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1.
Reumatol. clín. (Barc.) ; 9(2): 113-116, mar.-abr. 2013.
Article in Spanish | IBECS | ID: ibc-110343

ABSTRACT

Los medicamentos biotecnológicos (MBT) son moléculas complejas cuyo proceso de elaboración impide replicar con gran exactitud la sustancia original, por lo que no existe una equivalencia absoluta entre el fármaco original (innovador) y el biocomparable. Los MBT han probado su eficacia en diversas afecciones reumáticas, aunque su alto coste impide su utilización en muchos pacientes. Diversas patentes de medicamentos biotecnológicos han expirado o expirarán próximamente, detonando así el desarrollo de fármacos estructuralmente similares y probablemente con eficacia y seguridad comparable a los medicamentos innovadores, aunque estas características deben ser probadas. La Ley General de Salud Mexicana actual contempla el registro de estos medicamentos para su utilización en nuestro país. Este documento es una reflexión de miembros del Colegio Mexicano de Reumatología, farmacólogos e investigadores en epidemiología, en conjunción con nuestras autoridades sanitarias, sobre los estudios científicos necesarios de los biocomparables previos y posterior a su incursión en el mercado mexicano (AU)


Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence based medicine. The Mexican General Health Law contemplates the registry of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market (AU)


Subject(s)
Humans , Male , Female , Societies, Medical/ethics , Societies, Medical/legislation & jurisprudence , Specialty Boards/ethics , Specialty Boards/legislation & jurisprudence , Specialty Boards/organization & administration , Therapeutic Equivalency , Pharmacovigilance , Rheumatology/education , Rheumatology/organization & administration , Rheumatology/standards , Mexico/epidemiology , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Evidence-Based Medicine/methods
2.
Reumatol Clin ; 9(2): 113-6, 2013.
Article in English, Spanish | MEDLINE | ID: mdl-23395225

ABSTRACT

Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence based medicine. The Mexican General Health Law contemplates the registry of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market.


Subject(s)
Antirheumatic Agents/therapeutic use , Biosimilar Pharmaceuticals/therapeutic use , Drug Approval , Pharmacovigilance , Rheumatic Diseases/drug therapy , Drug Approval/legislation & jurisprudence , Humans , Mexico
3.
Arch. med. res ; 28(1): 61-5, mar. 1997. ilus
Article in English | LILACS | ID: lil-225197

ABSTRACT

The influence of chronica pre- and postnatal naltrexone exposure on the sensitivity of off spring to the locomotor effects of morphine was investigated i C-57 Black mice. Pregnant mice were injected subcutaneously (sc) with either saline (0.1 ml/10 g) or naltrexone (10 mg/kg) twice daily during gestation and throughout lactation, 21 days postpartum. One, three and seven weeks after bith, male offspring were tested for locomotor activity. At 7 weeks of age, dose-response curves were obtained with morphine (10, 31.6, and 100 mg/kg) and amphetamine (0.31, 10 and 31.6 mg/kg) in naltrexone-pretreated and in saline-treated animals. Naltrexone exposure during gestation and lactation resulted in an augmented sensitivity of offspring to the locomotor activity increasing effects of morphine. In these animals, the dose-response relationship for the effect of morphine on locomotor activity was displaced to the left about threefold. In contrast, naltrexone exposure did not alter the sensitivity of offspring to amphetamine. It was also found that ofsspring of naltrexone-treated animals have significantly greater spontaneous locomotor activity than that of the offspring of saline treated mothers. The increased locomotor activity persisted for at least 4 weeks after the last injection of naltrexone. These findings indicate that chronic opioid receptor blockade during gestation and early portnatal development induces supersensitivity to the locomotor effects of morphine and is associated with long-lasting behavioral alterations


Subject(s)
Animals , Male , Female , Pregnancy , Mice , Animals, Newborn , Narcotic Antagonists/pharmacology , Hyperkinesis/chemically induced , Maternal-Fetal Exchange , Morphine/pharmacology , Motor Activity/drug effects , Naltrexone/pharmacology , Receptors, Opioid/drug effects
5.
Compend. invest. clin. latinoam ; 6(2): 81-96, jun. 1986. ilus
Article in Spanish | LILACS | ID: lil-105197

ABSTRACT

Se valoró el efecto de dipirona, la mezcla de naproxén y acetaminofén y placebo sobre el dolor en un grupo de sujetos voluntarios. Se observó que la dipirona y a mezcla naproxén-acetaminofén disminuyeron signficativamente las respuestas al dolor en pulpa dental. El efecto de dipirona fue mayor después de dos a dos y media horas de la administración; la mezcla tuvo un efecto, aunque el efecto ya se observó media hora después de la administración. La diferencia con el placebo fue notable


Subject(s)
Adult , Humans , Male , Acetaminophen/pharmacology , Dental Pulp/drug effects , Dipyrone/pharmacology , Naproxen/pharmacology , Drug Combinations , Electroencephalography , Mexico , MMPI , Pain
6.
Rev. mex. anestesiol ; 8(4): 187-90, oct.-dic. 1985.
Article in Spanish | LILACS | ID: lil-33010

ABSTRACT

La teofilina se ha usado con éxito en neonatología para el tratamiento sintomático del Síndrome de Apneas del Sueño (SAS). Buscando un modelo experimental de este cuadro, estudiamos las interaciones de la xantina con un depresor respiratorio conocido: la morfina. Los efectos tipo naloxona (antagonista de los narcóticos) de la teofilina en preparaciones in vivo e in vitro nos condujeron a ensayar este fármaco en el SAS. La administración de hasta 3 mg. de naloxona en 3 sujetos apnéicos no mostró cambios significativos a nivel de la frecuencia respiratoria y cardiaca. Se discute la posible existencia de un error congénito de los opiáceos endógenos (endorfinas) en el SAS


Subject(s)
Infant, Newborn , Humans , Theophylline/therapeutic use , Morphine/therapeutic use , Naloxone/therapeutic use , Sudden Infant Death , Sleep Apnea Syndromes/drug therapy , Endorphins , Drug Interactions
7.
Rev. mex. anestesiol ; 8(3): 137-41, jul.-sept. 1985. tab
Article in Spanish | LILACS | ID: lil-31299

ABSTRACT

La nalbufina es un analgésico narcótico sintético tipo agonista-antagonista de la serie del fenantreno. Químicamente relacionada con la naloxona y la oximorfina. La nalbufina deprime la respiración tanto como las dosis equianalgésicas de morfina; sin embargo, la nalbufina tiene un efecto "TOPE", de tal forma que los aumentos en la dosis por arriba de los 30 mg. no producen un grado mayor de depresión respiratoria. Se estudiaron los efectos de la nalbufina en dosis única de 3 mg/kg por vía I.V., como analgésico de base en 30 pacientes; la mitad de ellos bajo anestesia con enflurano y los otros 15 recibieron anestesia con halotano. Se determinaron los cambios en los siguientes parámetros: frecuencia respiratoria, presión arterial y frecuencia cardiaca durante los periodos de preinducción, postinducción, trasanestésico y postoperatorio (tres horas). Se observó estabilidad cardiovascular en ambos grupos, sin embargo, hubo diferencia estadísticamente significativa (P < 0.05) a favor del grupo que recibió enflurano. En este estudio se demuestra el efecto analgésico prolongado de la nalbufina cuando se emplean dosis elevadas y el hecho de que no modifica "per se" el efecto de los anestésicos empleados. Los efectos colaterales fueron menores que los reportados para otros analgésicos narcóticos


Subject(s)
Adolescent , Adult , Middle Aged , Humans , Male , Female , Enflurane/pharmacology , Halothane/pharmacology , Anesthesia, General , Nalbuphine/administration & dosage , Preanesthetic Medication
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