Abstract: Objective To study the adverse reaction incidence, clinical manifestation and nature of organ involvement of Qingkailing injection, evaluate the safety of clinical usage of Qingkailing injection, offer references for rational application in clinical practice. Methods The multi-center, drug-induced and non-controlled intensive hospital monitoring was conducted. Results The rate of Qingkailing injection adverse reaction is 0.086%.Although many systems of the patients were involved, the symptoms of Qingkailing injection adverse reactions were mild, which were improved or disappeared quickly after drug withdrawal. Conclusion The adverse reactions of Qingkailing injection are rare, and consistent with its specification. Large-scale hospital monitoring is the main method of safety re-evaluation, which can reflect the real situation of clinical application, thus ensure the safety of drug use.

Key words: Qingkailing injection, adverse reaction, intensive hospital monitoring, post-market re-evaluation of clinical safety