Keywords
VigiAccess
Adverse reactions
Signal mining
Reporting odds ratio
Submitted : 2025-06-11
Accepted : 2025-06-26
Published : 2025-07-11
Abstract
Objective: This study aims to explore adverse events related to Technetium (Tc99m) Medronate using the VigiAccess database, uncover potential risk signals, and provide comprehensive reference for rational clinical drug use to ensure patient safety. Methods: The study retrieved adverse event reports related to Technetium (Tc99m) Medronate from the VigiAccess database, preprocessed the data, and employed the Reporting Odds Ratio (ROR) method to detect signals and analyze the characteristics and intensity of adverse events. Results: A total of 543 adverse event reports related to Technetium (Tc99m) Medronate were retrieved. The data showed that reports from female patients accounted for 48.62%, higher than the 26.15% from male patients, and the 18–64 age group had a higher proportion of reports at 52.89%. In terms of adverse event distribution, skin and subcutaneous tissue disorders accounted for 24.12%, general disorders and administration site conditions accounted for 21.68%, and nervous system disorders accounted for 14.83%. These three types of disorders were the most common adverse reactions during the use of Technetium (Tc99m) Medronate. Further ROR analysis revealed strong associations between Technetium (Tc99m) Medronate and adverse events such as product efficacy issues, vasodilation, and decreased therapeutic response. The ROR value for product efficacy issues was as high as 379.29 (95% CI: 180.18, 798.47), vasodilation was 60.75 (95% CI: 45.91, 80.51), and decreased therapeutic response was 36.35 (95% CI: 20.48, 64.81). Conclusion: This study analyzed adverse events related to Technetium (Tc99m) Medronate using the VigiAccess database, finding that female patients and the age group of 18 to 64 had a higher proportion. The related adverse events were mainly concentrated in skin and subcutaneous tissue disorders, general disorders and administration site conditions, and nervous system disorders. Adverse events such as product efficacy issues, vasodilation, and decreased therapeutic response were strongly associated with Technetium (Tc99m) Medronate, indicating the need for special attention to these adverse reactions in clinical use, strengthening drug monitoring and management to ensure patient safety, and providing important reference for clinicians in the rational use of Technetium (Tc99m) Medronate.
References
Shen S, Wang W, Yang C, et al., 2019, Effect of Technetium-99 Conjugated with Methylene Diphosphonate (99Tc-MDP) on OPG/RANKL/RANK System In Vitro. J Oral Pathol Med, 48(2): 129–135.
Shi L, Ning Y, Xu L, et al., 2018, Technetium-99 Conjugated with Methylene Diphosphonate Ameliorates Glucocorticoid Induced Osteoporosis by Inhibiting Osteoclastogenesis. Biomed Res Int, 2018: 7902760.
Fu Q, Feng P, Sun LY, et al., 2021, A Double-Blind, Double-Dummy, Randomized Controlled, Multicenter Trial of 99Tc-Methylene Diphosphonate in Patients with Moderate to Severe Rheumatoid Arthritis. Chin Med J (Engl), 134(12): 1457–1464.
Li Y, Cai M, Zhang R, et al., 2021, Investigating the Preventive Effects of 99Tc-Methylenediphosphonate on a Glucocorticoid-Induced Osteoporosis Rabbit Model. Curr Top Med Chem, 21(26): 2425–2433.
Deng G, Chen X, Shao L, et al., 2023, Effectiveness and Safety of 99Tc-Methylene Diphosphonate as a Disease-Modifying Anti-Rheumatic Drug (DMARD) in Combination with Conventional Synthetic (cs) DMARDs in the Treatment of Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of 34 Randomized Controlled Trials. Heliyon, 9(11): e21691.
Xie J, Yuan X, Mao W, et al., 2022, 99Tc-Methylene Diphosphonate Treatment is Safe and Efficacious for Osteoporosis in Postmenopausal Differentiated Thyroid Cancer Patients Undergoing TSH Suppression: A Three-Center Non-Randomized Clinical Study. Cancer Manag Res, 14: 995–1005.
Xu Y, Zhong Y, Zhao M, et al., 2018, Effects and Safety of 99Tc-MDP in Patients with Refractory Ankylosing Spondylitis: A 2-Stage (30-Week Follow-Up) Clinical Trial. Clin Exp Rheumatol, 36(3): 396–404.
Liu H, Guo H, Guo S, et al., 2019, Novel Treatment of 99Tc-MDP Improves Clinical and Radiographic Results for Patients with Osteochondral Lesions of the Talus. Q J Nucl Med Mol Imaging, 63(2): 199–206.
Chen J, Lan Y, He Y, et al., 2017, 99Tc-MDP-Induced Human Osteoblast Proliferation, Differentiation and Expression of Osteoprotegerin. Mol Med Rep, 16(2): 1801–1809.
Huang Z, Chen C, Tan L, et al., 2024, 16S rRNA Gene Sequencing of Gut Microbiota in Rheumatoid Arthritis Treated with 99Tc-MDP. Pharmgenomics Pers Med, 17: 237–249.