PMID- 31998127
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200929
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 10
DP  - 2019
TI  - The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing 
      Injection: A Large Population-Based Study in China.
PG  - 1523
LID - 10.3389/fphar.2019.01523 [doi]
LID - 1523
AB  - Background: Tanreqing injection (TRQ) is a traditional Chinese medicine commonly 
      used in China to treat pulmonary diseases presenting as phlegm-heat syndrome. 
      Robust data on the safety of TRQ from real-world observational cohorts are 
      currently lacking. Objective: To evaluate as the incidence, type, and predictors 
      of adverse events (AEs) and adverse drug reactions (ADRs) of TRQ in clinical 
      practice in China. Methods: We conducted a population-based cohort, multicenter 
      study to evaluate the incidence, manifestation, outcomes, and risk factors of AEs 
      and ADRs following TRQ use in China. Between April 2014 and May 2015 a total of 
      30,322 consecutive inpatients/emergency attendance patients from 90 hospitals 
      across China administrated TRQ were followed-up for 7 days. Odds ratios (ORs) 
      with 95% confidence intervals (CIs) were estimated using logistic regression to 
      identify predictors of ADRs. Results: The incidence of AEs and ADRs was 1.4 and 
      0.3%, respectively. Skin and subcutaneous tissue disorders were the most common 
      ADRs. All ADRs were mild or moderate in severity, except for one serious case of 
      anaphylactic reaction. The majority of ADRs (72.8%) occurred in the first 2 h 
      after TRQ administration. Two-thirds of patients (66.1%) in the study were 
      prescribed TRQ off-label, including infants aged </=24 months. A history of food 
      allergy (OR 4.50, 95% CI: 1.35-15.00), drug allergy (OR 2.77, 95% CI: 1.56-4.94), 
      and fast infusion speed (off-label use) (OR 2.10, 95% CI: 1.27-3.50) were 
      associated with an increased risk of ADRs. Conclusion: TRQ is well tolerated in 
      the general population, yet off-label use is prevalent. Efforts are required to 
      educate prescribers to adhere to the drug label in order to minimize potential 
      patient harm.
CI  - Copyright (c) 2020 Li, Zhuo, Zhang, Yang, Zhang, Zhan and Zhai.
FAU - Li, Xiao-Xiao
AU  - Li XX
AD  - Department of Pharmacy, Peking University Third Hospital, Beijing, China.
AD  - Department of Pharmacy Administration and Clinical Pharmacy, School of 
      Pharmaceutical Sciences, Peking University, Beijing, China.
FAU - Zhuo, Lin
AU  - Zhuo L
AD  - Research Center of Clinical Epidemiology, Peking University Third Hospital, 
      Beijing, China.
AD  - Department of Epidemiology and Biostatistics, School of Public Health, Peking 
      University, Beijing, China.
FAU - Zhang, Yan
AU  - Zhang Y
AD  - Technology and Development Center for TCM of China, State Administration of 
      Traditional Chinese Medicine of the People's Republic of China, Beijing, China.
FAU - Yang, Yi-Heng
AU  - Yang YH
AD  - Department of Pharmacy, Peking University Third Hospital, Beijing, China.
FAU - Zhang, Hong
AU  - Zhang H
AD  - Technology and Development Center for TCM of China, State Administration of 
      Traditional Chinese Medicine of the People's Republic of China, Beijing, China.
FAU - Zhan, Si-Yan
AU  - Zhan SY
AD  - Research Center of Clinical Epidemiology, Peking University Third Hospital, 
      Beijing, China.
AD  - Department of Epidemiology and Biostatistics, School of Public Health, Peking 
      University, Beijing, China.
FAU - Zhai, Suo-Di
AU  - Zhai SD
AD  - Department of Pharmacy, Peking University Third Hospital, Beijing, China.
AD  - Department of Pharmacy Administration and Clinical Pharmacy, School of 
      Pharmaceutical Sciences, Peking University, Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20200109
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC6962140
OTO - NOTNLM
OT  - adverse drug reactions
OT  - anaphylaxis
OT  - drug safety
OT  - off-label
OT  - pharmacovigilance
OT  - traditional Chinese medicine
EDAT- 2020/01/31 06:00
MHDA- 2020/01/31 06:01
PMCR- 2020/01/09
CRDT- 2020/01/31 06:00
PHST- 2019/06/11 00:00 [received]
PHST- 2019/11/25 00:00 [accepted]
PHST- 2020/01/31 06:00 [entrez]
PHST- 2020/01/31 06:00 [pubmed]
PHST- 2020/01/31 06:01 [medline]
PHST- 2020/01/09 00:00 [pmc-release]
AID - 10.3389/fphar.2019.01523 [doi]
PST - epublish
SO  - Front Pharmacol. 2020 Jan 9;10:1523. doi: 10.3389/fphar.2019.01523. eCollection 
      2019.