title: [Post-marketing surveillance ofTanreqinginjection in children: a real world study].
abstract: Objective:To evaluate the safety ofTanreqinginjection among children in the real world.Methods:A 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 usingTanreqinginjection 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) ofTanreqinginjection. Univariate analysis was used to explain the risk factors of ADR.Results:The 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 theTanreqinginjection but all the ADR cases got improved or cured. Having histories of allergies to drugs or foods would increase the incidence of ADR.Conclusion:Tanreqinginjection caused low incidence of ADR in children. Progams as stratifying high-risk patients and improving administrative management could further increase the safety level ofTanreqinginjection.
authors.affiliation: Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China.
authors.forename: X X
authors.initials: XX
authors.lastname: Li
authors.affiliation: School of Public Health, Peking University, Beijing 100191, China.
authors.forename: L
authors.initials: L
authors.lastname: Zhuo
authors.affiliation: Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China.
authors.forename: Y H
authors.initials: YH
authors.lastname: Yang
authors.affiliation: School of Public Health, Peking University, Beijing 100191, China.
authors.forename: S Y
authors.initials: SY
authors.lastname: Zhan
authors.affiliation: Department of Pharmacy, Third Hospital, Peking University, Beijing 100191, China.
authors.forename: S D
authors.initials: SD
authors.lastname: Zhai
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002681:China; D015331:Cohort Studies; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007267:Injections / Q000009:adverse effects*; D008297:Male; D011358:Product Surveillance, Postmarketing; D012449:Safety; D012867:Skin / Q000187:drug effects
chemical_list: D004365:Drugs, Chinese Herbal; C540817:tanreqing
keywords: Children; Real world study; Safety monitoring; TCM injection