[Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix]. / Efectividad y seguridad de erlotinib en 2 pacientes con carcinoma de cérvix uterino.

OBJECTIVE: To assess the effectiveness and safety of the use of erlotinib in the treatment of refractory cervical cancer after retrospective analysis of two clinical cases. METHODS: The clinical records were assessed for the patients who started treatment with erlotinib, on a compassionate-use basis, with an oral dosage of 150 mg/day until June 2008. The pharmacy dispensing records were also assessed to evaluate adherence to treatment. Progression-free survival was assessed and adverse reactions were recorded in the medical records. RESULTS: Three patients with recurrent, advanced cervical cancer were candidates for treatment with erlotinib, two of whom were only starting treatment. In both cases, the women had previously received between 3 and 4 different treatment lines. Progression-free survival was 6 months and 4 months in each case. The adverse reactions to the treatment were slight. CONCLUSIONS: Erlotinib presented some similar results to those obtained from cisplatin doublets in women with refractory cervical cancer, with minor adverse effects. However, these results need to be corroborated in the clinical studies field on a wider section of the population.

[Efficacy and safety of topical diltiazem 2 % in anal fissure]. / Efectividad y seguridad de diltiazem 2 % tópico en fisura anal.

OBJECTIVES: To evaluate the effectiveness and safety of 2 per cent diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment and the number of applications. METHODS: A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient's clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment and number of applications, among others. Follow-up was carried out for up to one year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs and Chi-square. RESULTS: A total of 70 patients were included in the study and anal fissure healed in 48.6 % of them. Healing occurred in 54.5 % of patients with anal fissure and in 33.3 % of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30 % of patients. Therapy was abandoned due to adverse reactions for 5.7 %. The fissure was cured for 60 % of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results. CONCLUSIONS: Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2 per cent diltiazem ointment has avoided surgery in nearly 50 % of patients, with few adverse effects.

Efectividad y seguridad de diltiazem 2 % tópico en fisura anal / No disponible

Objetivo: Evaluar la efectividad y la seguridad de la pomada de diltiazem al 2 % en el tratamiento de la fi sura anal. Analizar la relación entre la cicatrización de la fi sura y diagnóstico, duración del tratamiento y número de aplicaciones. Métodos: Estudio prospectivo observacional de todos los pacientes diagnosticados de fi sura anal que comenzaron tratamiento con diltiazem tópico entre enero y junio de 2007. La pomada de diltiazem al 2 % se preparó como fórmula magistral en el servicio de farmacia. La efectividad y la seguridad se evaluó mediante encuesta telefónica a cada paciente tras 8 semanas de tratamiento, completándose con la historia clínica del paciente. Las variables analizadas fueron cicatrización, efectos adversos, diagnóstico, duración del tratamiento y número de aplicaciones, entre otras. Se realizó seguimiento hasta resolución de la fi sura hasta un período de 1 año. El análisis de los datos se realizó mediante estadística descriptiva y frecuencia, tablas de contingencia y 2 (..) (AU)

Objectives: To evaluate the effectiveness and safety of 2 per cent diltiazem ointment in the treatment of anal fissure. To analyse the relationship between healing and diagnosis, and duration of the treatment and the number of applications. Methods: A prospective observational study of all patients diagnosed with anal fissure that began treatment with topical diltiazem between January and June in 2007. Diltiazem ointment was prepared in the Pharmacy Service. Effectiveness and safety were assessed by a telephone survey conducted with each patient after 8 weeks of treatment, adding it to the patient’s clinical records. The variables that were analysed were healing, adverse effects, diagnosis, duration of treatment and number of applications, among others. Follow-up was carried out for up to one year until complete healing of the fissure. The data analysis was carried out by descriptive statistics, crosstabs and Chi-square. Results: A total of 70 patients were included in the study and anal fissure healed in 48.6 % of them. Healing occurred in 54.5 % of patients with anal fissure and in 33.3 % of patients with anal fissure and haemorrhoids. Some adverse effects occurred in 30 % of patients. Therapy was abandoned due to adverse reactions for 5.7 %. The fissure was cured for 60 % of patients who underwent treatment for a month or more. More than twice-daily applications did not lead to improved healing. There were no significant statistical differences in these results. Conclusions: Despite not having found statistical differences between the analysed variables, treatment of anal fissures with 2 per cent diltiazem ointment has avoided surgery in nearly 50 % of patients, with few adverse effects (AU)

Efectividad y seguridad de erlotinib en 2 pacientes con carcinoma de cérvix uterino / Effectiveness and safety of erlotinib in 2 patients with carcinoma of the cervix

Objetivo: Evaluar la efectividad y la seguridad del tratamiento con erlotinib en cáncer de cérvix uterino refractario a través del análisis retrospectivo de 2 casos clínicos. Métodos: Se revisaron las historias clínicas de las pacientes que iniciaron tratamiento con erlotinib vía oral a dosis de 150 mg/día como uso compasivo hasta junio del 2008, así como los registros de dispensación de farmacia para valorar la adherencia al tratamiento. Se evaluó la supervivencia libre de progresión y se recogieron las reacciones adversas descritas en la historia clínica. Resultados: Tres pacientes con cáncer de cérvix avanzado recurrente fueron candidatas a tratamiento con erlotinib, 2 de las cuales iniciaron tratamiento. En ambos casos las mujeres habían recibido entre 3 y 4 líneas de tratamiento previas. La supervivencia libre de progresión fue de 6 y 4 meses en cada caso. Las reacciones adversas al tratamiento fueron leves. Conclusiones: El erlotinib presentó unos resultados similares a los logrados con los dobletes de cisplatino en mujeres con cáncer de cérvix refractario, con leves efectos adversos. Sin embargo, habrá que corroborar estos resultados en el ámbito de los ensayos clínicos con poblaciones más amplias (AU)

Objective: To assess the effectiveness and safety of the use of erlotinib in the treatment of refractory cervical cancer after retrospective analysis of two clinical cases. Methods: The clinical records were assessed for the patients who started treatment with erlotinib, on a compassionate-use basis, with an oral dosage of 150 mg/day until June 2008. The pharmacy dispensing records were also assessed to evaluate adherence to treatment. Progression-free survival was assessed and adverse reactions were recorded in the medical records. Results: Three patients with recurrent, advanced cervical cancer were candidates for treatment with erlotinib, two of whom were only starting treatment. In both cases, the women had previously received between 3 and 4 different treatment lines. Progression-free survival was 6 months and 4 months in each case. The adverse reactions to the treatment were slight. Conclusions: Erlotinib presented some similar results to those obtained from cisplatin doublets in women with refractory cervical cancer, with minor adverse effects. However, these results need to be corroborated in the clinical studies field on a wider section of the population (AU)

[Tacrolimus blood levels and incidence of graft rejection in heart transplantation]. / Relación entre los niveles de tacrolimus en sangre y la incidencia de rechazo en enfermos trasplantados de corazón.

OBJECTIVE: To determine the relationship between pharmacokinetic parameters and clinical outcomes after heart transplantation and to determine the range of tacrolimus blood levels which provides the most effective protection against graft rejection. To study other factors that predict graft rejection. METHOD: We retrospectively analyzed the clinical outcomes of all adult patients who received a heart transplant between January 2000 and October 2003 and had routine monitoring of tacrolimus trough levels at the time of scheduled endomyocardial biopsy. Rejection was defined as Grade = 3, based on the International Society for Heart and Lung Transplantation (ISHLT) criteria. The follow-up period was 1 year. All patients were on a triple therapy regimen of Tacrolimus (TAC), Corticosteroids and Azatioprine/Micophenolate Mofetil. Data were analyzed by Student s t-test, univariate logistic regression and ROC curve. RESULTS: Tacrolimus blood levels measured at day +5 postransplant were the strongest predictor of acute graft rejection over a 1-year follow-up period (rejection 5.76 +/- 3.4 ng/ml vs no rejection 9.66 +/- 2.73 ng/ml, p = 0.016). A decrease of one unit in TAC trough level values at day +5 postransplant implied a 1.58 greater risk of rejection (p = 0.05). Overall incidence of treated acute rejection was lower for patients with trough levels higher than 8 ng/ml on day +5 postransplant (33 vs 80%, p = 0.055, Fisher s exact test). CONCLUSIONS: Data suggest that in heart transplant patients it may be crucial to achieve tacrolimus levels of at least 8 ng/ml during the first days postsurgery to avoid rejection.

Relación entre los niveles de tacrolimus en sangre y la incidencia de rechazo en enfermos trasplantados de corazón / Tacrolimus blood levels and incidence of graft rejection in heart transplantation

Objetivo: Evaluar la relación entre los niveles en sangre de tacrolimus, la incidencia de rechazo agudo en enfermos trasplantados de corazón y determinar el rango de concentración más adecuado para prevenir el rechazo. Estudiar otros factores predictores del rechazo. Método: Se realizó un estudio retrospectivo de todos los enfermos adultos trasplantados de corazón entre enero de 2000 y octubre de 2003 en tratamiento con tacrolimus, corticoides y azatioprina/ micofenolato mofetil. La eficacia del tratamiento se evaluó por confirmación histopatológica del rechazo agudo como grado ≥ 3A según criterios del Sociedad Internacional de Trasplante de Pulmón y Corazón (ISHLT). Se registraron los resultados de las biopsias endomiocárdicas y de los niveles mínimos de tacrolimus en sangre durante el primer año postrasplante. El análisis de los datos se realizó mediante la t de Student, regresión logística univariante y curva ROC. Resultados: Se encontraron diferencias significativas en la concentración mínima de tacrolimus en sangre alcanzada el día +5 postrasplante entre los enfermos que presentaron algún episodio de rechazo agudo el primer año y los que no (5,76 ± 3,4 vs 9,66 ± 2,73 ng/ml, p = 0,016). El nivel el día +5 fue el mejor predictor del rechazo (p = 0,05) de modo que el riesgo de un paciente respecto a otro con una unidad menos en el nivel de tacrolimus es 1,58 veces mayor. 8 ng/ml es el nivel con mayor poder de discriminación (sensibilidad = 75% y especificidad = 72,7%), de modo que alcanzar una concentración mínima en sangre de 8 ng/ml el día +5 reduce la incidencia de rechazo agudo de 33 a 80% (p = 0,055, p. exacta de Fisher). Conclusiones: Alcanzar niveles mínimos adecuados de tacrolimus en los primeros días postrasplante (al menos de 8 ng/ml el día +5) puede ser crucial para evitar el rechazo agudo en pacientes trasplantados de corazón

Objective: To determine the relationship between pharmacokinetic parameters and clinical outcomes after heart transplantation and to determine the range of tacrolimus blood levels which provides the most effective protection against graft rejection. To study other factors that predict graft rejection. Method: We retrospectively analyzed the clinical outcomes of all adult patients who received a heart transplant between January 2000 and October 2003 and had routine monitoring of tacrolimus trough levels at the time of scheduled endomyocardial biopsy. Rejection was defined as Grade ≥ 3, based on the International Society for Heart and Lung Transplantation (ISHLT) criteria. The follow-up period was 1 year. All patients were on a triple therapy regimen of Tacrolimus (TAC), Corticosteroids and Azatioprine/Micophenolate Mofetil. Data were analyzed by Student’s t-test, univariate logistic regression and ROC curve. Results: Tacrolimus blood levels measured at day +5 postransplant were the strongest predictor of acute graft rejection over a 1- year follow-up period (rejection 5.76 ± 3.4 ng/ml vs no rejection 9.66 ± 2.73 ng/ml, p = 0.016). A decrease of one unit in TAC trough level values at day +5 postransplant implied a 1.58 greater risk of rejection (p = 0.05). Overall incidence of treated acute rejection was lower for patients with trough levels higher than 8 ng/ml on day +5 postransplant (33 vs 80%, p = 0.055, Fisher’s exact test). Conclusions: Data suggest that in heart transplant patients it may be crucial to achieve tacrolimus levels of at least 8 ng/ml during the first days postsurgery to avoid rejection