| アブストラクト | OBJECTIVE: To investigate safety signals associated with recombinant human growth hormone (rhGH) using the FDA Adverse Event Reporting System (FAERS) and make recommendations for its application. BACKGROUND: rhGH is widely used in the management of pediatric growth disorders, but a comprehensive evaluation of its safety in pediatric populations is limited. MATERIALS AND METHODS: Adverse event (AE) reports involving patients under 18 years of age where rhGH was the primary suspect (PS) drug were retrieved from the FAERS database for the period beginning the first quarter of 2004 to the end of the third quarter of 2024. The reports were standardized and duplicate reports removed. Disproportionality analysis of AE signals was conducted using four complementary methods, namely i) reporting odds ratio (ROR), ii) proportional reporting ratio (PRR), iii) Bayesian confidence propagation neural network (BCPNN), and iv) empirical Bayesian geometric mean (EBGM). RESULTS: A total of 33,888 AE reports were retrieved and analyzed. Disproportionality analysis identified 167 positive signals across 19 System Organ Classes (SOCs), the most frequently of which was "Investigations," and the most common preferred term (PT) was "Arthralgia". In addition to confirmed AEs, several endocrine-related signals were also recognized including a) fluctuations in thyroid-stimulating hormone, b) increase in unbound concentrations of thyroxine, c) type 1 diabetes mellitus, d) low concentrations of high-density lipoprotein, and e) abnormal body odor. CONCLUSION: A comprehensive safety profile was established for rhGH when used in pediatric populations and comprising several newly identified potential AE signals. The findings underscore the importance of surveillance to mitigate risks and ensure the safe clinical use of rhGH. |
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