1 To investigate the incidence, manifestations, outcomes and risk factors of Tanreqing injection ADRs in real world clinical practice; 2 To describe the prescription patterns of Tanreqing injection in real world clinical practice

  • General Information of Study
    • Overview
      Name Post-marketing safety surveillance of the Tanreqing Injection: A real world study (TReQS)
      Project Number CCC2018062701
      Website https://clinicaltrials.gov/ct2/show/NCT02094638?term=tanreqing&rank=1
      Investigators
      Suodi Zhai
      Institutions Peking University Third Hospital
      Contacts
      Xiaoxiao Li
      Funding State Administration of Traditional Chinese Medicine of the People’s Republic of China, project number: 2013ZX04
      Objectives 1 To investigate the incidence, manifestations, outcomes and risk factors of Tanreqing injection ADRs in real world clinical practice; 2 To describe the prescription patterns of Tanreqing injection in real world clinical practice
      Start Date Jan. 2014
      End Date May 2015
    • Study Design
      Number of Participants 30322
      Age Range 0-99 years
      Geographic Distribution Over 6 areas, 27 provincial-level administrative regions
      General Information of Study Design and Sample Methods consecutive sample
      Inclusion Criteria Patients who use the Tanreqing Injection in selected hospitals in China, including inpatients and emergency patients.
      Exclusion Criteria None
    • Other Information
      Key Achievements TReQS was an ambispective, multicenter, pharmacist-led cohort study. A total of 30322 consecutive patients over 90 hospitals prescribed and administrated Tanreqing injection, including inpatients and emergency patients, were enrolled in this study. We discribed the prescription patterns of Tanreqing injection in real world clinical practice; and investigated the incidence, manifestations, outcomes and risk factors of Tanreqing injection ADRs.
      Marker Papers 1. Li Xiao-xiao, Zhuo Lin, Yang Yi-heng, Zhan Si-yan, Zhai Suo-di. Post-marketing surveillance of Tanreqing injection in children: a real world study. Chin J Epidemiol. 2017, 38(2): 248-252.
      Strength 1 We discribed the prescription patterns of Tanreqing injection in real world clinical practice; 2 We evaluated the safety of Tanreqing injection
      Weakness 1 Only some patients having TCM diagnosis;2 The classification of allergic reactions was missing