0.13 u/mL [IQR, 0.05-0.19]. One patient (0.7%) developed symptomatic noncatheter related superficial vein thrombosis requiring therapeutic anticoagulation. Thromboprophylaxis was extended for 30 days after discharge in 108 out of 135 patients (80%). Bleeding events occurred in 5 patients during hospitalization (4.2%). All bleeding events were clinically relevant nonmajor bleeding. There were no deaths. CONCLUSIONS: Implementation of an institutional standardized thromboprophylaxis protocol in MIS-C was feasible and led to timely initiation of prophylactic anticoagulation and low rates of TEs and bleeding complications.
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Enoxaparina , Tromboembolia Venosa , Niño , Humanos , Enoxaparina/uso terapéutico , Anticoagulantes/uso terapéutico , Estudios Retrospectivos , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Hemorragia/inducido químicamente , Hemorragia/complicacionesRESUMEN
OBJECTIVE: The study aimed to investigate the protection of enoxaparin (E) against experimental ischemic (I) and ischemic-reperfusion (I/R) injury in rat ovaries on in vitro fertilization outcomes. METHODS: In total, 56 adult female Sprague-Dawley albino rats were randomly assigned to 6 groups of 8 animals each: Sham, Ischemia, I/R, Sham+E, I+E, and I/R+E. Ischemia groups were subjected to bilateral adnexal torsion for 3 h. In contrast, I/R and I/R+E groups received subsequent detorsion for 3 h. Enoxaparin (0.5 mg/kg s.c.) was administered 30 min prior to ischemia (I+platelet-rich plasma) or reperfusion (I/R+I+platelet-rich plasma). Ovaries were stimulated through intraperitoneal injection of 150-300 internal units IU/kg pregnant mare serum gonadotropin. Anti-Müllerian hormone levels were measured before and after surgery in all groups. RESULTS: When the number of metaphase II oocytes was evaluated, statistically significant differences were observed between the I and I+E (p=0.001) and I/R and I/R+E (p=0.000) groups. When both I and I+E groups and I/R and I/R+E groups were compared, it was found that E application increased the number of fertilized oocytes. The number of embryos on the second day was higher in the I/R+E group than that in the I/R group. Statistically significant differences were found in the number of grade 1 embryos between the I/R and I/R+E groups (p=0.003). In comparing anti-Müllerian hormone values within the group, the highest decrease was observed in the I and I/R groups. CONCLUSION: Enoxaparin effectively minimizes ovarian damage and preserves ovarian reserve following ovarian torsion.
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Enfermedades del Ovario , Daño por Reperfusión , Animales , Humanos , Ratas , Femenino , Antioxidantes , Enfermedades del Ovario/tratamiento farmacológico , Enfermedades del Ovario/prevención & control , Enoxaparina/farmacología , Enoxaparina/uso terapéutico , Hormona Antimülleriana , Ratas Sprague-Dawley , Daño por Reperfusión/prevención & control , Isquemia , Fertilización In VitroRESUMEN
BACKGROUND: Despite standard use of chemoprophylaxis, 30-day incidence of venous thromboembolism after geriatric, those older than 60 years, femur fracture surgery is reported to be up to 10%. Missing one dose of enoxaparin has been proven to increase the risk of developing venous thromboembolism. It is commonplace to hold preoperative chemoprophylaxis the morning of surgery because of concern for intraoperative bleeding or wound drainage. We sought to determine whether administration of prophylactic enoxaparin the morning of surgery resulted in an increased rate of blood transfusion or wound drainage in geriatric patients undergoing femur fracture treatment. METHODS: We retrospectively reviewed patients older than 60 years who underwent internal fixation of an isolated femur fracture, including femoral neck, intertrochanteric, subtrochanteric, femoral shaft, and distal femur fractures, at a Level 1 trauma center. Medical records, hospital billing data, and radiographs were reviewed to determine patient characteristics such as Charlson Comorbidity Index, enoxaparin dosing, packed red blood cell transfusion, and persistent wound drainage, defined as any drainage requiring utilization of closed incision negative pressure wound therapy. Thirty-day mortality served as the secondary outcome measure. RESULTS: Five hundred seven patients were included. One hundred sixty-four (32%) received enoxaparin on the morning of surgery, whereas 343 (68%) did not. 27% of patients received PRBC transfusion, and this did not differ between groups (27% vs. 28%, P = 0.72). Subgroup analysis of fixation strategies revealed no difference in the frequency of blood transfusion for any fixation type as related to the timing of enoxaparin dosage. Utilization of closed incision negative pressure wound therapy for the treatment of postoperative wound drainage did not differ between dosing groups. No difference was observed in thirty-day mortality between groups (2.4% vs. 2.7%, P = 0.9). DISCUSSION: Administration of a prophylactic dose of enoxaparin on the morning of surgery does not seem to increase the rate of postoperative blood transfusion or wound drainage after fixation of geriatric femur fracture. LEVEL OF EVIDENCE: Level III, therapeutic.
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Fracturas del Fémur , Tromboembolia Venosa , Humanos , Anciano , Enoxaparina/uso terapéutico , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Estudios Retrospectivos , Fracturas del Fémur/cirugía , Fracturas del Fémur/complicaciones , Transfusión Sanguínea , Fémur , Drenaje/efectos adversos , Resultado del TratamientoRESUMEN
Tecnologia: Enoxaparina comparada à profilaxia mecânica e/ou outros medicamentos disponíveis ou não no SUS. Indicação: Profilaxia de Tromboembolismo Venoso (TEV) em pacientes submetidos a cirurgia de abdome, pelve e varizes. Pergunta: Há superioridade em eficácia e segurança da enoxaparina (heparina de baixo peso molecular - HBPM) comparada à profilaxia mecânica e a outros medicamentos disponíveis ou não no SUS para prevenção de TEV em pacientes acima de 18 anos, não gestantes, em pós-operatório de cirurgias eletivas de abdome, pelve e varizes? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foram selecionadas quatro e incluídas duas revisões sistemáticas com metanálise. Conclusão: HBPM no pós-operatório de cirurgia abdominal e pelve reduziu a incidência de TEV geral e TEV sintomático, sem aumentar risco de sangramento e mortalidade. Nas cirurgias de veias varicosas, foi observado uma redução de todos os eventos trombóticos e risco de TVP, sem aumentar risco de sangramento
Technology: Enoxaparin compared to mechanical prophylaxis and/or other drugs available or not in the SUS. Indication: Prophylaxis of Venous Thromboembolism (VTE) in patients undergoing surgery of the abdomen, pelvis and varicose veins. Question: There is superiority in efficacy and safety of enoxaparin, compared to mechanical prophylaxis and other drugs available or not in the SUS, for the prevention of VTE for patients over 18 years old, non-pregnant in the postoperative period of elective surgeries of the abdomen, pelvis and varicose veins? Methods: Rapid review of evidence (overview) from systematic reviews, with a bibliographic search in the PUBMED database, using a structured strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (Methodological Quality Assessment of Systematic Reviews). Results: Four were selected and two systematic reviews with meta-analysis were included. Conclusion: LMWH in the postoperative period of abdominal and pelvic surgery reduced the incidence of general VTE and symptomatic VTE, without increasing the risk of bleeding and mortality. In varicose vein surgeries, a reduction in all thrombotic events and risk of DVT was observed, without increasing the risk of bleeding
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Humanos , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Adulto Joven , Enoxaparina/uso terapéutico , Tromboembolia Venosa/tratamiento farmacológico , Pelvis/cirugía , Várices/cirugía , Estudio Comparativo , Eficacia , Abdomen/cirugíaRESUMEN
BACKGROUND: Pharmacological and mechanical thromboprophylaxis are frequently used together after total knee arthroplasty (TKA). Most studies in this context compare anticoagulants versus a combination of these drugs with an intermittent pneumatic compression device (IPCD). However, there is uncertainty about the need for the combination of both and whether a unilateral IPCD would alone affect other important clinical outcomes: edema and blood loss. We compared the effects of enoxaparin versus unilateral portable IPCD after TKA on edema and blood loss. We hypothesised that unilateral IPCD would cause the same level of edema and the same blood loss as enoxaparin. METHODS: In this open, randomized trial (1:1), adults with no history of coagulation disorders, anticoagulant use, venous thromboembolism, liver or malignant diseases underwent TKA. For 10 days, participants received the IPCD, used 24 h/day on the operated leg from the end of surgery, or 40 mg of enoxaparin, starting 12 h after surgery. All underwent the same rehabilitation and were encouraged to walk on the same day of surgery. We measured edema (thigh, leg and ankle circumference) before and on the third postoperative day. Blood loss (volume accumulated in the suction drain and drop of hemoglobin and hematocrit in 48 h) was a secondary outcome. RESULTS: We randomized 150 patients and lost 3 to follow-up with enoxaparin and 2 with IPCD. There was no case of symptomatic venous thromboembolism. Four patients needed transfusions (three receiving enoxaparin), one had infection and one hemarthrosis (both in the enoxaparin group). Leg circumference increased by approximately 2 cm for enoxaparin group and 1.5 cm in IPCD (p < 0.001). The increase in ankle circumference was about 1.5 cm in the enoxaparin group (p < 0.001), and almost zero in IPCD (p = 0.447). Enoxaparin group lost 566.1 ml (standard deviation, SD, 174.5) of blood in the first 48 h, versus 420.8 ml (SD 142.5) in the IPCD. CONCLUSIONS: Exclusively mechanical prophylaxis after TKA with portable IPCD only on the operated leg reduces leg and ankle swelling and post-operative blood loss compared to exclusively pharmacological prophylaxis with enoxaparin. Portable devices that can prevent deep vein thrombosis and pulmonary embolism without increasing blood loss or other risks should be further investigated. TRIAL REGISTRATION: REBEC RBR-8k2vpx. Registration date: 06/04/2019.
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Artroplastia de Reemplazo de Rodilla , Tromboembolia Venosa , Adulto , Humanos , Enoxaparina/uso terapéutico , Artroplastia de Reemplazo de Rodilla/efectos adversos , Anticoagulantes/uso terapéutico , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control , Hemorragia Posoperatoria/prevención & control , Edema/prevención & control , Edema/complicaciones , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/tratamiento farmacológicoRESUMEN
In this letter to the editor, apropos of the article "Enoxaparin dose associated with decreased risk of death in COVID-19", it is discussed the role of the current thromboprophylactic strategies, as well as the potential role of heparins in the management of COVID-19.
En la presente carta al editor, a propósito del artículo "Dosis de enoxaparina asociada a disminución de riesgo de muerte en COVID-19", se discute el papel de las estrategias de tromboprofilaxis y el potencial rol de las heparinas en relación con la COVID-19.
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COVID-19 , Enoxaparina , Anticoagulantes/uso terapéutico , Enoxaparina/uso terapéutico , HumanosRESUMEN
Despite standard thromboprophylaxis, venous thrombosis is common in critically ill patients with COVID-19. The objective of this study was to evaluate deep venous thrombosis (DVT) incidence in patients with severe COVID-19 pneumonia with mechanical ventilation requirements under intermediate dose of chemical thromboprophylaxis (1 mg/kg/day of enoxaparin). This was a single-center, descriptive, cross-sectional study of prospectively collected data. An active and systematic protocol with venous doppler was carried out for DVT diagnosis in lower limbs (or in jugulo-subclavian venous confluence) every 7 days. Weekly doppler evaluation was continued until the end of mechanical ventilation, up to 28 days of intensive care unit admission, until death or until the thromboprophylaxis suspension for any cause. Forty-six patients were included. DVT was diagnosed in 5 (3 in lower limbs and 2 in jugulo-subclavian confluent). In 3 cases, DVT was catheter-related (2 in lower limbs and 1 in jugulo-subclavian confluent), 2 died during follow-up due to acute respiratory distress syndrome (ARDS) complications without thrombotic events or major bleeding. All thrombotic events were asymptomatic. In our series of patients with moderate/severe COVID-19 ARDS, DVT incidence was 10.9% under thromboprophylaxis with intermediate dose (1 mg/kg/ day) of enoxaparin.
A pesar de la tromboprofilaxis estándar, el diagnóstico de tromb osis es común en pacientes críticos con COVID-19. El objetivo del presente estudio fue evaluar la incidencia de trombosis venosa profunda (TVP) en pacientes con neumonía grave por COVID-19 con requerimientos de asistencia respiratoria mecánica, bajo tromboprofilaxis química con dosis intermedia (1 mg/kg/día) de heparina de bajo peso molecular (enoxaparina). Se trató de un estudio unicéntrico, descriptivo y de corte transversal de datos recopilados en forma prospectiva. Se realizó búsqueda activa y sistemática de TVP en miembros inferiores (o en confluente yúgulosubclavio en su defecto) mediante doppler venoso cada 7 días. Se continuó con la evaluación por doppler semanal hasta la finalización de la ventilación mecánica, el cum plimiento de los 28 días de internación en unidad de cuidados intensivos, el fallecimiento o la suspensión de la tromboprofilaxis con enoxaparina por cualquier causa. Se incluyeron 46 pacientes. Se realizó diagnóstico de TVP en 5 (3 en miembros inferiores y 2 en confluente yúgulosubclavio). Tres diagnósticos de TVP fueron asociados a la presencia de catéter venoso central (2 en miembros inferiores y 1 en el confluente yúgulosubclavio), dos fallecieron durante el seguimiento por causas vinculadas al síndrome de distrés respiratorio agudo (SDRA) pero no por eventos trombóticos o de sangrado mayor. En todos los casos, los eventos trombóticos fueron asintomáticos. En nuestra serie de pacientes con SDRA moderado/grave secundario a neumonía por COVID-19, la incidencia de TVP fue del 10.9% en aquellos bajo tromboprofilaxis con dosis intermedia (1 mg/kg/día) de enoxaparina.
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COVID-19 , Síndrome de Dificultad Respiratoria , Tromboembolia Venosa , Trombosis de la Vena , Anticoagulantes/uso terapéutico , COVID-19/complicaciones , Estudios Transversales , Enoxaparina/uso terapéutico , Humanos , Incidencia , Trombosis de la Vena/epidemiología , Trombosis de la Vena/etiología , Trombosis de la Vena/prevención & controlRESUMEN
Background: In December 2019, an outbreak of COVID-19 was reported for the first time. This disease has caused millions of deaths worldwide. To date multiple drugs have been tried, without finding an effective treatment yet. Objective: To describe the evolution and the pharmacological treatment used in patients hospitalized due to COVID-19. Material and methods: Observational study in 200 patients hospitalized due to COVID-19 in a regional hospital of Acapulco who were admitted between March and July 2020. The characteristics, pharmacological treatment and evolution of the patients were identified. Univariate, bivariate and multivariate analyses were performed. Results: 60% of the patients were male, 83% had at least one comorbidity, 56% died. The most used drug was enoxaparin, of which receiving a 60 mg dose was associated with a lower risk of death, compared to receiving 40 mg. Having received hydroxychloroquine, methylprednisolone, moxifloxacin and being 60 years or older was associated with a higher risk of progressing to death. Conclusions: There was a high mortality. The most used drug was enoxaparin, of which using doses of 60 mg reduced the risk of death.
Introducción: en diciembre de 2019 se reportó por primera vez un brote de COVID-19. Esta enfermedad ha ocasionado millones de muertes a nivel mundial. A la fecha se han probado multiples fármacos, sin encontrar un tratamiento eficaz aún. Objetivo: describir la evolución y el tratamiento farmacológico utilizado en pacientes hospitalizados por COVID-19. Material y métodos: estudio observacional en 200 pacientes hospitalizados por COVID-19 en un hospital regional de Acapulco que ingresaron entre marzo y julio de 2020. Se identificaron las características, el tratamiento farmacológico y la evolución de los pacientes. Se realizó analisis univarido, bivariado y multivariado. Resultados: el 60% de los pacientes fueron del sexo masculino, 83% presentaron al menos una comorbilidad, 56% fallecieron. El fármaco más utilizado fue la enoxaparina, del cual recibir dosis de 60 mg se asoció a menor riesgo de fallecer comparado con recibir 40 mg. Haber recibido hidroxicloroquina, metilprednisolona, moxifloxacino y tener 60 años o más se asoció a un mayor riesgo de morir. Conclusiones: se presentó una elevada mortalidad. El fármaco más utilizado fue la enoxaparina, del cual utilizar dosis de 60 mg disminuyó el riesgo de fallecer.
Asunto(s)
Tratamiento Farmacológico de COVID-19 , Enoxaparina , Enoxaparina/uso terapéutico , Hospitalización , Humanos , Masculino , SARS-CoV-2 , Resultado del TratamientoRESUMEN
INTRODUCTION: There is still controversy regarding thrombo-prophylaxis for the reduction of thromboembolic disease in major orthopedic surgery. OBJECTIVE: To answer the following question: is there a difference in the effectiveness and safety in the antithrombotic management of patients with a traditional regimen of enoxaparin against acetyl salicylic acid? MATERIAL AND METHODS: The surgeries were performed by 3 surgeons; the sample was randomized and the patients were subjected to the study criteria. We evaluated efficacy and safety as well as the need for readmission and secondary variables such as infection, acute myocardial infarction (AMI), cerebral vascular disease and death with a follow-up of 90 days. RESULTS: The total sample was 402 patients; 214 in the enoxaparin group and 188 in the aspirin group. There were 5 cases (1.24%) with thromboembolic disease, 3 (1.4%) enoxaparin and 2 (1.06%) aspirin without significant difference (p = 0.23). In terms of safety, major bleeding was zero in both groups, with minor bleeding in 7 patients (1.74%), 4 (1.86%) were from the enoxaparin group and 3 (1.59%) from the aspirin group without significant differences (p = 0.82). Secondary outcomes showed 5 (1.24%) superficial surgical wound infections and one AMI in the first 30 days of the procedure in the enoxaparin group. CONCLUSION: Aspirin as monotherapy is safe, effective in antithrombotic prophylaxis in patients operated on total knee arthroplasty.
INTRODUCCIÓN: Aún existe controversia en cuanto a la tromboprofilaxis para la disminución de la enfermedad tromboembólica en la cirugía ortopédica mayor. OBJETIVO: Responder la siguiente pregunta: ¿existe diferencia en la efectividad y seguridad en el manejo antitrombótico de pacientes con un régimen tradicional de enoxaparina contra ácido acetilsalicílico? MATERIAL Y MÉTODOS: Las cirugías se llevaron a cabo por tres cirujanos, se aleatorizó la muestra y los pacientes fueron sometidos a los criterios del estudio. Evaluamos eficacia y seguridad así como la necesidad de reingreso y variables secundarias como infección, infarto agudo de miocardio, enfermedad vascular cerebral y muerte con un seguimiento de 90 días. RESULTADOS: El total de la muestra fue de 402 pacientes, 214 en el grupo de enoxaparina y 188 en el de aspirina. Se presentaron cinco casos (1.24%) con enfermedad tromboembólica, tres (1.4%) enoxaparina y dos (1.06%) aspirina sin diferencia significativa (p = 0.23). En cuanto a seguridad, el sangrado mayor fue cero en ambos grupos, presentándose sangrado menor en siete pacientes (1.74%), cuatro (1.86%) fueron del grupo enoxaparina y tres (1.59%) del grupo aspirina sin diferencias significativas (p = 0.82). Los resultados secundarios mostraron cinco (1.24%) infecciones de herida quirúrgica superficiales y un IAM en los primeros 30 días del procedimiento en el grupo de enoxaparina. CONCLUSIÓN: La aspirina como monoterapia es segura y eficaz en profilaxis antitrombótica en pacientes operados de artroplastía total de rodilla.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Anticoagulantes/uso terapéutico , Aspirina/uso terapéutico , Enoxaparina/uso terapéutico , Fibrinolíticos/uso terapéutico , Humanos , Complicaciones Posoperatorias , Ácido SalicílicoRESUMEN
BACKGROUND: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. METHODS: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·3-0·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. FINDINGS: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28â899 (34·8%) wins in the therapeutic group and 34â288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·59-1·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·61-8·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. INTERPRETATION: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation. FUNDING: Coalition COVID-19 Brazil, Bayer SA.
Asunto(s)
Anticoagulantes/uso terapéutico , Tratamiento Farmacológico de COVID-19 , COVID-19/sangre , Enoxaparina/uso terapéutico , Heparina/uso terapéutico , Rivaroxabán/efectos adversos , Rivaroxabán/uso terapéutico , Adulto , Anciano , Coagulación Sanguínea/efectos de los fármacos , Brasil/epidemiología , Determinación de Punto Final , Femenino , Productos de Degradación de Fibrina-Fibrinógeno , Hemorragia/inducido químicamente , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Alta del Paciente , SARS-CoV-2 , Resultado del TratamientoRESUMEN
BACKGROUND: COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population. METHODS: We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged ≥18 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg/kg twice per day) or intravenous unfractionated heparin (to achieve a 0·30·7 IU/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov (NCT04394377) and is completed. FINDINGS: From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28 899 (34·8%) wins in the therapeutic group and 34 288 (41·3%) in the prophylactic group (win ratio 0·86 [95% CI 0·591·22], p=0·40). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3·64 [95% CI 1·618·27], p=0·0010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group. INTERPRETATION: In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation.
Asunto(s)
Humanos , Masculino , Femenino , Persona de Mediana Edad , Terapéutica , Coagulación Sanguínea , COVID-19 , Anticoagulantes , Productos de Degradación de Fibrina-Fibrinógeno , Heparina/uso terapéutico , Enoxaparina/uso terapéutico , Determinación de Punto Final , Hemorragia/inducido químicamente , HospitalizaciónRESUMEN
CONTEXTO: O tromboembolismo venoso (TEV) associado à gravidez, incluindo trombose venosa profunda (TVP) e embolia pulmonar (EP), embora incomum, continua sendo causa importante de morbimortalidade. Por ser uma condição próinflamatória com ativação de células endoteliais, as gestantes apresentam um risco maior de TEV quando comparado com mulheres não grávidas. Mulheres com trombofilia e aquelas que se submetem à cesariana representam a maioria das pacientes com TEV pós-parto. Atualmente, o Brasil possui um Protocolo Clínico e Diretrizes Terapêuticas (PCDT) de Profilaxia do Tromboembolismo Venoso em Gestantes com Trombofilia. O PCDT foi publicado por meio da Portaria Conjunta SAES-SCTIE nº 04, de 12 de fevereiro de 2020 e preconiza o uso do medicamento enoxaparina para prevenção e tratamento do tromboembolismo venoso em gestantes com trombofilia. Entretanto, a apresentação de 60 mg/0,6 mL de enoxaparina, necessária para uma dose precisa em grávidas ou puérperas com trombofilia com massa corporal acima de 90 kg com indicação de anticoagulação profilática ou em grávidas ou puérperas com trombofilia e indicação de esquema de anticoagulação plena, independentemente do peso corporal, atualmente não está disponível no SUS. TECNOLOGIA: Enoxaparina sódica 60 mg/0,6 mL injetável. PERGUNTA: A enoxaparina 60 mg/0,6mL é eficaz, efetiva e segura em grávidas ou puérperas com trombofilia com massa corporal acima de 90 kg que estiverem em tratamento com esquema de anticoagulação profilática ou em gestantes com indicação esquema de anticoagulação plena, independentemente do peso corporal? EVIDÊNCIAS CLÍNICAS: Foram incluídos 4 estudos descritos em 5 referências, sendo 02 ensaios clínicos randomizados (ECR) e dois estudos observacionais do tipo coorte retrospectiva. Os estudos apontam que não há diferenças significativas para os desfechos de eficácia, efetividade e segurança entre a dose mínima e o ajuste de dose de enoxaparina na Prevenção de Tromboembolismo Venoso em Gestantes com Trombofilia. Para o desfecho mais relevante que corresponde ao número de nascidos vivos por gestação, a meta-análise incluiu 165 gestantes recebendo enoxaparina com dose ajustada e 155 gestantes recebendo 40 mg/dia de enoxaparina em dose fixa. O resultado agrupado dos dois ECRs gerou um RR de 0,95 sem diferença estatisticamente significante entre os grupos no modelo de efeitos randômicos, (IC95% = 0,86 1,04; I 2 = 0%; p = 0,55). Nos efeitos indesejáveis da tecnologia, ambas as doses de enoxaparina indicam ser seguras e bem toleradas (Anexo 1). ANÁLISE DE IMPACTO ORÇAMENTÁRIO: Foi adotado um horizonte temporal de cinco anos (2021 a 2025). No cenário mais conservador, a análise de impacto orçamentário evidenciou uma economia de R$ 55.369.020,00 diante da incorporação da enoxaparina 60 mg/0,6 mL no SUS (Anexo 2). MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Não foram detectadas tecnologias para compor o esquema terapêutico de prevenção de tromboembolismo venoso em gestantes com trombofilia. No Brasil, a enoxaparina não está sob proteção patentária. CONSIDERAÇÕES FINAIS: Considerou-se que a enoxaparina 60 mg/0,6 mL mostra-se como uma alternativa segura quando comparada à dose mínima de 40 mg/0,4 mL. Ademais, a incorporação da enoxaparina 60 mg/0,6 mL pode levar à economia de R$ 55.369.020,00 ao longo de cinco anos. RECOMENDAÇÃO PRELIMINAR DA CONITEC: O Plenário da Conitec, em sua 96ª Reunião Ordinária, no dia 07 de abril de 2021, deliberou que a matéria fosse disponibilizada em Consulta Pública com recomendação preliminar favorável à incorporação da enoxaparina 60 mg/0,6 mL injetável para a prevenção de tromboembolismo venoso em gestantes com trombofilia no SUS. Os membros da Conitec consideraram que a incorporação desta nova apresentação de enoxaparina é necessária para a prevenção de tromboembolismo venoso em gestantes com sobrepeso ou com indicação de anticoagulação plena. Além disso, considerou-se que essa incorporação potencialmente irá representar economia para o Sistema Único de Saúde. CONSULTA PÚBLICA: Foram recebidas 16 contribuições, sendo 8 técnico-científicas e 8 sobre experiência ou opinião. A grande maioria destas concordou da recomendação inicial da Conitec. Ao final, o Plenário da Conitec entendeu que não foram apresentadas novas evidências que mudassem seu entendimento sobre o tema, fazendo com que sua recomendação preliminar fosse mantida. RECOMENDAÇÃO FINAL DA CONITEC: O Plenário da Conitec, em sua 98ª Reunião Ordinária, no dia 09 de junho de 2021, deliberou por unanimidade recomendar a incorporação da enoxaparina 60 mg/0,6 mL injetável para a prevenção de tromboembolismo venoso em gestantes com trombofilia. Assim, foi assinado o Registro de Deliberação nº 622/2021. DECISÃO: Incorporar a enoxaparina 60 mg/0,6 mL injetável para a prevenção de tromboembolismo venoso em gestantes com trombofilia, no âmbito do Sistema Único de Saúde SUS, conforme a Portaria nº 35, publicada no Diário Oficial da União nº 127, seção 1, página 143, em 08 de julho de 2021.
Asunto(s)
Femenino , Embarazo , Tromboembolia/prevención & control , Enoxaparina/uso terapéutico , Trombofilia/tratamiento farmacológico , Sistema Único de Salud , Brasil , Análisis Costo-BeneficioRESUMEN
Neurofibromatosis type 1 (NF1) is a genetic syndrome which typically presents with neurological manifestations. Some of the patients may also present with vasculopathies, among which arterial aneurysms and stenosis are the most common. Deep vein thrombosis (DVT) has rarely been described, and, to the best of our knowledge, the present is the first report of DVT due to venous compression by a neurofibroma in the setting of NF1. This is the case of a 23-year-old male with NF1 who experienced DVT due to compression of the left posterior tibial veins by a large tumor arising from the tibial nerve. The DVT was acutely treated with enoxaparin and then with rivaroxaban. Two months after the diagnosis, Doppler ultrasonography showed partial recanalization and persistence of the DVT. The patient was then referred to neurosurgery for surgical resection of the tumor. There were no complications during the procedure, and the patient did not present postoperative neurological deficits. The final histopathological diagnosis was of a benign neurofibroma. After one year of follow-up with vascular surgery, the patient presented no more episodes of DVT. In case there is a tumor compressing the deep vessels of the leg and promoting DVT, surgical resection with microsurgical techniques may be curative.
Asunto(s)
Humanos , Masculino , Adulto Joven , Neurofibromatosis 1/cirugía , Neurofibromatosis 1/complicaciones , Trombosis de la Vena/etiología , Trombosis de la Vena/tratamiento farmacológico , Neurofibromatosis 1/diagnóstico por imagen , Enoxaparina/uso terapéutico , Ultrasonografía Doppler/métodos , Trombosis de la Vena/diagnóstico por imagen , Rivaroxabán/uso terapéutico , Neurofibroma/cirugíaRESUMEN
BACKGROUND: Observational studies have suggested a higher risk of thrombotic events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer levels have been identified as an important prognostic marker in COVID-19 directly associated with disease severity and progression. Prophylactic anticoagulation for hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore, therapeutic anticoagulation regimens deserve clinical investigation. DESIGN: ACTION is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical trial that aims to enroll around 600 patients at 40 sites participating in the Coalition COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19 with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose heparin if oral administration is not feasible) vs standard of care with any approved venous thromboembolism prophylaxis regimen during hospitalization. A confirmation of COVID-19 was mandatory for study entry, based on specific tests used in clinical practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless of in the outpatient setting or not. Randomization will be stratified by clinical stability at presentation. The primary outcome is a hierarchical analysis of mortality, length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary outcomes include the World Health Organization's 8-point ordinal scale at 30 days and the following efficacy outcomes: incidence of venous thromboembolism , acute myocardial infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen therapy, disease progression, and biomarkers. The primary safety outcomes are major or clinically relevant non-major bleeding according to the International Society on Thrombosis and Haemostasis criteria. SUMMARY: The ACTION trial will evaluate whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients, or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared with standard prophylactic anticoagulation improves clinical outcomes in hospitalized patients with COVID-19 and elevated D-dimer levels.
Asunto(s)
Anticoagulantes/uso terapéutico , COVID-19/complicaciones , Enoxaparina/uso terapéutico , Rivaroxabán/uso terapéutico , Trombosis/prevención & control , Administración Oral , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Brasil , COVID-19/sangre , COVID-19/mortalidad , Esquema de Medicación , Enoxaparina/administración & dosificación , Enoxaparina/efectos adversos , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Hemorragia/inducido químicamente , Hospitalización , Humanos , Terapia por Inhalación de Oxígeno , Rivaroxabán/administración & dosificación , Rivaroxabán/efectos adversos , Trombosis/etiología , Factores de TiempoRESUMEN
BACKGROUND: Coronavirus disease 2019 (COVID-19)-related critical illness and acute illness are associated with a risk of venous thromboembolism (VTE). OBJECTIVE: These evidence-based guidelines of the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in decisions about the use of anticoagulation for thromboprophylaxis for patients with COVID-19-related critical illness and acute illness who do not have confirmed or suspected VTE. METHODS: ASH formed a multidisciplinary guideline panel and applied strict management strategies to minimize potential bias from conflicts of interest. The panel included 3 patient representatives. The McMaster University GRADE Centre supported the guideline-development process, including performing systematic evidence reviews (up to 19 August 2020). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, including GRADE Evidence-to-Decision frameworks, to assess evidence and make recommendations, which were subject to public comment. RESULTS: The panel agreed on 2 recommendations. The panel issued conditional recommendations in favor of prophylactic-intensity anticoagulation over intermediate-intensity or therapeutic-intensity anticoagulation for patients with COVID-19-related critical illness or acute illness who do not have confirmed or suspected VTE. CONCLUSIONS: These recommendations were based on very low certainty in the evidence, underscoring the need for high-quality, randomized controlled trials comparing different intensities of anticoagulation. They will be updated using a living recommendation approach as new evidence becomes available.
Asunto(s)
Anticoagulantes/uso terapéutico , COVID-19/patología , Tromboembolia Venosa/tratamiento farmacológico , COVID-19/complicaciones , COVID-19/virología , Enoxaparina/uso terapéutico , Medicina Basada en la Evidencia , Guías como Asunto , Humanos , SARS-CoV-2/aislamiento & purificación , Sociedades Médicas , Tromboembolia Venosa/complicacionesRESUMEN
BACKGROUND: Patients with severe viral pneumonia are likely to receive high-dose immunomodulatory drugs to prevent clinical worsening. Aspergillus species have been described as frequent secondary pneumonia agents in severely ill influenza patients receiving steroids. COVID-19 patients admitted to Intensive Care Unit (ICU) are receiving steroids as part of their treatment and they share clinical characteristics with other patients with severe viral pneumonias. COVID-19 patients receiving steroids should be considered a putative risk group of invasive aspergillosis. CASE REPORT: We are reporting a SARS-CoV-2/Aspergillus section Fumigati coinfection in an elderly intubated patient with a history of pulmonary embolism treated with corticosteroids. The diagnosis was made following the ad hoc definitions described for patients admitted to ICU with severe influenza, including clinical criteria (fever for 3 days refractory to the appropriate antibiotic therapy, dyspnea, pleural friction rub, worsening of respiratory status despite antibiotic therapy and need of ventilator support), a radiological criterion (pulmonary infiltrate) and a mycological criterion (several positive galactomannan tests on serum with ratio ≥0.5). In addition, Aspergillus section Fumigati DNA was found in serum and blood samples. These tests were positive 4 weeks after the patient was admitted to the ICU. The patient received voriconazole and after two month in ICU his respiratory status improved; he was discharged after 6 weeks of antifungal treatment. CONCLUSIONS: Severely ill COVID-19 patients would be considered a new aspergillosis risk group. Galactomannan and Aspergillus DNA detection would be useful methods for Aspergillus infection diagnosis as they allow avoiding the biosafety issues related to these patients.
Asunto(s)
Aspergillus fumigatus/aislamiento & purificación , Tratamiento Farmacológico de COVID-19 , COVID-19/complicaciones , Coinfección/diagnóstico , Inmunocompetencia , Inmunosupresores/efectos adversos , Aspergilosis Pulmonar Invasiva/complicaciones , Metilprednisolona/efectos adversos , SARS-CoV-2/aislamiento & purificación , Acetaminofén/uso terapéutico , Anciano , Antiinfecciosos/uso terapéutico , Líquido del Lavado Bronquioalveolar/microbiología , COVID-19/diagnóstico , COVID-19/terapia , COVID-19/virología , Prueba de Ácido Nucleico para COVID-19 , Coinfección/microbiología , Coinfección/terapia , Coinfección/virología , Terapia Combinada , Diagnóstico Diferencial , Quimioterapia Combinada , Enoxaparina/uso terapéutico , Galactosa/análogos & derivados , Humanos , Hidroxicloroquina/uso terapéutico , Inmunosupresores/uso terapéutico , Intubación Intratraqueal , Aspergilosis Pulmonar Invasiva/diagnóstico , Aspergilosis Pulmonar Invasiva/microbiología , Aspergilosis Pulmonar Invasiva/terapia , Masculino , Mananos/sangre , Metilprednisolona/uso terapéutico , Nasofaringe/virología , Neumonía por Mycoplasma/diagnóstico , Pseudomonas aeruginosa/aislamiento & purificación , Reacción en Cadena en Tiempo Real de la Polimerasa , Respiración Artificial , Staphylococcus aureus/aislamiento & purificación , Tráquea/microbiologíaRESUMEN
BACKGROUND: It's estimated that 40% to 60% of patients undergoing major orthopedic surgery of the hip or knee who do not receive thromboprophylaxis will develop deep venous thrombosis Instituto Nacional de Traumatologia e Ortopedia has established a guideline to prevent DVT with the administration of the Enoxaparin. Recently, institute stakeholders have been questioning this guideline as new oral anticoagulants that offer more comfort and efficacy, but present higher risk of bleeding, have been appearing in the market for treating deep venous thrombosis. OBJECTIVE: This study aims to validate the application of a multicriteria decision analysis in a real-world problem, the use of rivaroxaban and enoxaparin to prevent deep venous thrombosis. METHODS: The multicriteria method MACBETH (Measuring Attractiveness by a Categorical Based Evaluation Technique) was used in a decision conferencing process to develop an evaluation model for measuring the relative value of the drugs on each evaluation criterion, separately and globally. The model-building process was informed by a literature review and meta-analysis of randomized clinical trials with a critical appraisal of the evidence. RESULTS: We report a model-structure with eight criteria, each one associated with a weighting coefficient and value function. Following a simple additive aggregation process, the model-outputs showed that Rivaroxaban was considered a robust option for DVT. Sensitivity analysis and robustness analysis were performed and testify the consistency of the results. CONCLUSION: This article contributes to literature by showing how MACBETH method can be combined with scientific evidence and participatory group processes, for health technology assessment in hospitals.
Asunto(s)
Procedimientos Ortopédicos/economía , Preparaciones Farmacéuticas/normas , Complicaciones Posoperatorias/economía , Trombosis de la Vena/tratamiento farmacológico , Anticoagulantes/efectos adversos , Anticoagulantes/economía , Anticoagulantes/uso terapéutico , Brasil/epidemiología , Enoxaparina/efectos adversos , Enoxaparina/economía , Enoxaparina/uso terapéutico , Hemorragia/economía , Hemorragia/epidemiología , Hemorragia/etiología , Humanos , Procedimientos Ortopédicos/efectos adversos , Procedimientos Ortopédicos/métodos , Preparaciones Farmacéuticas/economía , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Rivaroxabán/efectos adversos , Rivaroxabán/economía , Rivaroxabán/uso terapéutico , Trombosis de la Vena/epidemiología , Trombosis de la Vena/prevención & controlRESUMEN
BACKGROUND: The speed and reach of the COVID-19 pandemic has created special scenarios to be considered, such as those in where patients who meet criteria for hospitalization due to moderate/severe disease cannot be hospitalized due to economic constraints and saturation of national health systems. The aim of this report is to present an unusual case of a severe COVID-19 patient managed at home in a developing country, and to discuss some of the available guidelines and potential therapeutic options for this type of cases. CASE PRESENTATION: A 60-year-old female seeking medical attention through teleconsultation presents with profound dyspnea, oppressive chest pain, fatigue, episodic hallucinations, and difficulty sleeping, for what she originally sought medical attention at an ER but could not be admitted due to saturation of the health system. A positive PCR test for COVID-19, and a CT scan of the chest showing bilateral consolidations with ground-glass opacities confirmed the diagnosis. The patient was managed at home, with corticosteroids, nitazoxanide and a single dose of 40 mg of subcutaneous enoxaparin. Colchicine was added at the third day of treatment. Standard oxygen therapy through nasal cannula was also recommended. Daily follow-ups were established to monitor for signs of clinical improvement. Two weeks later from the initial consultation the patient presents marked improvement in her symptoms, as well as in her CT scan, which prompted in discontinuation of the medications and the oxygen therapy. CONCLUSIONS: There are several limitations in this report regarding the clinical data and the management, but such limitations do also reflect the state of emergency and the chaos that resides in the health care systems of developing nations. For the ambulatory care of COVID-19 patients, several aspects of disease management may differ from current guidelines and basic requirements may represent a huge challenge to cover. Further research is needed to assist physicians in the daily clinical decision making, to optimize patient outcomes, and to reduce the probability of adverse scenarios of patients with COVID-19 managed in the ambulatory setting.