Abstract: Objective To explore the influencing factors of suspected allergic reactions caused by Ciwujia injection in the real world and to guide safe clinical medication. Methods Retrospective analysis was conducted of the data on inpatients who had used Ciwujia injection in the hospital information system (HIS) of 24 large tertiary hospitals in China between 2006 and 2014. Patients who discontinued Ciwujia injection within 24 hours of the first use and switched to loratadine, desloratadine, promethazine and dexamethasone within 24 hours of the first use were regarded as suspected cases of allergic reactions. A total of 93 cases were collected. Logistic regression analysis was used to explore the correlation between the information about comorbidities, combinations of drugs, single doses and the incidence of suspected allergic reactions. Results Data analysis found that the use of vitamin C or glycerin combined with Ciwujia injection could increase the chance of suspected allergic reactions. The combination of Ciwujia injection with isosorbide mononitrate, Huayu Tongmai traditional Chinese medicine preparation, nifedipine and its analogues, insulin for injection and its analogues, metoprolol, acetylsalicylic acid preparation and furosemide had no significant effect on the occurrence of suspected allergic reactions caused by Ciwujia injection. Comorbidities and single doses were not risk factors for suspected allergic reactions. Conclusion Ciwujia injection should not be combined with vitamin C or glycerin clinically to minimize the risk of suspected allergic reactions.

Key words: Ciwujia injection, prescription sequence analysis, nested case control study, allergic reactions, the real world