RESUMO
BACKGROUND: Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials. METHODS: We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was the patient's clinical status 30 days after the intervention, as measured on a six-point ordinal scale ranging from total recovery to death. RESULTS: A total of 228 patients were assigned to receive convalescent plasma and 105 to receive placebo. The median time from the onset of symptoms to enrollment in the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most frequent severity criterion for enrollment. The infused convalescent plasma had a median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to 1:3200). No patients were lost to follow-up. At day 30 day, no significant difference was noted between the convalescent plasma group and the placebo group in the distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83; 95% confidence interval [CI], 0.52 to 1.35; P = 0.46). Overall mortality was 10.96% in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of -0.46 percentage points (95% CI, -7.8 to 6.8). Total SARS-CoV-2 antibody titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups. CONCLUSIONS: No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo. (PlasmAr ClinicalTrials.gov number, NCT04383535.).
Assuntos
Anticorpos Neutralizantes/sangue , COVID-19/terapia , Imunoglobulina G/sangue , Pneumonia Viral/terapia , SARS-CoV-2/imunologia , Idoso , Idoso de 80 Anos ou mais , Transfusão de Componentes Sanguíneos , COVID-19/complicações , COVID-19/mortalidade , Progressão da Doença , Método Duplo-Cego , Feminino , Hospitalização , Humanos , Imunização Passiva , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Pneumonia Viral/etiologia , Pneumonia Viral/mortalidade , Índice de Gravidade de Doença , Soroterapia para COVID-19RESUMO
BACKGROUND: Some studies have suggested that exposure to antiretroviral therapy (ART) with abacavir is associated with an increased risk of acute myocardial infarction (AMI). METHODS: Using the Veterans Health Administration's Clinical Case Registry we calculated the risk of AMI and cerebrovascular events (CVA) associated with the cumulative use of abacavir and other nucleoside combinations. We also evaluated the impact of pre-existing chronic kidney disease on the selection of abacavir versus tenofovir in the last recorded ART regimen, and on highly active antiretroviral therapy-associated AMI and CVA risks. RESULTS: A total of 19,424 human immunodeficiency virus-infected patients contributed 76,376 patient-years of follow. After adjusting for age, hypercholesterolemia, hypertension, type 2 diabetes, and smoking, the hazard ratio (HR) for each year of abacavir use was 1.18 (95% confidence interval [CI], .92-1.50; P=.191) for AMI and 1.16 (95% CI, .98-1.37; P=.096) for CVA. Abacavir use was more common among patients with prior chronic kidney disease than was tenofovir use (12.46% versus 7.15%; P=.0001), and chronic kidney disease was associated with a significantly higher risk of AMI (HR, 2.41; 95% CI, 1.73-3.36), and CVA (HR, 1.80; 95% CI, 1.44-2.24). Compared with patients who received neither tenofovir nor abacavir, patients who received tenofovir had lower risk of AMI (HR, 0.16; 95% CI, .08-.33; P=.0001) and CVA (HR, 0.22; 95% CI, .15-.32; P=.001). Use of abacavir was associated with lower risk of CVA (HR, 0.60; 95% CI, .45-.79). CONCLUSIONS: We observed no association between cumulative or current abacavir use and AMI or CVA. Abacavir use was more common than was tenofovir use among patients with prior chronic kidney disease, and chronic kidney disease independently predicted higher rates of AMI and CVA.
Assuntos
Fármacos Anti-HIV/efeitos adversos , Didesoxinucleosídeos/efeitos adversos , Infecções por HIV/epidemiologia , Infarto do Miocárdio/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Adenina/efeitos adversos , Adenina/análogos & derivados , Adenina/uso terapêutico , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Didesoxinucleosídeos/uso terapêutico , Feminino , Infecções por HIV/tratamento farmacológico , Humanos , Ataque Isquêmico Transitório/induzido quimicamente , Ataque Isquêmico Transitório/epidemiologia , Ataque Isquêmico Transitório/virologia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Infarto do Miocárdio/induzido quimicamente , Infarto do Miocárdio/virologia , Organofosfonatos/efeitos adversos , Organofosfonatos/uso terapêutico , Modelos de Riscos Proporcionais , Insuficiência Renal Crônica/induzido quimicamente , Insuficiência Renal Crônica/epidemiologia , Insuficiência Renal Crônica/virologia , Fatores de Risco , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/virologia , Tenofovir , Estados Unidos/epidemiologia , United States Department of Veterans AffairsRESUMO
BACKGROUND: passive immunotherapy is a therapeutic alternative for patients with COVID-19. Equine polyclonal antibodies (EpAbs) could represent a source of scalable neutralizing antibodies against SARS-CoV-2. METHODS: we conducted a double-blind, randomized, placebo-controlled trial to assess efficacy and safety of EpAbs (INM005) in hospitalized adult patients with moderate and severe COVID-19 pneumonia in 19 hospitals of Argentina. Primary endpoint was improvement in at least two categories in WHO ordinal clinical scale at day 28 or hospital discharge (ClinicalTrials.gov number NCT04494984). FINDINGS: between August 1st and October 26th, 2020, a total of 245 patients were enrolled. Enrolled patients were assigned to receive two blinded doses of INM005 (n = 118) or placebo (n = 123). Median age was 54 years old, 65â¢1% were male and 61% had moderate disease at baseline. Median time from symptoms onset to study treatment was 6 days (interquartile range 5 to 8). No statistically significant difference was noted between study groups on primary endpoint (risk difference [95% IC]: 5â¢28% [-3â¢95; 14â¢50]; p = 0â¢15). Rate of improvement in at least two categories was statistically significantly higher for INM005 at days 14 and 21 of follow-up. Time to improvement in two ordinal categories or hospital discharge was 14â¢2 (± 0â¢7) days in the INM005 group and 16â¢3 (± 0â¢7) days in the placebo group, hazard ratio 1â¢31 (95% CI 1â¢0 to 1â¢74). Subgroup analyses showed a beneficial effect of INM005 over severe patients and in those with negative baseline antibodies. Overall mortality was 6â¢9% the INM005 group and 11â¢4% in the placebo group (risk difference [95% IC]: 0â¢57 [0â¢24 to 1â¢37]). Adverse events of special interest were mild or moderate; no anaphylaxis was reported. INTERPRETATION: Albeit not having reached the primary endpoint, we found clinical improvement of hospitalized patients with SARS-CoV-2 pneumonia, particularly those with severe disease.
RESUMO
The objective of this study was to estimate the prevalence of different serological markers of hepatitis A, B and C viruses and Treponema pallidum among the adult population of Argentina. To achieve this, adults who attended health services for premarital exams (which are mandatory and includes screening for syphilis) were recruited. A cross-sectional study was designed with a cluster sampling strategy. Couples who attended selected health services for premarital screening between 2013 and 2014 in Buenos Aires, Cordoba, Mendoza and Santa Fe provinces were included. A total of 3833 individuals were recruited. Anti-HAV prevalence was 63.9%, anti-HCV 0.3%, anti-HBc (without HBsAg) 1.9%, HBsAg 0.3%, and T pallidum 0.8%. Anti-HAV was higher among older participants, foreigners and those from the lower strata. HBV increased with age and was higher among foreigners and those with lower formal educational level. Anti-HCV frequency increased with age. Premarital screening of viral hepatitis could constitute an instance of diagnosis, vaccination and inclusion in care of those in need. Results from this study will allow the national hepatitis programs to design public policies in order to diminish the impact of these infections on the population.
Assuntos
Hepatite Viral Humana/epidemiologia , Hepatite Viral Humana/virologia , Sífilis/epidemiologia , Sífilis/microbiologia , Treponema pallidum , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Argentina/epidemiologia , Estudos Transversais , Feminino , Testes Hematológicos , Hepatite Viral Humana/diagnóstico , Humanos , Masculino , Programas de Rastreamento , Pessoa de Meia-Idade , Vigilância da População , Prevalência , Fatores de Risco , Fatores Socioeconômicos , Sífilis/diagnóstico , Adulto JovemRESUMO
We retrospectively evaluated 73 immunocompetent adult patients assisted at our Infectious Diseases Clinic between March 1999 and March 2004 who presented fever and asthenia, mild to moderate increase of transaminases and serological findings compatible with recent cytomegalovirus infection. We excluded patients with a history of transfusions, drug abuse, immunodeficiencies, preexistent hepatic impairment or serological findings compatible with acute hepatitis A, B and C (HAV, HBV, HCV) and Epstein-Barr virus (EBV). The laboratory diagnosis of recent cytomegalovirus infection was made by especific IgM detection (ELISA) or a significant increase of specific IgG. The most frequent symptoms were fever (85%) and asthenia (83%), followed by cephalea (25%), splenomegaly (20%), adenomegalies (22%), pharyngitis (25%), myalgias (25%) and hepatomegaly (19%). All the patients showed moderate increase of transaminases and lymphomonocytosis (73/73). In average, ALT was increased by 6 fold and AST by 3.5 fold. The clinical characteristics that differentiate CMV infection from Epstein-Barr infection are the lesser frequency of adenomegalies and pharyngitis in the former. The differential diagnosis of CMV infection with hepatic involvement from acute hepatitis A and B, is based on the absence of jaundice, the lower elevation of transaminases, the intense lymphomonocytosis and the presence of specific IgM against CMV that are characteristic of CMV infection. In conclusion, in previously healthy young adults with fever, intense asthenia, lymphomonocytosis and moderate increase in transaminases levels, cytomegalovirus infection should be investigated.
Assuntos
Infecções por Citomegalovirus/diagnóstico , Citomegalovirus/imunologia , Hepatite Viral Humana/diagnóstico , Adolescente , Adulto , Biomarcadores/sangue , Infecções por Citomegalovirus/complicações , Infecções por Citomegalovirus/imunologia , Diagnóstico Diferencial , Ensaio de Imunoadsorção Enzimática , Feminino , Seguimentos , Hepatite Viral Humana/imunologia , Hepatite Viral Humana/virologia , Humanos , Imunocompetência , Imunoglobulina G/sangue , Imunoglobulina M/análise , Imunoglobulina M/sangue , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Transaminases/metabolismoRESUMO
We retrospectively evaluated 89 episodes of bone and joint infections due to methicillin-resistant staphylococci: 56 chronic osteomyelitis (CO), 10 septic arthritis (SA) and 23 infections associated to arthroplasties (IAA). We analyzed the efficacy of Teicoplanin (T) in three times a week or daily administration schemes and adequate surgery (AS). Also, we determined cost savings derived from outpatient parenteral antibiotic therapy (OPAT). The overall efficacy of T in CO and both in cases with and without implants, was higher when antibiotic therapy was associated to AS (86 vs. 46%, p = 0.001; 100 vs. 33%, p = 0.0049 and 76 vs. 50%, p = 0.09). All SA were cured. The overall efficacy of T was higher in IAA with implant removal vs. surgical debridement (100 vs. 54%, p = 0.045). In all cases, T was similarly effective when administered three times a week vs. daily administration, when associated to AS. The savings derived from OPAT were 897 days/bed and USS 179,400. Adverse effects were few and light (8 episodes, 9%). The results obtained are similar to those published in the literature and show that T administered daily or in a three times a week scheme and associated to AS, is effective and safe for the treatment of bone and joint infections. The savings derived from OPAT, mainly related to reduced hospitalization, are significant in these pathologies, which usually require long treatment periods.
Assuntos
Antibacterianos/uso terapêutico , Doenças Ósseas Infecciosas/tratamento farmacológico , Artropatias/tratamento farmacológico , Resistência a Meticilina , Infecções Estafilocócicas/tratamento farmacológico , Teicoplanina/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/economia , Artrite Infecciosa/tratamento farmacológico , Artroplastia/efeitos adversos , Doença Crônica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteomielite/tratamento farmacológico , Infecções Relacionadas à Prótese/tratamento farmacológico , Estudos Retrospectivos , Teicoplanina/economia , Resultado do TratamentoRESUMO
Evaluamos retrospectivamente a 73 adultos inmunocompetentes que consultaron entre marzo de 1999 y marzo de 2004 a un centro infectológico ambulatorio por fiebre y astenia, con elevación discreta de las transaminasas y serología compatible con infección reciente por citomegalovirus (CMV). Excluimos a pacientes con antecedentes de transfusiones, adicciones e inmunodeficiencias, así como aquellos con alteraciones hepáticas preexistentes o con serología compatible con infección aguda por hepatitis A, B, C (VHA, VHB, VHC) o virus Epstein Barr (VEB). El diagnóstico de infección reciente por citomegalovirus se efectuó mediante la detección de IgM específica (ELISA de captura), seroconversión o aumento cuádruple del título de IgG específica, en presencia de un cuadro clínico compatible. Los síntomas más frecuentes fueron: fiebre (85%) y astenia (83%), cefalea (25%), esplenomegalia (20%), adenomegalia (22%), faringitis (25%), mialgia (25%) y hepatomegalia (19 %). Se encontró elevación discreta de transaminasas y linfomonocitosis en todos los pacientes (73/73). La elevación promedio de GPT fue de 6 veces y la de GOT fue de 3.5 veces su valor límite. Las características clínicas que diferencian la infección por CMV de la infección por VEB son la menor frecuencia de poliadenopatías y faringitis en la primera. El diagnóstico diferencial de la infección por CMV con compromise hepático con las hepatitis A y B agudas se basa en la ausencia de ictericia, la menor elevación de las transaminasas, la linfomonocitosis intensa y la presencia de IgM específica que caracterizan a la infección por CMV. En conclusión, ante un paciente joven, previamente sano, con fiebre, astenia intensa, linfomonocitosis y elevación discreta de transaminasas, es importante investigar infección por citomegalovirus.
We retrospectivelyevaluated 73 immunocompetent adult patients assisted at our Infectious Diseases Clinic betweenMarch 1999 and March 2004 who presented fever and asthenia, mild to moderate increase of transaminasesand serological findings compatible with recent cytomegalovirus infection. We excluded patients with a history oftransfusions, drug abuse, immunodeficiencies, preexistent hepatic impairment or serological findings compatible with acute hepatitis A, B and C (HAV, HBV, HCV) and Epstein Barr virus (EBV). The laboratory diagnosis ofrecent cytomegalovirus infection was made by especific IgM detection (ELISA) or a significant increase of specific IgG. The most frequent symptoms were fever (85%) and asthenia (83%), followed by cephalea (25%), splenomegaly (20%), adenomegalies (22%), pharyngitis (25%), myalgias (25%) and hepatomegaly (19%). All the patients showed moderate increase of transaminases and lymphomonocytosis (73/73). In average, ALT wasincreased by 6 fold and AST by 3.5 fold. The clinical characteristics that differentiate CMV infection from Epstein-Barr infection are the lesser frequency of adenomegalies and pharyngitis in the former. The differential diagnosisof CMV infection with hepatic involvement from acute hepatitis A and B, is based on the absence of jaundice,the lower elevation of transaminases, the intense lymphomonocytosis and the presence of specific IgMagainst CMV that are characteristic of CMV infection. In conclusion, in previously healthy young adults with fever, intense asthenia, lymphomonocytosis and moderate increase in transaminases levels, cytomegalovirus infectionshould be investigated.
Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto , Pessoa de Meia-Idade , Infecções por Citomegalovirus/diagnóstico , Citomegalovirus/imunologia , Hepatite Viral Humana/diagnóstico , Anticorpos Antivirais , Biomarcadores , Infecções por Citomegalovirus/complicações , Infecções por Citomegalovirus/imunologia , Diagnóstico Diferencial , Ensaio de Imunoadsorção Enzimática , Seguimentos , Hepatite Viral Humana/imunologia , Hepatite Viral Humana/virologia , Imunocompetência , Imunoglobulina G/sangue , Imunoglobulina M/análise , Imunoglobulina M/sangue , Estudos Retrospectivos , Transaminases/metabolismoRESUMO
Objetivo: Describir un programa de procreación responsable en parejas donde el varón está infectado con el VIH organizado en un centro ambulatorio infectológico de la ciudad de Bs. As. y llevado a cabo por un equipo interdisciplinario conformado por Infectólogos, Bioquímicos, Ginecólogos y Biólogos. Comentar algunas revisiones de la literatura que avalan la evidencia cientifica para realizar estos procedimientos. Métodos: las parejas serodiscordantes son candidatas para este programa si el varón tiene seguimiento infectológico, los estudios de esperma demuestran carga viral (CV) indetectable y DNA proviral de VIH negativo, y, la mujer tiene ADN proviral de VIH negativo en sangre, en el ciclo en el cual se realizará el procedimiento de fertilización asistida. Se realiza en la mujer pesquisa de infecciones connatales. Las muestras de esperma son procesadas con técnicas de lavado, swim up y swim down, y congeladas. Después de cada procedimiento de fertilización asistida la mujer es controlada controlada con estudios serológicos para anticuerpos (VIH ELISA) periódicos. Los recién nacidos son evaluados a través de ADN proviral de VIH en el 1er mes de vida, o, durante los primeros 6 meses de vida a través de anticuerpos (VIH ELISA). Resultadaos: desde 12/2000 y hasta mayo 2009 se incluyeron 165 parejas serodiscordantes. 147 pacientes VIH (+) realizaron estudios de muestras de esperma, 26, tuvieron muestras con estudios microbiológicos positivos (23, CV detectable, y 3, ADN proviral de VIH positivo). En 123 parejas se realizaron: 329 inseminaciones, 55 ICSI y 28 FIV. Se concretron 44 embarazos y nacieron 51 bebés. Todos los estudios realizados a las mujeres y recién nacidos mostraron resultados negativos. Conclusiones: este programa logró resultados satisfactorios en la prevención de infecciones por VIH y connatales.
Objective: to describe the data obtained during the development of an assisted reproduction program for couples where the man is HIV - Infected organized by an ambulatory infectologist center in BsAs city. a multidisciplinary team with infectious disease MD, biochemists, ginecologists and bilogist collaborate in the follow-up of the patients. Methods: couples seeking reproductive counseling were eligible for this programme if: the HIV positive male partner adhered to an infectious disease follow-up, he has undetectable viral load in the fresh sperm sample and is negative for HIV proviral DNA in the swim-up material after sperm washing, the female partner is negative for HIV proviral DNA immediately beforme each assisted reproduction attempt. Procedures comprised intrauterine insemination, intracytoplasmic sperm injection and in vitro fertilization accordin to gynecologist indication. After each procedure, women were tested for indication. After each procedure, women were tested for HIV antibodies periodically. Newborns were tested for HIV proviral DNA at one month of age or HE during the first six months. Results: One hundred and sixty five couples were assessed, semen analyses results were obtained from 147 HIV positive men, 23 had detectable viral load, 3 had positive HIV proviral DNA in swim up. One hundred and twenty three couples undervent AR procedures: 329 intrauterine inseminations, 55 intracytoplasmic sperm injections, and 28 in-vitro fertilizations. Forty four pregnancies resulted in fifty one live Births. All HE and HDP tests performed in women and new-borns were negative. Conclusions: This programme achieved satisfactory results in prevention of HIV and congenital infections.
Assuntos
Humanos , Masculino , Antivirais/imunologia , Controle de Doenças Transmissíveis , Carga Viral/estatística & dados numéricos , Declaração de Helsinki , HIV , Técnicas de Reprodução AssistidaRESUMO
We retrospectively evaluated 89 episodes of bone and joint infections due to methicillin-resistant staphylococci: 56 chronic osteomyelitis (CO), 10 septic arthritis (SA) and 23 infections associated to arthroplasties (IAA). We analyzed the efficacy of Teicoplanin (T) in three times a week or daily administration schemes and adequate surgery (AS). Also, we determined cost savings derived from outpatient parenteral antibiotic therapy (OPAT). The overall efficacy of T in CO and both in cases with and without implants, was higher when antibiotic therapy was associated to AS (86 vs. 46, p = 0.001; 100 vs. 33, p = 0.0049 and 76 vs. 50, p = 0.09). All SA were cured. The overall efficacy of T was higher in IAA with implant removal vs. surgical debridement (100 vs. 54, p = 0.045). In all cases, T was similarly effective when administered three times a week vs. daily administration, when associated to AS. The savings derived from OPAT were 897 days/bed and USS 179,400. Adverse effects were few and light (8 episodes, 9). The results obtained are similar to those published in the literature and show that T administered daily or in a three times a week scheme and associated to AS, is effective and safe for the treatment of bone and joint infections. The savings derived from OPAT, mainly related to reduced hospitalization, are significant in these pathologies, which usually require long treatment periods