Factores pronósticos de la neumonía comunitaria. Estudio prospectivo multicéntrico en Servicios de Medicina Interna / Prognostic factors in community acquired pneumonia. Prospective multicenter study in internal medical departments

Objetivo: Los objetivos de este estudio multicéntrico fueron evaluar las características clínicas y microbiológicas de pacientes que ingresaron en servicios de Medicina Interna y analizar los factores que influyeron en la mortalidad a los 30 días. Método: Se recogieron antecedentes personales de cada paciente, síntomas y signos, patrón radiológico y parámetros analíticos incluyendo albúmina y proteína C reactiva (PCR). También se registró el número de horas que transcurrieron hasta que se instauró la primera dosis de antibiótico y el seguimiento en días. Los pacientes fueron estratificados en cinco clases de riesgo según el Pneumonia Severity Index. Resultados: Se incluyeron 389 pacientes la mayoría distribuidos en las clase III a V de Fine. La mortalidad global fue del 12,1% (48 pacientes) elevándose al 40% en los pacientes de la clase V. Ni la edad, ni el sexo, ni el número de horas transcurrido hasta la primera dosis de tratamiento antibiótico influyeron en la mortalidad a los 30 días. Tampoco los niveles de PCR en plasma ni el conocer o no el diagnóstico microbiológico. Los pacientes orientados (OR 0,138, IC95% 0,055-0,324)y con mayores niveles de albúmina (OR 0,207, IC95% 0,103-0,417) tuvieron mejor supervivencia .La presencia de carcinoma activo (OR 3,2, IC95% 1,181-8,947) predijo tambien de forma independiente la mortalidad. Conclusiones: Concluimos que además de los parámetros universalmente aceptados de Fine, debería utilizarse la albúmina para seleccionar a aquellos pacientes en los que el pronóstico podría ser peor

Aims: the aims of the present study were to evaluate the clinical and microbiological characteristics of patients suffering from communityacquired pneumonia attended in the Internal Medical Departments of several Spanish institutions and to analyze those prognostic factors predicting thirty-day mortality in such patients. Material and methods: Past medical history, symptoms and signs, radiological pattern and blood parameters including albumin and C Reactive Protein, were recorded for each patient. Time from admission to starting antibiotics (in hours) and follow-up (in days) were also recorded. Patients were stratified by the Pneumonia Severity Index in five risk classes. Results: 389 patients were included in the study, most of them in Fine categories III to V. Mortality rate for all patients was 12.1% (48 patients), increasing up to 40% in Fine Class V. Neither age, sex nor time from admission to the start of antibiotic treatment predicted survival rates. Plasmatic levels of PCR or microbiologic diagnosis were not related to clinical outcome. In the Cox regression analysis, oriented patients (OR 0.138, IC95% 0.055-0.324), and those with normal albuminemia (OR 0.207, IC95% 0.103-0.417) showed better survival rates. On the contrary, those with active carcinoma (OR 3.2, IC95% 1.181-8.947) significantly showed a reduced life expectancy. Conclusion: Besides the fully accepted Fine scale criteria, albumin measurements should be included in routine evaluation in order to improve patient’s prognostic classification

[Prognostic factors in community acquired pneumonia. Prospective multicenter study in internal medical departments]. / Factores pronósticos de la neumonía comunitaria. Estudio prospectivo multicéntrico en Servicios de Medicina Interna.

AIMS: the aims of the present study were to evaluate the clinical and microbiological characteristics of patients suffering from community-acquired pneumonia attended in the Internal Medical Departments of several Spanish institutions and to analyze those prognostic factors predicting thirty-day mortality in such patients. MATERIAL AND METHODS: Past medical history, symptoms and signs, radiological pattern and blood parameters including albumin and C Reactive Protein, were recorded for each patient. Time from admission to starting antibiotics (in hours) and follow-up (in days) were also recorded. Patients were stratified by the Pneumonia Severity Index in five risk classes. RESULTS: 389 patients were included in the study, most of them in Fine categories III to V. Mortality rate for all patients was 12.1% (48 patients), increasing up to 40% in Fine Class V. Neither age, sex nor time from admission to the start of antibiotic treatment predicted survival rates. Plasmatic levels of PCR or microbiologic diagnosis were not related to clinical outcome. In the Cox regression analysis, oriented patients (OR 0.138, IC95% 0.055-0.324), and those with normal albuminemia (OR 0.207, IC95% 0.103-0.417) showed better survival rates. On the contrary, those with active carcinoma (OR 3.2, IC95% 1.181-8.947) significantly showed a reduced life expectancy. CONCLUSION: Besides the fully accepted Fine scale criteria, albumin measurements should be included in routine evaluation in order to improve patient s prognostic classification.

[Clinical trial comparing efficacy and safety of four highly active antiretroviral therapy (HAART) in antiretroviral-naive treatment with advanced HIV infection]. / Ensayo clínico comparativo de eficacia y seguridad de cuatro pautas de tratamiento antirretroviral de alta eficacia (TARGA) en pacientes naive con infección por VIH avanzada.

BACKGROUND: Comparison of efficacy and safety of four highly active antiretroviral therapy regimens (HAART) including two nucleoside analogues (NA) and a protease inhibitor (PI) in HIV positive patients with advanced infection and antiretroviral naive. PATIENTS AND METHODS: Multicenter, randomized and open labeled clinical trial in ten community hospitals of Castilla-La Mancha and Madrid. Regimen 1 contains zidovudine (AZT), lamivudine (3TC) and indinavir (IDV) regimen 2 includes AZT, 3TC and ritonavir (RTV), regimen 3 was didanosine (DDI), estavudine (D4T) and IDV, and regimen 4 included DDI, D4T and RTV. Decrease in viral load of HIV (VC) has been assessed as primary endpoint and as secondary one, the increase of the numbers of CD4 lymphocytes, percentage of disease progression, adverse reactions and adherence. Measurements were made at baseline visit and at 6, 12, 24, 36 and 48 weeks. RESULTS: A total of 98 patients with a mean baseline CD4 count of 122 x 10(6)/l (range of 5-340) and a baseline viral load of 5.1 log copies/ml were included. At 48 weeks, a mean increase of the CD4 and decrease of the viral load without significant difference between the 4 regimens (103 cells/2.62 log in regimen 1; 169 cells/2.86 log in regimen 2; 171 cells/2.56 log in regimen 3 and 141 cells/1.71 log in regimen 4) were observed in the analysis of the patients in treatment. Treatment was discontinued due to adverse reactions: 24% in regimen 1, 48% in regimen 2, 26% in regimen 3 and 32% in regimen 4, without significant difference. Analyzing by PI groups, 41% of the patients with RTV and 25% of those with IDV discontinued treatment due to adverse effects. There was withdrawal from treatment due to disease progression in 7% of the RTV patients and in 9% of IDV patients. CONCLUSIONS: In the HIV positive patients with advanced infection, efficacy between the four regimens of HAART is similar, but there is a tendency to require more withdrawal due to adverse effects in the RTV group than in those of IDV, the two used as single PI.

Ensayo clínico comparativo de eficacia y seguridad de cuatro pautas de tratamiento antirretroviral de alta eficacia (TARGA) en pacientes naive con infección por VIH avanzada / Clinical trial comparing efficacy and safety of four highly active antiretroviral therapy (HAART) in antiretroviral-naive treatment with advanced HIV infection

Introducción. Comparación de la eficacia y seguridad de cuatro pautas de terapia antirretroviral de gran actividad (TARGA) incluyendo dos análogos de nucleósidos (AN) y un inhibidor de proteasa (IP) en pacientes con el virus de la inmunodeficiencia humana (VIH) con infección avanzada y naive a antirretrovirales. Pacientes y método. Ensayo clínico, multicéntrico, randomizado y abierto en diez hospitales comunitarios de Castilla-La Mancha y Madrid. La pauta 1 contenía zidovudina (ZDV), lamivudina (3TC) e indinavir (IDV); la pauta 2 incluía ZDV, 3TC y ritonavir (RTV); la pauta 3 era didanosina (DDI), estavudina (D4T) e IDV, y la pauta 4 incluía DDI, D4T y RTV. Se ha valorado como variable principal de respuesta el descenso de la carga viral del VIH (CV), y como variables secundarias: el aumento del número de linfocitos CD4, el porcentaje de progresión de la enfermedad, las reacciones adversas y la adherencia. Las determinaciones se realizaron en la visita basal y a las 6, 12, 24, 36 y 48 semanas. Resultados. Se incluyeron 98 pacientes con una media de CD4 basal de 122 x 106/l (rango de 5-340) y una carga viral basal de 5,1 log copias/ml. A las 48 semanas, en el análisis de los pacientes en tratamiento se observó un incremento medio de los CD4 y una disminución de la carga viral sin diferencia significativa entre las 4 pautas (103 células/2,62 log en la pauta 1, 169 células/ 2,86 log en la pauta 2, 171 células/2,56 log en la pauta 3 y 141 células/1,71 log en la pauta 4). Interrumpieron el tratamiento por reacciones adversas: el 24% en la pauta 1, el 48% en la pauta 2, el 26% en la pauta 3 y el 32% en la pauta 4, sin diferencias significativas. Analizando por grupos de IP el 41% de los pacientes con RTV y el 25% de los pacientes con IDV suspendieron el tratamiento por efectos adversos. Se produjo retirada del tratamiento por progresión de la enfermedad en el 7% de los pacientes con RTV y en el 9% de los pacientes con IDV. Conclusiones. En los pacientes VIH positivos con infección avanzada la eficacia entre cuatro pautas de TARGA es similar, pero existe una tendencia a precisar mayor retirada por efectos adversos en los grupos de RTV que en los de IDV, los dos usados como IP único

Background. Comparison of efficacy and safety of four highly active antiretroviral therapy regimens (HAART) including two nucleoside analogues (NA) and a protease inhibitor (PI) in HIV positive patients with advanced infection and antiretroviral naive. Patients and methods. Multicenter, randomized and open labeled clinical trial in ten community hospitals of Castilla-La Mancha and Madrid. Regimen 1 contains zidovudine (AZT), lamivudine (3TC) and indinavir (IDV) regimen 2 includes AZT, 3TC and ritonavir (RTV), regimen 3 was didanosine (DDI), estavudine (D4T) and IDV, and regimen 4 included DDI, D4T and RTV. Decrease in viral load of HIV (VC) has been assessed as primary endpoint and as secondary one, the increase of the numbers of CD4 lymphocytes, percentage of disease progression, adverse reactions and adherence. Measurements were made at baseline visit and at 6, 12, 24, 36 and 48 weeks. Results. A total of 98 patients with a mean baseline CD4 count of 122 x 106/l (range of 5-340) and a baseline viral load of 5.1 log copies/ml were included. At 48 weeks, a mean increase of the CD4 and decrease of the viral load without significant difference between the 4 regimens (103 cells/2.62 log in regimen 1; 169 cells/2.86 log in regimen 2; 171 cells/2.56 log in regimen 3 and 141 cells/1.71 log in regimen 4) were observed in the analysis of the patients in treatment. Treatment was discontinued due to adverse reactions: 24% in regimen 1, 48% in regimen 2, 26% in regimen 3 and 32% in regimen 4, without significant difference. Analyzing by PI groups, 41% of the patients with RTV and 25% of those with IDV discontinued treatment due to adverse effects. There was withdrawal from treatment due to disease progression in 7% of the RTV patients and in 9% of IDV patients. Conclusions. In the HIV positive patients with advanced infection, efficacy between the four regimens of HAART is similar, but there is a tendency to require more withdrawal due to adverse effects in the RTV group than in those of IDV, the two used as single PI

Levofloxacino frente a betalactámicos en el tratamiento de la neumonía adquirida en la comunidad con ingreso hospitalario / Levofloxacin versus betalactamic therapy in commu nity-acquired pneumonia that requires hospitaliza tion

Objetivo: Comparar la eficacia y seguridad de levofloxacino frente al tratamiento estándar con betalactámicos en pacientes con Neumonía Adquirida en la Comunidad que cumplen criterios de ingreso hospitalario (NACH). Pacientes y métodos: Estudio prospectivo de un año de duración de 49 pacientes (ptes.) ingresados en el Servicio de Medicina Interna, diagnosticados de NACH con asignación aleatoria a recibir.- I: cefotaxima o ceftriaxona, II: amoxicilina-clavulánico, (las dos previas asociadas o no a un macrólido) o, III: levofloxacino. Se realizó Rx. tórax a los 7 -10 días, al mes y, posteriormente si era necesario. Resultados: 29 ptes. recibieron pauta estándar (I o II) y 20 ptes. levofloxacino. Eran varones el 84%, con edad media de 70,9 años, 57% con enfermedad de base moderada o grave, y 55% con criterios de gravedad inicial. En el 47% de los casos se llegó a diagnóstico etiológico, siendo en un tercio de los casos bacilos gramnegativos. Se produjo la curación en el 94% de los pacientes y éxitus en 2 pacientes (5%). No se observaron diferencias entre los dos grupos en las características demográficas, enfermedad de base ni gravedad inicial. No se detectaron diferencias en los efectos secundarios, complicaciones, estancia hospitalaria o porcentaje de curaciones. La necesidad de prolongar el tratamiento fue mayor en el grupo estándar que en el tratado con levofloxacino (52 vs 15%, p: 0,02). Conclusiones: En población mayor y con gravedad inicial el tratamiento con levofloxacino puede ser una alternativa válida al tratamiento estándar (AU)

Objective: To compare the effectiveness and security of levofloxacin treatment in front betalactamic therapy in patient with community-acquired pneumonia that require hospitalization (CAPH). Patient and methods: A prospective and randomized study along a year from 49 patients diagnosed of (CAPH) that were admitted in the Internal Medicine Service. The patients were assigned randomly to receive.- I: cefotaxime or ceftriaxone, II: amoxicillin/ clavulanate (both could be associated or not with a macrolide) or III: levofloxacin. It was accomplished Rx. thorax to 7 -10 days, to the month and, other reviews if was necessary. Results: 29 cases were in standard therapy (I or II) and 20 cases received levofloxacin therapy. Male 84 %, half age 70,9 years old, 57 % with moderate or severe underlying disease, and 55 % with approaches of initial severity criteria. In 47 % of the cases we arrived to etiologic diagnosis, in the third of the cases were BGN. The cure took place in 94 % of the patients and 2 patients died (5%). No differences were observed regarding demographic characteristics, underlying disease and severity. No differences were detected in: the secondary effects, complications, hospital stay or, mean stay or percentage of cures. The necessity to prolong the therapy was bigger in the standard group in front of the group tried with levofloxacin (52 % vs. 15 %, p:0.02). Conclusions: In bigger population and with initial severity the treatment with levofloxacin can be a valid alternative to the standard therapy (AU)

[Levofloxacin versus beta-lactamic therapy in community acquired pneumonia that requires hospitalization]. / Levofloxacino frente a betalactámicos en el tratamiento de la neumonía adquirida en la comunidad con ingreso hospitalario.

OBJECTIVE: To compare the effectiveness and security of levofloxacin treatment in front betalactamic therapy in patient with community-acquired pneumonia that require hospitalization (CAPH). PATIENT AND METHODS: A prospective and randomized study along a year from 49 patients diagnosed of (CAPH) that were admitted in the Internal Medicine Service. The patients were assigned randomly to receive.-I: cefotaxime or ceftriaxone, II: amoxicillin/clavulanate (both could be associated or not with a macrolide) or III: levofloxacin. It was accomplished Rx. thorax to 7-10 days, to the month and, other reviews if was necessary. RESULTS: 29 cases were in standard therapy (I or II) and 20 cases received levofloxacin therapy. Male 84%, half age 70.9 years old, 57% with moderate or severe underlying disease, and 55% with approaches of initial severity criteria. In 47% of the cases we arrived to etiologic diagnosis, in the third of the cases were BGN. The cure took place in 94% of the patients and 2 patients died (5%). No differences were observed regarding demographic characteristics, underlying disease and severity. No differences were detected in: the secondary effects, complications, hospital stay or, mean stay or percentage of cures. The necessity to prolong the therapy was bigger in the standard group in front of the group tried with levofloxacin (52% vs. 15%, p:0.02). CONCLUSIONS: In bigger population and with initial severity the treatment with levofloxacin can be a valid alternative to the standard therapy.

[Tularemia outbreak in the province of Cuenca associated with crab handling]. / Brote epidémico de tularemia en la provincia de Cuenca en relación con la manipulación de cangrejos.

OBJECTIVE: To report the clinical and epidemiologic characteristics of 19 patients diagnosed of tularemia at our hospital following an epidemic outbreak occurred in our health area. METHODS: Retrospective analysis of clinical records of patients admitted to our hospital who were examined at the Infectious Diseases Clinic and had clinical findings and epidemiologic data consistent with tularemia during the period from June 1998 to March 1999. CASE DEFINITION: A patient was considered to fulfill the case definition when clinical symptoms, epidemiologic data and the following laboratory criteria were met: antibody titer to Francisella tularensis (tube agglutination test) > or = 1/128 in the convalescence serum specimen, seroconversion or recovery of the microorganism from biological material. RESULTS: Nineteen patients with a median age of 60 years. Males predominated (63.1% male patients); all of them had handled red crayfish from the same source (río Mayor). The incubation period ranged from 0 to 15 days (mean 4.88 days). All patients presented with the ulceroglandular form. Seventy-three percent of patients received doxycycline. Only one patient relapsed. Water samples from the reservoir of the depuration plant of the river were positive to F. tularensis by PCR. This same result was confirmed in stomach and hepatopancreas of crayfish fished in río Mayor in the second half of July. CONCLUSIONS: The most likely hypothesis of this outbreak was the contamination of the river water with animals dead from tularemia which, together with the characteristics of the transmission mechanism (wounds caused by crabs) had contributed to the acquisition of this disease in humans. Interestingly too, red crayfish as the source of infection.

[The risk-benefit of the treatment of tuberculosis with a high bacilloscopy sensitivity in a provincial hospital]. / Riesgo-beneficio del tratamiento de tuberculosis, en un hospital provincial, con una sensibilidad alta de la baciloscopia.

BACKGROUND: To know the incidence and type of hepatic toxicity (HTX) of the tuberculous chemotherapy and to value the risk-benefit of treatment in our elderly population in a high sensibility context of the bacilloscopy. PATIENTS AND METHODS: Prospective study of 161 tuberculous patients with standards of 6 months, from January 1989 to December 1994. 75 patients with (INH, FR, PZ and ETB) and 83 patients with (INH, RF and PZ). It was accomplished clinical, analytical and microbiological control to all the patients during 24 months. RESULTS: 28% of the patients had more than 65 years and a 26% HIV infection. The tuberculosis (TBC) was disseminated in a 41%. A 74% of the patients ha positive bacilloscopy. The therapeutic fulfillment was correct in a 85% of the cases. A 48% of HTX was observed, with a 9% of serious HTX (associated with alcoholism and age greater tan 60 years). In 14% of he patients was changed in a way definitive the therapeutic standard. There was a 17% of therapeutic failure (associated with disseminated TBC and HIV infection) and a 7% of relapses. The attributive mortality of TBC was of a 4%. CONCLUSIONS: The transient and moderate increase in transaminase activity is frequent and it does not require to modify the chemotherapy. In the greater patients of 65 years the benefit of trying outweigh the risk, if is accomplished a narrow follow-up with precocious suspension of the drugs in the event of serious toxicity.

[Progressive multifocal leukoencephalopathy and AIDS. Response to cytarabine]. / Leucoencefalopatía multifocal progresiva y SIDA. Respuesta a la citarabina.

PML affects 4% of patients with AIDS and there is no effective treatment. Five cases of PML-AIDS have been described, showing clinical and radiological improvement after treatment with C-ara. We describe the case of a 33-year-old woman, addict to heroin, her clinical record including VIH infection, pneumonia by P. carinii, milliary tuberculosis, infection by virus B and C and treatment with AZT and tuberculostatics since January, 1992. In May, she began to develop a cerebellar syndrome. Images obtained with nuclear magnetic resonance were typical of PML. Subsequently, treatment with C-ara (2 mg/kg/day IV during 5 days each 4-6 weeks) was begun. From the third month of treatment on, the patient showed a clinical improvement and as of the sixth month, the affected areas of white substance were reduced in size. In addition, CD4 improved. Although in this patient a positive effect was observed after treatment with C-area, it should be verified in a controlled clinical trial.