The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China
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, a...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2020-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2019.01523/full |
| _version_ | 1818270608792748032 |
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| author | Xiao-Xiao Li Xiao-Xiao Li Lin Zhuo Lin Zhuo Yan Zhang Yi-Heng Yang Hong Zhang Si-Yan Zhan Si-Yan Zhan Suo-Di Zhai Suo-Di Zhai |
| author_facet | Xiao-Xiao Li Xiao-Xiao Li Lin Zhuo Lin Zhuo Yan Zhang Yi-Heng Yang Hong Zhang Si-Yan Zhan Si-Yan Zhan Suo-Di Zhai Suo-Di Zhai |
| author_sort | Xiao-Xiao Li |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-12T21:12:59Z |
| format | Article |
| id | doaj.art-5a858d50bc504b2b86f43de414499b51 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-12T21:12:59Z |
| publishDate | 2020-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-5a858d50bc504b2b86f43de414499b512022-12-22T00:11:50ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122020-01-011010.3389/fphar.2019.01523476387The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in ChinaXiao-Xiao Li0Xiao-Xiao Li1Lin Zhuo2Lin Zhuo3Yan Zhang4Yi-Heng Yang5Hong Zhang6Si-Yan Zhan7Si-Yan Zhan8Suo-Di Zhai9Suo-Di Zhai10Department of Pharmacy, Peking University Third Hospital, Beijing, ChinaDepartment of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, ChinaResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaTechnology and Development Center for TCM of China, State Administration of Traditional Chinese Medicine of the People’s Republic of China, Beijing, ChinaDepartment of Pharmacy, Peking University Third Hospital, Beijing, ChinaTechnology and Development Center for TCM of China, State Administration of Traditional Chinese Medicine of the People’s Republic of China, Beijing, ChinaResearch Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, ChinaDepartment of Pharmacy, Peking University Third Hospital, Beijing, ChinaDepartment of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Beijing, ChinaBackground: 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.https://www.frontiersin.org/article/10.3389/fphar.2019.01523/fulldrug safetyadverse drug reactionspharmacovigilanceanaphylaxistraditional Chinese medicineoff-label |
| spellingShingle | Xiao-Xiao Li Xiao-Xiao Li Lin Zhuo Lin Zhuo Yan Zhang Yi-Heng Yang Hong Zhang Si-Yan Zhan Si-Yan Zhan Suo-Di Zhai Suo-Di Zhai The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China Frontiers in Pharmacology drug safety adverse drug reactions pharmacovigilance anaphylaxis traditional Chinese medicine off-label |
| title | The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China |
| title_full | The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China |
| title_fullStr | The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China |
| title_full_unstemmed | The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China |
| title_short | The Incidence and Risk Factors for Adverse Drug Reactions Related to Tanreqing Injection: A Large Population-Based Study in China |
| title_sort | incidence and risk factors for adverse drug reactions related to tanreqing injection a large population based study in china |
| topic | drug safety adverse drug reactions pharmacovigilance anaphylaxis traditional Chinese medicine off-label |
| url | https://www.frontiersin.org/article/10.3389/fphar.2019.01523/full |
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