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Frontiers of Medicine

ISSN 2095-0217

ISSN 2095-0225(Online)

CN 11-5983/R

Postal Subscription Code 80-967

2018 Impact Factor: 1.847

Front Med Chin    2009, Vol. 3 Issue (2) : 171-176     DOI: 10.1007/s11684-009-0027-4
RESEARCH ARTICLE |
Clinical evaluation of recombinant human growth hormone injection in children with growth hormone deficiency
Ling HOU1, Xiaoping LUO1(), Minlian DU2, Huamei MA2, Chunxiu GONG3, Yuchuan LI3, Shuixian SHEN4, Zhuhui ZHAO4, Li LIANG5, Guanping DONG5, Chaoying YAN6, Hongwei DU6
1. Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China; 2. Department of Pediatrics, the First Affiliated Hospital of Zhongshan University, Guangzhou 510080, China; 3. Department of Endocrinology, Beijing Children's Hospital Affiliated to Capital Medical University, Beijing 100045, China; 4. Department of Pediatric Endocrinology and Metabolism, Children's Hospital of Fudan University, Shanghai 201102, China; 5. The Affiliated Children's Hospital of Zhejiang University School of Medicine, Hangzhou 310003, China; 6. Department of Pediatrics, The First Hospital of Jilin University, Changchun 130021, China
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Abstract  

Recombinant human growth hormone (rhGH) has been widely used in the clinical treatment of growth hormone deficiency. To simplify the injection process and increase drug compliance, application of the GH injection has become a new treatment plan in recent years. The purpose of the current study was to evaluate the efficacy and safety of rhGH injection for the treatment of growth hormone deficiency (GHD) in children in China. In a nationwide, noncomparative, prospective, randomized, open trial, 31 children with confirmed complete GHD received subcutaneous injection of rhGH at 0.25 mg/kg·wk (0.107 IU/kg·d). The injection was given daily and the total weekly amount was separated into 6-7 injections. The patients were followed up at 3-month intervals and the treatment duration was 12 months. The height (HT), annual growth velocity (GV), mean height standard deviation score (HT SDS), blood serum insulin-like growth factor I (IGF-I), insulin-like growth factor binding protein 3 (IGFBP-3), and bone maturity before and after treatment were compared, and the safety of the treatment was analyzed. The mean HT, GV, and HT SDS were increased from 109.0±14 cm, 2.7±0.9 cm/yr, and -4.62±1.46 at baseline to 121.8±13.4 cm, 12.9±3.3 cm/yr, and -2.47±1.86 after 12 months of treatment, respectively (P<0.001). At the same time, blood IGF-I and IGFBP-3 were increased significantly [41.27±64.43 μg/L vs 159.21±167.92 μg/L and 1540.00±1325.11 mg/L vs 3533.93±1413.82 mg/L, respectively (P<0.001)]. The bone age assessments performed 6 and 12 months after the treatment showed that no advanced bone maturation was noted. No serious adverse events occurred during the treatment, and the drug-related adverse events were mainly decreased thyroid function. We conclude that rhGH injection is a safe and effective drug for treatment of growth hormone deficiency in children.

Keywords recombinant human growth hormone      injection      growth hormone deficiency     
Corresponding Authors: LUO Xiaoping,Email:xpluo@tjh.tjmu.ed.cn   
Issue Date: 05 June 2009
URL:  
http://academic.hep.com.cn/fmd/EN/10.1007/s11684-009-0027-4     OR     http://academic.hep.com.cn/fmd/EN/Y2009/V3/I2/171
follow-up timeannual height growth/cmannual growth velocity/cm·yr-1mean height standard deviation score
before treatment109.0±14.12.7±0.9– 4.62±1.46
after treatment
3 months113.4±14.116.0±5.1– 3.80±1.53
6 months116.3±13.714.1±4.0– 3.28±1.60
9 months119.3±13.113.7±3.5– 2.86±1.75
12 months121.8±13.412.9±3.3– 2.47±1.86
F value6.14115.3622.71
P value&lt;0.001&lt;0.001&lt;0.001
Tab.1  Changes in the growth efficacy indices in children with GHD before and after treatment
follow-up timeannual height growth/cmannual growth velocity/cm·yr-1mean height standard deviation score
after treatment
3 months4.0±1.313.3±5.00.68±0.33
6 months7.0±2.011.4±4.01.20±0.56
9 months10.3±2.611.0±3.51.76±0.79
12 months12.9±3.310.2±3.32.21±0.97
Tab.2  Baseline correction of the growth efficacy index changes in children with GHD after treatment
follow-up timeIGF-I/μg·L-1IGFBP-3/mg·L-1
before treatment41.27±64.431540.00±1325.11
after treatment
3 months179.15±155.033891.18±1815.36
6 months202.32±141.344051.47±1308.51
9 months156.75±155.483408.93±1435.85
12 months159.21±167.923533.93±1413.82
F value3.528.79
P value&lt;0.001&lt;0.001
Tab.3  Changes in IGF-I and IGFBP-3 before and after treatment
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