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ABSTRACT Objective: To assess the effect of recombinant growth hormone (rGH) on body composition and metabolic profile of prepubertal short children born small for gestational age (SGA) before and after 18 months of treatment. Methods: It is a clinical, non-randomized, and paired study. Children born SGA, with birth weight and/or length <-2 standard deviations (SD) for gestational age and sex, prepubertal, born at full term, of both genders, with the indication for treatment with rGH were included. The intervention was performed with biosynthetic rGH at doses ranging from 0.03 to 0.05 mg/kg/day, administered subcutaneously, once a day at bedtime. Total lean mass (LM) and total fat mass (FM) were carried out using dual-energy X-ray absorptiometry (DXA), and the metabolic profile was assessed for insulin, glycemia, IGF-1 levels and lipid profile. Results: Twelve patients (nine girls, 8.17±2.39 y) were evaluated; three patients dropped out of the study. There was an increase of LM adjusted for length (LMI) (p=0.008), LMI standard deviation score (SDS) adjusted for age and sex (p=0.007), and total LM (p<0.001). The percentage of body fat (BF%) and abdominal fat (AF) remained unaltered in relation to the beginning of treatment. Among the metabolic variables, blood glucose remained within normal levels, and there was a reduction in the number of participants with altered cholesterol (p=0.023). Conclusions: The effect of rGH treatment was higher on LM than in FM, with increased LM adjusted for length and standardized for age and sex. Glycemia remained within the normal limits, and there was a decreased number of children with total cholesterol above the recommended levels.
RESUMO Objetivo: Avaliar o efeito do hormônio de crescimento recombinante (rHC) na composição corporal e no perfil metabólico de crianças pré-púberes com baixa estatura, nascidas pequenas para a idade gestacional (PIG) antes e depois de 18 meses de tratamento. Métodos: Estudo clínico, não randomizado e pareado. Foram incluídas crianças nascidas PIG, com peso e/ou altura ao nascer <-2 desvios padrão (DP) para idade gestacional e sexo, pré-púberes, nascidas a termo, de ambos os sexos, com indicação de tratamento com rGH. A intervenção foi realizada com rGH biossintético com doses variando de 0,03 a 0,05 mg/kg/dia, administrado por via subcutânea, uma vez ao dia ao deitar-se. A massa magra total (LM) e a massa gorda total (MG) foram determinadas por meio de absorciometria de raios X de dupla energia (DXA), e o perfil metabólico foi avaliado com dosagens de insulina, glicemia, IGF-1 e perfil lipídico. Resultados: Doze pacientes (nove meninas, 8,17±2,39 anos) foram avaliados; três pacientes abandonaram o estudo. Houve aumento da LM ajustada para estatura (LMI) (p=0,008), LMI standard deviation scores (SDS) ajustada para idade e sexo (p=0,007) e LM total (p<0,001). O percentual de gordura corporal (GC%) e gordura abdominal (AF) permaneceu inalterado em relação ao início do tratamento. Entre as variáveis metabólicas, a glicemia manteve-se na normalidade, e houve redução do número de participantes com colesterol alterado (p=0,023). Conclusões: O efeito do tratamento com HCr foi maior na MM do que na MG, com o aumento da MM ajustada para altura e padronizada para idade e sexo. A glicemia permaneceu normal e houve redução do número de crianças com colesterol total acima do recomendado.
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Objective To investigate the immune protective effect of recombinant growth hormone on chronic obstructive pulmonary disease ( COPD) patients with typeⅡin respiratory failure during the application of ventilator.Methods 52 patients with COPD with respiratory failure in Taizhou City Hospital from July 2014 to November 2015 in this study who were treated with ventilator therapy were divided into two groups.The control group received routine treatment, and the treatment group received more with recombinant growth hormone 8 U/d subcutaneous injected.Before and after treatment 14 days,determination of nutritional indicators,immune function,inflammatory markers and indicators of oxidative stress.Results Compared with before treatment,levels of total protein,albumin,transferrin and fibronectin in 2 groups after treatment increased,levels of IgM,IgG,CD4 +,CD8 +and CD4 +/CD8 +increased,levels of TNF-α,IL-8 and CRP decreased,levels of MDA,GSH and TAO decreased,levels of SOD increased(P<0.05), compared with the control group,levels of total protein,albumin,transferrin and fibronectin in the treatment group were higher,levels of IgM,IgG,CD4 +, CD8 +and CD4 +/CD8 +were higher,levels of TNF-α,IL-8 and CRP were lower,levels of MDA,GSH and TAO were lower,levels of SOD were higher (P<0.05).Conclusion Recombinant growth hormone has immune function protective effect on the COPD patients with type II respiratory failure in the process of breathing machine, which can improve the nutritional index and reduce the inflammatory reaction.
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OBJETIVO: Identificar preditores clínicos associados à recuperação do crescimento no primeiro ano de tratamento com somatropina (rhGH) em um grupo de crianças nascidas pequenas para a idade gestacional (PIG). SUJEITOS E MÉTODOS: Foram avaliadas 39 crianças que estavam em terapia com rhGH por pelo menos um ano (0,33 mg/kg/semana). As variáveis analisadas foram idade cronológica (IC), idade óssea (IO), altura-alvo e escores de desvios-padrão (Z-escore) do peso e comprimento ao nascer, altura, peso e velocidade de crescimento pré e pós-rhGH. RESULTADOS: A terapia com rhGH foi associada a incremento significativo de 0,67 Z-escore (p < 0,01) na estatura nesse primeiro ano. IO e Z-escore de peso ao nascimento foram reconhecidos como preditores dessa resposta, com diferença significativa na variação do Z-escore de estatura entre pré-púberes e púberes (p = 0,016). CONCLUSÃO: Esses dados mostram ganho estatural significativo com dose fixa de rhGH, observando-se melhores resultados quando a terapia foi iniciada na fase pré-puberal.
OBJECTIVE: To identify clinical predictors associated with catch-up growth in the first year of treatment with somatropin (rhGH) in a group of children born small for gestational age (SGA). SUBJECTS AND METHODS: Thirty nine children who have been on rhGH therapy for at least one year (0.33 mg/kg/week) were evaluated. The clinical parameters analyzed were chronological age (CA), bone age (BA), target height and standard deviations scores (SDS) of birth weight and length, height, weight and growth rate. RESULTS: rhGH therapy was associated with a first year height increment of 0.67 SDS (p < 0.01). BA and birth weight SDS were predictive of growth response, with statistical difference in height SDS variation between prepubertal and pubertal subgroups (p = 0.016). CONCLUSION: These data show a significant growth response with a fixed rhGH dose, those children who started rhGH in prepubertal ages presented the best outcomes.
Subject(s)
Adolescent , Child , Child, Preschool , Female , Humans , Infant, Newborn , Male , Body Height/drug effects , Growth Disorders/drug therapy , Human Growth Hormone/therapeutic use , Infant, Small for Gestational Age/growth & development , Cohort Studies , Predictive Value of Tests , Retrospective Studies , Recombinant Proteins/therapeutic use , Treatment OutcomeABSTRACT
Effectiveness of recombinant human growth hormone ( rhGH) in treating critically ill or severe burned patients have been demonstrated. Although adverse effects of rhGH have also been identified, they are controllable. The dosage and timing of rhGH must be well designed, and hyperglycemia be controlled. Application of rhGH in critically ill patients should be deliberately considered.
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PURPOSE: From a societal perspective, we evaluated the cost-effectiveness of a novel sustained-release injection of recombinant human growth hormone (GH) administered on a weekly basis compared with that of the present daily GH injection for the treatment of children with GH deficiency. METHODS: Health-related utility for GH therapy was measured based on the visual analogue scale. During July 2008, caregivers of 149 children receiving GH therapy form 2 study sites participated in a web-based questionnaire survey. The survey required the caregivers to rate their current subjective utility with daily GH injections or expected utility of weekly GH injections. Because there was no difference in the costs of the daily and weekly therapies, for the purposes of this study, only drug acquisition costs were considered. RESULTS: Switching from daily to weekly injection of GH increased the utility from 0.584 to 0.784 and incurred an extra cost of 4,060,811 Korean won (KW) per year. The incremental cost-utility ratio (ICUR) for a base case was 20,305,055 KW per quality-adjusted life year (QALY) gained. Scenario analyses showed that the ICUR ranged from 15,751,198 to 25,489,929 KW per QALY. CONCLUSION: The ICUR for a base case and worst case scenario analyses ranged from 0.85 to 1.37-times per capita gross domestic product of Korea, which is considered to be within the generally accepted willingness-to-pay threshold. Thus, it is concluded that switching from daily to weekly injection of GH would be cost-effective.
Subject(s)
Child , Humans , Caregivers , Cost-Benefit Analysis , Gross Domestic Product , Growth Hormone , Human Growth Hormone , Korea , Quality of Life , Quality-Adjusted Life Years , Surveys and QuestionnairesABSTRACT
PURPOSE: From a societal perspective, we evaluated the cost-effectiveness of a novel sustained-release injection of recombinant human growth hormone (GH) administered on a weekly basis compared with that of the present daily GH injection for the treatment of children with GH deficiency. METHODS: Health-related utility for GH therapy was measured based on the visual analogue scale. During July 2008, caregivers of 149 children receiving GH therapy form 2 study sites participated in a web-based questionnaire survey. The survey required the caregivers to rate their current subjective utility with daily GH injections or expected utility of weekly GH injections. Because there was no difference in the costs of the daily and weekly therapies, for the purposes of this study, only drug acquisition costs were considered. RESULTS: Switching from daily to weekly injection of GH increased the utility from 0.584 to 0.784 and incurred an extra cost of 4,060,811 Korean won (KW) per year. The incremental cost-utility ratio (ICUR) for a base case was 20,305,055 KW per quality-adjusted life year (QALY) gained. Scenario analyses showed that the ICUR ranged from 15,751,198 to 25,489,929 KW per QALY. CONCLUSION: The ICUR for a base case and worst case scenario analyses ranged from 0.85 to 1.37-times per capita gross domestic product of Korea, which is considered to be within the generally accepted willingness-to-pay threshold. Thus, it is concluded that switching from daily to weekly injection of GH would be cost-effective.
Subject(s)
Child , Humans , Caregivers , Cost-Benefit Analysis , Gross Domestic Product , Growth Hormone , Human Growth Hormone , Korea , Quality of Life , Quality-Adjusted Life Years , Surveys and QuestionnairesABSTRACT
Background:Eutropin is a recombinant human growth hormone preparation and has been used in patients with growth hormone deficiency. Short stature is a characteristic feature of Turner syndrome, which is caused by sexual chromosomal anomalies. Growth hormone therapy would increase growth velocity and increase the ultimate final height in patients with Turner syndrome. The purpose of this study was to evaluate the clinical effects and safety in patients with Turner syndrome with Eutropin treatment. Subjects and METHODS:60 patients with Turner syndrome,who were diagnosed by chromosome study,were treated with Eutropin 1IU/kg/week for 12 months and followed up every 3 month. The height and weight were evaluate at 0, 3, 6, 9, 12 months. A complete blood count, ESR, urinary analysis and chemistry studies were done every 3 month. IGF- I , T4, TSH & anti-GH antibody were measured at 6 months and 12 months. Chest X-ray was checked at 0, 6 ,12 months. RESULTS:60 patients were enrolled but 10 patients were lost or treated irregularly and excluded in the study of growth effect. but included all cases in safety analysis. At the onset of Eutropin therapy,their mean age was 10.8+/-2.9 years old(range 4.2- 14.9yr)and the height was 121.1+/-13.7cm(-3.1+/-0.9 SDS) and yearly growth velociy was 3.4+/-1.5cm. Their weight was 30.5+/-10.6kg and bone age 9.1+/-3.0 yrs. After Eutropin treatment, mean height was increased to 123.2+/-13.5cm at 3 months, 125.2+/-13.1cm at 6 months, 127.5+/-12.4cm at 9 months, 128.3+/-12.8cm at 12 months. Height velocity were increased to 8.3+/-3.1cm at 3 months, 8.1+/-2.6cm at 6 months, 7.6+/-1.9cm at 9 months and 7.1+/-1.9cm at 12 months(P0.001).Their bone age were 9.1+/-3.0yr, 9.6+/-2.9yr, 10.2+/-2.7yr before and 6 & 12 months after treatment respectively. HA/BA were 0.84+/-0.15, 0.87+/-0.13, 0.88+/-0.12 at before and 6 & 12 months after treatment respectively(P<0.05). Growth velocity of 4-8 yrs group was most prominent compared to other groups. Serum IGF- I concentration was increased from 167.4+/-85.8ng/ml to 368.4+/-158.1ng/ml at 6 months and 423.2+/-181.0ng/ml at 12 month(P<0.001) after treatment. No significant changes were observed in thyroid function, CBC, ESR, Blood chemistry and urinalysis. Anti-hGH antibody were positive in 2 patients, but these didnot attenualte the growth velocity. CONCLUSION: Treatment with Eutropin increased significantly height velocity in patients with Turner syndrome. No specific adverse events were observed during Eutropin therapy.
Subject(s)
Humans , Blood Cell Count , Chemistry , Growth Hormone , Human Growth Hormone , Thorax , Thyroid Gland , Turner Syndrome , UrinalysisABSTRACT
Objectives: To research the effects of recombinant human growth hormone(rhGH) with total parenteral nutrition(TPN) on the old patients following abdominal surgery. Methods: 26 old patients receiving TPN after major abdominal surgery were selected and distributed to study group(rhGH+TPN, n =13) and control group(TPN only, n =13).For 7 days after operation, rhGH (8 U/d) or normal saline(in control group) were used. The patients' weight, serum albumin, right hand grip, sleep time and the time of incision cicatrized were determined. Results: The increase of weight, level of plasma albumin, grip power of right hand and sleep time were improved more in study group than those in control group. The incision cicatrized time was also shortened in study group. Conclusions: Growth hormone can promote protein synthesis, accelerate incision healing and reduce the postoperative fatigue syndrome.
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Sine the success of human growth hormone (GH) synthesis by DNA recombinant technology, these GH products are widely used in the treatment of children with growth hormone deficiency. Recently, methionyl-GH has been produced in the yeast, Saccaromyces cerevisiae 2150, by the use of a DNA recombinant method in Korea. The purpose of this study was to investigate the clinical efficacy, side effect and immunogenicity of this GH product during therapy of 3year in 22 children with naive GH deficiency. The subjects of this study are aged 4.5~17.9 years, diagnosed by the failure of plasma GH to respond to insulin induced hypoglycemia, arginine and/or clonidine loading and height below -2 standard deviation of mean for their chronological age. Each subjcct received GH 0.45IU/kg/week, intramusculary in 3 devided dose, During treatment, vital signs, height and body weight checked before and every 3 months. Blood count urinalysis, blood chemistry, bone age and measurement of thyroid hormone were performed before, every 3months in year 1, and every 6 months in year 2 and 3. Assay of antibody against GH were performed before, year 1,2 and 3. The height velocity was significantly increased from an average baseline level of 2.9+/-1.1cm/year to 7.9+/-1.9cm/year after the first year, 6.6+/-1.1cm/year during the second year, and 5.9+/-1.2cm/year during the third year of GH treatment. The height standard deviation score for chronological age was decreased from an average baseline of 3.5+/-1.3 to 2.9 1.2 after the first year, 2.7 +/-1.1 during the second year, and 2.5+/-1.2 during the year of GH treatment. The increment in height age was significantly increased from an average baseline of 0.6+/-0.2 year to 1.3+/-0.3 year in year 1, 1.1+/-0.3 year in year 2, and 1.0+/-0.2 year in year 3. The increment in bone age was significantly increased from an average baseline of 0.6+/-0.2 year to 1.2+/-0.2 in year 1, 1.3+/-0.3 year in year , 2, and 1.1+/-0.3 year in year 3. Antibody against hGH was observed in 3 of the 22 patients(13.5%) in year 1 and 1 and in 2 of the 17 patients(17.7%) in year 3. And unwanted side effects were not observed in any of the 22 patients. These results suggest that this yeast derived recombinant methionyl growth hormone appears to be a safe very effective product for treating of children with GH deficiency.
Subject(s)
Child , Humans , Arginine , Body Weight , Chemistry , Clonidine , DNA , Growth Hormone , Human Growth Hormone , Hypoglycemia , Insulin , Korea , Plasma , Thyroid Gland , Urinalysis , Vital Signs , YeastsABSTRACT
No abstract available.