Abstract: Objective To study the reliable incidence and occurrence characteristics of the cutaneous adverse reaction and anaphylactic reaction and anaphylactic shock caused by cinepazide maleate, so as to provide reference information for clinic. Methods The adverse drug events' active surveillance and assessment system, on cutaneous allergy reaction module and anaphylactic shock module, was used to automatic surveillance for the hospitalized patients in General Hospital of PLA who received cinepazide maleate between January 2015 and December 2016. Suspected cases submitted by system were evaluated by professionals to obtain the incidence and occurrence characteristics. The risk factors were analysed by nested case-control study. Results A total of 11 052 patients using cinepazide maleate were retrospectively surveilled, 15 cases of cutaneous adverse reaction and its incidence was 0.14%, while 2 cases of anaphylactic reaction and its incidence was 0.018%, no severe cutaneous adverse reaction or anaphylactic shock was surveilled. Risk factor analysis indicated there was no significant statistical difference in age, gender, BMI, allergic history and severe diseases between positive group and matched group. Conclusion The incidence of cutaneous adverse reaction and anaphylactic reaction induced by cinepazide maleate were in occasional and rare ranges, respectively, and the symptoms are mild. The application of special software greatly improves the efficiency of text information research.

Key words: cinepazide maleate, adverse drug reactions, natural language processing, automatic surveillance