Safety of recombinant deoxyribonucleic acid-derived growth hormone: The National Cooperative Growth Study experience.
Identifieur interne : 005186 ( PubMed/Curation ); précédent : 005185; suivant : 005187Safety of recombinant deoxyribonucleic acid-derived growth hormone: The National Cooperative Growth Study experience.
Auteurs : S L Blethen [États-Unis] ; D B Allen ; D. Graves ; G. August ; T. Moshang ; R. RosenfeldSource :
- The Journal of clinical endocrinology and metabolism [ 0021-972X ] ; 1996.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Enfant, Femelle, Gynécomastie (), Hormone de croissance (déficit), Hormone de croissance (effets indésirables), Hormone de croissance (usage thérapeutique), Humains, Leucémies (), Lymphoedème (), Mâle, Naevus (anatomopathologie), Oedème (), Protéines recombinantes (effets indésirables), Protéines recombinantes (usage thérapeutique), Récidive, Syndrome d'hypertension intracrânienne bénigne (), Syndrome du canal carpien (), Tumeurs ().
- MESH :
- anatomopathologie : Naevus.
- déficit : Hormone de croissance.
- effets indésirables : Hormone de croissance, Protéines recombinantes.
- usage thérapeutique : Hormone de croissance, Protéines recombinantes.
- Adolescent, Adulte, Enfant, Femelle, Gynécomastie, Humains, Leucémies, Lymphoedème, Mâle, Oedème, Récidive, Syndrome d'hypertension intracrânienne bénigne, Syndrome du canal carpien, Tumeurs.
English descriptors
- KwdEn :
- Adolescent, Adult, Carpal Tunnel Syndrome (chemically induced), Child, Edema (chemically induced), Female, Growth Hormone (adverse effects), Growth Hormone (deficiency), Growth Hormone (therapeutic use), Gynecomastia (chemically induced), Humans, Leukemia (chemically induced), Lymphedema (chemically induced), Male, Neoplasms (chemically induced), Nevus (pathology), Pseudotumor Cerebri (chemically induced), Recombinant Proteins (adverse effects), Recombinant Proteins (therapeutic use), Recurrence.
- MESH :
- chemical , adverse effects : Growth Hormone, Recombinant Proteins.
- chemically induced : Carpal Tunnel Syndrome, Edema, Gynecomastia, Leukemia, Lymphedema, Neoplasms, Pseudotumor Cerebri.
- chemical , deficiency : Growth Hormone.
- pathology : Nevus.
- chemical , therapeutic use : Growth Hormone, Recombinant Proteins.
- Adolescent, Adult, Child, Female, Humans, Male, Recurrence.
Abstract
The National Cooperative Growth Study has monitored the safety of recombinant human GH (rhGH) since 1985. Data have been collected from more than 19,000 children representing over 47,000 patient-years of rhGH treatment. Children receiving GH for renal disease were more likely to develop problems such as intracranial hypertension than those with GH deficiency (P < 0.01). Children with idiopathic short stature were less likely to develop slipped capital femoral epiphysis than those with GH deficiency or Turner's syndrome (P < 0.01). There was no evidence of an increased recurrence of leukemia or central nervous system tumors. There were 3 new cases of leukemia in children without known risk factors for developing leukemia and 5 cases in children with known risk factors. Growth deceleration associated with high affinity, high capacity antibodies to GH was found in only 2 of 5039 subjects tested (0.04%). Major adverse events in association with rhGH treatment have been rare, and preexisting medical conditions such as renal insufficiency may affect their frequency.
DOI: 10.1210/jcem.81.5.8626820
PubMed: 8626820
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pubmed:8626820Le document en format XML
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<term>Edema (chemically induced)</term>
<term>Female</term>
<term>Growth Hormone (adverse effects)</term>
<term>Growth Hormone (deficiency)</term>
<term>Growth Hormone (therapeutic use)</term>
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<term>Protéines recombinantes (effets indésirables)</term>
<term>Protéines recombinantes (usage thérapeutique)</term>
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<term>Syndrome du canal carpien ()</term>
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<term>Pseudotumor Cerebri</term>
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<term>Protéines recombinantes</term>
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<term>Oedème</term>
<term>Récidive</term>
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<front><div type="abstract" xml:lang="en">The National Cooperative Growth Study has monitored the safety of recombinant human GH (rhGH) since 1985. Data have been collected from more than 19,000 children representing over 47,000 patient-years of rhGH treatment. Children receiving GH for renal disease were more likely to develop problems such as intracranial hypertension than those with GH deficiency (P < 0.01). Children with idiopathic short stature were less likely to develop slipped capital femoral epiphysis than those with GH deficiency or Turner's syndrome (P < 0.01). There was no evidence of an increased recurrence of leukemia or central nervous system tumors. There were 3 new cases of leukemia in children without known risk factors for developing leukemia and 5 cases in children with known risk factors. Growth deceleration associated with high affinity, high capacity antibodies to GH was found in only 2 of 5039 subjects tested (0.04%). Major adverse events in association with rhGH treatment have been rare, and preexisting medical conditions such as renal insufficiency may affect their frequency.</div>
</front>
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<Abstract><AbstractText>The National Cooperative Growth Study has monitored the safety of recombinant human GH (rhGH) since 1985. Data have been collected from more than 19,000 children representing over 47,000 patient-years of rhGH treatment. Children receiving GH for renal disease were more likely to develop problems such as intracranial hypertension than those with GH deficiency (P < 0.01). Children with idiopathic short stature were less likely to develop slipped capital femoral epiphysis than those with GH deficiency or Turner's syndrome (P < 0.01). There was no evidence of an increased recurrence of leukemia or central nervous system tumors. There were 3 new cases of leukemia in children without known risk factors for developing leukemia and 5 cases in children with known risk factors. Growth deceleration associated with high affinity, high capacity antibodies to GH was found in only 2 of 5039 subjects tested (0.04%). Major adverse events in association with rhGH treatment have been rare, and preexisting medical conditions such as renal insufficiency may affect their frequency.</AbstractText>
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