Análisis de la utilización de anfotericina B liposomal / Analysis of the use of liposomal amphotericin B

Antecedentes. El aumento en los últimos años de pacientes inmunodeprimidos y el uso de fármacos citotóxicos e inmunosupresores ha aumentado la incidencia de infecciones fúngicas invasivas. Objetivos. Evaluar la utilización de anfotericina B liposomal de acuerdo con la indicación, la dosis, la efectividad y la nefrotoxicidad. Métodos. Estudio retrospectivo de un período de 8 años donde se tomaron como referencia las indicaciones y posología descritas en la ficha técnica. La efectividad se midió en función de la resolución de la infección, no recurrencia o aparición, supervivencia a los 7 días, no suspensión y no adición de otro antifúngico. La efectividad se analizó en función de indicación, dosis, duración del tratamiento, dosis acumulada y comorbilidad. La nefrotoxicidad fue medida como un aumento de la creatinina sérica por encima de 2 veces la basal. Resultados. Se trataron 47 episodios, de los cuales el 91,5% de los tratamientos se ajustaron a las indicaciones. Se logró efectividad en un 44,7% de los casos: 33% en neutropénicos, 50% de las aspergilosis, 60% de las candidiasis y 100% de las leishmaniasis. Las tasas de respuesta en los tratados durante ≤ 15 días y > 15 días fueron de 25 y 56,5% (p = 0,039), respectivamente. Las causas principales del fracaso fueron exitus (23%) y falta de efectividad (17%). Un 9% de los pacientes sufrió nefrotoxicidad. Conclusiones. Los datos de efectividad y nefrotoxicidad concuerdan con los obtenidos en otros estudios. Su efectividad se ha visto asociada con la duración del tratamiento. La anfotericina B liposomal es un fármaco seguro con efectividad moderada (AU)

Background. The increase in immunosuppressed patients and in the use of cytotoxic and immunosuppressive agents in the last few years has led to a rise in the incidence of invasive fungal infections. Aims. he objective of this study is to evaluate the use of liposomal amphotericin B according to its indication, dosage, effectiveness and nephrotoxicity. Methods. This is a retrospective study over a 8 year-period. Indications and dosage described in the Summary of Product Characteristics were taken as reference. Effectiveness was measured in terms of resolution of infection, no recurrence or emergence, survival at 7th day, no discontinuation and no addition of another antifungal. Effectiveness was also analysed in relation to indication, dosage, treatment duration, cumulative dose and comorbidity. Nephrotoxicity was defined as a doubled serum creatinine when compared with basal values. Results. A total of 47 episodes were analysed, with 91.5% of treatments being adequate for the indications. Effectiveness was achieved in 44.7% of cases: 33% in neutropenic patients, 50% of aspergillosis, 60% of candidiasis, and 100% of the leishmaniasis. Response rates in patients treated for 15 days or less and those for more than 15 days were 25 and 56.5% (P = .039), respectively. The main causes of failure were death (23%) and lack of effectiveness (17%), with 9% of patients suffering from nephrotoxicity. Conclusions. The effectiveness and nephrotoxicity data agree with those obtained in other studies. Liposomal amphotericin B is a safe drug with a moderate effectiveness that is associated with the duration of the treatment (AU)

[Analysis of the use of liposomal amphotericin B]. / Análisis de la utilización de anfotericina B liposomal.

BACKGROUND: The increase in immunosuppressed patients and in the use of cytotoxic and immunosuppressive agents in the last few years has led to a rise in the incidence of invasive fungal infections. AIMS: The objective of this study is to evaluate the use of liposomal amphotericin B according to its indication, dosage, effectiveness and nephrotoxicity. METHODS: This is a retrospective study over a 8 year-period. Indications and dosage described in the Summary of Product Characteristics were taken as reference. Effectiveness was measured in terms of resolution of infection, no recurrence or emergence, survival at 7th day, no discontinuation and no addition of another antifungal. Effectiveness was also analysed in relation to indication, dosage, treatment duration, cumulative dose and comorbidity. Nephrotoxicity was defined as a doubled serum creatinine when compared with basal values. RESULTS: A total of 47 episodes were analysed, with 91.5% of treatments being adequate for the indications. Effectiveness was achieved in 44.7% of cases: 33% in neutropenic patients, 50% of aspergillosis, 60% of candidiasis, and 100% of the leishmaniasis. Response rates in patients treated for 15 days or less and those for more than 15 days were 25 and 56.5% (P=.039), respectively. The main causes of failure were death (23%) and lack of effectiveness (17%), with 9% of patients suffering from nephrotoxicity. CONCLUSIONS: The effectiveness and nephrotoxicity data agree with those obtained in other studies. Liposomal amphotericin B is a safe drug with a moderate effectiveness that is associated with the duration of the treatment.

Effectiveness and safety of thromboprophylaxis with enoxaparin in medical inpatients.

BACKGROUND: Venous thromboembolism (VTE) includes deep vein thrombosis and pulmonary embolism. Although effective prophylaxis exists for medical patients, there is little information outside of clinical trials. We will analyze our experience in the prophylaxis of VTE with enoxaparin in hospitalized medical patients. MATERIAL AND METHODS: We studied all of the patients ≥15 years admitted for emergency care to all of the medical departments of the hospital, except for the Hematology Department, between 1/April/1999 and 31/December/2005. The patients' age, sex, Charlson comorbidity index (CCI), whether they received prophylaxis with enoxaparin or not, dose, VTE, bleeding, thrombocytopenia, and mortality were analyzed. RESULTS: 40,349 patients were included, of which 55.87% were male, with an average age of 67.56, and an average CCI of 4.99. There were 19,834 patients who did not receive prophylaxis for which the rate of incidence of VTE was 0.61%, mortality 8.75%, bleeding 1.38%, and thrombocytopenia 0.04%. Prophylactic enoxaparin was administered to 20,515 patients, for which the rate of incidence of VTE was 0.44%, mortality 10.71%, bleeding 1.1%, and thrombocytopenia 0.04%. The adjusted Odds Ratio (OR) for VTE was 0.65 (95% confidence interval [95% CI] 0.49 to 0.87). The adjusted OR for mortality was 0.84 (95% CI 0.78 to 0.9). With the adjusted data, the number needed to treat (NNT) for VTE was 470.3 (95% CI 278.4 to 1413.3), and the NNT for mortality was 77.2 (95% CI 54.6 to 130.3). CONCLUSION: Thromboprophylaxis with enoxaparin in hospitalized medical patients is associated with a lower incidence of VTE and mortality, and is safe.