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      Aspectos de segurança do tratamento com hrGH Translated title: Safety aspects of treatments with hrGH

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          Abstract

          O tratamento com hormônio de crescimento recombinante humano (hrGH) tem sido realizado há mais de 20 anos, visto que seu perfil de segurança é considerado excelente. Nos principais bancos de dados internacionais, os eventos adversos relatados são raros, principalmente em pacientes com deficiência isolada do hormônio de crescimento e na baixa estatura idiopática. Em relação à associação com risco de malignidade ou de recorrência tumoral, os dados sugerem que não há maior incidência em pacientes em uso de hrGH do que na população geral. A hipertensão intracraniana benigna é rara, porém sua incidência é maior em pacientes com insuficiência renal crônica. Apesar de os eventos adversos serem raros, é importante manter a monitorização cuidadosa dos pacientes em uso do hrGH, principalmente aqueles em uso de doses farmacológicas ou com patologias associadas que confiram maior risco de complicação.

          Translated abstract

          Recombinant human growth hormone (hrGH) has been used for treatment of growth hormone deficient children over 20 years and it can be considered to have an excellent safety profile. The main international surveys show few adverse drug reactions reported, specially in idiopathic growth hormone deficiency and in idiopathic short stature. With regard to cancer risk or tumor recurrence, it seems that there is no greater risk with hrGH treatment in comparison to general population. The idiopathic intracranial hypertension is a rare condition, but its incidence is higher in patients with chronic renal failure. The adverse events are rare in patients treated with hrGH, but these patients should be carefully monitored, specially those with pharmacologycal doses or with another clinical condition of greater risk.

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          Lessons from the national cooperative growth study.

          To review the National Cooperative Growth Study (NCGS), a national post-marketing surveillance program for children treated with biosynthetic growth hormone (GH) products from Genentech. Representative data are presented to summarize the extensive experience of the NCGS. This study is a multicenter, observational surveillance registry begun in 1985 in coordination with the release of the first recombinant DNA biosynthetic GH. After almost 20 years, data from over 47 000 patients representing 165 000 patient years have been collected. There are over 12 000 active subjects (estimated to be approximately 75% of all current patients treated with a Genentech GH product) at 435 centers, providing extensive efficacy and safety data. The GrowTrak program is a secure, user-friendly database which encourages a high level of participation by the pediatric endocrine community in the USA. Efficacy has been shown in a variety of clinical diagnoses, including isolated (IGHD) and organic growth hormone deficiency (OGHD), idiopathic short stature (ISS), and Turner syndrome. Safety monitoring of this large population has provided reassuring evidence that leukemia (de novo or relapse), extracranial nonleukemic neoplasms and central nervous system (CNS) tumor recurrence are not associated with GH therapy. A small risk of intracranial hypertension and slipped capital femoral epiphyses has been suggested, especially in children with renal disease or Turner syndrome. NCGS substudies have also provided important insights into actual clinical practice. For example, screening for renal, cardiac, or auditory comorbidities in Turner syndrome is often done less than is recommended by national guidelines (NCGS 9). Furthermore, almost 65% of children referred for short stature may be lost to follow-up before an evaluation is completed (NCGS 8). The NCGS has proven to be a valuable method of monitoring the safety and efficacy of biosynthetic GH. The study has attracted wide physician participation due to the data collection software used and the extensive sharing of the analyses of that data with the providers.
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            Insulin-like growth factor-I: a key regulator of human cancer risk?

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              Untoward Events in Patients Treated with Growth Hormone in the USA

              Since 1960 more than 30,000 children have been treated with growth hormone (GH) in the USA. Ten cases of Creutzfeldt-Jakob disease have been associated with the use of GH purified from pituitaries in the USA, and more cases may appear in the future. Ten cases of leukemia or preleukemia have been reported in patients undergoing GH treatment in the US. Eight of these patients had previously diagnosed tumors of the central nervous system. As the indications for GH treatment broaden, and the dosages of GH increase, more unfavorable clinical events linked directly to the biological actions of GH can be expected to occur. Continued surveillance for clinically important GH-associated events is important.
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                Author and article information

                Contributors
                Role: ND
                Journal
                abem
                Arquivos Brasileiros de Endocrinologia & Metabologia
                Arq Bras Endocrinol Metab
                Sociedade Brasileira de Endocrinologia e Metabologia (São Paulo )
                1677-9487
                July 2008
                : 52
                : 5
                : 850-853
                Affiliations
                [1 ] Santa Casa de Misericórdia de São Paulo Brazil
                Article
                S0004-27302008000500017
                10.1590/S0004-27302008000500017
                18f01e06-2560-439f-bd09-299c520c82d3

                http://creativecommons.org/licenses/by/4.0/

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                SciELO Brazil

                Self URI (journal page): http://www.scielo.br/scielo.php?script=sci_serial&pid=0004-2730&lng=en
                Categories
                ENDOCRINOLOGY & METABOLISM

                Endocrinology & Diabetes
                Growth hormone,Adverse events,Hormônio do crescimento,Segurança,Eventos adversos

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