[A postmarketing surveillance study on 31,724 patients using Dengzhan Xixin injection in hospital].

Aim to explore the adverse drug reactions (ADR) characteristic and calculate the ADR incidence of Dengzhan Xixin injection (DZXX). A multicenter, large sample, and prospective cohort study was conducted from August 2012 to December 2014. A total of 31 724 patients using DZXX were observed. A total of 31 724 patients with 15 ADR cases among 31 724 patients, accounting for 0.06% , were reported. There were 8 male patients ADRs and 7 female patients with ADRs. ADRs included skin rashes, itching, headache, red face, abdominal pain, etc. 1 case with rhubarb radix scutellariae allergies. These ADRs happened from 5 min to within 0.5 h after DZXX were used to treat patients. ADR patients discontinued treatment, of which 2 patients used promethazine for recovery and improvement. There were 2 cases with different DZXX concentration, out of the normal range. DZXX injection could cause some ADRs. Users must not ignore these and be careful of its related side effects. This study was a cohort with large sample, which should produce strong evidence for clinical practice. However, there was still weak evidence to conclude that it was a safe Chinese medicine injection in clinical practice.