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Updated: Jul 3, 2026

Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
11:17

Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays

Published on: January 7, 2016

Recombinant human growth hormone in pediatric patients using the FAERS database: Safety profile and update for the

Lidan Tu, Huafeng Jiang, Jianming Liu

    International Journal of Clinical Pharmacology and Therapeutics
    |July 2, 2026
    PubMed

    Insights

    This study analyzed FDA Adverse Event Reporting System data to identify safety signals for recombinant human growth hormone (rhGH) in pediatric patients. Findings highlight potential endocrine-related adverse events, emphasizing the need for ongoing safety surveillance.

    Area of Science:

    • Pharmacovigilance and drug safety research.
    • Pediatric endocrinology and growth disorders.

    Background:

    • Recombinant human growth hormone (rhGH) is a key treatment for pediatric growth disorders.
    • Limited comprehensive safety data exists for rhGH in pediatric populations.

    Purpose of the Study:

    • To investigate safety signals of rhGH in pediatric patients using FAERS data.
    • To establish a comprehensive safety profile and recommend clinical applications.

    Main Methods:

    • Retrieved and analyzed 33,888 AE reports from FAERS (2004-2024) for pediatric rhGH use.
    • Standardized reports and removed duplicates.
    • Employed four disproportionality analyses: ROR, PRR, BCPNN, EBGM.

    Main Results:

    • Identified 167 positive AE signals across 19 System Organ Classes.
    • Most frequent SOC: "Investigations"; most common PT: "Arthralgia".
    • Detected potential endocrine signals: thyroid hormone fluctuations, type 1 diabetes, dyslipidemia, abnormal body odor.

    Conclusions:

    • Established a comprehensive safety profile for pediatric rhGH use.
    • Identified several novel potential adverse event signals.
    • Underscored the importance of pharmacovigilance for safe rhGH clinical application.
    Abstract

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