Optimization and verification of size exclusion chromatography-high performance liquid chromatography for determination of recombinant human growth hormone-Fc immunofusion protein polymer / 中国生物制品学杂志

@#Objective To optimize and verify the size exclusion chromatography-high performance liquid chromatography(SEC-HPLC) method for the determination of recombinant human growth hormone(rhGH)-Fc immunofusion protein polymer.Methods The multimer content of rhGH-Fc immunofusion protein was detected by SEC-HPLC.The detection conditions(salt concentration,mobile phase pH,flow rate,column temperature and column model) were optimized to observe the separation effect of the target proteins and polymers.The system suitability,specificity,linearity and range,precision,accuracy and limit of quantification of the method were verified.Results The optimized method was to use TSK-gel G2000SW_(x1)column(5 μm,7.8 mm × 300 mm),mobile phase of 50 mmol/L phosphate buffer(pH 6.80),detection wavelength of280 nm,injection volume of 100 μL,flow rate of 0.6 mL/min and column temperature of 45 ℃.The resolution of rhGHFc immunofusion protein and polymer,the theoretical plate number and the tailing factor all met the requirements;the peak time of rhGH-Fc immunofusion protein was the same as that of the control,while the peak time of GH national standard was different from that of the control,and the protein buffer showed no peak;the concentration of rhGH-Fc immunofusion protein was in the range of 0.307～1.842 mg/mL with good linear correlation between the peak area integral value and the injection volume(R~2=0.999 4);the RSD of peak area and purity in repeatability verification were 0.7% and 0.1%,respectively;the RSD of intermediate precision verification was 0.8%;the average recovery rate of accuracy verification was 99.1% with the RSD of 1.9%;the limit of quantification was 6 μg/mL.Conclusion The optimized SEC-HPLC method was used to detect the content of polymer in rhGH-Fc immunofusion protein with improved accuracy,and the column efficiency and separation were in accordance with the relevant requirements of Chinese Pharmacopoeia(Volume Ⅳ,2020edition),which could be used for the detection of polymer content in samples.

Development and verification of whole-column imaging capillary isoelectric focusing electrophoresis analysis method for charge heterogeneity of human growth hormone Fc fusion protein / 中国生物制品学杂志

@#Objective To develop and verify a whole-column image capillary isoelectric focusing(iCIEF) electrophoresis method to analyze the charge heterogeneity of recombinant human growth hormone Fc fusion protein(Fc-rhGH).Methods The iCIEF analysis method of Fc-rhGH was developed by optimizing the target protein concentration,cosolvent(urea)concentration and focusing time.The target protein was simultaneously analyzed by this method and traditional flat plate isoelectric focusing(IEF) electrophoresis,and the results were compared;The specificity,accuracy,precision,limit of quantitation(LOQ) and durability of the developed method were verified.Results The optimized method was using the mixed solution of 8 mol/L urea,0.35% methyl cellulose(MC),4% amphoteric electrolyte and 0.5% isoelectric point marker as the sample buffer,and the focusing condition was 1 500 V 1 min,3 000 V 5.5 min.IEF was not suitable for analyzing the charge heterogeneity of Fc-rhGH solution.Using the optimized iCIEF for analysis,the target protein was significantly different from the unrelated protein,and the baseline of blank reagent was stable;The recovery rate of accuracy verification was within 90%～110%,and the linear range was 0.25～0.75 mg/mL(50%～150% of the target loading volume);The RSD of each isomer pI in the repeatability verification was less than 0.3%,and the RSD of peak area percentage was less than 5%;The LOQ was 0.04 mg/ml.The sample storage time durability,amphoteric electrolyte pharmalyte 3-10 durability and MC durability of this method were good.Using this method to analyze the charge heterogeneity of Fc-rhGH physicochemical reference substance,eight charge heterogeneities of the reference substance were effectively separated,and the pI ranged from 5.9 to 6.4.Conclusion The developed iCIEF method had good specificity,accuracy,precision and durability,and was more suitable for efficient analysis of charge heterogeneity of Fc-rhGH than traditional flat plate IEF,which was of great significance for the quality control of Fc-rhGH and other Fc fusion proteins.

Application of Design of Experiment in development of purification process of recombinant human growth hormone-Fc fusion protein / 中国生物制品学杂志

@#ObjectiveTo optimize the condition for anion exchange chromatography in purification process of recombinant human growth hormone-Fc(rhGH-Fc)fusion protein by Design of Experiment(DOE)so as to decrease the content of host cell protein(HCP)in bulk of protein.MethodsA complete factorial experimental design with four factors at two levels was established by the DOE in Minitab 19 software.The condition(flow rate,sample load,pH value of buffer and salt concentration of eluent)for anion exchange chromatography in purification process of rhGH-Fc was optimized by DOE to find out the operating space.ResultsThe experimental results were predicted accurately by the established DOE model.The sample load,pH value of buffer,salt concentration of eluent as well as the interaction of pH value of buffer and salt concentration of eluent showed significant influence on the HCP content in the harvest.The optimal sample load,flow rate as well as pH value and salt concentration of eluent were 15 mg/mL,120 cm/h,7.0 ～ 8.0 and 0.1 mol/L respectively.The HCP contents in eluents under the optimal condition were less than 400 ng/mg,which met the requirements for verification within the range of results in determined operating space.ConclusionThe condition for removal of HCP by anion exchange chromatography was successfully optimized by DOE,which provided a reference for further application of DOE in the biopharmaceutical field.

Optimization of glycosylation type of recombinant human growth hormone-Fc fusion protein expressed in CHO cells / 中国生物制品学杂志

@#Objective To optimize the expression of recombinant human growth hormone-Fc(rhGH-Fc)fusion protein in CHO cells in order to obtain better glycosylation ratio and lower content of highmannose.Methods CHO cells expressing rhGH-Fc were cultured in a 7 L bioreactor.The glycosylation modifications of rhGH-Fc were adjusted by improving the composition of feeding media(using three commercial media:Gly-1:EX-CELL Glycosylation Adjust,Gly-2:SHEFF-CHO PLUS PG ACF and Gly-3:EfficientFeed C + AGT Supplement & GlycanTune C + Total Feed),and the glycosylation type and proportion of the target proteins were analyzed by mass spectrometry.Results The G0F(main glycosylation types:G0,G1 and G2;F:fucose)of Gly-1,Gly-2 and Gly-3 were 32.89%,58.66% and 33.28%,the G1F were 31.39%,18.03%and 34.90%,and the G2F were 31.39%,18.03% and 34.90%,respectively.Gly-1 and Gly-3 made the target protein contain less G0F while more G2F;Gly-3 feeding scheme-showed less high mannose modification than the other two schemes.Conclusion Gly-1 medium changed the glycosylation modification from G0F to G1F and G2F,while Gly-2 medium changed that from G2F and G1F to G0F.However,Gly-3 medium changed the glycosylation modification from G0F to G1F and G2F,and the contentof high mannose was less than 5%,which may have a better effect on modifying glycosylation type and proportion of the target protein.

Velocidad de crecimiento en pacientes con síndrome de Turner que recibieron hormona recombinante de crecimiento / Growth rate in patients with Turner syndrome who received recombinant growth hormone

El síndrome de Turner (ST) afecta a uno de cada 2000-2500 recién nacidos vivos y tiene una prevalencia de 50 por cada 100 000 mujeres. Las manifestaciones clínicas son variables, dependiendo del tipo de alteración cromosómica y de la edad de presentación. Una de las características más prevalentes y sobresalientes del síndrome es su estatura extremadamente baja. La hormona de crecimiento humana recombinante (rh-GH) se ha usado para aumentar el crecimiento y la estatura final en las niñas que tienen el síndrome de Turner. Para valorar los efectos de la hormona de crecimiento recombinante en las niñas y adolescentes con ST, hemos tomado en cuenta el efecto de la hGH, considerando la velocidad en la talla de crecimiento como un punto importante del estudio observacional retrospectivo. Resultados principales: El uso de rh-GH tiene una relación estadísticamente significativa (p0.049 <0.05), que se asocia con un factor de influencia positiva en relación con la velocidad de crecimiento, como variable principal. Al comparar a las pacientes que recibieron la hormona de crecimiento con las que no la recibieron, en las primeras existe la tendencia a acercarse a la curva del percentil 10 en comparación con la de aquellas que no recibieron la rh-GH, que estuvieron más lejos de la curva.

Turner syndrome (TS) affects about one in 1500 to 2500 live-born females. One of the most prevalent and salient features of the syndrome is extremely short stature. Recombinant human growth hormone (rh-GH) has been used to increase growth and final height in girls who have Turner syndrome. To assess the effects of recombinant growth hormone in children and adolescents with TS we have evaluated the effect of HGH considering growth rate as an important point through a retrospective observational study. Main results: The use of rh-GH has a statistically significant relationship (p0.049 <0.05) that is associated with an influencing factor in favor of the use of rh-GH in relation to the variable growth rate. When comparing the patients who received growth hormone with those who did not receive, there is the tendency to arrive closer to the 10th percentile curve compared to the curve of the patients who did not receive rh-GH, which is further away.

Aplicaciones de la hormona de crecimiento humana recombinante en HIV. Efectos sobre el aparato inmune / Aplication of the recombinant human growth hormone in HIV. Effects on the immune system

El presente trabajo realiza una investigación bibliográfica sobre el uso clínico de RhGH en pacientes adultos HIV en su rol inmunomodulador mediante búsqueda booleana en Pubmed de los términos RhGH yHIV en artículos de ensayos clínicos, únicamente en adultos a partir de los 19 o más años de edad hasta enero del 2019

RP-HPLC peptide mapping to determine pegylation sites of PEG-rhGH / 中国药学杂志

OBJECTIVE: To determine pegylation sites of PEG-rhGH by RP-HPLC peptide mapping. METHODS: Firstly, a RP-HPLC method was set up to get high resolution and detailed information of peptides by optimizing the separating and digestion conditions; secondly, MALDI-TOF mass was used to identify each separated peptide; finally, pegylation sites were determined through comparing the k values of changed peptides in the modified and unmodified digestion map. RESULTS: There were five major peptides modified by PEG in the digestion of PEG-rhGH from three pharmaceutical companies. They were T1(N-end), T4(lys38), T13 (lys140), T14(lys145) and T15(lys158), respectively. CONCLUSION: RP-HPLC peptide mapping can be used to determine pegylation sites of complicated and inhomogeneous positional isomers of PEGylated pharmaceuticals. Copyright 2012 by the Chinese Pharmaceutical Association.

Endocrine diseases, perspectives and care in Turner syndrome / Doenças endócrinas, perspectivas e cuidados na síndrome de Turner

Turner syndrome is a frequent chromosome disorder in clinical practice. It is characterized by short stature, gonadal dysgenesia and multisystemic involvement, responsible for a high morbidity and reduced life expectancy. The aim of the present paper is to describe the endocrinopathies and major problems at different ages, and to present suggestion for follow-up care in these patients.

A síndrome de Turner é uma doença cromossômica frequente na prática clínica. É caracterizada pela baixa estatura, disgenesia gonadal e alterações em diversos sistemas, o que leva a uma alta morbidade e diminuição da expectativa de vida. O objetivo do presente estudo é descrever as endocrinopatias e outros problemas em cada idade e apresentar uma sugestão de cuidados e segmentos dessas pacientes.

Talla final en pacientes transplantados renales bajo tratamiento con hormona de crecimiento / Final height in renal transplant patients after growth hormone treatment

El retardo de crecimiento es un importante problema clínico aun no resuelto ni correctamente manejado en niños con insuficiencia renal crónica (IRC). La optimización de todos los parámetros metabólicos y nutricionales no siempre lleva a una mejoría del crecimiento en estos pacientes. Desde hace aproximadamente 20 años se utiliza el tratamiento con rhGH para mejorar la talla en este grupo de niños. La bibliografía internacional muestra mejoría de la velocidad de crecimiento en estos pacientes sin embargo la experiencia publicada en la talla final (TF) alcanzada por los mismos es escasa. Los objetivos de este estudio fueron:1) evaluar la talla final alcanzada por pacientes transplantados renales(TxR) que recibieron tratamiento con rhGH (GrGH) comparándolos con un grupo control (GrC) con similares características clínicas, 2) evaluar los factores predictores de la TF, y 3) la repercusión de dicho tratamiento en la función renal. La TF en el GrGH fue significativamente mayor que la TF del GrC (-1.96 ± 1.13 vs -3.48 ± 1.19 SDS respectivamente, p <0.05). La talla (SDS) al inicio del tratamiento con rhGH fue la única variable significativa para predecir la respuesta al tratamiento (p= 0.001). Se observó una disminución significativa ClCr final en ambos grupos (GrGH: 76 ± 18 vs 66 ± 14 ml/min/m2 sup p<0.05; GrC: 72 ± 19 vs 56 ± 9 ml/min/m2 sup, p<0.05) lo que sugiere una caída similar del filtrado glomerular en ambos grupos independiente del tratamiento. Conclusión: Nuestros hallazgos permiten confirmar que el tratamiento con rhGH es efectivo para mejorar la talla final en pacientes TxR sin afectar la función renal (AU)

Growth retardation is a common and significant clinical problem that is not adequately managed in children with chronic renal disease. Despite optimization of metabolic parameters the growth of this patients not always amelioreted. About 20 years ago rhGH treatment became to be used for this group of children to optimization final height.The international experience show that rhGH treatment improve growth velocity but the results about final heigth are scarse. The aims of our trial were: 1) to evaluate final height in renal transplant patients treated with rhGH (n=23) comparing with a control group not treated with rhGH (n=14) with similar characteristics, 2) to evaluate the effect of rhGH on creatinine clearance,3) to establish predictive variables for final height. Final Heigth was significantly greater in treated group vs control group (-1.9±1.1 vs -3.5±1.2, p<0.05). Initial height was the only significant variable to predict final height (p=0.001). We described a significantly decrease of creatinine clearence in both groups during follow up (GH Group 76±9 vs 66±14 ml/min/m2 sup, p<0.05 and Control Group 72.5±19 vs 56±9 ml/min/m2 sup, p= p<0.05).This suggest a similar decrese of creatinine clearence in both groups. Conclution: Our data confirm that rhGH treatment was effective in improving final height in renal transplant patients and did not decline allograft function (AU)

Evaluación de la talla final y sobrevida libre de eventos en pacientes sobrevivientes de meduloblastoma con deficiencia de hormona de crecimiento, tratados o no con hormona de crecimiento biosintética recombinante humana en la niñez. Comparación con pacientes con craneofaringioma tratados con rhGH / Evaluation of final height and event-free survival in medulloblastoma patients with growth hormone deficiency with and without biosynthetic recombinant human growth hormone treatment in childhood

Introduccion: La deficiencia de GH (DGH) y la radioterapia espinal (RE) han sido implicadas en la etiología de la talla adulta (TA) baja en los sobrevivientes de meduloblastoma en la niñez. Sin embargo la dinámica del crecimiento luego del diagnóstico tumoral y la efectividad de la Hormona de crecimiento biosintética recombinante humana (rhGH) sobre la TA en comparación con sobrevivientes no tratados con rhGH no han sido reportadas. Objetivo. Evaluación de la talla (T) SDS (SDST) desde el diagnóstico del meduloblastoma y el efecto de la rhGH en pacientes con DGH comparando con pacientes no tratados con rhGH y con pacientes con craniofaringioma y DGH, tratados con rhGH. Analizar si había alguna diferencia en la sobrevida libre de eventos en los pacientes con meduloblastoma al ser tratados con rhGH. Material Clínico y Métodos. Catorce pacientes con meduloblastoma recibieron rhGH hasta la TA, grupo meduloblastoma tratado con GH (GrMGH). Diecinueve pacientes rechazaron la terapia con rhGH, grupo meduloblastoma control (GrMC). Se midieron la talla parada (T) y la talla sentada (Tsent). Ocho pacientes con craneofaringioma recibieron rhGH hasta la TA (GrCra). Se realizó seguimiento de 72 pacientes con meduloblastoma, 20 con tratamiento con rhGH. Resultados. En GrMGH, la media±DS SDST disminuyó de 0.09±0.63 al diagnóstico del tumor a -1.38±0.91 al diagnóstico del DGH, y a -1.90±0.72 al comienzo de rhGH, p<0.01, pero se mantuvo sin cambios durante el tratamiento con rhGH (TA -2.12±0.55). En GrMC la SDST (-0.25±0.88) no fue diferente de GrMGH al diagnóstico del tumor, pero fue -3.40±0.88 a la TA, significativamente menor que en GrMGH, p=0.001. La Tsent SDS a la TA (-4.56±0.82) fue significativamente menor que al comienzo de rhGH (-2.86±0.75), p=0.003, y no fue diferente de GrMC (-4.85±1.77). El GrCra mostró la mayor ganancia de talla (GT = TA-SDSTinicial), p< 0.007, y la menor pérdida de talla (PT= Tblanco - TA), p < 0.0001. Conclusión. El tratamiento con rhGH mejora la TA en sobrevivientes de meduloblastoma en la niñez con DGH, pero no el crecimiento espinal. Las características del crecimiento y la respuesta a rhGH son diferentes en GrMGH y en GrCra, mientras que el primer grupo sólo pudo mantener la talla relativa, el segundo mostró una franca recuperación del crecimiento. Además no hubo diferencias en la sobrevida libre de eventos en los pacientes con meduloblastoma con y sin tratamiento con rhGH (AU)

Background. GH deficiency (GHD) and spine irradiation (SI) have been implicated in the mechanism of reduced adult height (AH) in childhood survivors of medulloblastoma. However, growth dynamics after tumor diagnosis and the effectiveness of (rhGH) Recombinant human Growth Hormone on AH in comparison with rhGH-untreated survivors has not been reported. Aim. Follow up of height (H) SDS (HSDS) after diagnosis of meduloblastoma, and the effect of rhGH in GHD meduloblastoma patients. Comparison with GH-untreated GHD meduloblastoma patients and with GHD craniopharyngioma patients treated with rhGH. To evaluate event free survival in medulloblastoma patiens treated with rhGH. Clinical Material and Methods. Fourteen survivors of medulloblastoma received rhGH treatment until AH, Medulloblastoma GH-treated group (MGHGr). Nineteen patients refused rhGH therapy, GH-untreated Control Medulloblastoma Group, (MCGr). Standing H and sitting H (SitH) were measured. Eight patients with craniopharyngioma received rhGH treatment until AH (CraGr). 72 patients with medulloblastoma were followed up, 20 with rhGH. Results. In MGHGr, mean±SD HSDS decreased from 0.09±0.63 at tumor diagnosis to -1.38±0.91 at diagnosis of GHD, and to -1.90±0.72 at the onset of rhGH, p<0.01, but it remained unchanged during rhGH (AH -2.12±0.55). MCGr HSDS (- 0.25±0.88) was not different from MGHGr at tumor diagnosis, but it was -3.40 ± 0.88 at AH, significantly lower than in MGHGr, p=0.001. SitH SDS at AH (-4.56±0.82) was significantly lower than at the onset of rhGH (-2.86±0.75), p=0.003, and it was not different from MCGr (-4.85 ± 1.77). CraGr showed the highest height SDS gain (HG = FH ­ startHSDS), p<0.007, and the lowest height lost (HL = targetH - AH), p< 0.0001. Conclusions. rhGH treatment improves AH in GH-deficient childhood medulloblastoma survivors but not spinal growth. Growth pattern and response to rhGH differed in MGHGr and CraGR, while the former just could maintain height SDS under treatment, the latter showed a clear catch up growth. There wasn't any difference in the event free survival in medulloblastoma patients with or without rhGH (AU)

Research on Correlation between Selenium Level and Cognitive Function for Rural Elderly Population in China / 医学研究杂志

Objective To evaluate the safeness of this treatment by comparing the serum IGF-Ⅰ and IGFBP3 concentration level before and after receiving rhGH treatment in pediatric patients.Methods 30 pediatric patients in our hospital receiving rhGH treatment were subjected to monitor serum IGF-Ⅰ and IGFBP3 level before and after the treatment and calculate the IGF-Ⅰ and IGFBP3 ratio.At the same time the serum T3,T4 and TSH are also assayed.Results The average increase of booly heights was(8.77?3.01)cm /y(t=7.773,P0.05),but the serum IGFBP3(t=3.759,P0.05).However,there was statistical significance of the serum IGFBP3 level between subgroups(f=22.964 P0.05).Conclusion The serum IGF-Ⅰ and IGFBP3 level are able to be used as one of clinical evaluation benchmarks to detect the risks of inducing tumor during the rhGH treatment in the pediatric patients.

Effects of Recombined Human Growth Hormon-enhanced Early Enteral Nutrition on Healing of the Patients After Operation for Severe Abdomianl Trauma / 医学研究杂志

Objective To explore the effects of recombined human growth hormon-enhanced early enteral nutrition on healing of the patients after operation for sereve abdominal trauma.Methods 60 patients with severe abdominal trauma were randomly divided into PN(n=20),EN(n=20) and EN+ rhGH(n=20) groups.Nutrient status and immune function of 3 groups were detected on the postoperative day 1,7 and 10.Results EN+ rhGH group showed more effective process than EN and PN groups in improving postoperative nutrient status,immune function and nitrogen balance,whose indexs except CD8 changed significantly on the postoperative day 7 and 10 than that in PN group(P

The Effect of Recombinant Human Growth Hormone on Growth in Children with Nephropathy Receiving Long-term Steroid Therapy

PURPOSE: Growth retardation is one of the serious problems in children with nephropathy requiring long-term steroid therapy. We observed the efficacy and safety of recombinant human growth hormone(rhGH) on the growth in children with long-term steroid therapy. METHODS: We studied 60 children(male 47, female 13) with nephropathy who received rhGH (1 U/kg/week) for more than 0.5 years(1.39+/-1.12). Their mean age was 11.0 years (11.17+/-2.62). They received steroid therapy from January 1987 through July 2005, and the mean duration of steroid therapy was 4.32+/-2.97 years. Among the patients, there were 32 nephrotic syndrome, 9 IgA nephropathy, 4 mesangial proliferative glomerulonephritis, 4 focal segmental glomerulosclerosis, 2 Henoch Schonlein nephritis, 2 Alport syndrome and 7 other cases. Data were gathered on the growth parameters, such as growth velocity, height standard deviation score(SDS), IGF-1, IGFBP-3, bone mass density(BMD) and general chemistry changes. RESULTS: Height velocity increased significantly with rhGH therapy from 3.29+/-1.95 to 8.66+/-3.75(cm/yr) and height SDS decreased from -0.72+/-0.93 to -1.04+/-0.86 at one year after steroid therapy but increased to -0.55+/-0.96 at one year after rhGH administration(P<0.05). BMD improved from 0.71+/-0.14 to 0.79+/-0.15 g/cm2(P<0.05). IGF-1 increased from 445.09+/-138.01 to 506.62+/-181.31 ng/mL(P<0.05). IGFBP-3 decreased from 4073.75+/-700.78 to 3933.61+/-789.25 ug/L numerically, but there was no statistically significant difference(P=0.533). CONCLUSION: The administration of rhGH in the short stature patients who received long- term steroid therapy showed improvement in growth parameters such as SDS, growth velocity, and BMD without significant side-effects or changes in the biochemical parameters.

Influence of recombinant growth hormone on protein metabolismin hepatocirrhosis: an animal experiment / 肠外与肠内营养

Objective: We observed the influence of recombinant human growth hormone(rhGH) on protein metabolism in hepatocirrhotic rats and investigated mechanisms. Methods: Ninety rats were randomized into three groups(n=30 for each group): group A(normal rats), B(cirrhotic rats) and C(cirrhotic rats receiving rhGH). Rats in group C were subcutaneously given rhGH with a dosage of 1 U/(kg?d) for up to 1 week. The plasma concentrations of albumin(ALB), prealbumin(PA), transferrin(TF) and insulin-like growth factor-1(IGF-1) were detected on experimental day 14. And liver biopsy was taken to examine the expression level of albumin mRNA with TR-PCR. Results: The albumin, prealbumin, transferrin and IGF-1 levels in groups A and C were significantly higher than those in group B. The expression level of albumin mRNA in grup C was significantly higher than that in group B. Conclusions: The rhGH can improve the level of IGF-1 in plasma and improve the expression of albumin mRNA. Moreover, it may significantly improve the synthesis of protein and attenuate hypoproteinemia in cirrhotic rats.

Effect of rhGH on rat model of postoperative fatigue / 第三军医大学学报

Objective To investigate the effects of rhGH on rat model of postoperative fatigue syndrome (POFS) and to study its mechanism. Methods A total of 36 SD rats were randomly divided into 3 groups. The model group and rhGH group were estalished into the model of POFS by partial resection of the liver, and administrated with the same volume of physiological saline and rhGH, and control group was without any treatment. The behavioral changes and the disorder of nutrition intake after operation, stress reaction (pathological changes of mucous membrane in small intestine) and the liver albumin expression were observed. Results The rhGH could improve behavioral changes of rat model and increase the serum levels of the iron, total protein, albumin and globulin as the index of nutrition, and restore the injury of the mucous membrane resulted from the stress reaction and increase the expression of the liver albumin. Conclusion rhGH can shorten the time of POFS and mitigate POFS of rat model.

Effects of Recombinant Human Growth Hormone in the Treatment of Disease with Growth Hormone Deficiency / 中国医师杂志

Objective To evaluate the efficacy of both domestically manufactured and imported recombinant human growth hormone (rhGH) in the treatment of growth hormone deficiency(GHD) disease. Methods 67 patients with GHD were given domestically manufactured rhGH ,while imported rhGH were given to another 19 boys with GHD. The dose of rhGH in both groups was 0 1IU?Kg -1 ?d -1 . 19 boys with GHD received imported rhGH for 24 months in combination with administration of chorionic gonadotropin or Testoviron Depot in second year. Vital Capacity (VC) and Maximal Ventilation Volume(MVV) before and 6,12 months after rhGH treatment were measured in 10 cases. Results The increase in linear growth was significant in both groups. In 19 boys with GHD, HA was direct proportion to BA before and 6,12,18,24 months after treatment. In 10 boys with GHD, 12 months after rhGH treatment, VC and MVV significantly increased as compared with pre-treatment (P

The Effect of Recombinant Human Growthn Hormone on Prevention of Osteoporosis in Ovariectomized Rat / 대한정형외과학회잡지

GH concentration in plasma decline with age. GH and GH response to GHRH are influenced by sex hormones, thereby changing around the menopause. In several aspects, features of aging resemble those of a state of GH deficiency. It has been argued the declining GH function, along with other factors, might be a causal factor in osteoporosis. The purpose of this study was to investigate that postmenopausal osteoporosis in ovariectomized rat could be prevented by rhGH. Fifty-four Sprague-Dawley rats(weight 140-200g) were devided 3 groups. Group 1(n=18) was sham operation; Group 2(n=18) was ovariectomized and received subcutaneous injection with 0.05 cc normal saline; Group 3(n=18) was ovariectomized and received subcutaneous injection with 0.2 IU rhGH. Group 2 and 3 were injected daily, 6 day per week. Each group was devided three subgroups(n=6) and were sacrificed at 6 week, 10 week, 14 week, respectively. Group 2 showed a significant increase in body weight, femur length, serum IGF-1 level, serum PICP and ICTP level at 6 weeks, 10 weeks, 14 weeks and a significant decrease in ash weight of tibia, width of bony spicules, at 14 weeks than Group 1. Group 3 demonstrated a significant increase in body weight, femur length, serum IGF-1, serum PICP and ITCP levels and a insignificant decrease in ash weight of tibia and width of bony spicules, at 6 weeks, 10 weeks, 14 weeks than Group 1. At 14 weeks, Group 3 showed a significant increase in serum IGF-1, Serum PTH, Serum PICP. From these data, we conclude that although rhGH administration leads to an activation of bone turnover and more stimulation of bone formation, it does not prevent a bone loss in ovariectomized rat.

Metabolic response of different load of nutrition and recombinant human growthhormone after major abdominal surgery / 肠外与肠内营养

Objective:To investigate the metabolic response of different load of nutrition and recombinant human growth hormone(rhGH)after major abdominal surgery. Methods:32 patients were randomly divided into three groups as fellows:Group A : low calorie load,83.68 kJ/(kg?d);Group B: low calorie load combined with rhGH,83.68 kJ/(kg?d) and rhGH 4 U/d from d1-7 after operation;Group C :high calorie load combined with rhGH,125.52 kJ/(kg?d) and rhGH 4 U/d from d1-7 after operation.The levels of serum albumin and prealbumin and the excretion of urea nitrogen in urine were measured.after operation. Results:On day 8 after operation,the level of prealbumin in group B and C were higher than in group A(P

The trial of hypocaloric parenteral nutrition combined with recombinant human growth hormone in gastrointestinal tumor patients after operation / 肠外与肠内营养

Objective:To investigate the changes in protein metabolism after the use of recombinant human growth hormone(rhGH) in gastrointestinal tumor patients after operation.Methods:Thirty-nine patients with gastrointestinal tumor were randomly(double-blind) divided into two groups: ①the control group(n=20),which was treated with hypocaloric parenteral nutrition and placebo,②the rhGH group(n=19),which was treated with hypocaloric parenteral nutrition and rhGH.The levels IGF-1 and protein metabolism were observed.Results:The concentrations of IGF-1,pre-albumin,transferrin and fibronectin were decreased in the two groups on the 3th day after operation.The administration of rhGH resulted to significant increase in serum levels of IGF-1,pre-albumin,transferrin and fibronectin.Conclusion:The administration of recombinant human growth hormone can increase the protein synthesis and improve the nutritional condition.

Clinical observation of application of rhGH and Nutrison in treating severe burns / 肠外与肠内营养

Objectives:To investigate the therapeutic effect of rhGH and Nutrison nutrition on severely burned patients. Methods:Eighteen burn patients(test group) were treated with rhGH and Nutrison nutrition.The rhGH was daily administered hypodermically, Nutrison was given orally or by tube feeding.Fourteen cases(control group) were treated routinely without use of rhGH and Nutrison.Serum total protein, albumin, hematoglobin were monitored on postburn 21st day.The cases of SIRS, body weight at discharge,and the time of wound healing were also analysed. Results:In the experimental group, many nutritional indices were increased( P