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Background: In 2007, Omnitrope (R) 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-naive 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 naive 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-naive, 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-naive adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m(2) 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

Background: In 2007, Omnitrope (R) 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-naive 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 naive 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-naive, 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-naive adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m(2) 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

Background: In 2007, Omnitrope (R) 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-naive 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 naive 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-naive, 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-naive adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m(2) 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

Background: In 2007, Omnitrope (R) 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-naive 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 naive 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-naive, 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-naive adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m(2) 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

Background: In 2007, Omnitrope (R) 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-naive 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 naive 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-naive, 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-naive adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m(2) 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

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.

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.

Various Nile tilapia strains arecultured in Indonesia. This study was conducted to examine the growth response of four Nile tilapia strains, namely SULTANA (superior selected tilapia strain from Selabintana), NIRWANA (tilapia strain from Wanayasa), SRIKANDI (salinity resistant improvement from Sukamandi), and red tilapia fed on diet containing recombinant Epinephelus lanceolatus growth hormone (rElGH). In the first study, red tilapia were reared in 200-L glass aquaria and fed on artificial diet with different doses of crude rElGH protein, namely 0 (control), 0.03, 0.30, and 3.00 mg/kg diet. The results showed that growth, specific growth rate (SGR), and feed conversion ratio (FCR) were notsignificantly differentamongtreatments (p>0.05), but significantly different when comparedto the control (p<0.05).The second study was performed in the hapa (2x1x1m3) settled in a concrete pond (20x10x1.5 m3). By using 3 mg rElGH/kg diet, the results ofthesecond study showed that the highest (p<0.05) SGR was obtained in SULTANA (3.73%), followed by NIRWANA (3.41%). SRIKANDI (3.36 %),and red tilapia (3.14%) strain. Lowest FCR (p<0.05) was found in SULTANA (0.84), followed by NIRWANA (0.99), SRIKANDI (1.02), and red tilapia (1.22) strains. Survival of the four strains were similar, ranging from 84.67 to 90.00% (p>0.05). The highest (p<0.05) liver and muscle glycogen, protein and fat retention, and RNA/DNA ratio were found in SULTANA, followed by NIRWANA

Various Nile tilapia strains arecultured in Indonesia. This study was conducted to examine the growth response of four Nile tilapia strains, namely SULTANA (superior selected tilapia strain from Selabintana), NIRWANA (tilapia strain from Wanayasa), SRIKANDI (salinity resistant improvement from Sukamandi), and red tilapia fed on diet containing recombinant Epinephelus lanceolatus growth hormone (rElGH). In the first study, red tilapia were reared in 200-L glass aquaria and fed on artificial diet with different doses of crude rElGH protein, namely 0 (control), 0.03, 0.30, and 3.00 mg/kg diet. The results showed that growth, specific growth rate (SGR), and feed conversion ratio (FCR) were notsignificantly differentamongtreatments (p>0.05), but significantly different when comparedto the control (p<0.05).The second study was performed in the hapa (2x1x1m3) settled in a concrete pond (20x10x1.5 m3). By using 3 mg rElGH/kg diet, the results ofthesecond study showed that the highest (p<0.05) SGR was obtained in SULTANA (3.73%), followed by NIRWANA (3.41%). SRIKANDI (3.36 %),and red tilapia (3.14%) strain. Lowest FCR (p<0.05) was found in SULTANA (0.84), followed by NIRWANA (0.99), SRIKANDI (1.02), and red tilapia (1.22) strains. Survival of the four strains were similar, ranging from 84.67 to 90.00% (p>0.05). The highest (p<0.05) liver and muscle glycogen, protein and fat retention, and RNA/DNA ratio were found in SULTANA, followed by NIRWANA

Various Nile tilapia strains arecultured in Indonesia. This study was conducted to examine the growth response of four Nile tilapia strains, namely SULTANA (superior selected tilapia strain from Selabintana), NIRWANA (tilapia strain from Wanayasa), SRIKANDI (salinity resistant improvement from Sukamandi), and red tilapia fed on diet containing recombinant Epinephelus lanceolatus growth hormone (rElGH). In the first study, red tilapia were reared in 200-L glass aquaria and fed on artificial diet with different doses of crude rElGH protein, namely 0 (control), 0.03, 0.30, and 3.00 mg/kg diet. The results showed that growth, specific growth rate (SGR), and feed conversion ratio (FCR) were notsignificantly differentamongtreatments (p>0.05), but significantly different when comparedto the control (p<0.05).The second study was performed in the hapa (2x1x1m3) settled in a concrete pond (20x10x1.5 m3). By using 3 mg rElGH/kg diet, the results ofthesecond study showed that the highest (p<0.05) SGR was obtained in SULTANA (3.73%), followed by NIRWANA (3.41%). SRIKANDI (3.36 %),and red tilapia (3.14%) strain. Lowest FCR (p<0.05) was found in SULTANA (0.84), followed by NIRWANA (0.99), SRIKANDI (1.02), and red tilapia (1.22) strains. Survival of the four strains were similar, ranging from 84.67 to 90.00% (p>0.05). The highest (p<0.05) liver and muscle glycogen, protein and fat retention, and RNA/DNA ratio were found in SULTANA, followed by NIRWANA

Objective: Recombinant human growth hormone (rhGH) is used by some athletes and body builders with the aim of enhancing performance, building muscle and improving physique. Detection of the misuse of rhGH has proved difficult for a number of reasons. One of these is the effect of preceding exercise. In this randomised, double blind placebo-controlled study, we determined the effects of rhGH administration in male amateur athletes on two candidate markers of rhGH abuse, IGF-I and N-terminal pro-peptide of collagen type III (P-III-NP), following a bout of weightlifting exercise. Design: Sixteen men entered a four-week general weight training programme to homogenise their activity profile. They then undertook repeated bouts of standardised leg press weightlifting exercise (AHRET-acute heavy resistance exercise test). Blood samples were taken before and up to one hour after the AHRET. After the first laboratory visit (Test 1), the subjects were randomly assigned to receive daily injections of either rhGH (0.1IUkg-1day-1) or placebo for two weeks. The AHRET was repeated after the two-week dosing period (Test 2) and a further test was undertaken following a one-week washout (Test 3). Results: There was no effect of exercise on either IGF-I or P-III-NP in any test. Both markers were markedly elevated at Test 2 (p<0.001), with P-III-NP remaining elevated at Test 3 in the GH administration group (p<0.05). Application of the GH-2000 discriminant function positively identified GH administration in 17 of 40 blood samples taken at Test 2 from the rhGH group and none from the placebo group. Conclusion: The data show that rhGH results in elevated levels of IGF-I and P-III-NP in well-trained individuals and that leg press weightlifting exercise does not affect these markers. The GH-2000 discriminant function identified four of eight subjects taking rhGH with no false positive results.

The article describes and analyzes the results of numerous clinical studies on the correction of short stature in children with various endocrine disorders, such as precocious puberty, after the removal of produced androgen-adrenal tumors, congenital dysfunction of the adrenal cortex, a spondyloepiphyseal dysplasia, Shereshevsky-Turner syndrome, growth hormone deficiency, idiopathic growth retardation, biologically inactive growth hormone. Presented own data on treatment outcomes in the application of recombinant growth hormone preparations and analogues luteinizing hormone -releasing hormone in children with poor prognosis of growth., В статье проанализированы результаты многочисленных клинических исследований, посвященных проблемам коррекции низкорослости у детей, страдающих различной эндокринной патологией (преждевременное половое созревание, андрогенпродуцирующие опухоли надпочечников, врожденная дисфункция коры надпочечников, спондило-эпифизарная дисплазия, синдром Шершевского-Тернера, соматотропная недостаточность, идиопатическая низкорослость, синдром биологически неактивного синдрома роста). Представлены собственные данные о результатах лечения препаратами рекомбинантного гормона роста и аналогов ЛГ-РГ у детей с неблагоприятным прогнозом роста.

The GH receptor (GHR) plays a key role in the the function of the GH/IGF-I axis and is the major effector of human growth. A common polymorphic variant consisting of genomic exon 3 deletion or retention (d3-GHR and full-length GHR, respectively), described in 2000, has been linked with increased receptor activity due to enhanced signal transduction. Subsequent pharmacogenetic studies have addressed a possible role of GHR polymorphism on the response to recombinant human GH treatment first in short children and then in adults, many of them suggesting that growth response to GH may be influenced, at least in some aspects, by this polymorphism. Similar studies, performed in patients with acromegaly, assumed an influence of the d3-GHR variant in the relationship between GH and IGF-I levels. More recently, some studies have investigated the relation between GHR genotype and treatment with the GHR antagonist pegvisomant, suggesting a better clinical response to therapy related to d3-GHR genotype. This review provides a summary of the main pharmacogenetic studies performed on this current and still open topic. ©2011, Editrice Kurtis.

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.

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.

A gilthead sea bream growth hormone (sbGH) obtained by cloning and expression of sbGH cDNA was used to develop a sensitive and specific radioimmunoassay (RIA). Iodination of recombinant sbGH (rsbGH) was performed by the classical Chloramine-T method. Specific antiserum, raised in rabbits, was added in a final dilution of 1/36,000. The minimum detectable dose was 30 pg, and the midrange of the assay (ED50) was 275 pg. Intra- and inter-assay coefficients of variation (CV) were 3.3 and 5.8% at ED50 levels. Human GH (hGH), ovine GH (oGH), carp gonadotropin (cGtH), chinook salmon gonadotropin (sGtH), ovine prolactin (oPRL) and recombinant tilapia prolactin (rtiPRL) did not show cross-reactivity. Serial dilutions of chinook salmon GH (sGH) and recombinant rainbow trout GH (rtGH) showed a low but significant cross-reactivity. A good parallelism between rsbGH standard and serial dilutions of native sbGH, plasma and pituitary extracts was observed. In addition, when plasma and pituitary samples were analyzed for GH quantification, non-significant differences were observed within this and previous RIA for native sbGH. Therefore, it appears conclusive that our rsbGH can be used successfully as a standard and radioiodinated hormone in GH assays for gilthead sea bream, which is extensively cultured in the Mediterranean area.