The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China

Abstract

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.

Effects and safety of Tanreqing injection on viral pneumonia: Retraction

“…[ 8 , 9 ] In the diagnosis and treatment of new type of coronavirus pneumonia in China, it has been recommended to use Tanreqing Injection for adjuvant treatment for patients with systemic inflammatory response syndrome or / multiple organ failure. [ 10 ] Three systematic reviews of Tanreqing Injection in the treatment of viral pneumonia were published in 2012, 2014 and 2015, all confirming the effectiveness of Tanreqing Injection in the treatment of viral pneumonia, [ 11 , 12 ] but whether Reducing mortality in patients with viral pneumonia is controversial.…”

Urgent Hospital Admissions Caused by Adverse Drug Reactions and Medication Errors—A Population-Based Study in Spain

“…Moreover, this study does not provide data on the incidence of ADR-caused hospital admissions. On the other hand, some recent studies evaluate the incidence and risk factors of ADR attended in the emergency department that are related to a specific drug, such as Tanreqing injection, a traditional Chinese medicine commonly used in China (Li et al, 2020). This study is not comparable to ours, which provides much more general data that can be more easily extrapolated to the general population.…”

Clinical Progress on Management of Pneumonia Due to COVID-19 With Chinese Traditional Patent Medicines

“…Among these patients, two thirds of them can be treated with externally used drugs. Increased adverse reactions were related to history of food allergy [odds ratio (Lai et al ) 4.50, 95% CI: 1.35–15.00], drug allergy (OR 2.77, 95% CI: 1.56–4.94), and rapid infusion of these products (OR 2.10, 95% CI: 1.27–3.50) ( Li XX. et al, 2019 ).…”