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  • Author: Zhe Shen x
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Xiaoping Luo, Ling Hou, Li Liang, Guanping Dong, Shuixian Shen, Zhuhui Zhao, Chun Xiu Gong, Yuchuan Li, Min-lian Du, Zhe Su, Hongwei Du and Chaoying Yan

Objective

We assessed the efficacy and safety of a weekly pegylated human growth hormone (PEG-rhGH) (Jintrolong) vs daily rhGH for children with growth hormone deficiency (GHD).

Design

Phase II and III, multicenter, open-label, randomized controlled trials.

Methods

108 and 343 children with treatment-naive GHD from 6 hospitals in China were enrolled in the phase II and III studies respectively. Patients in the phase II study were randomized 1:1:1 to weekly Jintrolong (0.1 mg/kg/week PEG-rhGH complex), weekly Jintrolong (0.2 mg/kg/week PEG-rhGH complex) or daily rhGH (0.25 mg/kg/week) for 25 weeks. Patients in the phase III study were randomized in a 2:1 ratio to weekly Jintrolong (0.2 mg/kg/week) or daily rhGH (0.25 mg/kg/week) for 25 weeks. The primary endpoint for both studies was height velocity (HV) increase at the end of treatment. Other growth-related parameters, safety and compliance were also monitored.

Results

The phase II study established the preliminary efficacy, safety and recommended dose of Jintrolong PEG-rhGH. In the phase III study, we demonstrated significantly greater HV increases in patients receiving Jintrolong treatment (from 2.26 ± 0.87 cm/year to 13.41 ± 3.72 cm/year) vs daily rhGH (from 2.25 ± 0.82 cm/year to 12.55 ± 2.99 cm/year) at the end of treatment (P < 0.05). Additionally, significantly greater improvement in the height standard deviation scores was associated with Jintrolong throughout the treatment (P < 0.05). Adverse event rates and treatment compliance were comparable between the two groups.

Conclusion

Jintrolong PEG-rhGH at a dose of 0.2 mg/kg/week for 25 weeks is effective and safe for GHD treatment and is non-inferior to daily rhGH.

Restricted access

Zhe Shen, Li Cen, Xufeng Chen, Jiaqi Pan, Youming Li, Weixing Chen and Chaohui Yu

Background

Non-alcoholic fatty liver disease (NAFLD) has been suggested to be a risk factor associated with low BMD (bone mineral density) in several cross-sectional studies. The present longitudinal cohort study aims to explore the effect of NAFLD and its severity on low BMD.

Methods

Between January 2013 and August 2018, individuals who participated in annual comprehensive health examinations were included. BMD was presented using dual-energy X-ray absorptiometry (DXA). These subjects were diagnosed with fatty liver by ultrasound detection.

Results

A total of 1720 subjects were included (1064 subjects with normal BMD and 656 subjects with low BMD) at baseline. Among the 1064 participants with normal BMD at baseline, 399 participants developed low BMD. The multivariable-adjusted hazard ratio for incident low BMD comparing the NAFLD group vs the non-NAFLD group was 2.24 (1.18, 2.81). Increased non-invasive fibrosis markers of NAFLD were positively associated with an increased incidence of low BMD in a graded manner. In addition, obese subjects and women with NAFLD at baseline are more likely to develop low BMD.

Conclusion

NAFLD and its severity were independently associated with an increased incidence of low BMD. Obesity and female gender are risk factors associated with low BMD. Our findings indicated NAFLD can be a significant contributor to low BMD pathogenesis, requiring further studies to elucidate the potential mechanisms.