Clinical Epidemiology
Post-marketing surveillance of Tanreqing injection in children: a real world study
Xiaoxiao Li, Lin Zhuo, Yiheng Yang, Siyan Zhan, Suodi Zhai
Published 2017-02-10
Cite as Chin J Epidemiol, 2017, 38(2): 248-252. DOI: 10.3760/cma.j.issn.0254-6450.2017.02.023
Abstract
ObjectiveTo evaluate the safety of Tanreqing injection among children in the real world.
MethodsA multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection. Univariate analysis was used to explain the risk factors of ADR.
ResultsThe overall incidence of ADE was 4.20‰ (26 cases), including 4 serious ones. The incidence of ADR was 3.07‰ (19 cases), including 17 cases of general ADR and 2 cases of new ADR. All the ADR cases were mild or moderate, mostly showing damages in skin and appendages. The onset of disease happened in 24 hours after the Tanreqing injection but all the ADR cases got improved or cured. Having histories of allergies to drugs or foods would increase the incidence of ADR.
ConclusionTanreqing injection caused low incidence of ADR in children. Progams as stratifying high-risk patients and improving administrative management could further increase the safety level of Tanreqing injection.
Key words:
TCM injection; Safety monitoring; Real world study; Children
Contributor Information
Xiaoxiao Li
Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China
Lin Zhuo
School of Public Health, Peking University, Beijing 100191, China
Yiheng Yang
Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China
Siyan Zhan
School of Public Health, Peking University, Beijing 100191, China
Suodi Zhai
Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China
