Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study

Suodi ZHAI

Status: Completed

Conditions: Adverse Drug Reaction; Drug Allergy

Study type: Observational

Funder types: Other

Identifiers

NCT02094638

PekingUTH-Pharmacy-003

Details and patient eligibility

About

Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.

Full description

As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.

Enrollment: 30,400 estimated patients

Sex: All

Ages: 24+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient.
• Outpatients will be only in some hospitals which can get the patients' complete information.

Exclusion criteria

• Patients who are less than 24 months.

Trial design

30,400 participants in 1 patient group

Tanreqing

Description:

Inpatient using the Tanreqing Injection