Real-world Clinical Study of Recombinant Human Growth Hormone in the Treatment of Idiopathic Short Stature

Objective: To investigate the clinical efficacy and safety evaluation of Polyethylene Glycol Recombinant Human Growth Hormone Injection (PEG-rhGH) in the treatment of idiopathic short stature. Methods: A total of 1402 patients were enrolled from March 21, 2024 to January 13, 2025, including 778 males and 624 females, with ages mainly ranging from 5 to 13 years old. Follow-up visits were completed by 488 patients for the first time, 174 patients for the second time, and 81 patients for the third time. All patients were treated with PEG-rhGH (Jin Sai Zeng) as the main therapy after admission. The changes in height information, IGF-1, and thyroid examination results of each patient at the initial diagnosis, 6, 9, and 12 months after treatment were observed and analyzed. Results: There was no statistical difference between the baseline and the initial diagnosis, as well as the second follow-up visit (P < 0.05), while there was a statistical difference between the baseline and the first and third follow-up visits (P > 0.05). There was a statistically significant difference in IGF-1 between the initial diagnosis and the first follow-up visit (P < 0.05), but no statistical difference between the first, second, and third follow-up visits (P > 0.05). Additionally, IGF-1 levels increased with time. There was no statistical difference in TSH between the initial diagnosis and the first, second, and third follow-up visits (P > 0.05). There was a statistical difference in free T3 between the initial diagnosis and the first and second follow-up visits (P<0.05), but no statistical difference between the second and third follow-up visits (P>0.05). There was no statistical difference in free T4 between the initial diagnosis and the first and second follow-up visits (P > 0.05), but there was a statistical difference between the second and third follow-up visits (P < 0.05). Conclusion: PEG-rhGH (Jin Sai Zeng) is significantly effective in improving height and IGF-1 levels in patients with idiopathic short stature.