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Related Experiment Videos

[Security revaluation study based on nested case-control method of Danhong injection].

Chun-Xiao Li1, Jin-Fa Tang, Fei Meng

  • 1The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China. Lichunxiao@126.com

Zhongguo Zhong Yao Za Zhi = Zhongguo Zhongyao Zazhi = China Journal of Chinese Materia Medica
|January 5, 2013
PubMed
Summary
This summary is machine-generated.

This study investigated risk factors for adverse drug reactions (ADRs) and adverse drug events (ADEs) associated with Danhong injection. Female patients and those with a personal allergy history are at higher risk.

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Area of Science:

  • Pharmacovigilance
  • Traditional Chinese Medicine
  • Drug Safety

Background:

  • Danhong injection is a widely used Traditional Chinese Medicine (TCM) formulation.
  • Understanding its safety profile, including adverse drug reactions (ADRs) and adverse drug events (ADEs), is crucial for clinical practice.
  • Previous studies have not fully elucidated the influencing factors of Danhong injection-related ADRs/ADEs.

Purpose of the Study:

  • To re-evaluate the safety of Danhong injection.
  • To identify key factors influencing the occurrence of ADRs/ADEs associated with Danhong injection.

Main Methods:

  • A retrospective nested case-control study was conducted.
  • A cohort of 8,452 patients receiving Danhong injection was analyzed.
  • Case (52 patients with ADRs/ADEs) and control (208 patients) groups were matched to identify influencing factors.

Main Results:

  • Univariate analysis identified gender, personal allergy history, and medication duration as significant factors.
  • Multivariate logistic regression confirmed gender and personal allergy history as independent risk factors.
  • Medication duration was significant in individual matching but not in multivariate analysis.

Conclusions:

  • Gender and personal allergy history are significant influencing factors for Danhong injection-related ADRs/ADEs.
  • Healthcare providers should exercise caution and pay special attention to female patients and individuals with a history of allergies.
  • Further research may explore specific mechanisms underlying these associations.