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Original Articles
- Clinical Effects of E. coli Derived Recombinant Human Growth Hormone (DA - 3001) in Patients with Growth Hormone Deficiency.
- Sei Won Yang, Jeh Hoon Shin, Duk Hi Kim, Byung Churl Lee, Hyung Ro Moon
- J Korean Endocr Soc. 1995;10(4):377-385. Published online November 7, 2019
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- 31 Download
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Abstract
PDF - Recently, methionyl-hGH was produced in the E. coil K-12, W3110 by recombinant DNA technology in Korea. In this paper, the clinical efficacy and immunogenicity of this GH were studied in 43 patients with growth hormone deficency.The subjects of this study were aged 4.3-18.5 years and each patient received GH 0.5-0.71U/kg week subcutaneously, 6-7 times a week for 1 year. During treatment, height, body weight and bone age were checked. Blood count, urinalysis, blood chemistry and thyroid hormonal concentrations were checked before and every 3 months. The measurement of IGF-1 was performed and assay of antibody against hGH was performed before and every 6 months.The height velocities significantly increased from 3.7+-3.0 cm/year to 11.0+-4.2 cm/year and 9.9+-3.2 cm/year at 6 and 12 months after GH therapy, respectively. The Height SDS were significantly improved after GH therapy with increasing ratio of bone age to chronological age from 0.60+-0.19 at pretreatment to 0.68+-0.16 at 6 month, 0.69+-0.16 at 12 month of therapy. The plasma IGF-1 levels significantly increased during treatment. Three out of 35 patients(8.3%) showed antibody against hGH after 1 year of treatment. Thoughout study, we could not observe any remarkable side effect with GH treatment.These results indicate that this E. coli derived methionyl recombinant growth hormone is effective in improving the index of linear growth in the children with growth hormone deficiency without significant side effect.
- Clinical Effects of E. cole Derived Authentic REcombinant Human Growth Hormone(DA-3002) in Children with Growth Hormone Deficiency.
- Se Won Yang, Byung Chul Lee, Chul Woo Ko, Duk Hee Kim, Han Wook Yoo, Woo Young Chung
- J Korean Endocr Soc. 1998;13(4):526-535. Published online January 1, 2001
- 1,237 View
- 28 Download
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Abstract
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- BACKGROUND
Recently authentic human growth hormone(hGH) has produced in the E coli K-12, W3110 by recombinant DNA tecbnology in Korea In this paper, the clinical efficacy and immunogenicity of this GH was shdied in 38 children with growth hormone deficiency during therapy of 1 year. METHODS: The subjects of this study were aged 4.9-13.9 years, diagnosed by failure of plasma GH to respond to insulin-induced hypoglycemia, arginine and/or L-dopa loading and height below -2 standard deviation of mean for their chronological age. Each patient received GH 0.5-0.7IU/kg/week subcutaneously in 6-7 divided doses. During treatment, vital signs, height, body weight and bone age were checked every 3 months. Complete blood count, urinalysis, blood chemistry and thyroid hormone were checked before and every 6 months. The measurement of serum IGF-1 level and antibody against hGH were performed before and every 6 months during therapy of I year. RESULT: The height velocities significantly increased from 3.3 +/- 1.5cm/year to 10.1 +/- 2.5 and 9.0 +/- 1.8cm/year at 6 and 12 months of therapy, respectively. The height standard deviation score for chronological age were significantly improved from -2.141.50 to -1.74 +/- 1.43 and -1.54 +/- 1.38 at 6 and 12 months of therapy with increasing ratio of bone age to chronological age from 0.72 +/- 0.15 at pretreatment to 0.76 +/- 0.15 at 6 month, 0.79 +/- 0.16 at 12 month of therapy. The plasma IGF-1 level significantly increased during treatment. One of 36 patients(2.8%) showed positive antibody against hGH after 1 year of treatment. During therapy of 1 year, unwanted and remarkable clinical side effect were not observed in all subjects. CONCLUSION: These results indicate that this E. coli derived authentic recombinant growth hormone is very effective in stimulating linear growth in children with growth hormone deficiency.
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