Category Archives: Clinical Pharmacology

BPH treatment with the natural product Calprost®

J Pharm Pharmacogn Res 4(5): 187-198, 2016.

Original Article | Artículo Original

Clinical evaluation of patients with benign prostatic hyperplasia, treated with the natural product Calprost®: a randomized, controlled study

[Evaluación clínica de pacientes con hiperplasia prostática benigna, tratados con el producto natural Calprost®: estudio aleatorizado, controlado]

Magnelis Machado-Leiva1, Daise Jiménez-Rodríguez2, Tatiana Festary-Casanovas2, Deydree  C. Silveira-Pacheco3, Emilio S. Barroso-de la Cruz4, Mariela Suárez-Reyes1, Genma Salas-Cruz1, Haydee Wong-Arocha3, Roberto Fernández-Viera4, Ángela D. Tuero-Iglesias5, René Delgado-Hernández2, Idrian García-García2*, for the Calprost Study Group

1Urology and Natural and Traditional Medicine Services, Clinical-Surgical Hospital “Dr. Luis Díaz Soto”, Havana, Cuba
2Clinical Trials Group, Research Direction, Center for Drug Research and Development, Ave. 26 and Puentes Grandes, No. 1605, Nuevo Vedado,Havana, Cuba
3Urology Service, Clinical-Surgical Hospital “Joaquín Albarrán”, Havana, Cuba
4Urology Service, Clinical-Surgical Hospital “Iván Portuondo”, San Antonio de los Baños, Artemisa, Cuba
5Center for Genetic Engineering and Biotechnology, Havana, Cuba.

*E-mail: idrian.garcia@cidem.cu

Abstract

Context: Benign Prostatic Hyperplasia (BPH) is a common disease that course with Lower Urinary Tract Symptoms (LUTS), mainly in over 50 years-old men. Commonly indicated drugs such as alpha adrenergic-blockers are life-treatment with some adverse reactions. Center for Drug Research and Development produce a microencapsulated lipophilic extract of pumpkin seed oil (Calprost®) with anti-androgenic, anti-inflammatory, antioxidant, antiproliferative and diuretic properties.

Aims: To evaluate the effect and safety of Calprost® in patients with BPH and LUTS.

Methods: A multicenter, randomized, controlled, open exploratory clinical trial was conducted. Two experimental groups, study group (Calprost®, 140 mg daily) (n=81), and control group (terazosin, 2 mg daily) (n=50) were conformed. All the patients were treated during three months. Efficacy was evaluated through International Prostate Symptoms Score (IPSS), residual bladder volume and prostate volume.

Results: Most of the included patients (74.0%) were white skin color and their mean age was 66 yrs. Fifteen patients, nine of them from terazosin group, withdraw the trial voluntarily. A significant reduction in the overall IPSS scale was obtained for both groups. Nevertheless, some obstructive (intermittency, straining) and irritative (frequency, urgency) urinary symptoms decreased more markedly in the Calprost® group being milder. Median residual and prostatic volumes decreased significantly (p=0.048 and p=0.002, respectively) only into the Calprost® group. Most of the adverse events were recorded in the terazosin group (79.4%), where postural hypotension prevailed.

Conclusions: The natural product Calprost® was probed as a successful treatment of patients with BPH/LUTS, being also well-tolerated.

Keywords: Benign prostatic hyperplasia; Calprost®; IPSS; lower urinary tract symptoms, pumpkin seed oil, terazosin.

Resumen

Contexto: La Hiperplasia Prostática Benigna (HPB) es una enfermedad común en hombres mayores de 50 años de edad, que cursa con Síntomas del Tracto Urinario Bajo (STUB). Los tratamientos de por vida con medicamentos bloqueadores alfa-adrenérgicos producen algunas reacciones adversas. El Centro de Investigación y Desarrollo de Medicamentos produce un extracto lipofílico microencapsulado de aceite de semillas de calabaza (Calprost®) con propiedades anti-androgénicas, anti-inflamatorias, antioxidantes, antirproliferativas y diuréticas.

Objetivos: Evaluar el efecto  y seguridad del Calprost® en pacientes con BPH/STUB.

Métodos: Se realizó un  estudio exploratorio, multicéntrico, aleatorizado, controlado y abierto. Se conformaron dos grupos experimentales, estudio (Calprost®, 140 mg diarios) (n=81), y control (terazosina, 2 mg diarios) (n=50). Todos los pacientes fueron tratados durante tres meses. La eficacia se evaluó mediante la sintomatología urinaria (escala IPSS), volumen vesical residual y volumen prostático.

Resultados: La mayoría de los pacientes (74.0%) fueron blancos, con edad promedio de 66 años. Quince pacientes, nueve de ellos del grupo terazosina, abandonaron el estudio voluntariamente. Hubo disminución significativa de la escala global de síntomas en ambos grupos, aunque algunos de ellos se redujeron notablemente solo en el grupo Calprost®, llegando a ser más ligeros. La mediana tanto del volumen residual (p=0.048) como del prostático (p=0.002) disminuyó de manera significativa solo en el grupo tratado con Calprost®. El porcentaje de eventos adversos presentados fue mayor con la terazosina (79.4%), prevaleciendo la hipotensión postural.

Conclusiones: El producto natural Calprost® fue efectivo en el tratamiento de la HPB/STUB, siendo además bien tolerado.

Palabras Clave: Aceite de semilla de calabaza; Calprost®; hiperplasia prostática benigna; IPSS; síntomas del tracto urinario bajo; terazosina.

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Citation Format: Machado-Leiva M, Jiménez-Rodríguez D, Festary-Casanovas T, Silveira-Pacheco DC, Barroso-de la Cruz ES, Suárez-Reyes M, Salas-Cruz G, Wong-Arocha H, Fernández-Viera R, Tuero-Iglesias AD, Delgado-Hernández R, García-García Idrian, for the Calprost Study Group (2016) Clinical evaluation of patients with benign prostatic hyperplasia, treated with the natural product Calprost®: a randomized, controlled study.J Pharm Pharmacogn Res 4(5): 187-198.

© 2016 Journal of Pharmacy & Pharmacognosy Research (JPPRes)

Protectores gástricos en la profilaxis de úlceras por estrés en Medicina, HR Antofagasta

J Pharm Pharmacogn Res 3(3): 77-79, 2015.

Thesis Review | Reseña de Tesis

Uso de protectores gástricos en la profilaxis de úlcera por estrés en el Servicio de Medicina del Hospital Regional de Antofagasta: Julio a diciembre de 2014

[Use of gastric protectors in stress ulcer prophylaxis in medicine service of Regional Hospital of Antofagasta: July to December, 2014]

Silvana Tapia Aguirre

Departamento de Ciencias Farmacéuticas. Facultad de Ciencias. Universidad Católica del Norte. Edificio Ñ3, Av. Angamos 0610, Antofagasta, Chile.
*E-mail: silvana.tapia.aguirre@hotmail.com

Director: Patricio Araya Guerrero.

Fecha: 7 de abril de 2015.

TRABAJO PRESENTADO EN OPCIÓN AL TÍTULO DE QUÍMICO FARMACÉUTICO.

La tesis está vinculada con el área clínica del sistema gastrointestinal.

La prescripción de protectores gástricos para las úlceras por estrés ha ido aumentando durante el tiempo siendo inapropiado en ocasiones su uso, por lo que se evaluó la utilización de protectores gástricos en la profilaxis de úlcera por estrés en pacientes internados en el servicio de medicina del Hospital Regional de Antofagasta, durante 6 meses, con el fin de analizar el uso de estos medicamentos en el centro asistencial. Este estudio fue prospectivo de tipo descriptivo-experimental, que consistió en hacer seguimiento en dos grupos de estudio, denominados control y caso, en el que se realizaron intervenciones en el segundo grupo. Como resultado se obtuvo que en el grupo control el uso correcto de protectores gástricos fue menor en comparación al grupo caso. El omeprazol fue el medicamento más utilizado.

La tesis está constituida por 78 páginas y su estructura comprende una introducción, cuatro capítulos, referencias bibliográficas y otras informaciones (anexos).

En la Introducción se aborda en dos páginas, de forma sintética, tanto el estado del arte del proceso de evaluación de protectores gástricos en la profilaxis de úlcera por estrés como de la investigación y determinación de las consciencias clínicas y económicas que conlleva el mal uso de estos medicamentos. También se plantean la hipótesis, un objetivo general y cuatro objetivos específicos de manera clara y precisa, dirigidos al estudio de la evaluación de protectores gástricos en la profilaxis de úlcera por estrés en el Hospital Regional de Antofagasta, periodo de julio a diciembre de 2014.

El capítulo 1 presenta la Revisión Bibliográfica (Marco Teórico), en la que en 19 páginas, se hace un resumen de la definición de las úlceras por estrés, denominándose úlcera por estrés al “desarrollo de lesiones en la mucosa gástrica en pacientes que presenten estados de estrés fisiológico”. Luego se clasifican las úlceras por estrés en iníciales y finales, estudiando su fisiopatología. El sangrado importante por úlceras por estrés no es un evento frecuente, en Chile, la incidencia es baja pero la mortalidad es alta, por lo que la profilaxis debe realizarse de forma racional, utilizando la terapia profiláctica solo en los pacientes que presenten factores de riesgo. Por otra parte, las úlceras gastro-intestinales se manifiestan principalmente por hematemesis o melenas, donde la endoscopía y la escala Forrest cumplen un rol fundamental en su detección. Los medicamentos que se utilizan en la profilaxis para úlceras por estrés son principalmente tres: los antagonistas de receptores H2, los inhibidores de la bomba de protones y el sucralfato; sin embargo, su mala utilización trae consecuencias clínicas, como son los efectos adversos y las interacciones medicamentosas, y consecuencias económicas, provocando que no se optimicen bien los recursos en los centros asistenciales.

 El capítulo 2 aporta los Materiales y Métodos en cuyas cinco páginas se aborda la metodología con que se realizó el estudio. Se realiza una descripción del material de ensayo y la forma en que se obtuvo este. Se describe el diseño del programa, realizándose un estudio prospectivo de tipo descriptivo-experimental a pacientes que ingresaron al servicio de medicina del Hospital Regional de Antofagasta (HCRA) durante los meses de julio a diciembre de 2014. El universo estuvo constituido por los pacientes internados en el servicio de medicina del HCRA durante el periodo de estudio. La muestra se determinó a partir de los criterios de inclusión y exclusión, que alcanzó un total de 60 pacientes, de los cuales 30 fueron distribuidos en el grupo control y 30 en el grupo caso. Para la recolección de datos se elaboró una ficha clínica, se hizo seguimiento a los pacientes internados, se analizaron las terapias farmacológicas de los pacientes que eran potenciales a desarrollar úlcera por estrés y si su protector gástrico era el adecuado o no según sus características clínicas, se determinaron las consecuencias clínicas y económicas asociadas al uso inadecuado de los protectores gástricos y se intervino en el grupo caso cuando correspondía, mediante el uso de la tabla de factores de riesgo. El análisis se realizó por estadística descriptiva, por medio del análisis de medidas de tendencia central y pruebas de hipótesis. Los valores de p < 0,05 fueron considerados estadísticamente significativos.

 El capítulo 3 presenta en 24 páginas los Resultados del estudio y la Discusión de dichos resultados en base a las referencias bibliográficas actualizadas. Este capítulo se divide en seis subcapítulos: 3.1. Características biodemográficas; 3.2. Características clínicas; 3.3.Características terapéuticas; 3.4. Evaluación del uso de protec-tores gástricos en la profilaxis de úlcera por estrés; 3.5. Consecuencias clínicas; 3.6. Consecuencias económicas. En el análisis por sexo, tanto en el grupo control como en el grupo caso, la distribución fue homogénea, por lo que ambos grupos fueron comparables. En relación a la edad, el promedio en ambos grupos fue similar, siendo mayor en el sexo femenino. Las patologías más prevalentes fueron la hipertensión arterial, la diabetes mellitus tipo 2 y la insuficiencia renal crónica, que según las guías clínicas del MINSAL son las que se presentan en mayor proporción en Chile. El promedio de medicamentos en la terapia hospitalaria aumentaron en relación a la terapia habitual, debido a la descompensación de las patologías crónicas siendo los medicamentos más utilizados los protectores gástricos, debido al enfoque del estudio. En la evaluación, el uso correcto de los protectores gástricos fue menor en el grupo control que en el grupo caso, esto se debió a las intervenciones realizadas, en las que se retiraron los protectores gástricos en pacientes que no presentaban factores de riesgo a desarrollar úlceras por estrés. Por otra parte, en el grupo control se utilizaron más fármacos anti-ulcerosos en comparación al grupo caso. El medicamento más utilizado fue el omeprazol, por lo que en el grupo control se detectó una mayor cantidad de interacciones y una RAM en un uso inadecuado de estos medicamentos. Por último, en el grupo caso se disminuyeron el total y el promedio de días cama, además del gasto en protectores gástricos en comparación al grupo control, por lo que es importante protocolizar la terapia de profilaxis para úlcera por estrés.

 El capítulo 4 aporta las Conclusiones y Recomendaciones a las que arriba el estudio. Dentro de las conclusiones se destaca que en el grupo control el uso correcto fue menor que en el grupo caso, siendo el omeprazol el medicamento más consumido. De acuerdo a las RAM, en el grupo control se analizó una RAM; mientras que en el grupo caso no se manifestó ninguna, además en el grupo control se analizaron una mayor cantidad de interacciones en comparación con el grupo caso. En relación a las consecuencias económicas, en el grupo control el total y el promedio de días cama fue mayor que en el grupo caso y el gasto aproximado de protectores gástricos fue mayor en el grupo control que en el grupo caso, lo que constituyó un ahorro para el centro asistencial que sería bueno aplicar en otros servicios.

Las Referencias Bibliográficas del estudio cuentan con 65 citas bibliográficas; de ellas, 35 (53,85 %) de los últimos cinco años y 30 (46,15 %) de los últimos 10 años.

La tesis cuenta además, de tres tablas que resumen algunos datos relevantes en la Revisión Bibliográfica, los factores de riesgo, la clasificación Forrest y las dosis recomendadas para la profilaxis de úlcera por estrés y una figura en las que se muestra la fisiopatología de la enfermedad de la mucosa relacionada con el estrés, en Materiales y Métodos se muestra una tabla de la operacionalización de las variables. Además, se presentan 22 tablas en las que se exponen los resultados alcanzados.

Download the PDF file .

Citation Format: Silvana Tapia Aguirre (2015) Uso de protectores gástricos en la profilaxis de úlcera por estrés en el Servicio de Medicina del Hospital Regional de Antofagasta: Julio a diciembre de 2014. [Use of gastric protectors in stress ulcer prophylaxis in medicine service of Regional Hospital of Antofagasta: July to December, 2014]. J Pharm Pharmacogn Res 3(3): 77-79.

© 2015 Journal of Pharmacy & Pharmacognosy Research (JPPRes)

CO 038: FREQUENCY OF USE OF THE MONOCLONAL ANTIBODY RITUXIMAB ON THE NATIONAL CANCER INSTITUTE OF MEXICO: ONE YEAR EXPERIENCE

J Pharm Pharmacogn Res 2(Suppl. 1): S20, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 038: FREQUENCY OF USE OF THE MONOCLONAL ANTIBODY RITUXIMAB ON THE NATIONAL CANCER INSTITUTE OF MEXICO: ONE YEAR EXPERIENCE

López-Gamboa M1,2, Aguilar-Ponce JL2, Espinoza-Zamora JR2, DavalosFiesco M2, Mena-Rodríguez FJ2, Castañeda-Hernández G1.

1Departamento de Farmacología, Centro de Estudios Avanzados del Instituto Politécnico Nacional, Av. Instituto Politécnico Nacional 2508, San Pedro Zacatenco, C.P. 07360, México D.F.
2Instituto Nacional de Cancerología; Av. San Fernando No. 22, Sol. Sección XVI, C.P. 14080, México D.F. E-mail: dralopezg@gmail.com
Abstract

Introduction: For the health care professionals and for the maker decisions staff on the hospital is very important have a real panorama about the use of the drugs in order to improve the patient attention. In Mexico for the oncology therapeutic segment, Rituximab the chimeric, anti-CD20 monoclonal antibody is registered for: a) the treatment of Non-Hodgking´s Lymphoma (CD20+); b) also combined with chemotherapy for previously untreated patients with relapsed/refractory of chronic lymphocytic leukemia.

Methods: With the aim of determine the Rituximab frequency usage on the National Cancer Institute of Mexico we made a retrospective analysis of the rituximab dispensation data from march 2012 to march 2013. Our collected data were: the pharmaceutical presentation and vials quantity of Rituximab dispensed per patient; and from the clinical record the data recorded included: clinical indication (diagnostic) result of CD20 test, weigh, height, age, and Rituximab dosage prescribed.

Results: During the twelve-month period, a total of 2663 Rituximab vials where dispensed from the Institute pharmacy, 1353 were 500 mg vials, and 1308 were 100 mg vials, distributed on 304 patients. The list of primary diagnostics included 75 different pathologies. All patients had immunohystochemical test, the 95% of the cases were positive to the CD 20 test, 4.7% of the patients had not report and 0.3% were negative to the CD20 test.

Conclusion: Even when Rituximab was prescribed for a diverse range of clinical conditions, the use of CD20 test was a standard followed on the patients, this practice showed the specific use of Rituximab.

CO 037: MEDICAL PRACTICE CONFIRMS CLINICAL TRIAL RESULTS OF THE USE OF INTRALESIONAL HUMAN RECOMBINANT EPIDERMAL GROWTH FACTOR IN ADVANCED DIABETIC FOOT ULCERS

J Pharm Pharmacogn Res 2(Suppl. 1): S20, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 037: MEDICAL PRACTICE CONFIRMS CLINICAL TRIAL RESULTS OF THE USE OF INTRALESIONAL HUMAN RECOMBINANT EPIDERMAL GROWTH FACTOR IN ADVANCED DIABETIC FOOT ULCERS

López-Saura PA1, Yera-Alos IB1, Valenzuela-Silva C1, González-Díaz O1, del Río-Martín A1, Berlanga-Acosta J1, Fernández-Montequín JI2, Acevedo-Castro B1, López-Mola E1, Herrera-Martínez L1.

1Center for Genetic Engineering and Biotechnology, Havana, Cuba. E-mail: lopez.saura@cigb.edu.cu
2National Institute for Angiology and Vascular Surgery, Havana, Cuba.
Abstract

The intralesional injection of recombinant human epidermal growth factor (rhEGF) has been recently approved and introduced in several countries for the treatment of advanced diabetic foot ulcers (DFU), based on the results of five exploratory and one confirmatory, phase III clinical trials in 344 subjects. A significant stimulatory effect of this product on the healing process, given by granulation tissue development and re-epithelization was shown in these trials, as well as a reduction in lesion recurrences during follow-up, and a tendency to a reduction of the risk of amputations, with an acceptable safety profile. However, products not always perform the same way in current medical practice. The present review summarizes the clinical information available from the intralesional use of rhEGF for advanced DFU and shows that in this case the postmarketing experiences in more than 4000 subjects confirm the results of the clinical trials, with 75% probability of complete granulation response, 61% healing, and a 16% absolute and 71% relative reduction of the risk of amputation. The benefit includes ischemic patients. The safety profile in current practice was satisfactory. Serious adverse events are not attributable to the treatment but to the underlying conditions of the patients. No evidence of cancer promotion by the growth factor has been found. The benefitrisk ratio of the procedure is favorable.

CO 022: EFFICACY AND SAFETY OF RECOMBINANT STREPTOKINASE VERSUS HYDROCORTISONE ACETATEBASED SUPPOSITORIES IN THE TREATMENT OF HEMORRHOIDAL DISEASE. RANDOMIZED, CONTROLLED TRIAL (THERESA-4 STUDY)

J Pharm Pharmacogn Res 2(Suppl. 1): S11, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 022: EFFICACY AND SAFETY OF RECOMBINANT STREPTOKINASE VERSUS HYDROCORTISONE ACETATEBASED SUPPOSITORIES IN THE TREATMENT OF HEMORRHOIDAL DISEASE. RANDOMIZED, CONTROLLED TRIAL (THERESA-4 STUDY)

Hernández-Bernal F1, Castellanos-Sierra G2, Valenzuela-Silva CM1, Catasús-Álvarez KM1, Martínez-Serrano O3, Lazo-Diago OC1, CausaGarcía JR4, Domínguez-Suárez JE5 and López-Saura PA1 for the THERESA-4 (Treatment of HEmorrhoids with REcombinant Streptokinase Application) Group of Investigators.

1Center for Genetic Engineering and Biotechnology, La Habana, Cuba.
2“Juan B. Zayas” Hospital, Santiago de Cuba.
3“Ernesto Guevara” Hospital, Las Tunas, Cuba.
4“Celia Sánchez” Hospital, Manzanillo, Granma, Cuba. , Cuba 5“Gustavo Aldereguía” Hospital, Cienfuegos, Cuba.
Abstract

Introduction: The aim of this study was compare the efficacy and safety of two schedules of recombinant streptokinase (rSK) suppositories and a hydrocortisone acetate-based suppository (Anusol-HC®), for the treatment of acute hemorrhoidal disease.

Material and methods: A multicenter (11 sites), randomized (1:1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed consent to participate, were centrally randomized to receive, as outpatients, rSK (200000 IU, schedules A or B) or Anusol-HC® (25 mg hydrocortisone acetate) suppositories, which had different organoleptic characteristics. rSK was administered by the rectal route, three units, one every 8 hours, and then five units, one every 12 hours (schedule A) or six units, one every 8 hours (schedule B). Anusol-HC® suppositories were given every 8 hours up to a maximum of 24 administrations according to the product label. Evaluations were performed at 3, 5 and 10 days postinclusion. The main end-point was the 5th-day response (disappearance of pain and bleeding, and ≥70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were evaluated too.

Results: Response rates were 156/170 (91.8%) and 155/170 (91.2%) with rSK schedules A and B, respectively, which were significantly larger (p<0.001) than with Anusol-HC® suppositories (46/170; 27.1%). Time for response were significantly shorter (p<0.001; log-rank test) in the rSK groups (median: 3 days) with respect to the active control (median: 10 days). Thrombectomy was necessary in 2/122 and 2/129 with baseline thrombosis in the rSK schedules A and B, respectively vs. 14/133 in the Anusol-HC® group (p=0.001). There were no adverse events attributable to the experimental treatment.

Conclusion: rSK suppositories showed a significant advantage over the widely used over-the-counter Anusol-HC® for the treatment of acute hemorrhoidal illness, with an adequate safety profile.

CO 021: CLINICAL TRIAL DESIGNS THAT CAN SPEED UP NEW DRUG DEVELOPMENT

J Pharm Pharmacogn Res 2(Suppl. 1): S10, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 021: CLINICAL TRIAL DESIGNS THAT CAN SPEED UP NEW DRUG DEVELOPMENT

López-Saura PA, Valenzuela-Silva CM.

Center for Genetic Engineering and Biotechnology; La Habana, Cuba. E-mail: lopez.saura@cigb.edu.cu
Abstract

The “bottle-neck” of new product development in the last years has been safety and efficacy demonstration in the clinical setting, which is the most expensive stage as well. Following the established regulatory paradigm, this evaluation must follow the sequential phase I-IV pathway, which is quite time-consuming. A new approach is required in order to optimize this process. Recently, innovations concerning clinical trials design and interpretation have been introduced. They include adaptive designs where “bridges” between subsequent phases (I – II or II – III) can be envisaged. Improvements in knowledge on the biological mechanisms involved in disease and drug actions also permit a better rationale for trials justification and evaluation. Adaptive designs permit the modification of one or more aspects in a prospective way, based on analyses of data gathered from study subjects as long as they are obtained. These modifications should be previewed in the trial protocol. Examples of such trials, sponsored by the Center for Genetic Engineering and Biotechnology where these techniques have been used for several years (with the agreement of the corresponding ethics committees and the Cuban regulatory authority) will be shown. More than 300 subjects have been “saved” to be included in those trials, including more than one third that would had received a placebo. A more flexible and rational regulatory paradigm is proposed where an exploratory phase is conceived to gain knowledge on the products’ clinical performance in order to go into a confirmatory phase to attain approval.

CO 020: SUBJECT: NATIONAL BIOETHICS NETWORK AND RESEARCH IN PERU – RENABIP

J Pharm Pharmacogn Res 2(Suppl. 1): S10, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 020: SUBJECT: NATIONAL BIOETHICS NETWORK AND RESEARCH IN PERU – RENABIP

Socualaya P, Minaya G, Ayala B and Fuentes D.

Instituto Nacional de Salud – Perú. Calle Cápac Yupanqui 1400, Lima 11, Perú.
Abstract

Introduction: 85% of Research Ethics Committees exist in Peru and they are concentrated in Lima. Most are private and only 2 of them account for over 50% of approvals of clinical trials nationwide. Thus, the National Institute of Health assumes the challenge of developing a national system of monitoring and control in research ethics, creating the National Network of Bioethics and Research in Peru (RENABIP).

Material and methods: Strategies for the implementation process of the RENABIP were raised to determine regional capabilities, develop and disseminate policies, national standards, guidelines and technical tools, advocate and implement the Regional Coordinating Centers of Institutional Ethics Committees Research, develop skills, alliances and cooperation agreements and determination of extension mechanisms, communication, expansion and sustainability.

Results: In July 2012, the process of implementing the RENABIP began in 12 regions of Peru, achieving to involve 277 authorities of Regional Coordinating Centers of Research Ethics Committees; technical meetings and/or workshops were also performed, and coordination with key stakeholders in each region for research management were established. In March of 2013, the virtual platform was implemented for education and training in national Bioethics. In April 2013, the Research Ethics Course started, in order to train and strengthen the members of the Research Ethics Committees of the regions, and in this way support the management of research regional health priorities.

Conclusions: Today we continue with the process of implementing the National Plan of strengthening and sustainability RENABIP; and it has been scheduled the monitoring and evaluation of the RENABIP.

CO 019: SERUM LEVELS OF INFLAMMATORY MARKERS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION DURING A 6 MONTH FOLLOW UP

J Pharm Pharmacogn Res 2(Suppl. 1): S9, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 019: SERUM LEVELS OF INFLAMMATORY MARKERS IN PATIENTS WITH ACUTE MYOCARDIAL INFARCTION DURING A 6 MONTH FOLLOW UP

Brizuela NY, Ricarte Bratti JP, Vergottini JC, Ponce LN and Menara A.

Cátedra Farmacología General. Facultad de Ciencias Médicas. Universidad Nacional de Córdoba. Santa Rosa 1085. (5000), Córdoba. Argentina. E-mail: nildabrizuela@gmail.com, nilda@fcm.unc.edu.ar
Abstract

Introduction: The inflammation plays a fundamental role in pathogenesis and complication of the atherosclerosis. Cytokines and adhesion molecules are key components of these events that contribute to the development of an atherosclerotic plaque. Their determination of plasma levels provides an excellent reflection of the underlying inflammatory process, since it is positively correlated with other markers such as pro-inflammatory cytokines. The cytokine Tumor necrosis factor alpha (TNF-α), the interleukin-6 (IL-6) and vascular adhesion molecule-1 (VCAM-1) are indicators of basal inflammation. This study reports on the follow-up of 27 patients, aged 42–82 years with confirmed acute myocardial infarction (AMI group) and a matched control group of 10 patients without coronary artery disease (control group).

Material and methods: Blood samples for determination of inflammatory markers were taken on the 3rd day and after 6 months. Concentrations of cytokines and adhesion molecules were measured using commercial Immunoassay (ELISA) kits (Amersham Sciences).

Results: The serum level of VCAM-1 in the AMI group was significantly higher than in control groups (P<0.01). In the acute phase of myocardial infarction (MI) the levels of TNF-α and IL-6 were higher than in the control group (P<0.01). Six months later the levels of TNFα, IL-6 and ICAM-1 normalized (P<0.001).

Conclusions: The present study showed that in the acute phase of AMI increased activation of pro inflammatory markers. In the course of healing within 6 months after the infarction the inflammatory reaction disappears. It is necessary to carry out further studies to clarify the role of adhesion molecules in acute coronary syndrome. Future studies of the prediction of recurrent vascular events after AMI should concentrate on clinical variables and different blood inflammatory markers.

CO 013: BIOMODULINA T: IMMUNOMODULATOR NATURAL PRODUCT OF THE LIFE´S QUALITY

J Pharm Pharmacogn Res 2(Suppl. 1): S7, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 013: BIOMODULINA T: IMMUNOMODULATOR NATURAL PRODUCT OF THE LIFE´S QUALITY

Aznar García E1, Pereira Y1, Súarez Fundora S1, Batista Speranza G2, Leyva B3.

1Clinical Study and Sanitaries Register. Centro Nacional de Biopreparados. BioCen. Carretera de Beltrán Km 1 ½ Bejucal, La Habana, Cuba.
2Hosp. Oncológico GB Grassi Costia, Roma, Italia.
3Centro Iberoamericano para la Tercera Edad. MINSAP, La Habana, Cuba.
Abstract

Roundtable is will include a groups of lecture and free topics of one thematic: The role of the Biomoduline T, pharmaceuticals compositions based a natural polypeptide compound made up of specific thymus fractions and include the formulation for the parenteral administration. Others clinical application will be analyzed in oncology; experience in Oncology Hospital Roma, Quality specification and stability was defined. The non clinical and clinical assay was demonstrated effectiveness and safety in geriatrics patient, inflammatory and autoimmune diseases. Study in geriatrics patients with respiratory disease was evaluated clinical and immunological cellular test before and after the beginning of the treatment. This medication is recommended for the immunological dysfunction. The study about the effect of Biomodulin T in children present with recurrent infection and a decrease of thymic area showed that after the treatment decreases of infections and increases the thymic area. The others clinical applications are evaluated: Cancer patient with chemotherapy treatment, rheumatoid arthritis, multiple sclerosis, AIDS, and immunodeficiency atypical.

CO 006: CONCENTRATION OF MMP-3 AND IL-6 IN PATIENTS WITH SEPSIS AND MULTIORGAN FAILURE

J Pharm Pharmacogn Res 2(Suppl. 1): S4, 2014

Special supplement with the abstract book of LATINFARMA 2013

Oral Communication

CO 006: CONCENTRATION OF MMP-3 AND IL-6 IN PATIENTS WITH SEPSIS AND MULTIORGAN FAILURE

Ricarte Bratti JP, Montrull HL, Meirovich CI, Jaime NJ, Demurtas SL, Brizuela NY.

Universidad Nacional de Córdoba – Fac Cs Medicas – Cátedra de Farmacología. Santa Rosa 1085, Córdoba, Argentina. E-mail: jpricarte@yahoo.com.ar
Abstract

Introduction: Sepsis is the leading cause of mortality in intensive care. The study of its pathophysiology is essential to try to change the high mortality that this syndrome presents. The multiple organ dysfunction Syndrome (MODS) is a high mortality syndrome caused by sepsis. Cytokines are the main responsible for the inflammatory response in sepsis and MODS, including IL-1, 6 and TNF alpha. MMP-3 is a molecule relatively recent that has not been studied in sepsis yet.

Aim: To assess the predictive power of cytokines on MODS and death.

Material and methods: 48 patients older than 18 years with sepsis criteria who were attended the Hospital Nacional de Clínicas of Cordoba-Argentina have been included. Upon admission blood samples were drawn for the dosage of cytokines.

Results: Patients with MODS had a mean value of IL-6 of 210.10 ± 30.82 pg/mL and for patients without MODS of 155.32 ± 20.84 pg/mL (p=0.135). For MMP-3 MODS patients had an average of 14.57 ± 0.63 mg/mL whereas patients who did not develop MODS reached an average of 9.8 ± 0.83 mg/mL (p<0.0001). Evaluating mortality IL-6 in death patients was a medium term of 203.65 ± 26.64 pg/mL in slight contrast to the survivors, whose average was 161.88 ± 24.38 pg/mL, giving a difference without statistical significance (p = 0.26). Values of MMP-3 in survivors had an average of 10.55 ± 0.76 mg/mL, whereas the average of the deceased was 13.77 ± 0.98 mg/mL (p=0.012).

Conclusions: MMP-3 has shown that if at the time of admission it´s in a high value (Beyond 12 mg/mL) has a prognostic value since it predicts death and organ failure. IL-6 has a tendency to the above, but with nonsignificant results, so more studies are needed with larger numbers of patients.