A comparison of the quality of life in patients with severe ulcerative colitis after total colectomy versus medical treatment with intravenous cyclosporin.

Cyclosporin (CSA) has emerged as a medical alternative to colectomy in severe, steroid-refractory ulcerative colitis (UC) patients. This is the first formal quality-of-life study comparing such patients treated with intravenously administered cyclosporin with those treated surgically with colectomy. Quality-of-life analyses were conducted in all patients who underwent colectomy or received intravenous CSA for severe UC from 1991 to 1995 using the Inflammatory Bowel Disease Questionnaire, a visual-analog scale (VAS), and the Oresland scale, with additional questions regarding health care utilization and medication use. The 18 CSA-treated patients reported a better ability to sleep (p = 0.002; VAS), better stool consistency (p < 0.001; VAS), less abdominal or rectal pain (p = 0.009, VAS), and fewer daytime (p < 0.001; Oresland), nighttime (p = 0.006; Oresland), and daily trips to the toilet (p < 0.001; VAS) than the 46 surgical patients. The mean number and rate of hospitalizations within the first year was also lower in the CSA patients (p < 0.001 for both). The surgical patients reported fewer initial visits to their specialist (p < 0.001) and less medication use (p < 0.001; Oresland). Patients with severe steroid-refractory UC treated with intravenously administered CSA scored as well as or better than their surgical counterparts. The use of CSA in selected patients is substantiated both by clinical results and quality-of-life analysis.

[Prognostic factors and mortality among adult patients with acute leukemia and infection]. / Factores pronósticos y mortalidad en pacientes adultos con leucemia aguda e infección.

In order to define mortality rates and clinical findings with prognostic value in febrile infections among our adult patients with acute leukemia we prospectively studied--during a 34 months period--177 episodes of clinical suspected infection which occurred in 49 patients. By means of univariate analysis and a subsequent multiple logistic regression study, the association between 27 clinical and microbiological data and febrile episode survival rates were evaluated. Both the overall mortality rate and the specific one for febrile episodes were high (44.9% and 12.7% respectively). An age over 30 years old (p = 0.025), fever lasting more than five days (p = 0.025), lung involvement (p = 0.001) and fungal isolation in a culture specimen (p = 0.005) were all associated with a higher episode mortality. However, only an age older than 30 years (adjusted odds ratio, A.O.R. = 1.118; 95% confidence interval, C.I.95% = 1.015-1.232; p = 0.025) and pneumonia (A.O.R. = 1.454; C.I.95% = 1.288-1.642; p < 0.001) remained as independent predictors of a greater mortality in the multivariate analysis. Although fever of unknown origin was associated with a better prognosis (p = 0.024) two other variables--viral infections (A.O.R. = 0.642; C.I.95% = 0.421-0.979; P = 0.041) and the isolation of two or more etiologic agents (A.O.R. = 0.795; C.I.95% = 0.651-0.972; p = 0.027)--had a protective value with the multiple regression analysis.

[Chemotherapy schedules and bacteremia in adult patients with acute leukemia]. / Esquemas de quimioterapia y bacteriemias en pacientes adultos con leucemia aguda.

In a study undertaken to evaluate fluoroquinolone prophylaxis in afebrile granulocytopenic patients, an unexpected association between chemotherapy schedule and a later development of bacteremia--during the subsequent febrile neutropenic episodes--was found. Twenty five febrile neutropenic episodes consecutive to chemotherapy for acute leukemia were studied. Patients received either etoposide and mitoxantrone or citarabine--in standard, intermediate or high doses--combined with daunomicin or mitoxantrone. Microbiologic data analysis showed an increased incidence of bacteremia with combined anthracycline and intermediate or high dose citarabine administration, when compared to etoposide and mitoxantrone use (p = 0.000387). Both groups developed similarly fast and severe neutropenias and equivalent grades of digestive mucositis. Chemotherapy schedule was the only factor associated with a consecutive bacteremia--or not--during the subsequent neutropenic episode. We conclude that effects other than bone marrow aplasia and digestive mucositis may be relevant in infectious susceptibility induced by cytostatic drugs.

Profilaxis con fluoroquinolonas en pacientes neutropénicos / Prophylaxis with fluoroquinolones in patients with neutropenia

Para evaluar si el uso profiláctico de fluoroquinolona disminuye la incidencia y morbimortalidad de los episodios febriles durante la neutropenia, realizamos un estudio prospectivo, aleatorio y controlado en pacientes adultos con leucemia aguda (A.A.), con neutropenia secundaria a quimioterapia citotóxica y ambulatórios. Veinticinco episódios de neutropenia ocurridos en 14 pacientes fueron asignados aleatoriamente a recibir quinolonas (norfloxacina 800 mg/día o ciporfloxacina 1000 mg/dia), o a no recibir antibióticos profilácticos (grupo control). No hubo diferencias significativas entre ambos grupos en sexo, edad, tipo o estadio de la L.A., esquemas de quimioterapia empleados, duración y severidad de la neutropenia con fiebre (p = 0,0448), a una disminución del número de infecciones por bacilos gran negativos (p = 0,037), y a un aumento de las infecciones por Estreptococos (p = 0,0857). No hubo disminución significativa en la mortalidad, incidencia de infecciones severas, proporción de episodios de neutropenia sin fiebre, requerimiento de Anfotericina B, e incidencia de infecciones micóticas en el grupo con quinolonas respecto del control. Se concluye que la profilaxis con fluoroquinolonas no disminuyó la morbimortalidad infecciosa en estos pacientes (AU)

Profilaxis con fluoroquinolonas en pacientes neutropénicos / Prophylaxis with fluoroquinolones in patients with neutropenia

Para evaluar si el uso profiláctico de fluoroquinolona disminuye la incidencia y morbimortalidad de los episodios febriles durante la neutropenia, realizamos un estudio prospectivo, aleatorio y controlado en pacientes adultos con leucemia aguda (A.A.), con neutropenia secundaria a quimioterapia citotóxica y ambulatórios. Veinticinco episódios de neutropenia ocurridos en 14 pacientes fueron asignados aleatoriamente a recibir quinolonas (norfloxacina 800 mg/día o ciporfloxacina 1000 mg/dia), o a no recibir antibióticos profilácticos (grupo control). No hubo diferencias significativas entre ambos grupos en sexo, edad, tipo o estadio de la L.A., esquemas de quimioterapia empleados, duración y severidad de la neutropenia con fiebre (p = 0,0448), a una disminución del número de infecciones por bacilos gran negativos (p = 0,037), y a un aumento de las infecciones por Estreptococos (p = 0,0857). No hubo disminución significativa en la mortalidad, incidencia de infecciones severas, proporción de episodios de neutropenia sin fiebre, requerimiento de Anfotericina B, e incidencia de infecciones micóticas en el grupo con quinolonas respecto del control. Se concluye que la profilaxis con fluoroquinolonas no disminuyó la morbimortalidad infecciosa en estos pacientes

[Prophylaxis with fluoroquinolones in patients with neutropenia]. / Profilaxis con fluoroquinolonas en pacientes neutropénicos.

In order to evaluate whether the prophylactic use of fluoroquinolones diminishes the incidence of infections and/or mortality during neutropenia, we undertook a prospective, aleatory and controlled study in non-hospitalized adult patients with acute leukemia and chemotherapy-induced neutropenia including twenty five episodes of neutropenia including twenty five episodes of neutropenia which had occurred in 14 patients who were randomly selected either to receive or not quinolones (norfloxacin 800 mg daily or ciprofloxacin 1000 mg daily). Both groups were similar in terms of sex, age, underlying disease, chemotherapy for hematologic malignancy, duration and severity of neutropenia. The use of quinolones was associated with a delay in the fever onset during neutropenia (p = 0.0448), a decrease in the proportion of neutropenic febrile days (p = 0.0456), a decrease of infections caused by gram-negative bacilli (p = 0.037) and an increase of Streptococcus infections (p = 0.0857). There was no significant decrease in mortality, incidence of severe infections, proportion of neutropenic episodes without fever, empiric use of amphotericin B or fungal infections between both groups. The results of this study demonstrate that the prophylactic use of fluoroquinolones does not diminish the infectious morbidity and/or mortality in these patients.

Profilaxis con fluoroquinolonas en pacientes neutropénicos. / [Prophylaxis with fluoroquinolones in patients with neutropenia]

In order to evaluate whether the prophylactic use of fluoroquinolones diminishes the incidence of infections and/or mortality during neutropenia, we undertook a prospective, aleatory and controlled study in non-hospitalized adult patients with acute leukemia and chemotherapy-induced neutropenia including twenty five episodes of neutropenia including twenty five episodes of neutropenia which had occurred in 14 patients who were randomly selected either to receive or not quinolones (norfloxacin 800 mg daily or ciprofloxacin 1000 mg daily). Both groups were similar in terms of sex, age, underlying disease, chemotherapy for hematologic malignancy, duration and severity of neutropenia. The use of quinolones was associated with a delay in the fever onset during neutropenia (p = 0.0448), a decrease in the proportion of neutropenic febrile days (p = 0.0456), a decrease of infections caused by gram-negative bacilli (p = 0.037) and an increase of Streptococcus infections (p = 0.0857). There was no significant decrease in mortality, incidence of severe infections, proportion of neutropenic episodes without fever, empiric use of amphotericin B or fungal infections between both groups. The results of this study demonstrate that the prophylactic use of fluoroquinolones does not diminish the infectious morbidity and/or mortality in these patients.

Long-term treatment of rheumatoid arthritis comparing nabumetone with aspirin.

This report summarizes the results of a 17-investigator multicenter six-month randomized double-blind parallel group study. The safety and efficacy of nabumetone 1,000 mg taken at bedtime was compared with that of aspirin 900 mg four times daily in the treatment of adult patients with active class II or III classical or definite rheumatoid arthritis. Two hundred sixty-four patients were entered into the study. Two hundred fifty-seven (126 nabumetone and 131 aspirin) patients were evaluable for safety. Two hundred thirty-four (113 nabumetone and 121 aspirin) patients were evaluable for efficacy. There was significant improvement in each of six clinical measurements of efficacy in both treatment groups and little difference between groups. The somewhat greater improvement in articular index and duration of morning stiffness in the nabumetone-treated group did not reach statistical significance. There was an equal percentage of patient withdrawal for lack of efficacy in each group. Overall, the rate of patient withdrawal due to adverse experiences was greater (p = 0.01) for aspirin-treated patients. These experiences were usually dispepsia, abdominal pain, and tinnitus. It was concluded that nabumetone was an effective anti-inflammatory drug in the treatment of rheumatoid arthritis with less toxicity than aspirin.

Controlled evaluation of nabumetone in the treatment of active adult rheumatoid arthritis. Nabumetone versus naproxen double-blind parallel study.

Nabumetone is a new nonsteroidal anti-inflammatory agent. Therapy with nabumetone 1,000 mg given at bedtime was compared with naproxen 250 mg given twice daily in a prospective double-blind study of patients with rheumatoid arthritis. Both drugs were found to be efficacious in a comparable fashion. Both drugs were well tolerated in terms of patient withdrawal rates, which were 5 and 8 percent, respectively. Gastrointestinal side effects were the most commonly encountered problem. Nabumetone holds promise as an important new therapeutic approach in arthritis.

Six-month multi-center study comparing nabumetone with naproxen in the treatment of osteoarthritis.

This six-month, double-blind, controlled, randomized, parallel study at 13 medical centers compared the safety and efficacy of nabumetone (1,000 mg taken at bedtime) with that of naproxen (250 mg twice daily) in the treatment of osteoarthritis in symptomatic adult outpatients. Five efficacy parameters were measured: patients' assessment of overall osteoarthritis activity and pain, physicians' assessment of overall osteoarthritis activity and pain, and physicians' assessment of pain with respect to a declined activity. All 489 patients who took medication were included in the evaluation of safety, and 455 patients (227 in the nabumetone group and 228 in the naproxen group) were evaluated for efficacy. Significant improvement in all five efficacy parameters occurred in both groups. No significant differences were found between the two groups at the end of the study in any of the five efficacy parameters. Twenty-three percent of nabumetone and 17 percent of naproxen patients withdrew from the study for lack of efficacy. At least one possible or probable treatment-related adverse experience was reported for 45 percent of nabumetone-treated patients and 42 percent of those given naproxen, and in 19 percent of the nabumetone-treated and 18 percent of the naproxen-treated patients these experiences were moderate or severe. However, only 7 percent of patients in each group withdrew from the study due to adverse experiences. Nabumetone and naproxen have comparable safety and efficacy, suggesting that a single, nighttime dose of nabumetone is a convenient, effective, and safe treatment for osteoarthritis.