2013, Number 1
<< Back Next >>
Rev Hum Med 2013; 13 (1)
Bioethics and clinical trials in patients with Proliferative Diabetic Retinopathy
Hernández PA, Tirado MOM, Rivas CMC, Sureda MM, Hernández CC
Language: Spanish
References: 45
Page: 88-111
PDF size: 89.75 Kb.
ABSTRACT
The Second World War and the atrocities committed in research with prisoners in Japanese and Nazi concentration camps, awakened consciousness for the development of human rights that had gradually been conquered throughout history. That´s why a series of laws, rules and statements that deal with bioethical aspects in clinical trials, were passed. Special attention must be given to the doctor-patient relationship during the research and consider the benefit/risk ratio when conducting experiments on human beings. Proliferative Diabetic Retinopathy is one of the ophthalmological disorders that has given rise to more trials. The research goal is to analyze some ethical aspects when experimenting on patients with this condition.
REFERENCES
Núñez J, Macías ME (compiladores).Reflexiones sobre Ciencia, Tecnología y Sociedad. La Habana: ECIMED; 2008.
Delgado CJ. Bioética y Medio Ambiente. La Habana; 2005.
Gracia D. La bioética: una nueva disciplina académica. Jano 1987; 78:69-74.
Ambroselli C. Que sais-je? L'éthique médicale. París, Francia: PUF; 1988.
Velasco M, Cano F. Bioética. México: Editorial Piensa; 1998.
Mainetti JA. Oftalmoética. 2006. [Citado 2011 Feb 10]. Disponible en: http://www.bioética.org.
Huff TE. The Rise of Early Modern Science: Islam, China and the West. Cambridge University Press; 2003.
Tschanz DW. Arab Roots of European Medicine. Heart Views. 2003;4(2):1.
Craig D. Daly WJ. Clinical pharmacology in the Middle Ages: Principles that presage the 21st century. Clinical Pharmacology and Therapeutics. 2000;67(5):2.
Lind J. A Treatise of the Scurvy. 2001. [Citado 2011 Ene 17]. Disponible en: http://www.bruzelius.info/Nautica/Medicine/Lind(1753).html.
Diabetic Retinopathy Study Research Group. Photocoagulation treatment of proliferative diabetic retinopathy. Ophthalmology. 1981; 88:583-600.
Shahr J, Avery RL, Heilweil G, Barak A, Zemel E, Lewis GP, et al. Electrophysiologic and retinal penetration studies following intravitreal injection of bevacizumab. Retina. 2006; 26:262-9.
Avery RL. Regression of retinal and iris neovascularization after intravitreal bevacizumab (Avastin) treatment. Retina. 2006;26:352-4.
Shin YW, Lee YJ, Lee BR, Cho HY. Effects of an Intravitreal Bevacizumab Injection Combined With Panretinal Photocoagulation on High-Risk Proliferative Diabetic Retinopathy. Korean Journal of Ophthalmology 2009; 23:266-72.
Mirshahi A, Roohipoor R, Lashay A, Mohammadi SF, Abdoallahi A, Faghihi H. Bevacizumab-augmented retinal laser photocoagulation in proliferative diabetic retinopathy: A randomized double-masked clinical trial. European Journal of Ophthalmology. 2008; 18(2):263-9.
Mason JO, Nixon PA, White MF. Intravitreal injection of bevacizumab (Avastin) as adjunctive treatment of proliferative diabetic retinopathy. Am J Ophthalmol. 2006; 142(4):685-8.
Gracia D. Fundamentos de Bioética. Madrid, España: Eudema; 1989.
Luna F. Ensayos de bioética, reflexiones desde el sur. México: Distribuciones Fontamara; 2001.
Garduño-Espinosa A, Heshiki-Nakandakari L. Ética de la investigación. En: Garduño-Espinosa A, editor. Temas de pediatría, bioética. Primera edición. México: Asociación Mexicana de Pediatría/McGraw-Hill-Interamericana; 2001. p. 143-8.
Streiner DL, Norman GR. Ethics. En: PDQ Epidemiology. 2da edición. St. Louis, USA: Mosby; 1996. p. 135-47.
Sass HM. La Bioética: Fundamentos filosóficos y aplicación. Washington, DC: OPS-OMS; 1990. p. 18-24.
Galende I. Problemas éticos de la utilización de seres humanos en investigación biomédica. Consecuencias sobre prescripción de medicamentos. Med Clin (Barc). 1993; 101(20):2.
Edelman B. Experimentación en el hombre: una ley sacrificial. Mundo Cient. 1991; 12(130):1042-54.
Orta D, Pascual MA. Bioética desde una perspectiva cubana. La investigación clínica en seres humanos en Cuba. La Habana: Centro "Félix Varela"; 1997. p. 79-86.
Diamond GA, Denton TA. Alternative perspectives on the based foundations of medical technology assessment. Ann Intern Med. 1993;118:455-64.
Alami M. Guía ICH tripartita y armonizada para la buena práctica clínica (BPC). Medicamento.1997;(2):7-27.
Rudy LJ. The CRO of the future. Scrip Magazine; 1996.
Mendoza RMA, Nava ZN, Escalante PMA. Aspectos éticos y legales del consentimiento informado en la práctica e investigación médica. Gac Med Mex. 2003; 139:184-7.
Cortés GG. El consentimiento informado en la investigación clínica. En: Hernández JL, editor. Ética en la investigación biomédica. México: El Manual Moderno; 1999. p. 29-34.
Veatch R. Cross cultural perspectives in medical ethics: readings. Boston: Jones and Bartlett Publishers; 1989. p. 196-8.
Shannon T, DiGiacomo J. An introduction to Bioethics. Nueva York: Paulist Press; 1979. p. 105-10.
American College of Physicians. Cognitively impaired subjects. Ann Intern Med. 1989; 111:843-8.
Levine RJ. Ethics and regulation of clinical research. 2nd ed. Baltimore: Urban and Schwarzenberg; 1986.
Programa de Prevención de la Ceguera. Argentina [Seriada en línea]. 2005. [Citado 2011 Ene 17]. Disponible en: http://www.minsa.gob.pe/portal/03 EstrategiasNacionales/06ESNNoTransmisibles/Archivos/ProgPrevencionCeguera.pdf
Landín M, Romero RE. La ceguera y baja visión en el mundo: ¿un problema médico o social? Rev Hum Med. 2006;6(17):3.
Kempen JH, O'Colmain BJ, Leske MC. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004;122:552-63.
The Diabetic Control and Complications Trial Research Group. Progression of retinopathy with intensive versus conventional treatment in the Diabetes Control and Complications Trial. Ophthalmology 1995;102:647-61.
Resultados del UKPDS. Grupo Diabetes SAMFyC [Seriada en línea]. 1998. [Citado 2011 Ene 24]. Disponible en: http://www.cica.es/~samfyc/ukpds.htm
Emanuele N. Ethnicity, race and baseline retinopathy correlates in the Veterans Affairs Diabetes Trial. Diabetes Care 2005; 28(8):1954-8. Disponible en: http://care.diabetesjournals.org/cgi/content/full/28/8/1954 Consultado Diciembre 12, 2010.
Carmeliet P. Mechanisms of angiogenesis and arteriogenesis. Nat Med. 2000;6:389-95.
Gunther JB, Altaweel MM. Bevacizumab (Avastin) for the Treatment of Ocular Disease. Surv Ophthalmol. 2009; 54:372-400.
Shimura M, Yasuda K, Nakazawa T, Kano T, Ohta S, Tamai M. Quantifying alterations of macular thickness before and after panretinal photocoagulation in patients with severe diabetic retinopathy and good vision. Ophthalmology. 2003; 110:2386-94.
Kroll P, Meyer CH. Which treatment is best for which AMD patient?. Br J Ophthalmol. 2006;90:128-30.
Jansen RM, Gouws C. Clinical, legal and ethical implications of the intra-ocular (off-label) use of bevacizumab (avastin)--a South African perspective. S Afr Med J. 2009;99(6):446-9.
Vázquez R. Del aborto a la clonación. Principios de una bioética liberal. México: Fondo de Cultura Económica; 2004.