Background Recombinant human GH(rhGH)was first approved to treat children with growth hormone deficiency(GHD)by Food and Drug Administration(FDA)in the United States in 1985.The indications subsequently expanded to gr...Background Recombinant human GH(rhGH)was first approved to treat children with growth hormone deficiency(GHD)by Food and Drug Administration(FDA)in the United States in 1985.The indications subsequently expanded to growth failure secondary to chronic renal failure,Turner syndrome,Prader‒Willi syndrome,small for gestational age(SGA)without catch-up growth,idiopathic short stature(ISS),SHOX deficiency,Noonan syndrome and so on[1].The efficacy and the safety of rhGH have been proven in randomized controlled trials(RCTs),which are considered the highest level of evidences in clinical practice.However,due to the strict criteria and short observational time,RCTs could not fully reflect the reality of rhGH,especially in terms of safety[2].展开更多
文摘Background Recombinant human GH(rhGH)was first approved to treat children with growth hormone deficiency(GHD)by Food and Drug Administration(FDA)in the United States in 1985.The indications subsequently expanded to growth failure secondary to chronic renal failure,Turner syndrome,Prader‒Willi syndrome,small for gestational age(SGA)without catch-up growth,idiopathic short stature(ISS),SHOX deficiency,Noonan syndrome and so on[1].The efficacy and the safety of rhGH have been proven in randomized controlled trials(RCTs),which are considered the highest level of evidences in clinical practice.However,due to the strict criteria and short observational time,RCTs could not fully reflect the reality of rhGH,especially in terms of safety[2].
