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Growth hormone deficiency (GHD) is the most frequent pituitary hormone deficiency in childhood, with an incidence of 1 in 4000–10,000 live births. GHD can be congenital (genetic or due to hypothalamic/pituitary abnormalities) or acquired and can be isolated (IGHD) or associated with other pituitary hormone deficiencies, but most cases are idiopathic. GH stimulation testing is commonly used in the diagnostic workup of GHD, except for some clinical conditions that do not require GH stimulation tests for the diagnosis. Children with GHD receive replacement therapy with daily injections of recombinant human GH (rhGH). RhGH therapy is effective in increasing short-term height gain and adult height in patients with GHD. The safety of long term GH therapy has been confirmed in many large international studies. Recently, long-acting weekly GH formulations have been introduced, showing good efficacy and safety profiles.

Growth hormone deficiency (GHD) is the most frequent pituitary hormone deficiency in childhood, with an incidence of 1 in 4000–10,000 live births. GHD can be congenital (genetic or due to hypothalamic/pituitary abnormalities) or acquired and can be isolated (IGHD) or associated with other pituitary hormone deficiencies, but most cases are idiopathic. GH stimulation testing is commonly used in the diagnostic workup of GHD, except for some clinical conditions that do not require GH stimulation tests for the diagnosis. Children with GHD receive replacement therapy with daily injections of recombinant human GH (rhGH). RhGH therapy is effective in increasing short-term height gain and adult height in patients with GHD. The safety of long term GH therapy has been confirmed in many large international studies. Recently, long-acting weekly GH formulations have been introduced, showing good efficacy and safety profiles. [ABSTRACT FROM AUTHOR]

Growth hormone (GH) is crucial to growth and development. GH secretion is regulated by a complex feedback system involving the pituitary gland, hypothalamus, and other organs, and predominantly occurs during deep sleep. Isolated and idiopathic growth hormone deficiency (GHD) is a condition characterized by GHD without any other signs or symptoms associated with a specific syndrome or disease. The aim of this narrative review was to evaluate the relationship between GH and sleep in children using published data. Various databases (Medline/PubMed, Scopus, and Web of Science) were systematically searched for relevant English language articles published up to April 2023. Search strategies included the terms 'children/pediatric', 'growth hormone', 'growth hormone deficiency' and 'sleep'. Data were extracted by two independent reviewers; 185 papers were identified of which 58 were duplicates and 118 were excluded (unrelated n=83, syndromic/genetic GHD n=17, non-English n=13, abstract n=1, case report n=1). Overall, nine studies (six clinical studies, two case series, and one survey) were included. GHD appears to have an adverse effect on sleep in children, and GH therapy has only been shown to have a beneficial effect on sleep parameters in some individuals. Notably, identified data were limited, old/poor quality, and heterogenous/inconsistent. Further research of GHD in pediatric populations is necessary to improve the understanding of GHD impact on sleep and its underlying mechanisms, and to determine the specific impacts of GH therapy on sleep in children. [ABSTRACT FROM AUTHOR]

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 dualenergy 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. [ABSTRACT FROM AUTHOR]

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

Growth hormone (GH) is crucial to growth and development. GH secretion is regulated by a complex feedback system involving the pituitary gland, hypothalamus, and other organs, and predominantly occurs during deep sleep. Isolated and idiopathic growth hormone deficiency (GHD) is a condition characterized by GHD without any other signs or symptoms associated with a specific syndrome or disease. The aim of this narrative review was to evaluate the relationship between GH and sleep in children using published data. Various databases (Medline/PubMed, Scopus, and Web of Science) were systematically searched for relevant English language articles published up to April 2023. Search strategies included the terms ‘children/pediatric’, ‘growth hormone’, ‘growth hormone deficiency’ and ‘sleep’. Data were extracted by two independent reviewers; 185 papers were identified of which 58 were duplicates and 118 were excluded (unrelated n=83, syndromic/genetic GHD n=17, non-English n=13, abstract n=1, case report n=1). Overall, nine studies (six clinical studies, two case series, and one survey) were included. GHD appears to have an adverse effect on sleep in children, and GH therapy has only been shown to have a beneficial effect on sleep parameters in some individuals. Notably, identified data were limited, old/poor quality, and heterogenous/inconsistent. Further research of GHD in pediatric populations is necessary to improve the understanding of GHD impact on sleep and its underlying mechanisms, and to determine the specific impacts of GH therapy on sleep in children.

Abstract Background Short stature is one of the main causes of children referral to pediatric endocrinologists. Common etiologies include idiopathic growth hormone deficiency (IGHD), small for gestational age (SGA), and idiopathic short stature (ISS). Objectives The aim of this study was to assess and compare the response of children with IGHD, ISS, and SGA to growth hormone (GH) therapy. Methods This was a mixed cohort study that included 40 children with short stature (classified into IGHD, ISS, and SGA) following up at Diabetes, Endocrine, and Metabolism Pediatric Unit (DEMPU), Cairo University Children’s Hospital. Ages ranged between 3 and 18 years. Recruited cases were evaluated for their 1-year response to GH therapy. In addition to history taking, physical examination, and anthropometric measurements, serum levels of IGF-1 were assayed at recruitment. Results Among the 3 groups, height gain (cm/year) was significantly higher in the IGHD group (6.59 cm/year), followed by the ISS (4.63 cm/year) and SGA groups (4.46 cm/year) (p = 0.039). Using the Bang criterion for first-year responsiveness to GH therapy, most cases (30/40, 75%) were considered poor responders. Conclusion There is a male predominance in children seeking medical advice for short stature. Starting GH therapy at an older age was associated with poor response. Children with IGHD respond better to GH therapy than those with ISS and SGA.

Objective: The objective of this study was to describe in a real-life set ting the treatment burden and adherence and quality of life (QOL) of children trea ted with daily injections of growth hormone and their relationship with treatment duration. Design: This non-interventional, multicenter, cross-sectional French study involved children aged 3–17 years treated with daily growth hormone inje ctions. Methods: Based on a recent validated dyad questionnaire, the mean overa ll life interference total score (100 = most interference) was described, with treatment adherence and QOL, using the Quality of Life of Short Stature Y outh questionnaire (100 = best). All analyses were performed according to treatment dura tion prior to inclusion. Results: Among the 275/277 analyzed children, 166 (60.4%) had only grow th hormone deficiency (GHD). In the GHD group, the mean age was 11.7 ± 3.2 years; median treatment duration was 3.3 years (interquartile range 1.8–6.4). The mean overall life interference total score was 27.7 ± 20.7 (95% CI (24.2; 31.2)), with non-significant correlation with treatment duration (P = 0.1925). Treatment adherence was good (95.0% of children reported receiving >80% of planned injections over the last month); it slightly decreased with treatment duration (P = 0.0364). Children’s overall QOL was good (81.5 ± 16.6 and 77.6 ± 18.7 according to children and parents, respe ctively), but subscores of the coping and treatment impact domains were

Background: Turner syndrome (TS) is the commonest chromosomal abnormality in females with an incidence of 25–50 per 100,000 females. Girls with TS universally have short stature (95%), along with gonadal failure (>90%) and infertility (99%); however, the ethnic differences are not well elaborated. Objectives: This study has been planned to evaluate the presentation and course of Indian girls with TS. Methods: Patients with TS presenting to our referral endocrinology clinic were included in this study. Diagnosis of TS was done by karyotyping. A retrospective chart review of these patients formed the basis of this study. Results: A total of 55 patients with TS karyotype were seen, and the mean age at diagnosis was 12.3 years. The commonest presenting features were short stature alone seen in 37 (65.45%) and short stature with delayed puberty in 18 (32.72%). The earliest age at presentation was 4.5 years who presented with short stature. The mean height was 124.17 cm and mean BMI 17.54 kg/m2. The most common karyotype was 45, XO found in 34 (61.6%) of the cases. 15 (27.27%) the cases were started on growth hormone therapy. 26 cases (47.27%) required pubertal induction. Conclusion: A vast number of cases with TS in India remain undiagnosed until puberty or present very late. A high degree of clinical suspicion can help us diagnose these children earlier. If TS is diagnosed earlier, growth can be achieved up to their maximum potential. Early identification and management will help us provide multidisciplinary care and hence prevent complications.

INTRODUCTION: Reports on the association between growth hormone (GH) therapy and cardiovascular risk factors in children are limited. This study aimed to evaluate carotid intima-media thickness (cIMT) in children treated with recombinant human GH (rhGH) and assess the effects of rhGH therapy and changes in serum carbohydrate metabolism, lipid profile and adipocytokines on cIMT. METHODS: Seventy-one isolated idiopathic GH deficiency (GHD) children and 44 age- and sex-matched healthy controls were enrolled in this study. The study group was divided into two subgroups according to insulin resistance (IR) on oral glucose tolerance tests. Insulin secretion [homeostatic model assessment (HOMA) B, total insulin] and sensitivity (HOMA-IR, QUICKI, Matsuda) indices were calculated. cIMT was measured and the standard deviation scores (SDS) were calculated. Associations between cIMT-SDS and insulin secretion and sensitivity indices, serum lipid levels, adipocytokines (leptin, resistin, ghrelin), and other rhGH treatment-related factors were evaluated. RESULTS: cIMT-SDS was increased in GHD children treated with rhGH compared to the controls [0.02 (2.27) vs. -1.01 (1.63), p=0.003]. cIMT-SDS did not differ between those children on rhGH treatment with or without IR. High cIMT-SDS was significantly associated with higher serum ghrelin levels and lower serum high density lipoprotein (HDL) levels (β=0.491, p=0.001 and β=-0.027, p=0.017), but not with BMI-SDS, blood pressure, insulin secretion and sensitivity indices, or the dose and duration of rhGH therapy. DISCUSSION AND CONCLUSION: Our findings showed that GHD children treated with rhGH have increased cIMT. Alterations in carbohydrate metabolism were not associated with cIMT in children treated with rhGH. GH therapy per se appears to be associated with this increased cIMT but causality should be elucidated in further studies. cIMT also appears to be associated with higher ghrelin and lower HDL levels.

Objective: Reports on the association between growth hormone (GH) therapy and cardiovascular risk factors in children are limited. This study aimed to evaluate carotid intima-media thickness (cIMT) in children treated with recombinant human GH (rhGH) and assess the effects of rhGH therapy and changes in serum carbohydrate metabolism, lipid profile and adipocytokines on cIMT. Methods: Seventy-one isolated idiopathic GH deficiency (GHD) children and 44 age- and sex-matched healthy controls were enrolled in this study. The study group was divided into two subgroups according to insulin resistance (IR) on oral glucose tolerance tests. Insulin secretion [homeostatic model assessment (HOMA) B, total insulin] and sensitivity (HOMA-IR, QUICKI, Matsuda) indices were calculated. cIMT was measured and the standard deviation scores (SDS) were calculated. Associations between cIMT-SDS and insulin secretion and sensitivity indices, serum lipid levels, adipocytokines (leptin, resistin, ghrelin), and other rhGH treatment-related factors were evaluated. Results: cIMT-SDS was increased in GHD children treated with rhGH compared to the controls [0.02 (2.27) vs. -1.01 (1.63), p=0.003]. cIMT-SDS did not differ between those children on rhGH treatment with or without IR. High cIMT-SDS was significantly associated with higher serum ghrelin levels and lower serum high density lipoprotein (HDL) levels (ß=0.491, p=0.001 and ß=-0.027, p=0.017), but not with BMI-SDS, blood pressure, insulin secretion and sensitivity indices, or the dose and duration of rhGH therapy. Conclusion: Our findings showed that GHD children treated with rhGH have increased cIMT. Alterations in carbohydrate metabolism were not associated with cIMT in children treated with rhGH. GH therapy per se appears to be associated with this increased cIMT but causality should be elucidated in further studies. cIMT also appears to be associated with higher ghrelin and lower HDL levels. [ABSTRACT FROM AUTHOR]

This article discusses the history and development of human growth hormone (hGH) therapy. It begins by tracing the discovery of growth-promoting substances in the pituitary glands of rats in 1921 and the subsequent extraction of hGH from human pituitary glands in the 1950s. The article then highlights the discontinuation of pituitary-derived hGH due to the risk of Creutzfeldt-Jakob disease in 1985 and the introduction of recombinant hGH (rhGH) through genetic engineering. The use of rhGH has expanded to include various conditions such as GH deficiency, Turner syndrome, and Prader-Willi syndrome. The article also mentions ongoing research on long-acting rhGH formulations that could potentially reduce the frequency of injections. The safety and efficacy of rhGH therapy are emphasized, along with the need for continued surveillance and evaluation of new treatment options. [Extracted from the article]

Turner syndrome (TS) is a genetic disease with an incidence rate of between 1:2000 and 1:5000 live female births. The treatment of TS differs according to age and Recombinant Human Growth Hormone (RHGH) therapy is usually given for the treatment of short stature in girls with TS in childhood. We describe the first case of a TS patient who presented with a clinical picture compatible with oral and palmoplantar lichen planus-like reaction during RHGH therapy; spontaneous remission occurred after therapy suspension.

Background and purpose: Beta thalassemia major is one of the most common inherited blood diseases and patients with this condition require regular blood transfusions. The resulting iron overload deposition causes endocrine gland disorders, including growth hormone (GH) abnormality. In this study, we examined the effects of recombinant growth hormone (rGH) in these patients. Materials and methods: This retrospective study was performed in thalassemia major patients in Amirkola Thalassemia Center, using the medical records (2011-2018), to evaluate the therapeutic effects of rGH on growth velocity of six short stature patients aged 7-15 years (four boys and two girls). On the basis of abnormal or normal response to GH provocation test, the patients were included in GH deficiency (GHD) group (n=3) and idiopathic short stature (ISS) group (n=3), respectively. The data were analyzed in SPSS-18. Results: The mean age of patients was 11.00 ± 2.75 years old. The mean values for growth velocity before and after the treatment were 4.00± 0.86 and 7.83 ± 1.25 cm/year in GHD group (P=0.057) and 4.06 ± 0.81 and 6.00 ± 1.50 cm/year in ISS group, respectively (P=0.023). Conclusion: In this study, the positive therapeutic effects of rGh in improvement of growth velocity were seen in thalassemia major patients (both GHD and ISS groups).

Abstract Background In 2007, Omnitrope® was the first biosimilar recombinant human growth hormone (rhGH) to be approved in Sweden for treatment in adults and children. Over 10 years’ safety and effectiveness data for biosimilar rhGH can now be presented. Methods PATRO Children and PATRO Adults are multicenter, longitudinal, observational, post-marketing surveillance studies. Eligible patients include children 0–18 years and adults receiving biosimilar rhGH treatment. Adverse events (AEs) are monitored for safety evaluation. Growth variables in children and metabolic data in adults are recorded for effectiveness evaluation. Results As of January 2019, data from 136 children (48% male) were reported from Swedish centers. Mean age in rhGH treatment-naïve patients at study entry (n = 114) was 7.5 years, with mean 3.6 years treatment duration. No severe AEs of diabetes, impaired glucose tolerance, or malignancy were reported. The most frequently reported AE was nasopharyngitis (n = 16 patients). No clinically relevant anti-hGH or neutralizing antibodies were observed. The mean change from baseline in height standard deviation score (SDS) in naïve prepubertal GH deficiency patients was + 0.79 at 1 year, + 1.27 at 2 years, and + 1.55 at 3 years. Data from 293 adults (44% rhGH-naïve, 51% male) were included. Fatigue was the most frequently reported AE (n = 26 patients). The incidence of new neoplasms or existing neoplasm progression was 23.8 patients per 1000 patient-years. Type 2 diabetes mellitus was reported in four patients. At baseline in rhGH-naïve adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m2 and mean (SD) insulin-like growth factor (IGF)-I SDS was − 3.0 (1.4). Mean daily dose increased from 0.1 mg at baseline to 0.3 mg after 4 years. IGF-I SDS normalized during the first year of treatment. Mean BMI and glucose were unchanged over 4 years, while low−/high-density lipoprotein cholesterol ratio decreased. Conclusions For the first time, Swedish data from the PATRO Children and Adults studies are presented. The 10-year data suggest that biosimilar rhGH is well tolerated across pediatric and adult indications. Safety and effectiveness were similar to previous reports for other rhGH preparations. These results need to be confirmed in larger cohorts, highlighting the importance of long-term post-marketing studies.

Copyright of Pediatric Endocrinology, Diabetes & Metabolism is the property of Termedia Publishing House and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Abstract Background Human growth is a complex mechanism that depends on genetic, environmental, nutritional and hormonal factors. The main hormone involved in growth at each stage of development is growth hormone (GH) and its mediator, insulin-like growth factor 1 (IGF-1). In contrast, vitamin D is involved in the processes of bone growth and mineralization through the regulation of calcium and phosphorus metabolism. Nevertheless, no scientific study has yet elucidated how they interact with one another, especially as a dysfunction in which one influences the other, even if numerous biochemical and clinical studies confirm the presence of a close relationship. Main body We reviewed and analyzed the clinical studies that have considered the relationship between vitamin D and the GH/IGF-1 axis in pediatric populations. We found two main areas of interest: the vitamin D deficiency status in patients affected by GH deficit (GHD) and the relationship between serum vitamin D metabolites and IGF-1. Although limited by some bias, from the analysis of the studies presented in the scientific literature, it is possible to hypothesize a greater frequency of hypovitaminosis D in the subjects affected by GHD, a reduced possibility of its correction with only substitution treatment with recombinant growth hormone (rGH) and an improvement of IGF-1 levels after supplementation treatment with vitamin D. Conclusions These results could be followed by preventive interventions aimed at reducing the vitamin D deficit in pediatric age. In addition, further research is needed to fully understand how vitamin D and growth are intertwined.

Introduction GHD is a chronic and systemic disease requiring daily replacement of growth hormone (GHRT). Adherence and attitudes of adult GHD patients are not well known. We sought to assess patients' knowledge of growth hormone deficiency (GHD) in association with treatment adherence and attitudes regarding available and upcoming treatment options. Methods We performed a cross-sectional survey with a custom-made questionnaire at a single centre assessing data on demographics, knowledge of GHD, adherence and attitudes towards GHRT. Results Of 106 eligible patients actively followed for GHD 70 returned the completed survey (return-rate 66%, 34 m/36 f; age 56±14 years). 46 patients were actively treated, but almost one third (n=24) refused GHRT. 12 patients had participated in clinical trials with LAGH (long-acting growth hormone). Overall, patients with GHRT showed good adherence. Patients refusing GHRT mostly feared side effects and/or had a lack of information/perceived effect. Disease knowledge and level of education were higher in treated than untreated patients (p=0.023/0.017). Only 36% of respondents would initiate treatment with LAGH. Patients with prior LAGH experience and patients with childhood-onset GHD were more likely to adopt LAGH (p=0.048/0.031). Discussion Most often, misinformation causes patients to refuse GHRT. Possibly the understanding of their condition and consequences of non-treatment is limited. To improve adherence more focused educational and behavioural strategies may be needed. Willingness to begin a therapy with LAGH was lower than expected (36%). The reasons for reluctance against LAGH need to be elucidated. [ABSTRACT FROM AUTHOR]

Background. The purpose was to study the psychological state of children with syndrome of biologically inactive growth hormone (SBIGH) and to evaluate the effect of speci­fic growth­stimulating therapy on improving the psychosocial adaptation of patients in society. Materials and methods. The study involved 46 children with SBIGH during puberty, including 30 boys and 16 girls. To investigate the psychological state of children with SBIGH, the patients were examined on the scale of depression self­esteem prior to the application of specific hormonal growth­stimulating therapy and 6 months after continuous treatment. The control group consisted of 25 healthy children. Results. Our testing showed that 72 % of the respondents with SBIGH had a predisposition to depression, while among healthy children, this index was only 24 %. When the treatment was initiated using recombinant growth hormone and gonadotropin­releasing hormone analogues for 6 consecutive months in children with short stature, and when a higher rate of growth in them was reached, the susceptibi­lity to depression remained only in 27.6 % of patients. Conclusions. Short stature among children with SBIGH results in a lower self­esteem and manifestations of depression. The treatment of children using recombinant growth hormone with motivation for a positive growth effect significantly improves their psychological state and adaptation in society. It is recommended to conduct a questionnaire survey of patients with SBIGH on the scale of depression self­esteem, and in the presence of manifestations of a tendency to depressive state, it is advisable to consult with a medical psychologist or specialist in psychosomatic medicine.

Background. Growth hormone therapy for idio­pathic short stature (ISS) is a subject of debate, because of the heterogeneous endocrine profile in these children. The purpose of this work was to evaluate the effectiveness of mono- (testosterone enanthate) and combined therapy (testosterone enanthate and recombinant growth hormone) in adolescents with idiopathic short stature. Materials and methods. The examined youths of Uzbek population (n = 46) with constitutional delay in growth and puberty aged 14.8–16.2 years were divided into three groups in accordance with the type of treatment. Results. It was found that recombinant growth hormone (somatropin) therapy (0.033 mg/kg/day) in combination with testosterone enanthate (50 mg once eve­ry 21 days) is effective and increases the rate of growth in idiopathic short stature with delayed puberty. Conclusions. Monotherapy with testosterone enanthate at a low dose significantly increases the rate of growth in boys with constitutional delay in growth and puberty, compared with the group without treatment, but is significantly less effective than in the group of combined therapy.

Background and purpose: Beta thalassemia major is one of the most common inherited blood diseases and patients with this condition require regular blood transfusions. The resulting iron overload deposition causes endocrine gland disorders, including growth hormone (GH) abnormality. In this study, we examined the effects of recombinant growth hormone (rGH) in these patients. Materials and methods: This retrospective study was performed in thalassemia major patients in Amirkola Thalassemia Center, using the medical records (2011-2018), to evaluate the therapeutic effects of rGH on growth velocity of six short stature patients aged 7-15 years (four boys and two girls). On the basis of abnormal or normal response to GH provocation test, the patients were included in GH deficiency (GHD) group (n=3) and idiopathic short stature (ISS) group (n=3), respectively. The data were analyzed in SPSS-18. Results: The mean age of patients was 11.00 ± 2.75 years old. The mean values for growth velocity before and after the treatment were 4.00± 0.86 and 7.83 ± 1.25 cm/year in GHD group (P=0.057) and 4.06 ± 0.81 and 6.00 ± 1.50 cm/year in ISS group, respectively (P=0.023). Conclusion: In this study, the positive therapeutic effects of rGh in improvement of growth velocity were seen in thalassemia major patients (both GHD and ISS groups). [ABSTRACT FROM AUTHOR]

Background: In 2007, Omnitrope® was the first biosimilar recombinant human growth hormone (rhGH) to be approved in Sweden for treatment in adults and children. Over 10 years' safety and effectiveness data for biosimilar rhGH can now be presented. Methods: PATRO Children and PATRO Adults are multicenter, longitudinal, observational, post-marketing surveillance studies. Eligible patients include children 0–18 years and adults receiving biosimilar rhGH treatment. Adverse events (AEs) are monitored for safety evaluation. Growth variables in children and metabolic data in adults are recorded for effectiveness evaluation. Results: As of January 2019, data from 136 children (48% male) were reported from Swedish centers. Mean age in rhGH treatment-naïve patients at study entry (n = 114) was 7.5 years, with mean 3.6 years treatment duration. No severe AEs of diabetes, impaired glucose tolerance, or malignancy were reported. The most frequently reported AE was nasopharyngitis (n = 16 patients). No clinically relevant anti-hGH or neutralizing antibodies were observed. The mean change from baseline in height standard deviation score (SDS) in naïve prepubertal GH deficiency patients was + 0.79 at 1 year, + 1.27 at 2 years, and + 1.55 at 3 years. Data from 293 adults (44% rhGH-naïve, 51% male) were included. Fatigue was the most frequently reported AE (n = 26 patients). The incidence of new neoplasms or existing neoplasm progression was 23.8 patients per 1000 patient-years. Type 2 diabetes mellitus was reported in four patients. At baseline in rhGH-naïve adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m2 and mean (SD) insulin-like growth factor (IGF)-I SDS was − 3.0 (1.4). Mean daily dose increased from 0.1 mg at baseline to 0.3 mg after 4 years. IGF-I SDS normalized during the first year of treatment. Mean BMI and glucose were unchanged over 4 years, while low−/high-density lipoprotein cholesterol ratio decreased. Conclusions: For the first time, Swedish data from the PATRO Children and Adults studies are presented. The 10-year data suggest that biosimilar rhGH is well tolerated across pediatric and adult indications. Safety and effectiveness were similar to previous reports for other rhGH preparations. These results need to be confirmed in larger cohorts, highlighting the importance of long-term post-marketing studies. [ABSTRACT FROM AUTHOR]

Stable isotope (18O/16O and 13C/12C) and minor-element compositions (Sr/Ca and Mg/Ca ratios) of ostracodes and gastropods separated from marsh sediments from San Francisco Bay, Northern California, were used to reconstruct paleoenvironmental changes in Petaluma Marsh over the past 700 yr. The value of d18O in the marsh carbonates reflects changes in freshwater inflow, evaporation, and temperature. Mg/Ca and Sr/Ca in ostracode calcite reflect changes in both freshwater inflow and temperature, although primarily reflect temperature changes in the salinity range of about 10-35 o/oo. Ostracode d18O values show a gradual increase by 5 o/oo between 500 yr BR and the present, probably reflecting rising sea level and increased evaporation in the marsh. Superimposed on this trend are higher frequency Mg/Ca and d18O variations (3-4 o/oo), probably reflecting changes in freshwater inflow and evaporation. A period of low Mg/Ca occurred between about 100-300 cal yr BR, suggesting wetter and cooler conditions during the Little Ice Age. Higher Mg/Ca ratios occurred 600-700 cal yr BR, indicating drier and warmer conditions during the end of the Medieval Warm Period. Both ostracode and gastropod d13C values decrease up-core, reflecting decomposition of marsh vegetation, which changes from C4 (d13C ~; -12 o/oo) to CAM (d13C = -26 o/oo)-type vegetation over time.

One of the most important parameters of health in children is growth. Stunted growth leads to the development of inferiority complex in patients and often hampers social self-realization. Over the past two decades, the Republic of Tatarstan has been actively diagnosing and treating growth hormone deficiency in children with short stature. Children with isolated growth hormone deficiency receive monotherapy with recombinant growth hormone. Early treatment of children with growth hormone deficiency led to an improvement in anthropometric parameters and, consequently, psychological and social adaptation of this group of patients.

The biological activity of Persian sturgeon (PS) enfolded crude recombinant growth hormone (rGH) recovered from inclusion bodies (IB) estimated by administrating to fish fingerlings. The psrGH IBs expressed in E. coli were dissolved in cold guanidine HCl solution, immediately diluted ~1000 fold in cold sodium chloride 0.9% solution do not allow the rGH folding and administrated to fishes. It was revealed that intramuscularly injections of rGH at dosage of 0.5 μg/ g once a week for 8 weeks significantly accelerate the growth of fishes. Comparison of the mean growth rate and daily weight and length gain dates of Persian sturgeon fingerlings administrated by pure and crude grade rGH revealed the existence at list 2-5% potentially biologically active psrGH molecules in IBs. This fact enables to avoid the time and cost consuming processes of refolding and purification of rGHs.

Recombinant growth hormone (GH) is administered as daily subcutaneous injections. Daily treatment can be challenging for children/adolescents as well as for parents and/or caregivers (legal representatives, guardians of children in institutional care). Challenges associated with daily treatment may result in missing several doses and non-adherence with treatment leads to inadequate growth response. As an inadequate growth response does not meet criteria for continuing treatment, payers (commercial or public) may decide to end reimbursement. Novel long-acting GH formulations (LAGH) with extended half-life can be administered less frequently and target to improve patient convenience and consequently to improve adherence and responses to treatment. LAGH formulations can restore growth velocity and body composition as effectively as daily treatment, without unexpected adverse effects as reported in randomized clinical trials.

Growth hormone (GH) regulates metabolic processes, modulates the growth of the body, stimulates cell proliferation and differentiation. Human recombinant growth hormone is administered in growth disorders related to GH deficiency, wound treatment, as well as, contrary to the recommendations, in aesthetic medicine. GH and IGF affect skin homeostasis, primarily through the influence on the dermis and synthesis of collagen fibers but also on the epidermis and appendages of the skin. GH and IGF have also been shown to be involved in the pathogenesis of skin lesions and diseases, primarily of the proliferative basis. Particular attention is paid to the proven positive effects of GH, IGF-I and IGF-II on the healing process, including wound healing. The work outlines the effects of GH i rhGH on skin processes, skin diseases, chronic wound healing, the occurrence and dysplasia of melanocytic nevi and also describes the role of GH in melanoma pathogenesis and metastasis. [ABSTRACT FROM AUTHOR]

Copyright of International Journal of Endocrinology / Mìžnarodnij Endokrinologìčnij Žurnal is the property of Zaslavsky O.Yu and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

An increase in growth rates of children suffering from growth hormone deficiency (GHD) subjected to recombinant growth hormone treatment (rGHT) was shown to be accompanied by acceleration of metabolic processes that may stimulate oxygen consumption in various organs and tissues. Therefore, oxygen-transporting properties of RBC should undergo considerable changes during the rGHT. The aim of this study was to examine the effects of rGHT on erythrocyte shape and hemoglobin state in GHD children. The level of oxyhemoglobin (Oxy-Hb) in RBC was analyzed by Raman spectroscopy. The RBC count, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV) and other parameters were calculated. The blood of eleven treatment-naive prepubertal children with GHD (aged 3–9, median 5.7 years) was examined and compared with control group (aged 5–7; median 6.0 years) at three time points: 0, 3 and 12 months of rGHT. Before rGHT, the MI in GHD children was higher (median 0.48 vs 0.14 p = 0.0018) and the RBC count was lower (median 4.20 vs 4.96 10 12 cells/L p = 0.0022) than in control group. After the treatment, cell count in GHD patients did not differ significantly from the control group, but Oxy-Hb level became higher (median 0.64 vs 0.41 p = 0.0075). During rGHT, MCV decreased (median 80.3 vs 83.2 μm 3 p = 0.0231). Morphological and functional characteristics of erythrocytes in GHD children were shown to differ significantly from the healthy control group. A twelve-month rGHT partially improved some of the studied parameters but Oxy-Hb level and echinocyte count remained high. [ABSTRACT FROM AUTHOR]

Copyright of International Journal of Endocrinology / Mìžnarodnij Endokrinologìčnij Žurnal is the property of Zaslavsky O.Yu and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: It is thought that growth hormone (GH) therapy success depends on the patient's adherence to their treatment regimen, but an optimal approach to improve adherence has not yet been established. Methods: To evaluate the effect of patient choice of a GH device on adherence to GH therapy, we carried out a retrospective longitudinal study of 46 GH deficient patients (24 boys, mean age of commencing GH therapy: 7.70 ± 3.12 years) treated with recombinant GH therapy for 3 years, either with or without patient choice (n = 28, 18, respectively). Results: The group comparison study for adherence, which evaluated the frequency of missed injections based on self-report, revealed that patient choice reduced the proportion of patients with low adherence 3 years after commencing GH therapy (33.3%--7.1%, p = 0.042). Furthermore, this longitudinal study revealed that the patients with choice yielded significantly greater height standard deviation scores (SDS) (ΔHt SDS: 1.34 ± 0.44 vs. 0.92 ± 0.57, p = 0.020) and insulin-like growth factor 1 (IGF-1) SDS (ΔIGF-1 SDS: 2.49 ± 0.75 vs. 1.89 ± 1.13, p = 0.038) than those without choice. Conclusions: These results indicate that patient choice might improve adherence to GH therapy, which improves the therapeutic effects of GH therapy. [ABSTRACT FROM AUTHOR]

Humpback grouper take a long time to grow to marketable size. In this study, recombinant Epinephelus lanceolatus growth hormone (rElGH) was applied orally and by intraperitoneal injection to accelerate their growth. Daily application of crude rElGH at a dose of 50 mg kg−1 in commercial diet for 42 days or with injections of 0.2 μg rElGH g−1 total body weight every 2 weeks resulted in significant increases in growth performance, protein and lipid content, plasma glucose, liver glycogen and innate immunity compared to control groups. Relative weight gain from the oral and injection doses above compared to C− (Control negative, only commercial diet without rElGH treatment or chemical substances related to treatment, either for oral or injection route) were 40.25% and 38.77%, respectively. There was no specific histological damage to the kidneys, liver or spleen that was attributable to rElGH administration. These results strongly suggested that the stimulation of growth and immunity following oral and intraperitoneal administration was due to a specific action of rElGH and that recombinant GH is safe for fish consumption. [ABSTRACT FROM AUTHOR]