ABSTRACT
There are many reasons that molecules fail to progress to market and various principles of risk-benefit decisions that can help drive the molecule through development. This symposium included discussions on global strategies involved in pushing promising molecules to market, what to do when a molecule stalls in its progress to market, and options for rescuing the molecule and pushing it forward again. Innovative partnerships that bring stalled drugs back into clinical development were also addressed. A regulatory perspective on common reasons for a molecule to fail in its forward progress was presented. In addition, situations arise when a third-party advisory committee can provide input to help overcome issues identified by a regulatory agency. Using examples from the private and public domain, presentations centered on how to repurpose a molecule and when more science is needed.
Subject(s)
Drug Evaluation, Preclinical , Drug Repositioning , Therapeutics/standards , Animals , Drug Industry/standards , HumansABSTRACT
El presente trabajo revisa los múltiples beneficios de la terapia asistida con animales, desde sus orígenes a la actualidad. Se exponen los requisitos y características de la terapia asistida con perros en pacientes pediátricos crónicos. Finalmente, se defiende la utilidad de la creación e implementación de la terapia asistida con perros en hospitales (AU)
This paper reviews the multiple benefits of animal assisted therapy since its inception to the present. The requirements and characteristics of dog assisted therapy with chronic pediatric patient are described. Finally, this work defends the utility of the creation and implementation of dog assisted therapy in hospitals (AU)
Subject(s)
Humans , Child , Adolescent , Animal Assisted Therapy/methods , Animal Assisted Therapy/standards , Chronic Disease/psychology , Chronic Disease/therapy , Chronic Disease , Psychotherapy/methods , Research Design , Therapeutics/methods , Therapeutics/standards , Social Welfare/trendsABSTRACT
Natural product drugs, or botanical drugs, are drugs composed of natural substances which have constituents with healthenhancing or medicinal activities. In Korea, government-led projects brought attention to botanical drugs invigorating domestic botanical drug industry. Foreign markets, as well, are growing bigger as the significance of botanical drugs stood out. To follow along with the tendency, Korea puts a lot of effort on developing botanical drugs suitable for global market. However, standards for approving drug sales vary by countries. And also, thorough standardization, certification, clinical studies and data of these will be required as well as data confirming safety and effectiveness. Meanwhile, as an international exchange in botanical drug market continues, the importance of plant resources was emphasized. Thus countries' ownership of domestic natural resources became vital. Not only establishing a systematic method to secure domestic plant resources, but also cooperation with other countries on sharing natural resources is essential to procure natural resources effectively. Korea started to show visible results with botanical drugs, and asthma/COPD treatment made out of speedwell is one example. Sufficient investment and government's active support for basic infrastructure for global botanical drugs will bring Korea to much higher level of botanical drug development. [BMB Reports 2017; 50(3): 111-116].
Subject(s)
Drug Approval/methods , Drug Discovery/trends , Pharmaceutical Preparations/standards , Phytotherapy/statistics & numerical data , Plant Extracts/therapeutic use , Commerce , Conservation of Natural Resources , Dietary Supplements , Drug Industry , Drugs, Generic/standards , Economics , Global Health , Government , Humans , International Cooperation , Plant Extracts/pharmacology , Plant Preparations , Plants , Plants, Medicinal , Public Policy , Reference Standards , Republic of Korea , Therapeutics/standardsABSTRACT
El objetivo de esta revisión es definir las características clínico-patológicas y aclarar el tratamiento de la enfermedad diverticular del colon derecho. Es poco frecuente en Europa, Estados Unidos y Australia, y más común en Asia. Durante los últimos años, su incidencia ha aumentado en Occidente, con diferentes distribuciones entre poblaciones. Muchos estudios han mostrado que es difícil diferenciar antes de la cirugía los síntomas de presentación de esta enfermedad de los de la apendicitis, ya que los síntomas y signos son similares, por lo que no es infrecuente encontrarse con un diagnóstico incorrecto. Con estudios de diagnóstico por la imagen exactos es posible establecer un diagnóstico preoperatorio preciso a fin de evaluar una estrategia de tratamiento adecuada. Actualmente, el tratamiento de esta enfermedad no está bien definido, no se han propuesto recomendaciones claras y no se sabe si también se pueden aplicar las recomendaciones para la enfermedad diverticular del colon izquierdo. Varios autores han señalado que el tratamiento conservador es el mejor enfoque, incluso en caso de reincidencia, y que la cirugía solo estaría indicada en determinados casos
The aim of this narrative review is to define the clinical-pathological characteristics and to clarify the management of right colonic diverticular disease. It is rare in Europe, USA and Australia and more common in Asia. In the recent years its incidence has increased in the West, with various distributions among populations. Many studies have reported that it is difficult to differentiate the presenting symptoms of this disease from those of appendicitis before surgery, because the signs and symptoms are similar, so misdiagnosis is not infrequent. With accurate imaging studies it is possible to reach a precise preoperative diagnosis, in order to assess an accurate treatment strategy. Currently the management of this disease is not well defined, no clear guidelines have been proposed and it is not known whether the guidelines for left colonic diverticular disease can also be applied for it. Several authors have stated that conservative management is the best approach, even in case of recurrence, and surgery should be indicated in selected cases
Subject(s)
Humans , Male , Female , Diverticulosis, Colonic/metabolism , Diverticulosis, Colonic/pathology , Therapeutics/methods , Europe/ethnology , Abdominal Pain/diagnosis , Peritonitis/pathology , Appendicitis/metabolism , Colonoscopy/methods , Enema/methods , Diverticulosis, Colonic/complications , Diverticulosis, Colonic/diagnosis , Therapeutics/standards , Asia/ethnology , Abdominal Pain/complications , Peritonitis/metabolism , Appendicitis/complications , Colonoscopy/instrumentation , EnemaABSTRACT
Objetivos. Determinar si la puesta en marcha de un programa de ahorro de sangre y la adopción y asociación progresiva de diferentes métodos reducen las necesidades transfusionales en pacientes pediátricos intervenidos de escoliosis de múltiples etiologías. Material y método. Estudio cuasiexperimental, no aleatorizado y descriptivo, aprobado por el Comité de Ética para la Investigación de nuestra institución. Se incluyeron 50 pacientes pediátricos (ASA I-III) de edades comprendidas entre los 5 y los 18 años, intervenidos de cirugía de escoliosis de cualquier etiología mediante un único tiempo posterior o doble abordaje, anterior y posterior. Se compararon un grupo histórico (recogida retrospectiva de datos), sin alternativas a la transfusión (Grupo No ahorro = 15 pacientes), y otros 3 grupos prospectivamente: Grupo HNA (hemodilución normovolémica aguda) = 9 pacientes, Grupo HNA + Rec (recuperación intraoperatoria) = 14 pacientes, Grupo EPO (HNA + Rec + eritropoyetina ± donación preoperatoria) = 12 pacientes, conforme se implementaron las diferentes alternativas a la transfusión en nuestra institución. Resultados. La tasa de transfusión en los diferentes grupos (No ahorro, HNA, HNA + Rec, EPO) fue del 100, 66, 57 y 0% de los pacientes, con una media ± DE de 3,40 ± 1,59; 1,33 ± 1,41; 1,43 ± 1,50; 0 ± 0 unidades de CH transfundidas por paciente, respectivamente, con diferencias estadísticamente significativas (p < 0,001) tanto en la tasa de transfusión como en el número de unidades. Conclusiones. La aplicación de un programa multimodal de alternativas a la transfusión sanguínea en cirugía de escoliosis pediátrica, individualizado para cada paciente, puede evitar la transfusión en la práctica totalidad de los casos (AU)
Objectives. To determine whether the implementation of a blood conservation program, and the adoption and progressive association of different methods, reduces transfusion requirements in pediatric patients undergoing scoliosis surgery of different origins. Material and method. Quasi-experimental, nonrandomized, descriptive study, approved by the Ethics Committee for Research of our institution. 50 pediatric patients (ASA I-III) aged 5 to 18 years, undergoing scoliosis surgery of any etiology by a single posterior or double approach (anterior and posterior) were included. A historical group with no alternatives to transfusion: Group No ahorro = 15 patients (retrospective data collection) was compared with another 3 prospective study groups: Group HNA (acute normovolemic hemodilution) = 9 patients; Group HNA + Rec (intraoperative blood salvage) = 14 patients, and Group EPO (HNA + Rec + erythropoietin ± preoperative donation) = 12 patients; according with the implementation schedule of the transfusion alternatives in our institution. Results. The rate of transfusion in different groups (No ahorro, HNA, HNA + Rec, EPO) was 100, 66, 57, and 0% of the patients, respectively, with a mean ± SD of 3.40 ± 1.59; 1.33 ± 1.41; 1.43 ± 1.50; 0 ± 0 RBC units transfused per patient, respectively. Statistically significant differences (P < .001) were found in both the transfusion rate and number of RBC units. Conclusions. The application of a multimodal blood transfusion alternatives program, individualized for each pediatric patient undergoing scoliosis surgery can avoid transfusion in all cases (AU)
Subject(s)
Humans , Male , Female , Blood Transfusion/methods , Scoliosis/congenital , Pediatrics/education , Erythropoietin , Cerebral Palsy/pathology , Anesthesia/methods , Pharmaceutical Preparations/administration & dosage , Therapeutics/methods , Blood Transfusion/standards , Scoliosis/metabolism , Pediatrics/methods , Epidemiology, Descriptive , Erythropoietin/metabolism , Cerebral Palsy/metabolism , Anesthesia/classification , Pharmaceutical Preparations , Therapeutics/standardsABSTRACT
El uso de productos naturales ha impactado diversos aspectos de la medicina incluyendo la salud sexual y repreductiva, con efectos deletéreos sobre los espermatozoides o afrodisiacos Se ha evaluado el efecto de diversas plantas afrodisiacas sobre los mecanismos del desempeño sexual y la calidad de los espermatozoides, lo que permite plantear que extractos de las mismas podrian facilitar la capacitación espermática. En esta revisión bibliográfica se reportan los usos farmacológicos y tradicionales de 20 plantas consideradas tradicionalmente afrodisiacas que podrian ser utilizadas como agentes naturales con efecto capacitante sobre espermatozoides humanos (AU)
O uso de produtos naturais tem tido impacto em diversos aspectos da medicina, incluindo a saude sexual e reprodutiva, tanto pelos potenciais efeitos nocivos sobre os espermatozoides como atraves do use de afrodisiacos. Estudou-se o efeito de varias plantas afrodisiacas sobre os mecanismos de desempenho sexual e qualidade das células espermaticas, para avaliar a possibilidadede melhoria da capacitagao dos espermatozoides. Neste revisao da literatura sao relatados os uses farmacologicos e tradicionais de 20 plantas tradicionalmente consideradas afrodisiacas, que poderiam ser utilizadas como compostos naturais com efeito na capacitaçao de esperma humano (AU)
The use of natural products has impacted various aspects of medicine including sexual and reproductive health, through their deleterious effect on sperm cells or as aphrodisiacs. The mechanisms of sexual performance and sperm cells quality of several aphrodisiac plants have been studied, in order of evaluating the possibility of enhancing sperm capacitation. In this literature review, the pharmacological and traditional uses of 20 aphrodisiac plants that could be used as natural agents with effect on human sperm capacitation are reported (AU)
Subject(s)
Humans , Animals , Aphrodisiacs/agonists , Aphrodisiacs/chemical synthesis , Spermatozoa/cytology , Spermatozoa/physiology , Sexual Health , Reproductive Health/education , Reproductive Health/ethnology , Plants/anatomy & histology , Pregnancy/genetics , Therapeutics/methods , Aphrodisiacs/administration & dosage , Aphrodisiacs/adverse effects , Spermatozoa/abnormalities , Spermatozoa/classification , Reproductive Health/classification , Reproductive Health/trends , Plants/adverse effects , Pregnancy/metabolism , Therapeutics/standardsABSTRACT
La nutrición e hidratación artificial constituyen elementos básicos en la atención de los recién nacidos prematuros y han contribuido a la mejoría en la esperanza de vida y el los resultados clínicos en estos pacientes. Aunque se considera que la nutrición artificial es un tratamiento médico y está sujeto, por tanto, a las mismas consideraciones que otros tratamientos (oportunidad, ventajas, inconvenientes), por sus connotaciones especiales las decisiones sobre no iniciar o retirar el soporte nutricional tienen una carga emocional especial. Este hecho es todavía más relevante en el caso de los prematuros, pues por debajo de la 34 semana de edad gestacional no es posible la alimentación por vía oral. Aunque la toma de decisiones y cuidados al final de la vida en neonatos debe realizarse no sólo basada en datos clínicos, sino también teniendo en cuenta los valores y las creencias de todos los intervinientes en el proceso, y siempre teniendo en cuenta el mejor interés del niño. Con el fin de poder conjugar todos los intereses y bajo la perspectiva de considerar que no hay ninguna vida inferior a las demás, podemos considerar adecuado incluir la retirada de la alimentación e hidratación artificial al final de la vida en aquellos niños en los que el pronóstico de vida sea infausto a corto plazo. No ocurre lo mismo en las situaciones en las que se prevé un mal pronóstico funcional, por ejemplo secuelas de daño neurológico, sin riego vital inmediato aumentado, y en quienes la retirada del soporte nutricional significaría el fallecimiento por este motivo
Artificial hydration and nutrition are key elements in the treatment in Neonatal Units, especially in premature babies. It has led to improved survival and better clinical outcomes. Artificial nutrition is considered a medical treatment and, in such a way, a balance between burdens and benefits should be taken into consideration. Nevertheless decisions on withholding or withdrawing artificial nutrition and hydration have special and emotional considerations. In premature babies it is also necessary to consider than below the 34th week of gestational age, effective suckling is not present, and so, oral nutrition is not a possibility. Decisions regarding the end-of-life care of neonates should be made taking into account clinical facts but also values and beliefs of all concerned, and always "in the best interest" of infants. In order to consider all this aspects, we could respect withdrawing or withholding artificial nutrition and hydration in those babies with an ominous prognosis in a short term basis. It has not the same consideration if there is a clear life risk but a prognosis based on severe future burden, mainly because of neurologic damage. In those cases withholding or withdrawing fluids and feedings would be the direct cause of death
Subject(s)
Female , Humans , Infant , Infant, Newborn , Male , Infant, Premature/blood , Infant, Premature/growth & development , Fluid Therapy/ethics , Fluid Therapy/instrumentation , Fluid Therapy/trends , Quality of Life/legislation & jurisprudence , Bottle Feeding/standards , Bottle Feeding/trends , Bottle Feeding , Fluid Therapy/standards , Fluid Therapy , Therapeutics/ethics , Therapeutics/standards , TherapeuticsABSTRACT
La hipnosis es una técnica potente para la mejora de la calidad de vida de una gran variedad de pacientes. Sin embargo, es frecuente que tanto pacientes como terapeutas tengan creencias erróneas que dificultan que la hipnosis clínica se utilice más. El presente trabajo disipa estas creencias erróneas, destaca la eficacia clínica de la hipnosis y la investigación de vanguardia, y argumenta en favor de un uso más extendido de esta técnica terapéutica adjunta (AU)
Hypnosis is a powerful technique for improving quality of life for a wide variety of patients. Unfortunately, misconceptions about hypnosis are too often held by patients and therapists alike, possibly preventing greater use of clinical hypnosis. The present paper dispels these misconceptions, highlights clinical effectiveness of hypnosis and cutting edge research, and argues for more widespread use of this adjunctive therapeutic technique (AU)
Subject(s)
Female , Humans , Male , Hypnosis, Anesthetic/nursing , Hypnosis, Anesthetic/psychology , Patients/psychology , Therapeutics/methods , Therapeutics/psychology , Relaxation/psychology , Biomedical Research/ethics , Biomedical Research/legislation & jurisprudence , Pharmacology, Clinical/classification , Hypnosis, Anesthetic/instrumentation , Hypnosis, Anesthetic/methods , Treatment Outcome , Patients/classification , Therapeutics/standards , Therapeutics , Relaxation/physiology , Biomedical Research , Biomedical Research/methods , Pharmacology, Clinical/methodsABSTRACT
En esta revisión se contrasta la investigación académica y clínica relacionada con la sugestionabilidad hipnótica. La investigación académica básica usando medidas estandarizadas ha demostrado varias relaciones consistentes y significativas. La investigación sobre el constructo, absorción, y otras variables relacionadas con la habilidad imaginativa parecía prometedora, pero investigación posterior indicó que los resultados estaban influidos por el contexto de la evaluación. En general, la investigación básica sobre personalidad y sugestionabilidad hipnótica indica que pueden haber correlaciones válidas, pero los niveles de las relaciones son bajas. Sin embargo, la investigación clínica sobre la relación de varios síntomas psicopatológicos y síndromes indica la existencia de relaciones significativas entre alta sugestionabilidad hipnótica y psicopatología. Se discute las razones de la discrepancia entre los hallazgos de las investigaciones académicas y clínicas (AU)
Academic and clinical research on correlates of hypnotic suggestibility is contrasted in this review. Basic academic research using standardized measures has yielded few consistent, significant relationships. Research on the construct, absorption, and other variables related to imaginative ability seemed promising, but further research indicated that results were biased by the context of assessment. Overall, basic research on personality and hypnotic suggestibility indicates that there may be some valid correlates, but the levels of the relationships are quite low. However, clinical research on the relationship of various psychopathological symptoms and syndromes indicates a number of meaningful relationships between high hypnotic suggestibility and psychopathology. Reasons for the discrepancy between academic and clinical research findings are discussed (AU)
Subject(s)
Female , Humans , Male , Personality Disorders/pathology , Personality Disorders/psychology , Hypnosis/ethics , Hypnosis/methods , Therapeutics/psychology , Surveys and Questionnaires , Patients/classification , Patients/psychology , Personality Disorders/genetics , Personality Disorders/metabolism , Hypnosis/instrumentation , Therapeutics/standards , Surveys and Questionnaires/standards , Patients/legislation & jurisprudence , Patients/statistics & numerical dataABSTRACT
PIP: The randomized, controlled clinical trial now makes it possible to test the hypothesis that 1 form of treatment is preferable to another and to express the results in the form of the probability of the differences found being because of chance or not. The means exist to evaluate much of medical and surgical therapy, and the problems of evaluating surgical procedures, increasing drug use and adverse reactions to therapy are discussed. The purpose is to raise key issues and critical questions. The example of a minor epidemic of drug induced cancer is described to illustrate the use of the epidemiologic method in detecting adverse effects and for its implications for the development of of a more resonsible public policy to prevent such occurrences. The example of the use of DES in pregnancy and the resulting minor "epidemic" of adenocarcinoma of the vagina among the adolescent daughters of these women was chosen because this example of an adverse drug reaction reveals 1) the complexities of detection; 2) the role of the epidemiologist; 3) the possible results of uncritical acceptance of therapeutic reports; and 4) the need for a new policy of drug regulation. Advances in the epidemiologic detection of adverse effects, along with the development and application of the controlled clinical trial have provided the needed evidence for the development of new governmental regulations which ensure safety and efficacy. Such evidence suggests that regulation should be expanded to require that manufacturers of new drugs introduced into the market demonstrate, in addition to safety and efficacy, the relative efficacy of their products over existing formulations. Surgical procedures also need to be subjected to scrutiny. More attention needs to be paid to the ecologic consequences of drugs and food additives.^ieng