Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.

The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules

Time frame: 3 years

The incidence of new ADRs to the Qizhi Tongluo Capsules

Time frame: 3 years

The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules

Time frame: 3 years

Changes in biological indicators of patients with serious adverse events

Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for liver function (ALT, AST, ALP, TBIL, DBIL)

Time frame: 3 years

Changes in biological indicators of patients with serious adverse events

Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for renal function (BUN, SCr, UA)

Time frame: 3 years

Changes in biological indicators of patients with serious adverse events

Patients with serious adverse events and suspected unintended serious adverse reactions should be tested for immune indicators (IgA, IgE, T-lymphocyte, B lymphocyte, cell surface antigen, serum histamine concentration and complement).

Time frame: 3 years