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[Post-marketing surveillance of Tanreqing injection in children: a real world study]

X X Li1, L Zhuo2, Y H Yang1

  • 1Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China.

Zhonghua Liu Xing Bing Xue Za Zhi = Zhonghua Liuxingbingxue Zazhi
|February 24, 2017
PubMed

Insights

Tanreqing injection demonstrated a low incidence of adverse drug reactions (ADRs) in children, with most cases being mild. Allergy history increases ADR risk, but further safety measures can enhance its use.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety Monitoring
  • Clinical Epidemiology

Background:

  • Tanreqing injection is used in pediatric care.
  • Real-world safety data for Tanreqing injection in children is limited.

Purpose of the Study:

  • To evaluate the real-world safety and incidence of adverse drug reactions (ADRs) and adverse drug events (ADEs) associated with Tanreqing injection in pediatric patients.

Main Methods:

  • A multicenter, ambispective cohort study involving 6,188 pediatric patients (≤14 years) across 59 hospitals in China.
  • Clinical safety monitoring was conducted from January 2014 to May 2015.
  • Univariate analysis identified risk factors for ADRs.

Main Results:

  • The overall incidence of ADEs was 4.20‰ (26 cases), with 4 serious events.
  • The incidence of ADRs was 3.07‰ (19 cases), all mild or moderate, primarily affecting skin and appendages.
  • Patients with a history of drug or food allergies had an increased incidence of ADRs.

Conclusions:

  • Tanreqing injection exhibits a low incidence of ADRs in the pediatric population.
  • Stratifying high-risk patients and enhancing administrative management can further improve the safety profile of Tanreqing injection in children.

Keywords:
ChildrenReal world studySafety monitoringTCM injection

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