Xu Xiaolin, Wang Luquan, Yang Mengyang, Li Yan, Yang Changqing, Mei Dong, Guo Peng, Mao Huawei
Department of Immunity, Beijing Children's Hospital, National Center for Children's Health, Capital Medical University, Beijing, China.
Department of Pharmacy, Beijing Children's Hospital, National Center for Children's Health, Capital Medical University, Beijing, China.
Front Pediatr. 2025 Jul 7;13:1571381. doi: 10.3389/fped.2025.1571381. eCollection 2025.
The prevalence of glucocorticoids (GCs) administration in pediatric populations has resulted in numerous adverse reactions, notably osteoporosis. Given its role in managing glucocorticoid-induced osteoporosis, the efficacy and safety of bisphosphonates hold considerable importance. This study conducted a meta-analysis by systematically reviewing and incorporating relevant literature on the efficacy and safety of bisphosphonates in the management of osteoporosis or bone infarction induced by GCs therapy in pediatric populations. Additionally, the analysis of potential adverse reactions was augmented by utilizing real-world data from the FAERS database. The primary objective of this study is to offer insights and guidance for the treatment of glucocorticoid induced osteoporosis in pediatric patients.
A meta-analysis was performed on existing literature to assess the efficacy and safety of bisphosphonates for managing glucocorticoid-induced osteoporosis. Additionally, a retrospective pharmacovigilances study was carried out to investigate adverse reactions and medication variations in pediatric patients with glucocorticoid-induced osteoporosis, using data from the FDA Adverse Event Reporting System (FAERS) database between Q1 2004 and Q4 2023.
The meta-analysis incorporated a total of 14 articles encompassing 572 patients. The findings of this study indicate that bisphosphonate therapy is more effective in enhancing bone mineral density (BMD) and BMD -scores in children compared to the control group, albeit with a heightened risk of adverse reactions. Furthermore, there was no significant disparity observed between the impact of bisphosphonate treatment and control groups on fracture outcomes. Subsequently, in the ensuing Pharmacovigilance investigation, 668 instances of adverse reactions associated with bisphosphonates are analyzed. The findings indicated that the most prevalent adverse reactions, as evidenced by the highest number of positive signals were various examinations, musculoskeletal and connective tissue diseases, injuries, poisoning and operational complications, as well as systemic diseases and reactions at the administration site.
This study conducted a comprehensive analysis of the efficacy and safety of bisphosphonates in the treatment of osteoporosis caused by GCs use in pediatric patients, laying the groundwork for future research. Nevertheless, the constraints of retrospective studies highlight the need for additional investigation through prospective studies.
糖皮质激素（GCs）在儿科人群中的广泛使用已导致众多不良反应，尤其是骨质疏松症。鉴于双膦酸盐在治疗糖皮质激素诱导的骨质疏松症中的作用，其疗效和安全性具有重要意义。本研究通过系统回顾和纳入关于双膦酸盐在治疗儿科人群中糖皮质激素治疗引起的骨质疏松症或骨梗死的疗效和安全性的相关文献进行荟萃分析。此外，通过利用来自FAERS数据库的真实世界数据加强了对潜在不良反应的分析。本研究的主要目的是为儿科患者糖皮质激素诱导的骨质疏松症的治疗提供见解和指导。
对现有文献进行荟萃分析，以评估双膦酸盐治疗糖皮质激素诱导的骨质疏松症的疗效和安全性。此外，进行了一项回顾性药物警戒研究，使用2004年第一季度至2023年第四季度期间FDA不良事件报告系统（FAERS）数据库中的数据，调查糖皮质激素诱导的骨质疏松症儿科患者的不良反应和用药差异。
荟萃分析共纳入14篇文章，涉及572例患者。本研究结果表明，与对照组相比，双膦酸盐治疗在提高儿童骨密度（BMD）和BMD评分方面更有效，尽管不良反应风险更高。此外，双膦酸盐治疗组和对照组对骨折结局的影响没有显著差异。随后，在随后的药物警戒调查中，分析了668例与双膦酸盐相关的不良反应病例。结果表明，阳性信号数量最多的最常见不良反应是各种检查、肌肉骨骼和结缔组织疾病、损伤、中毒和操作并发症，以及全身性疾病和给药部位反应。
本研究对双膦酸盐治疗儿科患者糖皮质激素使用引起的骨质疏松症的疗效和安全性进行了全面分析，为未来研究奠定了基础。然而，回顾性研究的局限性突出了通过前瞻性研究进行进一步调查的必要性。
