5 research outputs found

    Terapia fotodinámica con luz de día para la prevención de nuevas queratosis actínicas y carcinomas queratinocíticos en trasplantados de órgano sólido. Ensayo clínico aleatorizado controlado con crioterapia

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    Introducción: Los pacientes trasplantados de órgano sólido (TOS) presentan un riesgo aumentado de la incidencia de queratosis actínicas (QA) y carcinomas queratinocíticos (CQs) debido a la terapia inmunosupresora. No hay ensayos clínicos que evalúen la efectividad de la modalidad de TFD con luz de día (TFDLD) para la prevención de nuevas QAs y CQs mediante el tratamiento repetido del campo de cancerización en pacientes TOS. Objetivo: Evaluar si el tratamiento repetido del campo de cancerización con TFDLD con metil aminolevulinato (MAL) puede prevenir la aparición de nuevas QAs y CQs en pacientes TOS. Evaluar la tolerancia al dolor, la preferencia de tratamiento, la satisfacción del paciente con el tratamiento, el resultado cosmético y la calidad de vida. Métodos: Ensayo clínico aleatorizado, controlado intraindividualmente, con evaluador ciego, desde abril de 2016 hasta octubre de 2018. Se incluyeron pacientes TOS mayores de 18 años, al menos un año post-trasplante, con al menos 5 QAs en cada hemicara/hemicuero cabelludo. Los criterios de exclusión fueron hipersensibilidad al fármaco, porfiria, embarazo y lactancia. Se realizó tratamiento del campo de cancerización en un lado de la cara y/o cuero cabelludo con TFDLD y el lado contralateral fue el control. El lado asignado aleratoriamente a TFDLD recibió un total de 6 sesiones, dos sesiones separadas 15 días al inicio del estudio, 2 sesiones separadas 15 días a los 3 meses del inicio y 2 sesiones separadas 15 días a los 9 meses del inicio. En el lado control no se trató el campo de cancerización, pero las QAs visibles se trataron con terapia dirigida a la lesion (doble ciclo de congelación- descongelación con crioterapia) al inicio, a los 3 y a los 9 meses (en total 3 sesiones). Se realizó seguimiento a los 15 y 21 meses. Resultados: De los 24 pacientes incluidos, 23 fueron analizados a los 3 meses y 21, a los 9, 15 y 21 meses. Todos los pacientes fueron hombres y de raza caucásica. La edad media fue 69.8 años (SD 9.2). El número total de lesiones (nuevas y persistentes) a los 21 meses fue menor en el lado de la TFDLD que en el lado control (media 4.7 [SD 4.3] versus 5.8 [5.0], respectivamente, P=0.09). A lo largo de todo el estudio hubo un menor número de lesiones nuevas en el lado que recibió tratamientos repetidos del campo de cancerización con TFDLD en comparación con el lado control. Estas diferencias fueron estadísticamente significativas a los 3 meses (media 4.2 [SD 3.4] versus 6.8 [4.8], p<0.001) , a los 9 meses (3.0 [3.3] versus 4.3 [3.4], P=0.04), y a los 15 meses (3.0 [4.6] versus 4.8 [5.0], P=0.02); y no significativas a los 21 meses (3.7 [3.5] versus 5 [4.5], P=0.06). El hecho de que hubiera una diferencia a los 15 y 21 meses (aunque no fuera estadísticamente significativa a los 21 meses) sugieren que el régimen de tratamientos repetidos podría prolongar el efecto preventivo de la TFDLD. La TFDLD fue significativamente mejor tolerada que la crioterapia. Los pacientes estuvieron más satisfechos con el resultado obtenido con la TFDLD y la mayoría prefirió la TFDLD a la crioterapia. No se encontraron diferencias significativas en el resultado cosmético (rejuvenecimiento cutáneo global, cambios en la pigmentación y cicatrices). No hubo diferencias en la escala de calidad de vida (Skindex-29) al comparar ambos lados pero si al comparar los cuestionarios antes del inicio de los tratamientos y al final del estudio. Conclusiones: La TFDLD es un tratamiento con potencial para prevenir nuevas QAs y CQs en pacientes TOS mediante tratamientos repetidos del campo de cancerización. La mayor preferencia de los pacientes por la TFDLD puede facilitar la adherencia al tratamiento a largo plazo necesario en estos pacientes por el carácter crónico de su patología

    Daylight photodynamic therapy for prevention of new actinic keratosis and keratinocyte carcinomas in organ transplants. A cryotherapy-controlled randomized clinical trial

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    Background Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR. Objectives To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR. Methods A randomized, intra-subject controlled, evaluator-blind, split-face and/or scalp trial, from April 2016 to Octo- ber 2018. Participants were OTR older than 18 years, 1-year posttransplant, with at least 5 AK on each hemi-face/ hemi-scalp. One side received six field treatments with DPDT: two sessions 15 days apart at baseline, two at 3 months and two at 9 months after baseline. Control side received lesion-directed treatment with cryotherapy (double freeze– thaw) at baseline, 3 and 9 months. Total number of lesions (AK and KC) at 21 months, number of new AK and KC at 3, 9, 15 and 21 months and treatment preferences were analysed. Results Of 24 men included, 23 were analysed at 3 months; and 21, at 9, 15 and 21 months. Mean (SD) age was 69.8 years (9.2). The total number of lesions at 21 months was 4.7 (4.3) for DPDT and 5.8 (5.0) for control side; P = 0.09. DPDT showed significantly lower means [SD] of new lesions compared to control side at 3 months (4.2 [3.4] vs. 6.8 [4.8]; P < 0.001), 9 months (3.0 [3.3] vs. 4.3 [3.4]; P = 0.04) and 15 months (3.0 [4.6] vs. 4.8 [5.0]; P = 0.02), and non-signifi- cant at 21 months (3.7 [3.5] vs. 5.0 [4.5]; P = 0.06). Most participants preferred DPDT. Conclusion DPDT showed potential effectiveness in preventing new AK and KC in OTR by consecutive treatments of field cancerization. The preference for DPDT could facilitate adherence to the long-term treatment necessary in these patients

    Daylight photodynamic therapy for prevention of new actinic keratosis and keratinocyte carcinomas in organ transplants. A cryotherapy-controlled randomized clinical trial

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    Background: Organ transplant recipients (OTR) have a higher risk of actinic keratosis (AK) and keratinocyte carcinomas (KC). There are no clinical trials assessing the effectiveness of daylight photodynamic therapy (DPDT) to prevent new AK and KC in OTR. Objectives: To determine whether repeated treatments of field cancerization with DPDT are effective in preventing new AK and KC in OTR. Methods: A randomized, intra-subject controlled, evaluator-blind, split-face and/or scalp trial, from April 2016 to October 2018. Participants were OTR older than 18 years, 1-year posttransplant, with at least 5 AK on each hemi-face/hemi-scalp. One side received six field treatments with DPDT: two sessions 15 days apart at baseline, two at 3 months and two at 9 months after baseline. Control side received lesion-directed treatment with cryotherapy (double freeze-thaw) at baseline, 3 and 9 months. Total number of lesions (AK and KC) at 21 months, number of new AK and KC at 3, 9, 15 and 21 months and treatment preferences were analysed. Results: Of 24 men included, 23 were analysed at 3 months; and 21, at 9, 15 and 21 months. Mean (SD) age was 69.8 years (9.2). The total number of lesions at 21 months was 4.7 (4.3) for DPDT and 5.8 (5.0) for control side; P = 0.09. DPDT showed significantly lower means [SD] of new lesions compared to control side at 3 months (4.2 [3.4] vs. 6.8 [4.8]; P < 0.001), 9 months (3.0 [3.3] vs. 4.3 [3.4]; P = 0.04) and 15 months (3.0 [4.6] vs. 4.8 [5.0]; P = 0.02), and non-significant at 21 months (3.7 [3.5] vs. 5.0 [4.5]; P = 0.06). Most participants preferred DPDT. Conclusion: DPDT showed potential effectiveness in preventing new AK and KC in OTR by consecutive treatments of field cancerization. The preference for DPDT could facilitate adherence to the long-term treatment necessary in these patients

    Improvement of the elevated tryptase criterion to discriminate IgE- from non-IgE-mediated allergic reactions

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    BACKGROUND: Differentiating between immunoglobulin E (IgE)-dependent and IgE-independent hypersensitivity reactions may improve the etiologic orientation and clinical management of patients with allergic reactions in the anesthesia setting. Serum tryptase levels may be useful to discriminate the immune mechanism of allergic reactions, but the diagnostic accuracy and optimal cutpoint remain unclear. We aimed to compare the diagnostic accuracy of tryptase during reaction (TDR) alone and the TDR/basal tryptase (TDR/BT) ratio for discriminating IgE- from non–IgE-mediated allergic reactions, and to estimate the best cut point for these indicators. METHODS: We included 111 patients (45% men; aged 3–99 years) who had experienced an allergic reaction, even though the allergic reaction could be nonanaphylactic. Allergy tests were performed to classify the reaction as an IgE- or non–IgE-mediated one. The area under the curve (AUC) of the receiver operating characteristic analysis was performed to estimate the discriminative ability of TDR and TDR/BT ratio. RESULTS: An IgE-mediated reaction was diagnosed in 49.5% of patients, of whom 56% met anaphylaxis criteria. The median (quartiles) TDR for the IgE-mediated reactions was 8.0 (4.9–19.6) and 5.1 (3.5–8.1) for the non–IgE-mediated (P = .022). The median (quartiles) TDR/BT ratio was 2.7 (1.7–4.5) in IgE-mediated and 1.1 (1.0–1.6) in non–IgE-mediated reactions (P < .001). The TDR/BT ratio showed the greatest ability to discriminate IgE- from non–IgE-mediated reactions compared to TDR (AUC TDR/BT = 0.79 [95% confidence interval (CI), 1.1–2.2] and AUC TDR = 0.66 [95% CI, 1.1–2.2]; P = .003). The optimal cut point for TDR/BT (maximization of the sum of the sensitivity and specificity) was 1.66 (95% CI, 1.1–2.2). CONCLUSIONS: The TDR/BT ratio showed a significantly better discriminative ability than TDR to discriminate IgE- from non–IgE-mediated allergic reactions. An optimal TDR/BT ratio threshold of approximately 1.66 may be useful in clinical practice to classify allergic reactions as IgEor non–IgE-mediated. (Anesth Analg 2018;127:414–9
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