Dexketoprofen más pamabrom versus acetaminofen en dismenorrea primaria: estudio controlado, randomizado, doble ciego, multicéntrico / Dexketoprofen plus pamabrom versus acetaminophen in primary dysmenorrhea: a controlled, randomized, double-blind, multicenter study

RESUMEN Introducción: se sabe que las concentraciones plasmáticas de hormona antidiurética o vasopresina son más altas en las mujeres con dismenorrea primaria (DiPr) y podría ser causa de retención de agua con signos y síntomas concomitantes que agravan su cuadro clínico. La monoterapia con AINEs en ocasiones alcanza solo un alivio parcial porque no incide sobre la vasopresina. Objetivo: evaluar la eficacia y tolerabilidad del dexketoprofeno + pamabrom en la DiPr tomando como referencia el acetaminofén. Materiales y métodos: estudio doble ciego, controlado, randomizado, en pacientes con DiPr asignados al azar. Fueron aleatorizadas 172 pacientes, 86 en cada grupo 1) Grupo casos (DP): dexketoprofeno + pamabrom o 2) Grupo control (AC): acetaminofén. Se evaluó la evolución de la intensidad del dolor, el alivio del dolor, la gravedad de otros síntomas presentes y la satisfacción global del médico y paciente. Se registró las reacciones adversas. Resultados: la disminución de la intensidad del dolor, de los síntomas acompañantes y el alivio del dolor evaluados por la EVA, la PID, la SPID, el PAR y el TOTPAR respectivamente es mayor y más rápida de modo significativo en todos los tiempos para la combinación DP. Las reacciones adversas fueron mínimas. La satisfacción global de pacientes y médicos respecto al tratamiento es significativa a favor de la combinación DP. Conclusiones: dexketoprofeno + pamabrom es significativamente más eficaz y rápido en el control del dolor y otros síntomas presentes en la dismenorrea primaria que acetaminofén demostrando la validez de añadir un diurético suave a un AINE para incrementar su eficacia. El tratamiento DP es bien tolerado (AU).

ABSTRACT Background: It is known that plasma concentrations of antidiuretic hormone or vasopressin are higher in women with primary dysmenorrhea (DiPr) and could cause water retention with concomitant signs and symptoms that aggravate the illness. Monotherapy with NSAIDs sometimes achieves only partial relief because it does not affect vasopressin. Objective: The aim was to evaluate the efficacy and tolerability of dexketoprofen + pamabrom in DiPr taking as reference acetaminophen. Materials and methods: Double-blind, controlled, randomized study in patients with DiPr random to 1) Case group (PD): dexketoprofen + pamabrom or 2) Control group (CA): acetaminophen. The evolution of pain intensity, pain relief, severity of other present symptoms and overall satisfaction of the doctor and patient were evaluated. Adverse reactions were recorded. Results: 172 patients were randomized, 86 in each group. The decrease in pain intensity, accompanying symptoms and pain relief evaluated by VAS, PID, SPID, PAR and TOTPAR respectively is significantly greater and faster at all times for the combination DP. Adverse reactions were minimal. The overall satisfaction of patients and doctors regarding treatment is significant in favor of the DP combination. Conclusions: Dexketoprofen + pamabrom is significantly more effective and faster in the control of pain and other symptoms present in primary dysmenorrhea than acetaminophen demonstrating the validity of adding a mild diuretic to an NSAID to increase its effectiveness. DP treatment is well tolerated (AU).

Quantitative Analysis Of Pamabrom And Ibuprofen In Synthetic Mixture Using 1st Order Derivative Spectroscopy

Objective: The preliminary goal was to develop and validate 1st order derivative spectroscopic method for quantitative analysis of Pamabrom (PAMA) which is a xanthine diuretic and ibuprofen (IBU) which is a non-steroidal anti-inflammatory agent from its synthetic mixture. Methods: Analytical method was developed on Shimadzu double beam spectrophotometer equipped with UV probe 2.42 as software using methanol as solvent. Quantification of PAMA was carried out at zero cross over point of IBU that is 291 nm and for IBU, it was achieved at 278 nm which is zero cross over point of PAMA. Method was validated according to ICH Q2 R1 guidelines. Results: Method showed a linear response in the range of 2-12 µg/ml of PAMA and 20-120 µg/ml of IBU. Method was found to be accurate with recovery between 99.7–100.9 % for PAMA and 100.3–100.7 % for IBU. The method was found to be accurate and precise for quantitative analysis of PAMA and IBU. Conclusion: The developed method was successfully validated as per ICH Q2 R1 guidelines and was successfully applied for quantitative analysis of a synthetic mixture of PAMA and IBU.