| ABSTRACT Objective:To assess relevant factors of ADR/ADE of Traditional Chinese Medicine Injections through ADR/ADE reports and promote rational drug use. Methods:369 ADR/ADE cases induced by traditional Chinese medicine injections collected by the ADR drugs monitoring center in our hospital from 2010 to 2016 were analyzed. The patients’ sex, age, allergic history, suspected drugs, clinical manifestation, type, relevance evaluation and outcome were recorded, the suitability of traditional Chinese medicine injections in the ADR/ADE cases were evaluated.Results: In the total 369 ADR/ADE cases, patients over the age of 61 years were prone to have ADR/ADE, accounting for 57.45%. There were 31 cases with history of drug allergy. The 369 ADR/ADE cases were related to 33 kinds of traditional Chinese medicine injections. Of them, the drug caused most ADR/ADE was Huachansu injection. The main consequences of these ADR/ADE cases involved following damages: skin and its accessories damage(23.9%), medical site damage (21.7%) and nervous system damage (12.0%). In all cases, there were 38 patients with no existing reasonable drug application with the indication and 11 patient with overdose.Conclusion: The contributing factors of the ADR/ADE included patients individual differences, medicines themselves and clinical application. Only through standarding the clinical rational drug use and clinical rational drug use could patient’s safe medication be ensured. |
