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1.
Clin Transl Oncol ; 7(5): 205-12, 2005 Jun.
Artigo em Espanhol | MEDLINE | ID: mdl-15960932

RESUMO

INTRODUCTION: Oral trans-mucosal fentanyl citrate (OTFC) is the one drug specifically developed for the management of breakthrough pain. This study assesses the long-term safety and efficacy of OTFC standard clinical conditions. Patients and methods. Six-month observational study performed on cancer patients with episodes of breakthrough pain. Safety was assessed by recording the advent of adverse events and efficacy by the evaluating the intensity of breakthrough pain. RESULTS: 174 cancer patients were recruited into the study. All adverse reactions reported were mild or moderate. OTFC was significantly faster (time to the commencement of pain relief: 12.7 +/- 11.4 vs 32.7 +/- 18.4 minutes; p < 0.001) and potent (post-treatment pain intensity: 3.4 +/- 1.5 vs 4.3 +/- 1.5; p < 0.001) than the previously-used drugs. CONCLUSIONS: This observational study confirms the good safety profile of OTFC as well as its effectiveness over long-term period treatment of breakthrough pain.


Assuntos
Analgésicos Opioides/administração & dosagem , Fentanila/administração & dosagem , Dor Intratável/tratamento farmacológico , Administração Oral , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/efeitos adversos , Feminino , Fentanila/efeitos adversos , Humanos , Assistência de Longa Duração , Masculino , Pessoa de Meia-Idade , Mucosa Bucal , Medição da Dor/métodos , Segurança , Resultado do Tratamento
2.
Clin. transl. oncol. (Print) ; 7(5): 205-212, jun. 2005. tab, graf
Artigo em Es | IBECS (Espanha) | ID: ibc-039758

RESUMO

Introducción. El citrato de fentanilo oral transmucosa (CFOT) es el único fármaco desarrollado específicamente para el tratamiento del dolor irruptivo (DI). Este estudio evalúa la seguridad y efectividad a largo plazo del CFOT en condiciones asistenciales habituales. Pacientes y métodos. Estudio observacional de 6 meses de duración, realizado en pacientes oncológicos con crisis de DI. Se evaluó la seguridad del fármaco recogiendo las reacciones adversas y su efectividad, midiendo intensidad y tiempo de respuesta del episodio de DI por el paciente. Resultados. Participaron 174 pacientes. Las reacciones adversas recogidas fueron leves o moderadas. El CFOT fue significativamente más rápido (tiempo hasta alivio del dolor: 12,7 ± 11,4 minutos frente a 32,7 ± 18,4 minutos; p < 0,001) y potente (reducción intensidad del DI: 3,4 ± 1,5; frente a 4,3 ± 1,5; p < 0,001) que los fármacos utilizados previamente. Conclusiones. Este estudio observacional confirma el buen perfil de seguridad y efectividad del CFOT a largo plazo en el tratamiento del DI


Introduction. Oral trans-mucosal fentanyl citrate (OTFC) is the one drug specifically developed for the management of breakthrough pain. This study assesses the long-term safety and efficacy of OTFC standard clinical conditions. Patients and methods. Six-month observational study performed on cancer patients with episodes of breakthrough pain. Safety was assessed by recording the advent of adverse events and efficacy by the evaluating the intensity of breakthrough pain. Results. 174 cancer patients were recruited into the study. All adverse reactions reported were mild or moderate. OTFC was significantly faster (time to the commencement of pain relief: 12.7 ± 11.4 vs 32.7 ± 18.4 minutes; p < 0.001) and potent (post-treatment pain intensity: 3.4 ± 1.5 vs 4.3 ± 1.5; p < 0.001) than the previously-used drugs. Conclusions. This observational study confirms the good safety profile of OTFC as well as its effectiveness over long-term period treatment of breakthrough pain


Assuntos
Masculino , Feminino , Adulto , Idoso , Humanos , Dor Intratável/tratamento farmacológico , Fentanila/administração & dosagem , Analgésicos Opioides/administração & dosagem , Mucosa Bucal , Medição da Dor/métodos , Fentanila/efeitos adversos , Analgésicos Opioides/efeitos adversos , Resultado do Tratamento
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