RESUMEN
The Delphi technique has been used since the 1950s to collect the opinions of experts; to gauge their indications, and in some instances, to develop a consensus. This systematic collection and aggregation of informed judgments from a group of experts on specific questions or issues is a highly efficient and cost-effective means to establish guidelines and policies, when compared to other strategies, such as committee meetings or personal interviews. OBJECTIVE: Examine the content validation process of the proposed criteria of the American Society of Health System Pharmacists (ASHP) for amikacin use in hospital settings. MATERIAL AND METHODS: The Delphi technique was applied using the proposed ASHP criteria questionnaire containing 102 specific questions related to the nosocomial use of amikacin by individual patients. The questionnaire contained six groups of questions: 1) Identification and basic demographic data, 2) Relevant data for the use of amikacin, 3) Justification of its usage, 4) Critical parameters of amikacin use, 5) Complications, 6) Measurement of results. Eight hospital specialist medical doctors were selected, including five in the area of infectious diseases, one surgeon, one nephrologist and one in critical care medicine. The questionnaire was e-mailed to the doctors and they were asked for their opinion about the appropriateness of the questions. They were to say whether the general concept seemed totally or partially adequate to the proposed process, what grade (0 to 10) they would give to each section, and if there were any perceived deficiencies, they could add, omit or modify individual questions. A second questionnaire containing the questions for which there had been no consensus based on the answers to the previous one was re-sent to the participants for consolidation. RESULTS: Feedback revealed an agreement of 75 percent concerning the utility and appropriateness of sections 1 and 2. The section about the justification of amikacin usage was agreed on by 50 percent. There was a total agreement of 62 percent for the critical parameters of amikacin use, and a partial agreement of 37 percent. The complication of usage of the questionnaire was agreed upon by 50 percent of the participants, and positive measurement of the results was totally agreed on by 62 percent, and partially by 37 percent. The overall score for the questionnaire was 8.77 ± 0.25. CONCLUSION: The usage criteria for amikacin recommended by ASHP were validated by the Delphi technique for utilization in Brazilian hospital settings. The Delphi technique applied to validate a questionnaire instrument for monitoring the correct use of a specific strategic antibiotic indicated for the treatment and prophylaxis of serious antibiotic-resistant Gram-negative bacteria, proved to be a reliable and simple tool for designing guidelines and a consensus document for hospital use of antibiotics.
Asunto(s)
Humanos , Amicacina/administración & dosificación , Antibacterianos/administración & dosificación , Infección Hospitalaria/tratamiento farmacológico , Técnica Delphi , Brasil , Infección Hospitalaria/prevención & control , Utilización de Medicamentos/normas , Sociedades MédicasRESUMEN
UNLABELLED: The Delphi technique has been used since the 1950s to collect the opinions of experts; to gauge their indications, and in some instances, to develop a consensus. This systematic collection and aggregation of informed judgments from a group of experts on specific questions or issues is a highly efficient and cost-effective means to establish guidelines and policies, when compared to other strategies, such as committee meetings or personal interviews. OBJECTIVE: Examine the content validation process of the proposed criteria of the American Society of Health System Pharmacists (ASHP) for amikacin use in hospital settings. MATERIAL AND METHODS: The Delphi technique was applied using the proposed ASHP criteria questionnaire containing 102 specific questions related to the nosocomial use of amikacin by individual patients. The questionnaire contained six groups of questions: 1) Identification and basic demographic data, 2) Relevant data for the use of amikacin, 3) Justification of its usage, 4) Critical parameters of amikacin use, 5) Complications, 6) Measurement of results. Eight hospital specialist medical doctors were selected, including five in the area of infectious diseases, one surgeon, one nephrologist and one in critical care medicine. The questionnaire was e-mailed to the doctors and they were asked for their opinion about the appropriateness of the questions. They were to say whether the general concept seemed totally or partially adequate to the proposed process, what grade (0 to 10) they would give to each section, and if there were any perceived deficiencies, they could add, omit or modify individual questions. A second questionnaire containing the questions for which there had been no consensus based on the answers to the previous one was re-sent to the participants for consolidation. RESULTS: Feedback revealed an agreement of 75% concerning the utility and appropriateness of sections 1 and 2. The section about the justification of amikacin usage was agreed on by 50%. There was a total agreement of 62% for the critical parameters of amikacin use, and a partial agreement of 37%. The complication of usage of the questionnaire was agreed upon by 50% of the participants, and positive measurement of the results was totally agreed on by 62%, and partially by 37%. The overall score for the questionnaire was 8.77 +/- 0.25. CONCLUSION: The usage criteria for amikacin recommended by ASHP were validated by the Delphi technique for utilization in Brazilian hospital settings. The Delphi technique applied to validate a questionnaire instrument for monitoring the correct use of a specific strategic antibiotic indicated for the treatment and prophylaxis of serious antibiotic-resistant Gram-negative bacteria, proved to be a reliable and simple tool for designing guidelines and a consensus document for hospital use of antibiotics.
Asunto(s)
Amicacina/administración & dosificación , Antibacterianos/administración & dosificación , Infección Hospitalaria/tratamiento farmacológico , Técnica Delphi , Brasil , Infección Hospitalaria/prevención & control , Utilización de Medicamentos/normas , Humanos , Sociedades MédicasRESUMEN
Community-acquired pneumonia is very common, but some of the cases do require hospitalization for treatment, particularly when older patients and/or co-morbidities are involved; both "typical" and "atypical" respiratory pathogens take part etiologically, and there is increasing concern about the emergence of resistance. There is interest in therapeutic options that can: a) comprehend such a spectrum of bacteria and resistance; b) allow parenteral to oral sequential treatment. We made a multicenter, prospective and randomized trial to compare the "standard" treatment of ceftriaxone IV alone or in combination with erythromycin IV, followed by clarithromycin PO (ceftriaxone treatment arm), with gatifloxacin IV, followed by oral administration (gatifloxacin treatment arm). The need for hospitalization was based on clinical criteria as judged by the investigators. Standardized criteria for diagnosis and follow-up were employed. Fifty-six patients were enrolled, with 48% over 65 years old, and there were frequent co-morbidities. Of these, 51 were clinically evaluable, 26 in the gatifloxacin and 25 in the ceftriaxone arm, with comparable success rates, 92% and 88%, respectively, even when major prognostic factors were considered. There were no serious adverse events or significant laboratory value changes attributable to the study drugs. Gatifloxacin as monotherapy (initially IV then orally until completion of treatment) was shown to be effective and safe, comparable to ceftriaxone IV alone or in combination with a macrolide (initially IV then orally until completion of treatment), in empirical therapy for community-acquired pneumonias, for patients that, at the physician s discretion, require initial treatment as inpatients.
Asunto(s)
Antibacterianos/uso terapéutico , Ceftriaxona/uso terapéutico , Fluoroquinolonas/uso terapéutico , Macrólidos/uso terapéutico , Neumonía Bacteriana/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Ceftriaxona/administración & dosificación , Infecciones Comunitarias Adquiridas/tratamiento farmacológico , Femenino , Gatifloxacina , Humanos , Macrólidos/administración & dosificación , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
Community-acquired pneumonia is very common, but some of the cases do require hospitalization for treatment, particularly when older patients and/or co-morbidities are involved; both "typical" and "atypical" respiratory pathogens take part etiologically, and there is increasing concern about the emergence of resistance. There is interest in therapeutic options that can: a) comprehend such a spectrum of bacteria and resistance; b) allow parenteral to oral sequential treatment. We made a multicenter, prospective and randomized trial to compare the "standard" treatment of ceftriaxone IV alone or in combination with erythromycin IV, followed by clarithromycin PO (ceftriaxone treatment arm), with gatifloxacin IV, followed by oral administration (gatifloxacin treatment arm). The need for hospitalization was based on clinical criteria as judged by the investigators. Standardized criteria for diagnosis and follow-up were employed. Fifty-six patients were enrolled, with 48 percent over 65 years old, and there were frequent co-morbidities. Of these, 51 were clinically evaluable, 26 in the gatifloxacin and 25 in the ceftriaxone arm, with comparable success rates, 92 percent and 88 percent, respectively, even when major prognostic factors were considered. There were no serious adverse events or significant laboratory value changes attributable to the study drugs. Gatifloxacin as monotherapy (initially IV then orally until completion of treatment) was shown to be effective and safe, comparable to ceftriaxone IV alone or in combination with a macrolide (initially IV then orally until completion of treatment), in empirical therapy for community-acquired pneumonias, for patients that, at the physician s discretion, require initial treatment as inpatients.
Asunto(s)
Humanos , Femenino , Adulto , Persona de Mediana Edad , Antiinfecciosos , Antibacterianos/uso terapéutico , Ceftriaxona , Cefalosporinas , Macrólidos , Neumonía Bacteriana , Anciano de 80 o más Años , Infecciones Comunitarias Adquiridas , Macrólidos , Estudios ProspectivosRESUMEN
We evaluated samples of peripheral blood mononuclear (PBMC) cells from 46 AIDS patients, before starting therapy with HIV-1 reverse transcriptase inhibitors (RTI), and after 6 months of drug use. PBMC were stored and tested by a Line Probe Assay (LiPA), in order to assess the frequency of RT mutations in this population. Six patients were taking AZT before initial blood collection (1 to 16 weeks of drug use) and 40 patients had no prior therapy. After baseline evaluation, 19 patients received AZT, 23 AZT plus DDI, 3 started AZT only with DDI added after 3 months, and 3 received a combination of AZT plus 3TC. Detection of at least one mutation was found in 33% (15/46) of patients at baseline, and 83% (38/46) had at least 1 mutation after 6 months of therapy. In the majority of cases, samples presented with the wild type and variants of HIV, simultaneously. Patients receiving monotherapy had a higher frequency of mutations (L41 and F214, Y215) than did patients receiving double-drug therapy (19 vs. 10). No specific mutation associated with DDI was identified in 26 patients so treated. Despite the finding of a mean increase in CD4 count and a mild decrease in viral load, patients tended to have an inverse correlation between the CD4 variation and number of mutations detected after 6 months, suggesting potential loss of drug efficacy in the presence of these genotypic changes.
Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Fármacos Anti-VIH/farmacología , Farmacorresistencia Viral , VIH-1/efectos de los fármacos , VIH-1/genética , Inhibidores de la Transcriptasa Inversa/farmacología , Síndrome de Inmunodeficiencia Adquirida/sangre , Fármacos Anti-VIH/uso terapéutico , Brasil , Recuento de Linfocito CD4 , Humanos , Leucocitos Mononucleares/virología , Mutación Puntual , Inhibidores de la Transcriptasa Inversa/uso terapéutico , Carga ViralRESUMEN
Immunotherapy has been proposed as a method to treat mucosal leishmaniasis for many years, but the approach has been hampered by poor definition and variability of antigens used, and results have been inconclusive. We report here a case of antimonial-refractory mucosal leishmaniasis in a 45 year old male who was treated with three single injections (one per month) with a cocktail of four Leishmania recombinant antigens selected after documented hypo-responsiveness of the patient to these antigens, plus 50 microg of GM-CSF as vaccine adjuvant. Three months after treatment, all lesions had resolved completely and the patient remains without relapse after two years. Side effects of the treatment included only moderate erythema and induration at the injection site after the second and third injections. We conclude that carefully selected microbial antigens and cytokine adjuvant can be successful as immunotherapy for patients with antimonial-refractory mucosal leishmaniasis.
Asunto(s)
Antígenos de Protozoos/uso terapéutico , Factor Estimulante de Colonias de Granulocitos y Macrófagos/uso terapéutico , Inmunoterapia , Úlcera de la Pierna/tratamiento farmacológico , Leishmania/inmunología , Leishmaniasis Mucocutánea/tratamiento farmacológico , Adyuvantes Inmunológicos/uso terapéutico , Animales , Humanos , Leishmaniasis Mucocutánea/patología , Masculino , Persona de Mediana EdadRESUMEN
Co-infection with HTLV-1 reaches 20% among patients infected by HIV-1 in Bahia, Brazil. To evaluate its impact on survival, we conducted a retrospective, case-control study involving 198 patients (63 cases). Co-infection was associated with parenteral exposure (P = 0.0001) and female sex (P = 0.02). Co-infected patients had a shorter mean survival (1849 days) than controls (2430 days, P = 0.001), regardless of sex or baseline CD4 cell count. In Bahia, Brazil, co-infection with HIV-1 and HTLV-1 is associated with a shorter survival time.
Asunto(s)
Infecciones por VIH/complicaciones , Infecciones por VIH/mortalidad , VIH-1 , Infecciones por HTLV-I/complicaciones , Virus Linfotrópico T Tipo 1 Humano , Adolescente , Adulto , Brasil/epidemiología , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Estudios Retrospectivos , Análisis de SupervivenciaRESUMEN
To identify antigens that would improve the accuracy of serological diagnosis of active tuberculosis, we cloned the genes encoding nine potentially immunogenic secreted or surface-associated proteins of Mycobacterium tuberculosis. Recombinant proteins were reacted with sera from HIV-negative individuals with extrapulmonary tuberculosis (EP-TB) or HIV-positive individuals with pulmonary tuberculosis (TBH). Specific and high level antibody responses were obtained for four recombinant proteins, of which antigen GST-822 was recognized by 60% of EP-TB and 42% of TBH and antigen MBP-506 was recognized by 45% of EP-TB and 61% of TBH. These results suggest that these proteins are strong candidates as subunits in a polyvalent serodiagnostic test.
Asunto(s)
Anticuerpos Antibacterianos/sangre , Antígenos Bacterianos/inmunología , Ensayo de Inmunoadsorción Enzimática , Mycobacterium tuberculosis/inmunología , Tuberculosis/diagnóstico , Antígenos Bacterianos/genética , Proteínas Bacterianas/genética , Proteínas Bacterianas/inmunología , Clonación Molecular , Genes Bacterianos , Humanos , Mycobacterium tuberculosis/genética , Sistemas de Lectura Abierta , Reacción en Cadena de la Polimerasa , Proteínas Recombinantes de Fusión/inmunología , Proteínas Recombinantes de Fusión/metabolismoRESUMEN
Diarrhea due to intestinal microbial infections is a frequent manifestation among HIV-infected patients. It has been postulated that HIV-infected patients may have special types of intestinal infections, and that immune activation from such parasites may affect the progression of HIV disease. To evaluate these associations, the frequency of infections was examined in HIV-infected patients in Bahia, Brazil. To determine the potential impact of the presence of intestinal parasitic infections on HIV disease progression, a retrospective study approach was used. The medical charts of 365 HIV-infected patients who had been treated at the AIDS Clinic of the Federal University of Bahia Hospital were reviewed, and the prevalence of parasites was compared with 5,243 HIV-negative patients who had attended the hospital during the same period of time. Among HIV-infected subjects, CD(4) count, RNA plasma viral load (VL), and number of eosinophils were compared according to their stool examination results. The overall prevalence of each parasite was similar for HIV-positive and HIV-negative patients. However, the prevalence of S. stercoralis (p<10(-7)) and G. lamblia (p=0.005) was greater for HIV-infected subjects. The mean CD(4) count and viral load of HIV patients in our clinic who had stool examinations was 350 cells +/- 340 and 4.4 +/- 1.4 log RNA viral load, respectively. In this patient group there was no clear association between the level of the absolute CD(4) count or the viral load and a specific parasitic infection. The presence of an intestinal parasitic infection was not associated with faster progression of the HIV disease among HIV-infected patients. We conclude that strongyloidiasis and giardiasis are more frequent in HIV-infected patients in Bahia, Brazil. If this association is due to immune dysregulation, as has been proposed elsewhere, it must occur in patients after only minor shifts in CD(4) count from normal levels, or as a result of immune dysfunction not represented by CD(4) count. These infections do not appear to alter the progression of HIV disease.
Asunto(s)
Infecciones Oportunistas Relacionadas con el SIDA/epidemiología , Giardiasis/epidemiología , Estrongiloidiasis/epidemiología , Infecciones Oportunistas Relacionadas con el SIDA/parasitología , Adulto , Animales , Brasil/epidemiología , Recuento de Linfocito CD4 , Heces/parasitología , Femenino , Giardia lamblia/aislamiento & purificación , Giardiasis/parasitología , VIH-1/fisiología , Humanos , Parasitosis Intestinales/epidemiología , Parasitosis Intestinales/parasitología , Masculino , Persona de Mediana Edad , Prevalencia , ARN Viral/sangre , Estudios Retrospectivos , Strongyloides stercoralis/aislamiento & purificación , Estrongiloidiasis/parasitología , Carga ViralRESUMEN
Preliminary preclinical and clinical data suggest that granulocyte-macrophage colony-stimulating factor (GM-CSF) may decrease viral replication. Therefore, 105 individuals with AIDS who were receiving nucleoside analogue therapy were enrolled in a placebo-controlled, double-blind study and were randomized to receive either 125 microgram/m(2) of yeast-derived, GM-CSF (sargramostim) or placebo subcutaneously twice weekly for 6 months. Subjects were evaluated for toxicity and disease progression. A significant decrease in mean virus load (VL) was observed for the GM-CSF treatment group at 6 months (-0.07 log(10) vs. -0.60 log(10); P=.02). More subjects achieved human immunodeficiency virus (HIV)-RNA levels <500 copies/mL at >/=2 evaluations (2% on placebo vs. 11% on GM-CSF; P=.04). Genotypic analysis of 46 subjects demonstrated a lower frequency of zidovudine-resistant mutations among those receiving GM-CSF (80% vs. 50%; P=.04). No difference was observed in the incidence of opportunistic infections (OIs) through 6 months or survival, despite a higher risk for OI among GM-CSF recipients. GM-CSF reduced VL and limited the evolution of zidovudine-resistant genotypes, potentially providing adjunctive therapy in HIV disease.
Asunto(s)
Síndrome de Inmunodeficiencia Adquirida/tratamiento farmacológico , Fármacos Anti-VIH/uso terapéutico , Factor Estimulante de Colonias de Granulocitos y Macrófagos/uso terapéutico , Zidovudina/uso terapéutico , Síndrome de Inmunodeficiencia Adquirida/inmunología , Síndrome de Inmunodeficiencia Adquirida/virología , Adulto , Terapia Antirretroviral Altamente Activa , Recuento de Linfocito CD4 , Método Doble Ciego , Femenino , Genotipo , Factor Estimulante de Colonias de Granulocitos y Macrófagos/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , ARN Viral/sangreRESUMEN
The prevalence of HTLV-I reaches 1.8% among blood donors in Salvador, and 40% among chronic myelopathy patients in the state of Bahia, Brazil. The present study shows the epidemiological and clinical picture of patients attending the HAM/TSP Outpatient Unit at the Foundation of Neurology and Neorusurgery (FNN). 114 patients had epidemiologic data collected and 51 of these patients, who had regularly attended the HAM/TSP Unit for at least 1 year, were evaluated for signs, symptoms and disease progression. Most of the 114 patients were female (70%), of African descent, and with a mean age of 51. Sexually transmitted diseases and blood transfusion were the most common risk factors. Paraparesis with spasticity was the predominant sign (85%), bladder dysfunction occurred in 75%, intestinal dysfunction was recorded in 48%. Sensory examination was normal in 50% of the cases studied. The patients' functional status, as measured by the Kurtzke Disability Scale, during the 1 year observation period changed only in early disease. Steroid therapy with prednisone was the most commonly used treatment in this group.
Asunto(s)
Paraparesia Espástica Tropical/epidemiología , Paraparesia Espástica Tropical/fisiopatología , Adulto , Factores de Edad , Anciano , Evaluación de la Discapacidad , Femenino , Anticuerpos Anti-HTLV-I/sangre , Anticuerpos Anti-HTLV-I/líquido cefalorraquídeo , Virus Linfotrópico T Tipo 1 Humano/inmunología , Humanos , Masculino , Persona de Mediana Edad , Paraparesia Espástica Tropical/virología , Factores de Riesgo , Factores SexualesAsunto(s)
Vacunas contra el Cólera , Vacunas Tifoides-Paratifoides , Cólera/prevención & control , Vacunas contra el Cólera/administración & dosificación , Vacunas contra el Cólera/inmunología , Ensayos Clínicos como Asunto , Salud Global , Humanos , Fiebre Tifoidea/prevención & control , Vacunas Tifoides-Paratifoides/administración & dosificación , Vacunas Tifoides-Paratifoides/inmunología , Vibrio cholerae/inmunologíaRESUMEN
A tetrapeptide and a recombinant protein, each representing 4 immunodominant epitopes of Trypanosoma cruzi, were tested by use of ELISA for the detection of serum antibodies. Sera from individuals with Chagas' disease, including persons untreated and successfully or unsuccessfully treated, were tested. These assays detected antibody in 100% of the parasitemias. The antibody reactivity decreased based on the success of treatment. Higher sensitivity was observed for tetrapeptide/recombinant protein assays than for lysate-based ELISA, and specificity was improved, particularly with Leishmania sera. The results indicate that multiepitope antigens provide a more sensitive and specific alternative to lysate for detection of anti-T. cruzi antibodies, as required for developing blood screening assays.
Asunto(s)
Anticuerpos Antiprotozoarios/sangre , Enfermedad de Chagas/diagnóstico , Ensayo de Inmunoadsorción Enzimática/métodos , Oligopéptidos , Proteínas Recombinantes , Brasil/epidemiología , Humanos , Epítopos Inmunodominantes , Parasitemia/diagnóstico , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadAsunto(s)
Brotes de Enfermedades/prevención & control , Brasil/epidemiología , Control de Enfermedades Transmisibles/economía , Control de Enfermedades Transmisibles/métodos , Dengue/epidemiología , Dengue/prevención & control , Entomología , Humanos , Medicina , Ciudad de Nueva York/epidemiología , Salud Pública , Especialización , Fiebre del Nilo Occidental/epidemiología , Fiebre del Nilo Occidental/prevención & controlRESUMEN
To better understand the origin of human T-cell leukemia virus type l (HTLV-l) in South America, we conducted a phylogenetic study on 27 new HTLV-ls in Brazil. These were obtained from Brazilians of various ethnic origins, such as Japanese immigrants, whites, blacks and mulattos. We amplified and sequenced proviral DNAs of a part of the long terminal repeats. Phylogenetic trees revealed that all but 6 of the new isolates were not only similar to each other but also similar to HTLV-ls of other South American countries, including those from Amerindians. However, the isolates differed from the HTLV-ls of Africa and Japan. The other six isolates were from Japanese immigrants and were phylogenetically almost identical to HTLV-ls in Japan but different from the majority of South American HTLV-ls, including the other new Brazilian HTLV-ls. These findings indicate that the recent introduction of HTLV-1 from Japan is limited to Japanese immigrants. In addition, the results do not support the prevailing hypothesis that HTLV-ls in South America were introduced by blacks who were brought from Africa as slaves. Rather, these results suggest that the majority of HTLV-1s prevailing in South America have spread from Amerindians, some of whom are likely to have possessed this human retrovirus from the beginning of their settlement in South America.
Asunto(s)
Infecciones por HTLV-I/epidemiología , Infecciones por HTLV-I/virología , Virus Linfotrópico T Tipo 1 Humano/genética , Filogenia , Adulto , África , Anciano , Anciano de 80 o más Años , Secuencia de Bases , Brasil/epidemiología , Emigración e Inmigración , Etnicidad , Femenino , Virus Linfotrópico T Tipo 1 Humano/aislamiento & purificación , Humanos , Japón/etnología , Masculino , Persona de Mediana Edad , Epidemiología Molecular , Datos de Secuencia Molecular , Reacción en Cadena de la Polimerasa , Polimorfismo de Longitud del Fragmento de Restricción , Análisis de Secuencia de ADN , Secuencias Repetidas Terminales/genéticaRESUMEN
Five cases of Trypanosoma cruzi meningoencephalitis in HIV-infected patients are reported. All patients presented with mass lesions on head computed tomographic scan, trypanosomes in the cerebrospinal fluid and failure to respond to antitoxoplasmosis therapy. Benznidazole therapy was associated with clinical improvement in 1 patient. Another 4 patients had T cruzi identified in a peripheral smear. T cruzi needs to be considered in the differential diagnosis of HIV-infected patients with central nervous system mass lesions if they have a history of appropriate exposure.