Visualization of Real-World Adverse Drug Reaction Based on a Traditional Chinese Medicine Preparation as Empirical Evidence

doi:10.19803/j.1672-8629.20260022

Abstract

Abstract: Objective To visualize the characteristics of and relationships between adverse drug reactions (ADR) so as to provide methodological support for revision of package inserts of drugs, safety research, and safe medication. Methods Different analytic methods for information visualization were used to display the distribution of and correlations between ADR based on 1 898 adverse reaction reports of a preparation from reports collected in Shandong Province in 2020-2024. Results As confirmed by multiple visualization maps and indicators, ADR fell into four types. Gastrointestinal ADR were the core cluster. The intragroup connections between ADR were much stronger than the intergroup ones. Allergic, neurological, and cardiovascular ADR were peripheral clusters around the core cluster. “Hepatic dysfunction” was independent of any cluster that required special attention. Conclusion Marketing authorization holders should strengthen proactive collection of ADR reports and signal detection for “hepatic dysfunction”, and conduct safety research on unexpected ADR in “neurological” and “cardiovascular” groups to improve the instructions about ADR in drugs' package inserts. Medical institutions can prevent and treat ADR according to their characteristics displayed in visualization maps.

Key words: Traditional Chinese Medicine Preparation, Hepatic Dysfunction, Neurological, Cardiovascular, Adverse Drug Reaction, Information Visualization, Real-World

CLC Number:

R994.11
R282

WEI Wei, QUAN Qinbo, WANG Linghua, TIAN Yuejie, HUANG Lin, LI Na, WANG Weibo. Visualization of Real-World Adverse Drug Reaction Based on a Traditional Chinese Medicine Preparation as Empirical Evidence[J]. Chinese Journal of Pharmacovigilance, 2026, 23(5): 564-568.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20260022

https://zgywjj.magtechjournal.com/EN/Y2026/V23/I5/564

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